Administrative Orders

Animal Industry AO #95 series of 1990

Hiring Of Veterinarians As Consultants Of Commercial
Feed Manufacturers Producing Medicated Feeds.

Republic of the Philippines

DEPARTMENT OF AGRICULTURE

Elliptical Road, Diliman, QC

19 July 1990

ANIMAL INDUSTRY

ADMINISTRATIVE ORDER   )

No. ____95_____________ )

Series of 1990                         )

SUBJECT : HIRING OF VETERINARIANS AS CONSULTANTS OF COMMERCIAL FEED

                      MANUFACTURERS PRODUCING MEDICATED FEEDS.

Pursuant to the provisions of R.A. 1556 as amended, (otherwise known as The Livestock and Poultry Feeds Act) and to ensure production of quality MEDICATED-FEEDS that do not produce residues, in meat, milk and eggs, Commercial ad Feed Manufacturers are hereby directed to hire VETERINARIANS as their consultants for the manufacture of medicated feeds.

This order, shall take effect upon approval and strict compliance is hereby enjoined.

APPROVED ON _____________August 8, 1990.

 

 

 

(Sgd.) SENEN C. BACANI

     Secretary

Recommended by:

(Sgd.) ROMEO N. ALCASID

Director

Bureau of Animal Industry

DA AO #40 and DOH AO #111-C series of 1990

Rules And Regulations On Dispensing Of Veterinary
Drugs And Products

August 30, 1991

 

DEPARTMENT OF AGRICULTURE

Administrative Order No. 40

Series 1990

 

DEPARTMENT OF HEALTH

Administrative Order No. 111-C

Series 1990

 

 

SUBJECT:   RULES AND REGULATIONS ON DISPENSING OF VETERINARY DRUGS AND

                      PRODUCTS

 

 

Pursuant to R.A. No. 3720, as amended by Executive Order No. 175 otherwise known as the �Foods, Drugs and Devices and Cosmetics�, R.A. No. 6675, otherwise known as the �Generics Act of 1988�, R.A. 382 known as the �Veterinary Practice Act�, R.A. 5921 known as the �Pharmacy Act�, R.A. 6425 known as the �Dangerous Drugs Act 1972�, as amended R.A. 1556, otherwise known as the �Livestock and Poultry Feeds Act�, R.A. 1071, an Act to regulate the sale of veterinary biologics and medicinal preparation and R.A. 3101, an Act authorizing the Director of the Bureau of Animal Industry, subject to the approval of the Secretary of Agriculture and Natural Resources to promulgate regulations for the preparation, sale, traffic in, shipment and importation of viruses, sera, toxins or analogous products used for the treatment of domestic animals, the following are hereby promulgated for the information guidance and compliance of all concerned:

 

Section 1. DEFINITION OF TERMS

 

1.1    �Dispensing� refers to the act by a duly-licensed pharmacist or veterinarians of filling a veterinary prescription or veterinary drug order.

 

1.2      �Generic Dispensing� refers to dispensing the client�s�/buyer�s choice from among generic equivalents.

 

1.3     �Partial Filling of Veterinary Prescription or Veterinary Drug Order (VDO)� refers to dispensing less than the total number of units prescribed.

 

1.4    �Veterinary Drug and Product Outlet� refers to drugstore, pharmacy or other business establishment registered with Bureau of Food and Drugs (BFAD) Bureau of Animal Industry (BAI) which dispenses or sells veterinary drugs and products.

 

Section 2. GUIDELINES ON DISPENSING BASED ON PRIOR LAWS

 

Prior to the Generics Act of 1988, the following general guidelines on dispensing have been operative. In order to have an integrated implementation of all relevant guidelines on dispensing these guidelines based on prior laws are restated hereunder.

 

2.1 �Veterinary Presentation or Ethical Drugs� refer to any drug preparation that is to be dispensed only upon written order of a duly-licensed veterinarian for the treatment of a condition or a diagnosed disease of animals.

 

2.2 Non-Prescription or Over-the-Counter (OTC) or Self-Service (SS) Veterinary Drugs� refer to drug preparations that can be approved for animal use and even without the written order of a duly-licensed veterinarian.

 

2.3 All prescriptions for veterinary prescription or ethical drugs in a drug outlet shall be kept in file for two (2) years and recorded in a prescription book duly-registered BFAD which shall open for inspection to Food and Drug Inspectors and Biological and Feed Product Inspectors at any time during business hours of the outlet. The prescription book shall be kept for two (2) years after the last entry.

 

Section 3. ADDITIONAL GUIDELINES ON DISPENSING TO IMPLEMENT THE GENERICS ACT OF 1988

 

In addition to the guidelines contained in Section 2, the following shall specifically guide dispensing under the Generics Act of 1988;

 

3.1 All veterinary drug and product outlets are required to practice generic dispensing as defined in Section 1.2 of these Rules and Regulations, with some exceptions, modifications or qualification in certain cases or circumstance, as described in Section 3.2 and 3.4

 

3.1.1 Veterinary Drug and Product Outlets as defined in Chapter II of Administrative Order No. __ Regulations for Licensing of Veterinary Drug and Product Establishments and Outlets.

 

In order to ensure the informed choice and use of veterinary drugs and products by the client/buyer, the veterinary drug and product outlets is required to:

 

3.1.1.1 Inform the client/buyer of all available veterinary drugs and products generically equivalent to the one prescribed with their corresponding prices.

 

3.1.1.2 For this purpose, all veterinary drug and product outlets shall post in a conspicuous place in their establishment a list of veterinary drugs and products using generic names with their brand names, if any, and their corresponding current prices. A handbook or directory containing the above required information, readily accessible to the client/buyer shall be considered substantial compliance.

 

3.2 Recognizing the special needs and circumstances of veterinary clinics, veterinary hospitals and farms, they shall be allowed to maintain veterinary drug and product storage area. A veterinary drug and product storage area refers to a place in the veterinary clinic, hospitals and farm where drugs and veterinary products are stored for use within the veterinary clinic, hospital and farm.

 

3.3 In dispensing veterinary drugs and products in unit dose or veterinary drugs and products which are not in their original containers but transferred to small bottles, tin cans, boxes plastic and/or paper envelopes and the like, the pharmacist/veterinarian shall place legibly on the required drug outlet�s label the following information:

 

1.       Name of the client;

2.       name of patient, when applicable;

3.       Species of client;

4.       Generic name of the drug;

5.       Brand name in parenthesis, if any;

6.       Dosage strength;

7.       Expiry date;

8.       Direction for use; and

9.       Name of pharmacist/veterinarian with their license number.

 

3.4 In partial filling of the prescription/veterinary drug order the following shall be written on the face of the prescription:

 

1.       the date of partial filling

2.       the quantity served and balance of the prescription unserved; and

3.       name and address of the veterinary drug and product outlet

 

The partially filled prescription/veterinary drug order shall be returned to the buyer after recording the partial filling on the prescription book. The veterinary drug and product outlet which completes the filling of the prescription veterinary drug order shall keep the prescription in the file.

 

3.5  Dispensing Drugs in List A and List B

 

In dispensing drugs included in List A (Prohibited and Regulated Drugs) and List B (Drugs Requiring Strict Precautions in their Use), attached as Annex A and B respectively, the following shall be observed:

 

 

3.5.1  Dispensing must be done by the pharmacist/veterinarians who shall affix his/her signature on the prescription/veterinary drug order filled.

 

3.5.2  The order and instructions of the veterinarian as written on the prescription/veterinary drug order, must be precisely followed.

 

3.5.3  Partial filling of prescription/veterinary drug order for drugs belonging to List A shall not be allowed.

 

Section 4. VIOLATIONS ON THE PART OF DISPENSERS AND VETERINARY DRUG AND PRODUCT

                  OUTLETS

 

The following acts of commissions are considered violations of these rules and regulations:

 

4.1 Imposing a particular brand or product on the buyer.

 

4.2 Inaccurate dispensing i.e. dispensing a veterinary drug and product which does not meet the prescription/veterinary drug order as to or all of the following: active ingredient, dosage form and strength.

 

4.3 Failure to post or make accessible the required up-to-date information on veterinary drugs and products.

 

4.4 Failure to adequately inform the buyer on available veterinary drugs and products that meet the veterinary prescription/veterinary drug order.

 

4.5 Failure to indicate generic name/official name designated by BFAD/BAI and other required information on the drug outlet�s label of the dispensed veterinary drug and product.

 

4.6 Failure to record and keep prescriptions/veterinary drug orders filled.

 

4.7 Failure to report to the nearest DOH/DA office cases of violative erroneous, and/or impossible prescription/veterinary drug orders within three (3) months after receipt of such prescription/veterinary drug orders.

 

Section 5. REPORTING AND MONITORING OF NON-COMPLIANCE

 

Any interested party may report any verifiable violation of these Rules and Regulations to the nearest DOH/DA-BAI office. The local DOH/DA-BAI office is responsible for giving notice to erring pharmacist/veterinarian, drug outlets and for transmitting the report on violations to the Secretary of Health/Secretary of Agriculture or the fiscal�s office for appropriate action.

 

Section 6. ADMINISTRATIVE SANCTIONS                                                                                 

 

For violation of these Rules and Regulations, the following sanctions, after due notice and summary hearing, may be imposed:

 

6.1 Suspension, or revocation of the license to operate the veterinary drug and product outlet by the Secretaries of Health / Agriculture.

 

6.2 Professionals directly involved in the violations shall be recommended by the Secretaries of Health / Agriculture for appropriate administrative  sanctions by the Philippine Regulation Commission (PRC).

 

Section 7. CRIMINAL LIABILITY

 

The imposition of the above sanctions does not preclude the institution of appropriate criminal proceedings pursuant to Section 12 of RA 6675 known as the �Generics Act of 1988�, R.A. 1556 known as the livestock and poultry feeds Act, R.A. 1071, R.A. 3101 and other relevant laws, upon receipt of complaints or reports of violations.

 

Section 8. TIMETABLE OF IMPLEMENTATION

 

In order to give all affected parties adequate time for learning and adjustment, the implementation of these Rules and Regulations shall be in three (3) phases, as follows:

 

Phase 1 Education Drive and Information Dissemination

This phase shall be from the date of the effectivity of these Rules and Regulations up to six months during this period, the DOH/DA-BAI in cooperation with the Department of Education Culture and Sports, the Department of Local-Government and the Philippine Information dissemination and education drive concerning the provisions of these Rules and Regulations as well as the Generics Act of 1988.

 

Phase 2 Monitoring of Compliance Without Sanctions of Penalties

Within six months the DOH/DA-BAI shall monitor voluntary compliance with the provisions of the Rules and Regulations on Prescribing and Dispensing. During this period, the associations of affected professionals are enjoined to promote compliance in order to achieve a smooth transition to the next phase of full implementation.

 

Phase 3 Full Implementation

Beginning August 1, 1991 the DOH/DA-BAI and the other relevant agencies of governments shall monitor compliance with these Rules and Regulations and all violations shall be subject to the appropriated sanctions and penalties provided for under these Rules and Regulations and all violations shall be subject to the appropriated sanctions and penalties provided for under these Rules and Regulations and the Generics Act of 1988.

 

Section 9. SEPARABILITY CLAUSE

 

In case any provision of this Administrative Order is declared contrary to law or unconstitutional, other provisions which are not affected thereby shall continue to be in force and in effect.

 

Section 10.  REPEALING CLAUSE

 

All Administrative Orders. Rules and Regulations and other Administrative issuances or parts thereof, inconsistent with the provisions of the Administrative Order are hereby repealed and modified accordingly.

 

Section 11. EFFECTIVITY

 

This Order shall take effect fifteen (15) days after its publication in two (2) newspapers of general circulation.

 

 

 

                                                                    

(Sgd.) SENEN C. BACANI                                                                    (Sgd.) ALFREDO R.A. BENGZON, M.D.

Secretary of Agriculture                                                                                            Secretary of Health

 

DA AO #138 and DOH AO #100 series of 1990

Regulations For The Licensing Of Veterinary Drug
And Product Establishment And Outlets

Republic of the Philippines

Department of Health

OFFICE OF THE SECRETARY

December 10, 1990

DEPARTMENT OF AGRICULTURE

Administrative Order No. 138

Series of 1990

 

DEPARTMENT OF HEALTH

Administrative Order No. 100

Series of 1990

 

 

SUBJECT:    REGULATIONS FOR THE LICENSING OF VETERINARY DRUG AND  PRODUCT

                       ESTABLISHMENT AND OUTLETS.

 

Pursuant to R.A. No. 3720, as amended by Executive Order No. 175, otherwise known as the Food, Drugs and Devices and Cosmetics Act� R.A. 6675 otherwise known as the �Generics Act� of 1988, R.A. 1556, otherwise known as the �Livestock and Poultry Feeds Act�, R.A. 1071, an act to regulate the sale of veterinary biologics ad medicinal preparation and R.A. 3101, an act authorizing the Director of the Bureau of Animal Industry, subject to the approval of the Secretary of Agriculture and Natural Resources to promulgate regulations for the preparation, sale, traffic in, shipment, and importation of viruses, sera toxins of analogous products used for the treatment of domestic animals, the following requirements for the licensing of veterinary drug and product establishments and outlets are hereby promulgated for the information, guidance and compliance of all concerned.

 

In accordance with the above laws, any organization company or business establishments in the veterinary drugs and products industry shall fall under the following general classification:

 

I.  Veterinary Drug and Product Establishment refers to any organization or company involved in the manufacture importation, repacking, labeling, advertising and / or distribution of veterinary drugs and products. This is covered by Chapter 1 below.

 

II.   Veterinary Drug Outlet refers to drugstore, pharmacy, livestock and poultry supply store and other business

establishments selling veterinary drugs and products. This is covered by Chapter II below.

 

CHAPTER I � VETERINARY DRUG AND PRODUCT ESTABLISHMENTS.

 

1. Definition of Different Types of Veterinary Drug and Product Establishments

 

1.1 Veterinary Drug and Product Manufacturer refers to any establishment engaged in operations involved in the production of a drug including propagation, processing, compounding, finishing, filing, repacking, labeling, advertising, storage, distribution or sale of the veterinary drug products proving that for the purpose of this regulation the compounding and filling of prescription by drugstores shall not be considered as production operations.

 

1.2  Veterinary Drug and Product Traders refers to any establishment which is a registered owner of the drug product, procures the raw materials and packaging components, and provides the production monographs, quality control standards and procedures, but subcontracts the manufacture of such veterinary drug and product to a licensed manufacturer. In addition a trader may also engage in distribution, and/or marketing of its veterinary drugs and products.

 

1.3 Veterinary Drug and Product Distributor / Importer refers to any veterinary drug and product establishment that imports raw materials, active ingredients and / or finished products, for its own use or for wholesale or distribution to other drug establishments or outlets.

 

1.4 Veterinary Drug and Product Distributor / Exporter refers to any veterinary drug and product establishment that exports raw materials, active ingredients and / or finished products to another country.

 

1.5 Veterinary Drug and Product Distributor, Wholesaler refers to any veterinary drug and product establishment that procures raw materials, active ingredients and/or finished products from local establishments for local distribution on wholesale basis.

 

2. Standards and Requirements for License To Operate (LTO)

 

2.1     General Requirements

 

2.1.1  Application � any person desiring to operate or establish, a veterinary drug and product establishment shall file with the BFAD/BAI an application supported by the following documents:

 

2.1.1.1 A standard petition form containing among others the name, age, citizenship and a passport size picture (5 x 5 cm), of the petitioner and other pertinent circumstances pertaining to the proposed veterinary drug and product establishment including the place where it is to be established.

 

2.1.1.2  Proof of registration as an establishment, ie.:

 

a)  For single proprietorship an authenticated photocopy of the certificate of Business Name Registration issued by the Bureau of Domestic Trade (BDT) of the Department of Trade and Industry.

 

b)  For partnerships, corporations and other judicial persons authenticated photocopies of the Certificate of Registration issued by the Securities and Exchange Commission (SEC) and the Articles of Incorporation or Partnership.

 

2.1.1.3  A valid Certificate of Registration of the establishment�s Filipino Veterinarian issued by the Professional Regulation Commission (PRC).

 

2.1.1.4  A valid Certificate of Registration of the establishment�s Filipino Pharmacist issued by the Professional Regulation Commission (PRC).

 

2.1.1.5  A valid credential of the establishment�s Filipino Microbiologist in case of veterinary biological manufacturer and trader.

 

2.1.1.6  A certificate of attendance to a BFAD/BAI sponsored / accredited Seminar on Licensing of Veterinary Drug and Product Establishments:

 

2.1.1.7   An Affidavit of Undertaking providing that the applicant shall;

 

a)  change the establishment�s name if there is already a validly registered name similar to it.

 

b)  Display the duly approved LTO in conspicuous place within the establishment.

 

c)  Notify BFAD/BAI in case of any change in the circumstances described in the application, among others; change of location, change of veterinarian, change of pharmacist, change in veterinary drugs and products.

 

2.1.1.8  An authenticated photocopy of Contract of Lease for the space to be occupied if the applicant does not own it.

 

2.1.2 A Certificate of continuing compliances with specific technical requirements (to be specified by BFAD/BAI according to section 2.2 below).

 

2.1.3  A Batch Distribution Record Book duly registered with BFAD/BAI.

 

2.1.4  A contingency plan procedure for a systematic, effective and prompt recall in case any of its products is found violative and ordered recalled from the market by BFAD/BAI.

 

2.1.5 An orderly and secure system of filing up to date invoices from suppliers and buyers identifying lot numbers or batch numbers of manufacturers stock pursuant to BFAD Memo Circular No. 001 s. 1983.

 

2.2  Specific Requirements:

 

An entity applying for a LTO as a veterinary drug and product manufacturer or veterinary drug and product trader or veterinary drug and product distributor shall be required to demonstrate its capacity to perform adequately as such in a manner that satisfactorily assumes the safety, efficacy and quality of its veterinary drugs and product. It should be required to conform with the following relevant standards and requirements specific for each category in addition to the above general requirements.

 

2.2.1 Veterinary Drug Manufacturers

 

2.2.1.1 Guidelines on Current Good Manufacturing Practices (GMP) provided for under A.O. No. 220 s. 1974, as amended including location, building and floor plans, and additional guidelines issued by BFAD.

 

2.2.1.2 Minimum standards for pharmaceutical manufacturing equipment / machines owned by the manufactured described in Annex A.

 

2.2.1.3 Minimum standards for quality control facilities owned by the manufacturers described in Annex B.

 

2.2.1.4 If importing raw materials active ingredients and / or finished products for use in manufacture of veterinary drug and products, a certificate that the manufacturer is registered in the country of origin, duly authenticated by the territorial Philippine Consulate, and evidence that the manufacturer meets BFAD/BAI standards for local manufacturers. If inspection of the foreign manufacturers by BFAD/BAI is necessary, the cost of inspections shall be borne by the applicant establishment. However, in lieu of the above a Certification Scheme from WHO or from an acceptable equivalent drug regulatory agency or organization.

 

2.2.2 Veterinary Biological Manufacturers

 

2.2.2.1 Guidelines on Current �Good Manufacturing Practices (GMP)� provided for under A.O. No. 220 s. 1974, as amended including location, building and floor plans, and any additional guidelines issued by BFAD, administrative Order No. 9 issued by BAI and other guidelines as required by NDC and other agencies.

 

2.2.2.2 Minimum standards for veterinary biological manufacturing equipment / machine described in Annex C.

 

2.2.2.3 Minimum standards for quality control facilities described in Annex D.

 

2.2.2.4 If importing raw materials, active ingredients and / or finished products for use in manufacture of veterinary drug and products, a certificate that the manufacturer is registered in the country of origin, duly authenticated by the territorial Philippine Consulate, and evidence that the manufacturer meets BFAD/BAI standards for local manufacturers. If inspection  of the foreign manufacturer by BFAD/BAI is necessary, the cost of inspection shall be borne by the applicant establishment.

 

2.2.3 Veterinary Medicated Feeds, Medicated Feed Premix, Medicated Feed Supplement, Medicated Feed Additive and Medicated Water Additive Manufacturer.

 

Medicated feed refers to any feed which contains drug ingredients intended or represented for the cure, mitigation, treatment or prevention of diseases of animal other than man or which intended to affect certain drug ingredients the structure or any function of the body of animal other than man.

 

2.2.3.1 Relevant guidelines on Current Good Manufacturing Practices (GMP) provided for under A.O. No. 220 s. 1974, as amended including location, building and floor plans, and any additional guidelines issued by BFAD and Administrative Order No. 35 issued by BAI.

 

2.2.3.2 Minimum standards for Veterinary Medicated Feed manufacturing equipment / machine described in Annex E.

 

2.2.3.3 Minimum standards for quality control facilities described in Annex F whether owned or contracted by the manufacturer provided the contracted quality control facility is accredited by BAI.

 

2.2.3.4 If importing raw materials, active ingredients and/or finished products for use in manufacture of veterinary drugs and products, a certificate that the manufacturer is registered in the country of origin, duly authenticated by the territorial Philippine Consulate, in the absence of the Consulate any equivalent governments regulatory agency and evidence that the manufacturer meets BFAD/BAI standards for local manufacturers. If inspections of the foreign manufacturers by BFAD/BAI is necessary, the cost of inspection shall be done by the applicant establishment.

 

2.2.4 Veterinary Drug and Product Traders.

 

2.2.4.1 A valid contract of agreements with a BFAD/BAI licensed manufacturers containing a stipulated authentications that both the veterinary drug trader and the manufacturer are jointly responsible for the quality of the veterinary drug and products;

 

2.2.4.2 If importing raw materials, active ingredients and/or finished products for use in the manufacturer of veterinary drug and product, a certificate that the manufacturer is registered with the country of origin, duly authenticated by the territorial Philippine Consulate, in the absence of the consulate, any equivalent regulatory government agency and evidence that the manufacturer meets BFAD/BAI standards for local manufacturers. If inspection of the foreign manufacturer by the BFAD/BAI is necessary, the cost of inspection shall be borne by the applicant establishment.

 

2.2.4.3 A description of the production process and quality control procedures to be followed by the contracted manufacturer, jointly certified by the owner and the pharmacist of the veterinary drug and product establishment.

 

2.2.5 Veterinary Drug and Product Distributors

 

2.2.5.1 Importers

 

2.2.5.1.1 Foreign Agency Agreement between the Philippine Importer and foreign supplier duly authenticated by the territorial Philippine Consulate, in the absence of the Consulate, any equivalent regulatory government agency.

 

2.2.5.1.2 A certificate that the manufacturer of the raw material, active ingredient and/or finished product is registered in the country of origin, duly authenticated by the territorial Philippine Consulate, in the absence of the Consulate, any equivalent regulatory government agency and evidence that the manufacturer meets BFAD/BAI standard for local manufacturers. If inspection of the foreign manufacturers of the BFAD/BAI is needed the cost of inspection shall be borne by the applicant establishments.

 

2.2.5.1.3 In case of finished products Certificate of Free Sale of the product in the country of origin, duly authenticated by the territorial Philippine Consulate, in the absence of the Consulate, any equivalent regulatory government, agency and evidence that such certificates is issued in substantial compliance with BFAD/BAI standards.

 

2.2.5.2 Exporters

 

2.2.5.2.1  A valid contract with a BFAD/BAI licensed manufacturer in addition to other requirements set by other competent authorities.

 

2.2.5.3 Wholesalers

 

2.2.5.3.1  A valid contract with BFAD/BAI licensed veterinary drug and product manufacturer, trader or distributor.

 

2.2.5.3.2  A certification that the products it sells are registered with BFAD/BAI.

 

2.3  Other Additional Requirements:

 

In addition to the above standards and requirements, BFAD/BAI in the course of evaluating an application may require other additional documentation or evidence to satisfactorily ascertain the capability of the veterinary drug and product establishment.

 

3. Renewal of License to Operate (LTO)

 

3.1 The License to Operate shall have the following validities for all categories of veterinary drug and product establishments:

 

3.1.1 Initial Period (Initial Application) 1 year.

 

3.1.2. Subsequent, Period (Renewal Application) 2 years

 

3.2  At least one month prior to the expiration of the LTO, veterinary drug and product establishment shall apply to renew their license.

 

3.3 In considering the renewal applications, BFAD/BAI shall ascertain the continued compliance by the veterinary drug and product establishment with the standards and requirements stipulated in section 2.1 and 2.2

 

4. Administrative Sanctions

 

4.1 Grounds for Revocation of LTO.

 

4.1.1 Misrepresentation of any material fact in the application for LTO and in any documentation used as a basis for issuing the LTO.

 

4.1.2 For manufacturers and traders any deficiency in GMP that is likely to result in adulterated, misbranded, substandard or unsafe products as determined by BFAD/BAI. This included, among others, grossly inadequate premises, lack of key technical and professional personnel, lack of key equipment in production or quality control, inadequate or improper documentation of the production process.

 

4.1.3 For distributors; distribution of fake, substandard, misbranded, adulterated or unsafe veterinary drugs and products.

 

4.1.4 Violation of BFAD/BAI standards of quality, efficacy, purity and safety of veterinary drugs and products.

 

4.1.5 Sale and distribution of therapeutic antibiotic and biological products without batch certification by BFAD/BAI.

 

4.1.6 Failure to take adequate remedial or corrective measures for deficiencies identified in accordance with requirements of BFAD/BAI.

 

4.1.7  Failure to keep up to date, secure, orderly, and easily inspected records that would indicate continued compliance with standards.

 

4.2 Grounds for Suspension of LTO.

 

4.2.1 Minor deficiencies in GMP or material management that need to be corrected but are not immediately or likely to result in adulterated, misbranded, substandard or unsafe veterinary  drugs and products as determined by BFAD/BAI. These include, among others, poor housekeeping inadequate storage facilities, non-functional equipment, and failure to comply with laboratory safety standards.

 

4.2.2 Lapses in record keeping of invoices, receipts or distribution records.

 

4.3 Lapses in record keeping of invoices, receipts or distribution records.

 

No establishment whose LTO was revoked may apply for LTO within 5 years after the revocation of its license.

 

5. Schedule of Fees

 

5.1 Upon application for a license to operate of a veterinary drug and product establishment, the following non-refundable fees shall be charged for each application:

 

Veterinary Drug and Product Manufacturer (Code VDAPM)

 

Veterinary Drug and Product Trader (Code VDAPT)

 

Veterinary Drug and Product Distributor (Code VDAPDW/VDAPDE/VDAPDI)

 

            Code                                                     Initial                 Renewal (good for 2 years)

 

VDAPM                                                P 5,000            P 10,000

 

VDAPT                                                 P 3,000            P   6,000

 

VDAPDW/VDAPDE/VDAPDI          P 2,000             P  4,000

 

5.2 If a veterinary drug and product establishment engaged in activities belonging to more than one of the above categories, applicant must apply for LTO for each of the category and pay the corresponding fees.

 

5.3 Only upon payment of application fees may the application be processed. A surcharge of fifty percent (50%) of the above fees shall be imposed on applications for renewal filed after the validity of the license has lapsed. Any change in the category of veterinary drug and product establishment or change in ownership shall require a new application.

 

CHAPTER II � VETERINARY DRUG AND PRODUCT OUTLETS

 

1. Definitions of Different Types of Veterinary Drug and Product Outlets.

 

1.1 Drugstore, Pharmacy and Botica and drug outlets where registered veterinary drugs and products, chemical products, active pharmaceutical, proprietary medicines or pharmaceutical specifications are compounded and/or dispensed and hold executive veterinary hospitals, clinic and Farm storage store where drugs and products are stored for their exclusive use.

 

1.2 Veterinary and agricultural supply store, livestock and poultry supply and any other outlets selling prescription veterinary drugs and products.

 

1.3  Retail outlet for non-prescription drugs including the traditional outlets such as supermarkets and stores means a drug outlet where registered non-prescription or over-the-counter (OTC) or self-service (SS) Veterinary drugs and products are sold in their original packages, bottle or containers or in mail quantities nor in their original containers.

 

2.  Standards and Requirements for License to Operate (LTO)

 

2.1 General Requirements

 

2.1.1 Application of person desiring to operate or establish a veterinary drug and product outlet shall file with the BFAD/BAI application supported by the following documents:

 

2.1.1.1 A standard petition form containing among others the name, age, citizenship and a passport size picture (5x5cm) or the petitioner and other pertinent circumstances pertaining to the proposed veterinary drug and product outlet including the place where it is to be established.

 

2.1.1.2 Proof of registration as an establishment, i.e.:

 

a) For single proprietorship; an authenticated photocopy of the Certificate of Business Name Registration issued by the Bureau of Domestic Trade (BDT) of the Department of Trade and Industry.

 

b) For partnership, corporation and other judicial persons; authenticated photocopy of the Certificate of Registration issued by the Securities and Exchange Commission (SEC) and the Articles of Incorporations or partnership.

 

2.1.1.3 A valid Certificate of Registration of the establishment�s Filipino Pharmacy/Veterinarian issued by the Professional Registration Commission (PRC)

 

2.1.1.4 A certificate of attendance to a BFAD/BAI accredited Seminar for Licensing of veterinary drug and product outlet.

 

2.1.1.5 An Affidavit of undertaking providing that the applicant shall;

 

a)  change the establishment�s name if there is already a validly registered name similar to it.

 

b)  display the duly approved LTO in a conspicuous place within the establishment.

 

c) notity BFAD/BAI in case of any change in the circumstances described in the application such as: change of location, change of pharmacist, etc.

 

2.1.1.6 Tentative list of veterinary drugs and products intended to be sold using generic names with brand names when applicable.

 

2.1.1.7 An authenticated photocopy of Contract of Lease for the space to be occupied if the applicant does not own it.

 

2.1.2 For drugstore, pharmacy or botica, see Specific Requirements 2.2.1

 

2.2  Specific Requirements:

 

Any entity applying for a license to operate drugstore, pharmacy or botica or retail outlet shall be required to demonstrate its capacity to perform adequately its functions to inform its clientele in accordance with Section 6 (d) of R.A. 6675 and sell veterinary drugs and products, which are safe, effective and of good quality to the public. It shall be required to conform with relevant standards and requirements specific for each, category, in addition to the foregoing general requirements.

 

2.2.1   Drugstore, Pharmacy or Botica requirements are provided for in A.O. No. 56 s. 1989 and therefore shall secure the license to operate from the BFAD. However, they shall secure a license to operate from the BAI if they shall sell veterinary drugs and products. Such LTO shall be automatically granted by the BAI upon presentation of LTO from BFAD, payment of corresponding fees and tentative list of veterinary drugs and products intended to be sold using generic names with brand names when applicable.

 

2.2.2 Veterinary and agricultural supply store livestock and poultry supply store are outlets selling prescription veterinary drugs and products.

 

2.2.2.1 Premises

 

2.2.2.1.1 A signboard in front at the place of business bearing the registered name of the veterinary drugstore, but veterinary drugs and product outlet selling exclusively non-prescription or over-the-counter (OTC) or self-service veterinary drug and product, the signboard should indicate so by putting the symbol non �Rx or equivalent.

 

2.2.2.1.2 A well-ventilated area not less than 12 sqm. in floor area with concrete, tile or wooden flooring.

 

2.2.2.1.3 A suitable and proper place (e.g. refrigerator) for the adequate storage of veterinary drugs and products as specified on the label.

 

2.2.2.1.4 A suitable cabinet for keeping poisons and/or dangerous drugs when applicable.

 

2.2.2.1.5 An adequate water and electrical supply.

 

2.2.2.1.6 Other additional requirements of BA and FPA.

 

2.2.2.2  Reference Books and Documents

 

2.2.2.2.1   Philippine National Veterinary Drug Formulatory.

 

2.2.2.2.2   Philippine Veterinary Drug Codex.

 

2.2.2.2.3  R.A. 3720, otherwise known as the Foods, Drugs and Devices and Cosmetics Act as amended and relevant implementing rules and regulations.

 

2.2.2.2.4   R.A. 6675, Generics Act of 1988 and relevant implementing rules and regulations.

 

2.2.2.2.5 R.A. 5921 Pharmacy Law, as amended and relevant implementing rules and regulations.

 

2.2.2.2.6  R.A. 3101, An Act authorizing the Director of Animal Industry to promulgate regulation for the preparation sale, traffic in, and shipment, and importation of viruses, serum, toxins, or analogue products used for the treatment of domestic animals and relevant implementing guidelines.

 

2.2.2.2.7   R.A. 1071, An Act to regulate the sale of veterinary biologics and medicinal preparation and relevant implementing guidelines.

 

2.2.2.2.8  R.A. 1556 Livestock and Poultry Feeds Act, and relevant implementing guidelines.

 

2.2.2.3   Record Books Duly Registered with BFAD/BAI.

 

2.2.2.3.1  Prescription Book

 

2.2.2.3.2  Dangerous Drugs Book, when applicable.

 

2.2.2.3.3  Poisons Book, when applicable.

 

2.2.2.4   A duly BFAD/BAI Registered pharmacist or veterinarian.

 

2.2.2.5   Other Additional Requirements:

 

2.2.2.5.1   Invoices indicating the lot number or batch number of the manufacturer�s stock pursuant to BFAD Memo. Circular No. 001 s. 1983.

 

2.2.2.5.2   File of prescriptions filled, consecutively numbered.

 

2.2.2.5.3  Dry Seal or Rubber Stamp containing the name and address of the veterinary drug and product outlet.

 

2.2.3   Requirements for a Retail Outlet for Non-Prescription, Over-the-Counter and Self-Service Veterinary Drugs and Products.

 

2.2.3.1 Premises

 

2.2.3.1.1 A signboard in front at the place of business bearing the registered name of the retail outlet and the symbol product or equivalent.

 

2.2.3.1.2 An adequate, well ventilated area with concrete, tile or wooden flooring.

 

2.2.3.1.3 A suitable and proper place for the adequate storage of non-prescription drugs when where are products sold other than drugs, area exclusively for veterinary drugs and shall be allocated within the premises.

 

2.2.3.2 Reference Books and Documents

 

2.2.3.2.1 Philippine National Veterinary Drug Formulary.

 

2.2.3.2.2 Philippine Veterinary Drug Index.

 

2.2.3.2.3 R.A. 5921, Pharmacy Law and its implementing rules and regulations.

 

2.2.3.2.4 R.A. 6675 the Generics Act of 1988 and relevant implementing rules and regulations;

 

2.2.3.2.5 R.A. 3720 as amended or Foods, Drugs and Devices and Cosmetics Act.

 

2.2.3.2.6 R.A. 3101, An Act authorizing the Director of Animal Industry to promulgate regulation for the preparation, sale, traffic in and shipment, and importation of viruses, serum, toxins, or analogue products used for the treatment of domestic animals and relevant implementing guidelines.

 

2.2.3.2.7 R.A. 1071, An Act to regulate the sale of veterinary biologics and medicinal preparation and relevant implementing guidelines.

 

2.2.3.2.8 R.A. 1556 Livestock and Poultry Feeds Act and relevant implementing guidelines.

 

2.2.3.3 Other Additional Requirements

 

2.2.3.3.1 Invoices indicating the Act number or batch number of the manufacturer�s stock pursuant to BFAD Memo. Circular Law 001 s. 1983.

 

2.2.3.3.2 Dry Seal or Rubber Stamp containing the name and address of the veterinary drug and product outlet.

 

3. Renewal of License to Operate (LTO)

 

In case of renewal of LTO THE Veterinary drug and product outlet must have all categories of performance, consistent with BFAD/BAI standard and requirements, without any cases of serious violation of existing laws, rules and regulations.

 

4.  Administrative Sanctions

 

4.1   Temporary Closure

 

Failure to comply with the standards and requirements for LTO as stated above.

 

4.2    Suspension of License to Operate

 

4.2.1 Failure to product invoices and receipts together with lot number, expiry dates for the veterinary drugs and products in stock.

 

4.2.2 Failure to properly record and keep a file of all prescriptions filled in the last two years.

 

4.2.3 Refusal to allow entry of BFAD/BAI inspectors.

 

4.3   Revocation of License to Operate

 

4.3.1 Sale or offer for sale of adulterated, misbranded, sub-standard, unregistered, expired and/or unsafe veterinary drugs and products marked �Not for Sale�.

 

4.3.2 Failure to properly record dangerous drugs as determined by DDB.

 

4.3.3 Lack of pharmacist / veterinarian.

 

4.3.4 Failure to take necessary remedial or corrective measures within the prescribed period as directed by BFAD/BAI.

 

5. Validity

 

The license to operate shall have the following validities:

 

Initial Period of validity                            Validity of Subsequent Renewal

 

1 year                                                               2 years

 

6. Schedule of Fees

 

Upon application for a license to operate, the following non-refundable fees shall be charged for each application:

 

            Initial                                                     Renewal (Good for two years)

 

P 200.00                                                           P 400.00

 

Only upon payment of application fees may the application be processed. A surcharge of fifty percent (50%) of the above fees shall be imposed on applications for renewal filed after the validity of the license has lapsed.

 

SEPARABILITY CLAUSE

 

In case any provision of this rules and regulations is declared contrary to law or unconstitutional other provisions which are not affected thereby shall continue to be in force in effect.

 

REPEALING CLAUSE

 

All administrative orders, rules and regulations and other administrative issuance or parts thereof inconsistent with the provisions of this Regulations are hereby repealed or modified accordingly.

 

EFFECTIVITY

 

This Regulation shall take effect fifteen (15) days after its publication in a newspaper of general circulation.

 

 

 

 

 

(Sgd.) SENEN C. BACANI                                                        (Sgd.) ALFREDO R.A. BENGZON, M.D.

Secretary of Health                                                                                      Secretary of Health

 

Animal Industry AO #35 series of 1975

Rules And Regulations Governing The Manufacture,
Importation, Labeling, Advertising, Distribution
And Sale Of Livestock And Poultry Feeds And Feeding Stuffs.

* Administrative Order No. 35-2

Amending Certain Provisions Of Animal Industry Administrative Order No. 35
Dated September 23, 1975, Otherwise Known As The Livestock And Poultry Feeds Regulations,
By Inserting a New Section To Be Known As Section 10-a To Said Order.
(Re: Inspection Of Results Of Chemical Analysis By The Director Of Animal Industry
Or His Authorized Representative).

* Administrative Order No. 35-3

Amending Certain Provisions Of Animal Industry Administrative Order No. 35
Dated September 23, 1975 Entitled "Rules And Regulations Governing The Manufacture,
Importation, Labeling, Advertising, Distribution And Sale Of Livestock And
Poultry Feeds And Feeding Stuffs.

Republic of the Philippines

Department of Agriculture

BUREAU OF ANIMAL INDUSTRY

Visayas Avenue, Diliman

Quezon City

September 23, 1975

ANIMAL INDUSTRY

ADMINISTRATIVE ORDER )

No. ____35____________ )

 

 

 

SUBJECT : RULES AND REGULATIONS GOVERNING THE MANUFACTURE, IMPORTATION, LABELING, ADVERTISING, DISTRIBUTION AND SALE OF LIVESTOCK AND POULTRY FEEDS AND FEEDING STUFFS.

 

 

Pursuant to the provisions of Republic Act. No. 1556 as amended by Presidential Decree No. 7, the following rules and regulations governing the manufacture, importation, labeling, advertising, distribution and sale of livestock and poultry feeds are hereby promulgated for the information and guidance of all concerned:

 

ARTICLE I � TITLE

 

Section 1. This Order shall be known as the Livestock and Poultry Feeds Regulations.

 

ARTICLE II � DEFINITIONS

 

Section 2.  For purposes of these regulations, the following words or terms shall mean:

 

  1. Act � refers to Republic Act No. 1556, as amended by Presidential Decree No. 7.

 

  1. Adulterated feeds � are mixed feeds, feedstuffs or ingredients found to contain any material that may be injurious, damaged or of no food value or if any substance has been added thereto that may increase its bulk or weight and/or may reduce its quality or strength. For purposes of this Order, a mixture of two or more mixed feeds of different formula or brand with intent to sell is also considered adulterated feeds.

 

  1. Analyst � Any official analyst appointed or designated as such by the Director of Animal Industry for the purpose of implementing this Act.

 

  1. Animal Nutritionist � Any person who has at least a scholastic credit of nine (9) units in animal nutrition from a duly recognized educational institution and five (5) years experience in compounding animal feeds in a duly registered feed mill, or one who has a degree in animal science major in animal nutrition.

 

  1. Association, duly recognized � Any association of persons engaged in the development of livestock industry, either as animal raisers or animal feed manufacturers which has been extended recognition by the Bureau.

 

  1. Base � refers to the main or chief ingredients (quantitatively) in a mixture.

 

  1. Brand � means any distinctive mark or name applied to feed or feeding stuff.

 

  1. Commercial feed or feeding stuff � refers to feed or feeding stuff intended for sale whether to the general public or to a limited clientele.

 

  1. Complete feed � a mixture of feed ingredients by specific formula to be fed as the sole ration and is capable to furnish the nutritive requirements to maintain life for promoting production without any additional substance except water.

 

  1.  Concentrates � shall apply to feed stuffs low in fiber and high in total digestible nutrients.

 

a)  Concentrates, mixed � these are mixed feed ingredients containing a high amount of protein, vitamins and minerals intended to be used as a complete feed after the addition of cereal grains and their by-products.

b) Concentrates, simple � these are single feed ingredients containing at least 60% total digestible nutrients, such as fishmeal, soybean oil meal, etc. and intended to be further diluted and mixed with other ingredients to produce a supplement or a complete feed.

 

  1.  Custom mixed feeds � are commercial feeds mixed in accordance with the specifications of the final buyer or consumer.

 

  1.  Damaged feeds � any feed or feedstuff which has been subjected to any factor that has decreased the nutritive value of any feed or feedstuff which when fed to livestock may be injurious to the health of the animals.

 

  1.  Dealer � Any person engaged in the business of buying and selling to any person other than the end-user.

 

  1.  Director � means the Director of Animal Industry and Bureau refers to the Bureau of Animal Industry.

 

  1.  Distributor � An agent of the manufacturer for the purpose of marketing finished products.

 

  1.  Feed or feeding stuff � shall embrace all such articles to be used as feeds purporting to supply proteins, carbohydrates, fats, minerals, vitamins, antibiotics, growth promoting factors whether identified or unidentified and/or correcting nutritional disorders. Such articles may be locally produced or imported, mixed or in the form of simple ingredients; Provided, however, that the following are excluded.

 

(1)  Whole Seeds or grains, unmixed.

 

(2)  Fresh green roughage and unprocessed liquid milk in all its forms.

 

(3) Dried and ground hays and straws, dried and ground corn stalks or other parts of the corn plant not included in the grains, rice hulls, cane sugar, bagasse, dried beet pulp, oat hulls, barley hulls, clipped oat by-products, sorghum plant by-products and flax plant by-products, cotton seed hulls, mongo bean hulls, buckwheat hulls, cocoa shells, or other materials of a similar character.

 

  1.  Importer � A person who imports feed or feedstuff from any point outside of the Philippines.

 

  1.  Indentor � A person who makes an order for another for the importation of feed or feedstuff.

 

  1.  Ingredient � means any single article of feed or feeding stuff which enters into the composition of a ration, concentrate, or supplement.

 

  1.  Inspector � Any person authorized by the Director of Animal Industry to enforce the provisions of the Act and the regulations provided for in this Order.

 

  1.  Label � means and includes any written, printed or graphic matter attached or affixed to any package, bale or bundle of feeds.

 

  1.  Licensed Chemist � Any person licensed to practice the Science of Chemistry by the Board of Chemist of the Philippines.

 

  1.  Livestock � include all domestic animals with economic value. For this purpose, poultry is included in the term livestock.

 

  1.  Manufacturer � Any person who mixes feed ingredients into complete feed and/or processes feed ingredients, for sale.

 

  1.  Manufacturer of non-commercial feeds � Any person who mixes feed ingredients into complete feed and/or processes feed ingredients solely for personal consumption of his or his immediate family�s livestock.

 

  1.  Mixture � means any combination of two or more feed ingredients used in the manufacture of feeding stuff.

 

  1.  Non-commercial feed or feeding stuff � any feed or feeding stuff not intended for sale.

 

  1.  Owner � is the person, firm, partnership, cooperative, association, or corporation applying for the required registration under this Act or any person or establishment actually engaged in the manufacture, importation, distribution and sale of livestock and poultry feeds.

 

  1.  Package � means sack, bag, barrel, bin or any other container for feeds.

 

  1.  Person � refers to natural or juridical person in the singular or plural.

 

  1.  Regulation � refers to this order and such other orders issued by the Bureau of Animal Industry to implement the provisions of R.A. 1556, as amended.

 

  1.  Retailer � Any person engaged in the business of selling feeds or feedstuffs to end-users.

 

  1.  Roughages � shall include dried and ground hays and straws, dried and ground corn stalks or other parts of the corn plant not included in the grain, dried beet pulp, oat hulls, barley hulls, clipped oat by-products, sorghum plant by-products and flax plant by-products, cotton seed hulls, buckwheat hulls, cocoa shells, grain screening, coffee ground or other materials of a similar character. This shall not include adulterated feed.

 

  1.  Secretary � means the Secretary of Agriculture and Department refers to the Department of Agriculture.

 

  1.  Small Feed Miller � Any person engaged in the manufacture of animal feeds with a daily production of not more than twenty (20) metric tons.

 

  1.  Supplement � is a feed ingredient or mixture of feed ingredients intended to supply the deficiencies in a ration or improve the nutritive balance or performance of the total mixture.

 

  1.  Supplier � Any person who supplies feed or feed ingredients with an average gross sale of P1,000.00 per day.

 

  1.  Veterinarian � Any person authorized to practice veterinary medicine by the Board of Veterinary Medicine.

 

 

ARTICLE III � REGISTRATION

 

Section 3. Any person desiring to engage in the manufacture, importation, sale or distribution of feeds or feeding stuffs shall be first registered with the Bureau.

 

Section 4. All application for registration for the manufacture, importation, sale or distribution of livestock feeds shall be made in writing and under oath and shall be accomplished in forms provided by the Bureau. Said application shall be signed by the applicant himself, in case of natural persons, or by a partner or manager in case of juridical persons and shall distinctly indicate the kind or nature of feeds or feedstuffs to be manufactured, imported, sold or distributed, the brand name, and in the case of retailer, the number of stores and the locations thereof; and finally, in the case of manufacturers, the number of factories and the locations thereof. The application shall be accompanied with a sample of the labels or tags which the manufacturer will use on the feed or feeding stuff manufactured and any subsequent changes therein shall be registered with the Bureau without any additional cost.

 

Section 5. Upon verification and approval of the application and payment of corresponding registration fee, a certificate of registration will be issued by the Director in the form adopted for the purpose, which shall be placed conspicuously in a place of business and readily visible to the public.

 

Section 6. Registration shall automatically expire every end of the calendar year and may be renewed annually thereafter in accordance with the provisions of this Order.

 

Section 7. There shall be a separate registration for feed ingredient manufacturers, feed importers, feed indentors, distributors, suppliers, and retailers. Registration shall not be transferable to any person and shall not apply to any location other than that specified in the certificate of registration.

 

Section 8. Feed and feed ingredient manufacturer and/or importer who maintain retail establishments other than their place of business shall pay both manufacturers and/or importers and retailers fee.

 

ARTICLE IV � QUALITY CONTROL SERVICE

 

Section 9. All person engaged or desiring to engage in the manufacture of mixed feeds for commercial purposes, shall establish and maintain a quality control laboratory and shall retain the services of licensed chemist and a veterinarian or a licensed chemist and an animal nutritionist to be responsible for the analysis and test of mixed feeds before they are released for sale to determine their conformity with the feed formula of the particular feed and feeding stuff.

 

Section 10. It shall be mandatory to all persons engaged in the manufacture of feeds for poultry and swine for commercial purposed to maintain livestock to be fed with its manufactured feeds for experimental purposes. The number of said experimental purposes shall not be less than the following:

 

Poultry � 50 for broilers, 50 day-old pullets; 50 growers, and 50 layers.

Swine � 5 piglets, 5 growers, 5 breeding gilts and sows and 5 finishers

 

Provided that only the class of animals which are the object of the particular kind of feed produced need be maintained.

 

Section 11. Two or more small feed millers may agree among themselves to establish and maintain a common quality control laboratory and retain the services of a common personnel therefore and such shall be considered sufficient compliance to the provisions of Section 8 hereof; Provided, that in lieu of the above, any small feed miller may attach and avail itself of the laboratory services of any recognized college / institute / university offering its laboratory for feed quality control services.

 

ARTICLE V � LABELING

 

Section 12. All containers of feed and/or feeding stuff offered for sale shall bear a complete label as required by Section 5 of Republic Act 1556, as amended by P.D. 7.

 

Section 13. Each label shall be printed in English, must be legible, clear and distinct in its meaning. Brand names of feeds must be printed in larger sized type than that of the ingredients. Labels must be attached to the package, printed or affixed on one side of the container in such a way that the whole content of the label can be read without detaching it.  The standard name of the feed must likewise be clearly printed.

 

Section 14. Custom mixed feed must be accompanied by an invoice issued to the consumer-buyer showing total weight of feed ingredients used, name of the consumer-buyer, date and name, address and registration number of the number of the manufacturer in lieu of the tag or label.

 

Section 15. The guaranteed analysis specified in the label shall conform to the actual calculated nutrient contents of feed and any changes in the said analysis shall be made known in writing to the Director of Animal Industry before such changes are made.

 

Section 16. The minimum percentage of crude protein shall form part of the brand name of all high protein mixed concentrates.

 

Section 17. In the case of mineral feeds or mixed feed containing more than a total of five percent of one or more added mineral ingredients, the minimum and maximum percentages of calcium (Ca), the minimum percentage of phosphorus (P) and iodine (I), and the maximum percentage of salt (NaCl) must be declared; Provided, that if not nutritional properties other than those of a mineral nature be claimed for mineral feed product, the percentage of crude protein, crude fat, and crude fiber may be omitted.

 

Section 18. Feeds containing drug or drug ingredients for the prevention of diseases of livestock should be labeled to show:

 

(a) The name and percentage of drug used;

(b) Directions for use;

(c) Warning against use under those conditions in which its use may be dangerous to the health of livestock and man.

 

Section 19. Net weight � Label on each container must show the net weight in kilograms of the feed and/or feeding stuff in the container. Such statements as �4 kilos gross� or 45 �kilos when packed�, etc. are prohibited. Each bag of mixed feeds feeding stuff for commercial purpose shall have weight of either 10, 25, 40, and 50 kilograms.

 

Section 20. Misleading advertisement � Labels of containers of feed and/or feeding stuff must not contain any form of advertisement and/or claims that are false and misleading. Any advertisement containing any claim that the feed is suited for all purposes shall considered a misleading advertisement under this Order.

 

Section 21. The use of urea in mixing feeds or the sale of mixed feeds, feedstuffs and ingredients, containing urea is prohibited except for mixed feeds for ruminants, the amount in which should appear in the label.

 

ARTICLE VI � CLASSIFICATION

 

Section 22. By-products of grains shall be classified as follows:

 

  1. Rice by-products:

 

a. Rice polish is the finely powdered material obtained in polishing rice kernels. It shall have the following analysis:

 

Crude Protein����������������� 12.0% min.

Fat   ��������������������� 15.0% min.

Fiber  ��������������������.. 6.0% max.

Moisture  ������������������� 13.0% max.

 

b. Rice bran is the pericarp of bran layer of rice, with only such quantity of full fragments as is unavoidable in the regular milling of rice.

 

Cono: D1 � First class or fine rice bran

 

Crude Protein����������������� 11.0% min.

Fat   ��������������������� 12.0% min.

Fiber  ��������������������.. 7.0% max.

Moisture  ������������������� 13.0% max.

 

Cono: D2 � Second class or coarse rice bran

 

Crude Protein�����������������. 4.0% min.

Fat   ��������������������.� 2.0% min.

Fiber  ��������������������.. 30.0% max.

Moisture  ������������������� 13.0% max.

 

  1. Corn by-products:

 

a. Corn bran is the outer coating of the corn kernel, with little or none of the starchy part of germ. It shall have the following analysis:

 

Crude Protein����������������� 10.0% min.

Fat   ��������������������� 5.0% min.

Fiber  ��������������������.. 8.0% max.

Moisture  ������������������� 13.0% max.

 

b. Corn grits are hard, flinty portions of sound corn, with little or none of the bran or germ. These broken small particles are separated from the rest by screens of different gauges. Thus these grits are of three sizes � fine (no. 22), intermediate (no. 16) and coarse (no. 14). They shall have the following analysis:

 

Crude Protein����������������� 7.0% min.

Fat   ��������������������� 0.5% min.

Fiber  ��������������������.. 2.0% max.

Moisture  ������������������� 13.0% max.

 

c. Corn gluten meal � that part of commercial shelled corn that remains after the extraction of the larger part of the starch and germ, and the separation of the bran by the processes employed in the wet milling manufacture of corn starch or syrup. It may or may not contain either corn solubles or corn oil meal.

 

Crude Protein����������������� 42.0% min.

Fat   ��������������������� 1.5% min.

Fiber  ��������������������.. 4.5% max.

Moisture  ������������������� 13.0% max.

 

d. Corn gluten feed � that part of commercial shelled corn that remains after the extraction of the larger part of the starch and germ by the processes employed in the wet milling manufacture of corn starch or corn syrup. It may or may not contain either corn solubles or corn oil meal.

 

Crude Protein����������������� 20.0% min.

Fat   ��������������������� 2.0% min.

Fiber  ��������������������.. 8.0% max.

Moisture  ������������������� 13.0% max.

 

e. Corn germ meal � This is ground corn germ cake (the residual product after extraction of oil from corn germ with other parts of the corn kernel) as separated in the dry milling process of manufacture of corn meal, corn grits, hominy feed, and other corn by-products.

 

  1. Whey By-products:

 

a. Wheat Pollard � is that portion of the wheat bran between the skin or the bran and the white interior (source of white flour). It shall have the following analysis.

 

Soft:

 

Crude Protein����������������� 12.0% min.

Fat   ��������������������� 4.0% min.

Fiber  ��������������������.. 8.0% max.

Moisture  ������������������� 13.0% max.

 

Hard:

 

Crude Protein����������������� 16.0% min.

Fat   ��������������������� 3.0% min.

Fiber  ��������������������.. 8.0% max.

Moisture  ������������������� 13.0% max.

 

ARTICLE VII � METHODS OF ANALYSIS

 

Section 23. The methods of analysis as published in the official methods of the Association of Official Agricultural Chemists, latest edition, shall be adopted in making analysis.

 

ARTICLE VIII � PUBLICATION

 

Section 24. Results of analysis and test of samples of feeds and feedstuffs collected from feed ingredient suppliers and feed manufacturers shall be published quarterly by the Bureau or as often as may be considered necessary, in which shall be specified the feeds and feedstuffs, the name of manufacturers and suppliers, the date of analysis and the results thereof.

 

ARTICLE IX � SAMPLING

 

Section 25. The following methods of obtaining samples by feed inspectors shall be adopted:

 

1.  The Director of Animal Industry or his authorized agent, representative, or inspector shall be permitted at all reasonable time to enter and inspect any premises or conveyances in which feeds or feed ingredients are sold, produced, processed, transported or held possession for sale or distribution when he has reasonable cause to believe that any feed or feeding stuff is being prepared for sale and may open any package containing or supposed to contain any feed or feeding stuff there found without cost. He shall likewise be permitted to inspect only records or documents which are necessary in verifying the volume of production and/or importation for proper assessment of the inspection fee as provided for in Republic Act No. 1556, as amended.

 

2.  Duplicate samples of a total of not less than � kilo and not more than � kilo may be taken from random-sampled unopened bags.

 

3.  Each sample must be properly labeled according to the tag attached to the feed containers where it was taken. Then each sample shall be sealed, signed and dated by the inspector in the presence of one of the manufacturer�s /dealer�s and/or importer�s representative who shall also be requested to sign. One of the samples shall be taken to the Bureau of Animal Industry for appropriate analysis, and the other sample given to the manufacturer, owner, processor, and/or importer.

 

4.  Results of analysis will be recorded in the Bureau files and may be published in accordance with the provisions of this Order.

 

ARTICLE X � PAYMENT OF FEES

 

Section 26. Any person applying for registration under the Act shall pay a registration fee of:

 

1.       For manufacturer of feed or feedstuff, P 300.00

 

2.       For manufacturer of non-commercial feed, free

 

3.       For importer or indentor, P 200.00

 

4.       For supplier, P 100.00

 

5.       For distributor, P 50.00

 

6.       For retailer, P 5.00 per store

 

Section 27. Inspection fees of P 0.20 per metric ton shall be levied on all feed ingredients, mixed feeds, supplement and/or concentrates that are manufactured locally or imported from abroad.

 

Section 28. Inspection fees should be paid monthly on the basis of total feeds or feedstuffs manufacturer or imported, Provided that the manufacturer or importer shall show to the inspector upon request all records of production or importation for the months in question. Part of fractions of one (1) ton shall be considered as one ton.

 

Section 29. The inspection fee shall be paid monthly to the Cashier of the Bureau of Animal Industry or his duly authorized representative directly. Payments of inspection fees shall be accompanied, showing the following:

 

1.       Name of manufacturer or importer

 

2.       Address

 

3.       Date

 

4.       Kinds of feeds manufactured or imported

 

5.       Total weight (metric ton) of each kind of feed manufactured and/or imported.

 

Section 30. Surcharges. Fees imposed by the preceding sections which are not paid on the dates they are due shall be levied an additional charge in accordance with the following rates:

 

Within fifteen (15) days after due date � 25% of amount due.

 

Over fifteen (15) days but not more than thirty (30) days after due date � 50% of the amount due.

 

Over thirty (30) days but not more than forty five (45) days after due date � 75% of the amount due.

 

Provided, that the surcharges herein provided shall be without prejudice to whatever other legal remedies or actions which the government may take for the protection of its rights and interests.

 

ARTICLE XI � PROHIBITIONS

 

Section 31. Damaged and adulterated feed and feedstuff shall not be sold or offered for sale. For purposes of this Order, the addition of ground rice hull to rice bran is expressly prohibited.

 

Section 32. No custom � mixed feed shall be sold in the open market.

 

Section 33. Containers which have been previously used for things or objects harmful to animals shall not be used as containers for feed or feedstuffs. Feeds or feedstuffs found in said containers shall be considered damaged for purposes of this Order.

 

ARTICLE XII � DAMAGED AND ADULTERATED FEED DISPOSITION

 

Section 34. The Director may order the disposition and condemnation of feed and feeding stuff found to the damaged or adulterated under his direct supervision or he may order the disposition, under his supervision, of the damaged and/or adulterated feed and feeding stuff by the manufacturer, importer or any other person in possession thereof without prejudice for the damage or adulteration.

 

Section 35. The Director, upon recommendation of the Animal Feed Control Advisory Committee and with the approval of the Secretary, may order, in lieu of the disposition provided in the preceding section, the sale subject to conditions he may impose of the said damaged or adulterated feeds of some other economic value other than as animal feed, in which event the proceeds thereof shall accrue to the fund established under the Act.

 

ARTICLE XIII � OFFENSES AND PENALTIES

 

Section 36. (a) It shall be unlawful for any person partnership, firm, cooperative, corporation or association to engage in the manufacture, importation, sale or distribution of feeds or feeding stuff, without having first registered in accordance with this Act in the Office of the Director of Animal Industry. (b) Any firm, partnership, cooperative, corporation or association or its president/general manager or any person which will be unlawfully use a registration number, fraudulently lessen or adulterate the feeding value of any feed or feeding stuff, or tamper with packaged feeds for fraudulent purposes willfully remove, alter or efface the prescribed tags, labels, markings, or other information placed on packages of feeds or feeding stuffs, fraudulently alter or use certificates of analysis of any official analyst; willfully obstruct, hinder, resist or in any other way oppose the Director or his duly authorized representative in the execution of his duties under this Act; make unauthorized disposition of feed placed under detention; imports, manufacture, distribute, advertise, sell or offer for sale or possess for sale any feed which does not conform with or contravenes the provisions of this Act; or otherwise violate any provision of this Act and the rules and regulations issued hereunder, shall be punished by a fine of not less than One Thousand pesos or by imprisonment of not more than one year and one day, or by both, at the discretion of the court.

 

ARTICLE XIV � REPEALING CLAUSE

 

Section 37. This Order revokes Animal Industry Administrative Order No. 16 and shall revoke, amend and/or supersede such other orders, memoranda, rules and regulations which are inconsistent herewith.

 

ARTICLE XV � SEPARABILITY CLAUSE

 

Section 38.  Any section or portion of this Order which may hereafter be declared unconstitutional shall not affect the constitutionality of any other portions of this Order.

 

ARTICLE XVI � EFFECTIVITY

 

Section 39. This Order shall take effect six months after publication in the Official Gazette or in a newspaper of general circulation except the provisions of Articles II, III, XI, XII, and XIII which shall take effect one month after said publication. (Published in the Philippines Daily Express on November 26, 1975).

 

 

SO ORDERED.

 

 

 

(Sgd.) SALVADOR H. ESCUDERO III

Director

 

 

 

RECOMMENDED BY:

 

 

THE ANIMAL FEED CONTROL

ADVISORY COMMITTEE

 

BY:

 

            (Sgd.) GERONIMO DELA CERNA

Chairman

 

 

 

APPROVED:

 

 

(Sgd.) ARTURO R. TANCO, JR.

Secretary of Agriculture

 

 

 

ATTESTED BY:

 

 

(Sgd.) JAIME ABELLA SISON

Secretary, AFCAC

 

 

 

 

 

Republic of the Philippines

Department of Agriculture

BUREAU OF ANIMAL INDUSTRY

Visayas Avenue, Diliman

Quezon City

 

 

1977 � 05- 12

 

ANIMAL INDUSTRY              )

ADMINISTRATIVE ORDER )

No. 35-2, s.1977                    )

 

 

 

SUBJECT :  AMENDING CERTAIN PROVISIONS OF ANIMAL INDUSTRY ADMINISTRATIVE ORDER NO. 35 DATED SEPTEMBER 23, 1975, OTHERWISE KNOWN AS THE LIVESTOCK AND POULTRY FEEDS REGULATIONS, BY INSERTING A NEW SECTION TO BE KNOWN AS SECTION 10-A TO SAID ORDER. (RE: INSPECTION OF RESULTS OF CHEMICAL ANALYSIS BY THE DIRECTOR OF ANIMAL INDUSTRY OR HIS AUTHORIZED REPRESENTATIVE).

 

Section 1. A new section to be known as Section 10-a is hereby inserted after Section 10 of Animal Industry Administrative Order No. 35, dated September 23, 1975, otherwise known as the Livestock and Poultry Feeds Regulations, to read as follows.

 

�Section 10-a. It shall be mandatory for all commercial feed millers to allow the Director of Animal Industry or his authorized representative to inspect the results of chemical analysis of their finished products for purposes of the enforcement of these regulations.�

 

Section 2. This Order shall take effect upon approval.

 

APPROVED ON May 20, 1977.

 

 

(Sgd.) SALVADOR H. ESCUDERO III

Director

 

 

 

APPROVED:

 

 

(Sgd.) ARTURO R. TANCO, JR.

Secretary of Agriculture                                           CERTIFIED TRUE COPY:

 

 

 

           JAIME ABELLA SISON

Chairman, Animal Feed

Control Advisory Committee

 

 

 

 

 

Republic of the Philippines

Department of Agriculture

BUREAU OF ANIMAL INDUSTRY

Visayas Avenue, Diliman

Quezon City

 

 

1977 � 08 - 04

 

ANIMAL INDUSTRY             )

ADMINISTRATIVE ORDER )

No. 35-3, s.1977                   )

 

 

 

SUBJECT : AMENDING CERTAIN PROVISIONS OF ANIMAL INDUSTRY ADMINISTRATIVE ORDER NO. 35 DATED SEPTEMBER 23, 1975 ENTITLED "RULES AND REGULATIONS GOVERNING THE MANUFACTURE, IMPORTATION, LABELING, ADVERTISING, DISTRIBUTION AND SALE OF LIVESTOCK AND POULTRY FEEDS AND FEEDING STUFFS.

 

Pursuant to the provisions of Section 8, paragraphs (b) and (e), of Republic Act No. 1556, as amended, Section 12 and 25, paragraph (b) of Animal Industry Administrative Order No. 35 dated September 23, 1975 are hereby amended and the following supplemental rules and regulations are hereby promulgated for the information and guidance of all concerned:

 

Section 1. � Section 12 of the Order is hereby amended to read as follows:

 

Section 12 � All containers of mixed feeds and/or feed ingredients offered for sale shall bear a complete label as required by Section 5 of R.A. 1556, as amended by P.D. 7. Any commercial feed ingredients distributed in bulk shall be labeled by invoice. The invoice, which shall accompany delivery and be supplied to the purchaser at the time of delivery, shall contain in brief but concise statements the following:

 

a.       Net weight of the contents in the metric system;

b.       Name and address of manufacturer or supplier;

c.       Name and address of the purchaser;

d.       Brand or trademark;

e.       Date of Sale;

f.         Conditions: i.e. whole grain, cracked, middlings, cake, pellet, ground fine or coarse, etc.;

g.       Class: i.e. first, second or third (as prescribed by standard set by the Director of Animal Industry);

h.       Minimum percentage of crude protein and crude fat;

i.         Maximum percentage of crude fiber, ash and moisture; and

j.         Registration number.

 

Section 2. � Section 25 (b) of the Order is hereby amended to read as follows:

 

�Section 25.

 

b. Duplicate samples of a total of not less than � kilo and not more than � kilo may be taken from random sampled unopened bags. In case of liquid feed like molasses, a minimum of � pint in a plastic jar shall constitute a sample.

 

Section 3. � This Order shall take effect upon approval.

 

APPROVED ON August 11, 1977.

 

 

 

(Sgd.) SALVADOR H. ESCUDERO III

Director

 

 

APPROVED:

 

 

 

(Sgd.) ARTURO R. TANCO, JR.

Secretary of Agriculture

 

 

BAI AO #25 series of 1991

Registration And Licensing Of Veterinary Drug
And Product Premixes And Water Solubles And The
Corresponding Manufacturers, Importers, Suppliers, Distributors
And Retailers Of Said Products With The Animal Feeds Standard Division.

Republic of the Philippines

DEPARTMENT OF AGRICULTURE

Office of the Secretary

Elliptical Road, Diliman, QC

                                    October 4, 1991

Administrative Order

No. ____25_______

Series of 1991

SUBJECT :  REGISTRATION AND LICENSING OF VETERINARY DRUG AND PRODUCT PREMIXES AND WATER SOLUBLES AND THE CORRESPONDING MANUFACTURERS, IMPORTERS, SUPPLIERS, DISTRIBUTORS AND RETAILERS OF SAID PRODUCTS WITH THE ANIMAL FEEDS STANDARD DIVISION.

Pursuant to Republic Act 3720, as amended otherwise known as the �Feeds, Drugs and Devices and Cosmetics�, R.A. 6675, otherwise known as the �Generics Act of 1988� and R.A. 1556, as amended, otherwise known as the �Livestock and Poultry Feeds Act� and through the execution of Memorandum of Agreement between the Department of Agriculture (DA) and the Department of Health (DOH), the Bureau of Animal Industry (BAI) through the Animal Feeds Standard Division (AFSD) shall:

  1. Take charge of the licensing of the establishment which are engaged in the manufacture, distribution and sale of veterinary drugs and product premixes and water solubles;

  1. Take charge of the evaluation and registration of veterinary drugs and product premixes and water solubles;

  1. Conduct inspection and examination of veterinary drugs, and product premixes and water solubles; and

  1. Adopt and use the existing standard and requirements of DOH for licensing and registration including the applicable regulations related to generic labeling for veterinary drugs.

This order shall take effect on January 1, 1992

 

(Sgd.) SENEN C. BACANI

     Secretary

Recommending Approval:

(Sgd.) ROMEO N. ALCASID

                Director

 

DA AO #33 and DOH AO #111-A series of 1991

Rules And Regulations On Registration Of Veterinary Drugs And Products

Annex A

List Of Pharmaceutical Products Classified
As Prohibited Drugs Or Regulated Drugs
By The Dangerous Drugs Board

Annex B

List Of Veterinary Drugs And Products Requiring
Strict Precaution In Prescribing, Dispensing And Use

Annex C

Requirements For Registration

 October 7, 1991

 

DEPARTMENT OF AGRICULTURE

Administrative Order No. 33

Series of 1991

 

DEPARTMENT OF HEALTH

Administrative Order No. 111-A

Series of 1991

 

SUBJECT          :           RULES AND REGULATIONS ON REGISTRATION OF VETERINARY DRUGS

                                                    AND PRODUCTS

 

Pursuant to R.A. No. 3720, as amended by Executive Order No. 175 otherwise known as the �Foods, Drugs and Devices, and Cosmetics, R.A. No. 6675, otherwise known as the �Generics Act of 1988� R.A. 1556, biologics and medicinal preparations and R.A. 3101, an Act authorizing the Director of the Bureau of Animal Industry, subject to the approval of the Secretary of Agriculture and Natural Resources to promulgate regulations for the preparation, sale, traffic in, shipment and importation of viruses, sera, toxins, or analogous products used for the treatment of domestic animals, the following requirements for the registration of veterinary drugs and products are hereby promulgated for the information, guidance and compliance of all concerned:

 

Section 1. DEFINITION OF TERMS:

 

For purposes of these Rules and Regulations, the following definitions are adopted:

 

1.1    �Registration� refers to the process of approval for the manufacture, importation, exportation, sale, offer for sale, distribution, labeling, advertising or transfer of veterinary drugs and products obtaining active ingredients(s) known chemical structures and properties determined to be safe, efficacious, and of good quality according to standards of Bureau of Food and Drugs (BFAD)/Bureau of Animal Industry (BAI).

 

1.2     �Veterinary Drugs and Products� refer to any substance, including biological products, applied or administered to food producing, companion, aquatic, laboratory and exotic animals, whether used for therapeutic, prophylactic or diagnostic purposes or for modification of physiological functions or behaviors.

 

1.3     �Veterinary Drug for General Use� refers to a veterinary drug approved for sale for animal use without restriction other than the usual.

 

1.4     �Veterinary Drug for Restricted Use� refers to a veterinary drug approved for sale for animal use under certain conditions.

 

Section 2. GENERAL STANDARDS

 

2.1 Establishments applying to register a veterinary drug and product are required to fully disclose all pertinent documentation and information regarding the veterinary drug and product. Failure to fully disclose material information about the veterinary drug and product is a ground for disapproval of registration application and one of the bases for withdrawal of the establishment�s license to operate.

 

2.2 Action on registration application shall be based on the complete set of specification of the veterinary drug and product proposed to appear on the label, i.e. formulation, dosage form, strength, therapeutic indications and manufacturer. Any change in any of the above specification shall require a new registration.

 

2.3 Action on registration application shall include the classification of the veterinary drugs and products among each of the classification categories defined in Section 3 below. Any change in classification shall require a new registration. However, any change in the name of the same manufacturer shall require proper notification of BFAD/BAI.

 

2.4 The standards of veterinary drug and product registration as well as the methods of evaluation are subject to revisions. Any major change shall be made after proper consultation with the parties concerned. Revised standards and evaluation methods shall be made applicable to all covered veterinary drugs and products as appropriate.

 

2.5 Only establishments with valid license to operate required under joint Administrative Orders No. 100, Department of Agriculture and No. 138, Department of Health, series 1990 can apply to register veterinary drug and products.

 

Section 3. CLASSIFICATION

 

All veterinary drugs and products shall be evaluated and registered on the basis of specific requirements and standards pertinent to the classification of such veterinary drugs and products. All registered veterinary drugs and products shall be classified in terms of each of the following categories.

 

3.1 Number of Active Ingredients

 

3.1.1 Single Active Ingredients

 

3.1.2 Fixed-dose combination of two or more active ingredients

 

3.2 Available scientific and product�s evidence and experience on the veterinary

drug use

 

3.2.1 �Investigational Veterinary Drugs and Products� refer to any new chemical or structural modification of Tried and Tested or Established Veterinary Drug and Product proposed to be used for a specific therapeutic indication. Investigational veterinary drug and product need further clinical pharmacology studies (Phase I, II, or III) to determine their safety and efficacy, and meet the requirements of new veterinary drugs and products.

 

3.2.2 �New Veterinary Drug and Product� refer to any new chemical or structural modification of Tried and Tested or Established Veterinary Drugs and Products proposed to be used for a specific therapeutic indication, which have undergone adequate clinical pharmacology Phase I, II, and III studies but which need further Phase IV Clinical Pharmacology studies before they can be given regular registration.

 

3.2.3 �Tried and Tested Veterinary Drugs and Products� refers to any veterinary drug and product which have been used for at least five (5) years.

 

3.2.4 �Established Veterinary Drug and Product� refers to veterinary drug and product the safety and efficacy of which have been demonstrated through long years of general use and can be found in current official USP-NF, and other internationally-recognized pharmacopeias.

 

3.2.5 �Pharmaceutical or Therapeutic Innovation of Tried and Tested or Established Veterinary Drug and Product� includes any or all the following:

 

3.2.5.1   An innovation involving use for new indication(s)

 

3.2.5.2   An innovation involving a new mode of administration

 

3.2.5.3   An innovation involving a new dosage form

 

3.2.5.4   An innovation involving a new fixed dose combination of two or more ingredients.

 

3.3   Pharmacologic/therapeutic category as specified in the Philippine National Veterinary Drug Formulary (See joint A.O. DOH-No. 100 and DA-No. 138 s. 1990)

 

3.4    Source or circumstance of veterinary drug and product production

 

3.4.1 Imported as finished

 

3.4.2 Locally-manufactured from imported materials

 

3.4.3 Locally-manufactured from local materials

 

3.5   Brand identification and patent protection of the veterinary drug and product

 

3.5.1 Brand and patented

 

3.5.2 Branded and off-patent

 

3.5.3 Unbranded and off-patent (generic veterinary drug and product)

 

3.6   Prescribing and dispensing regulations applicable

 

3.6.1 Over-the-counter (OTC) Veterinary Drugs and Products or Non-prescription Veterinary Drugs and Products or

Self Service (SS) Veterinary Drugs and Products.

 

3.6.2 Ethical or Prescription Veterinary Drugs and Products

 

3.6.3 Dangerous Drugs (Annex A � List A)

 

3.6.4 Veterinary Drugs requiring strict precaution in prescribing and dispensing (Annex B � List B)

 

Section 4. INITIAL PRODUCT REGISTRATION

 

4.1 Application

 

Any establishment applying for the initial registration of veterinary drug and product shall file an application under oath. The application shall be in a form promulgated by BFAD/BAI and supported by the documents and requirements listed in Annex C.

 

4.2 Evaluation by Review of Submitted Data

 

BFAD/BAI evaluates the submitted data. First, it determines if the data presented are complete. If not complete, applicant is requested to submit additional data or undertake needed animal or clinical studies. Second, it determines if on the basis of data submitted, veterinary drug and product meet current BFAD/BAI standards for quality, purity, safety, efficacy, potency or therapeutic value.

 

4.3 Evaluation by Testing of Submitted Samples

 

BFAD/BAI evaluates submitted samples of veterinary drug and product. The evaluation shall cover physical, chemical and biological tests for quality, purity, safety, potency or efficacy.

 

4.4 Assessment of Findings

 

At any point during the evaluation, BFAD/BAI may conclude that the veterinary drug and product do not meet the standards of quality, safety, potency, purity, efficacy and therapeutic value. In such case, the application shall be denied. At the end of the evaluation, BFAD/BAI shall arrive at a recommendation regarding action on the registration application.

 

4.5 Action on Registration Application

 

BFAD/BAI action on the registration application consists of the following possible courses:

 

4.5.1 Disapproval of application for failure to meet standards of quality, safety, potency, efficacy, purity or therapeutic value.

 

4.5.2 Disapproval of application for lack of qualification required from veterinary drug and product establishment.

 

4.5.3 Approval for investigational use over a period of variable duration depending on the BFAD/BAI accepted protocol.

 

4.5.4 Approval for post-marketing surveillance for a period of 3 years subject to annual evaluation.

 

4.5.5 Approval for general use for a period of five (5) years subject to annual evaluation.

 

4.5.6 Approval for restricted use for a period of five (5) years subject to annual evaluation.

 

4.6 Grounds for Disapproval

 

The two (2) types of disapproval action (4.5.1 and 4.5.2) shall be taken on the following grounds.

 

4.6.1 Review of submitted data or testing of submitted samples indicate that the product does not meet current BFAD/BAI and or manufacturer�s guaranteed standards of identity, purity, strength, quality, safety, potency, efficacy or therapeutic value.

 

4.6.2 The labelling material of the veterinary drug and product is false and misleading or does not conform with current labelling requirements.

 

4.6.3 Applicant materially misrepresented or withheld significant data or information regarding the veterinary drug and product.

 

4.6.4 Applicant failed to comply with the requirements for registration.

 

4.7 Grounds for Limited Approval

 

The two (2) types of limited approval actions (4.5.3 and 4.5.4) shall be taken on the following grounds:

 

4.7.1 An investigational Veterinary Drug and Product Application shall be approved when the following are met.

 

4.7.1.1 The results of prior laboratory animal studies are found adequate to warrant further clinical pharmacology studies (phase I, II and/or III)

 

4.7.1.2 The protocol submitted for the clinical pharmacology studies is found to be adequate and scientifically sound in experimental design.

 

4.7.1.3 The clinical investigator who shall undertake the study is competent and reliable and the facilities and control used for the study are adequate.

 

4.7.2 A New Veterinary Drug and Product Application shall be approved for post-marketing surveillance when the following are met.

 

4.7.2.1 The results of prior laboratory animal studies are found adequate and the clinical pharmacology Phase I, II and III show that the New Veterinary Drug and Product are safe and efficacious when used for their therapeutic indication.

 

4.8 Grounds for Approval

 

The two (2) types of approval actions (4.5.5 and 4.5.6) shall be taken on the following grounds.

 

4.8.1 Review of submitted data and testing of submitted samples indicate that the application is supported by substantial evidence showing the veterinary drug and product to be safe, efficacious and good quality.

 

4.8.2 Applicant demonstrated that the methods used in as well as the facilities and controls used for, manufacture of the veterinary drug and product are adequate to assure their identity, strength, quality, purity, safety, potency, efficacy and therapeutic value.

 

4.8.3 The label of the veterinary drug and product is a correct representation of such veterinary drug and product and conforms with current labeling requirements.

 

Section 5. RENEWAL OF REGISTRATION

 

5.1 Only veterinary drugs and products registered for general and restricted use are eligible for renewal of registration.

 

5.2 Application for renewal of registration shall be made on a form promulgated by BFAD/BAI.

 

5.3 Renewal application shall be reviewed and evaluated on the basis of the veterinary drug and product and the applicant meeting the current BFAD/BAI and manufacturers guaranteed standards of identity, purity, strength, quality, safety, potency, efficacy and therapeutic value.

 

Section 6. SCHEDULE OF FEES

 

Upon application for registration of a veterinary drug and product, the following non-refundable fees to be paid in full for the entire selected period of registration, shall be charged:

 

6.1 Initial Registration

 

6.1.1 Investigational � P 1,000 per year or any fraction thereof

veterinary drug and

product application

 

6.1.2 New veterinary � P 6,000 for 3 years + cost of laboratory analysis

drug and product

application for mar-

keting-surveilance

 

6.1.3 New veterinary �    P 4,000 for 2 years or P10,000 for 5 years + cost of laboratory analysis

drug and product

application for gene-

ral or restricted use

 

6.1.4 New pharmaceu -   P 4,000 for 2 years or P10,000 for 5 years + cost of laboratory analysis

tical or therapeutic

innovation of tried

and tested or estab-

lished veterinary

drug or product

 

6.1.5 Unbranded Generic � P 1,000 for 2 years or P 2,500 for 5 years + cost of laboratory analysis

Veterinary Drug or

Product

 

6.1.6 Branded Generic � P 2,000 for 2 years or P 5,000 for 5 years + cost of laboratory analysis

Product

 

6.2 Renewal of Registration � P 1,500 for 5 years + cost of laboratory analysis

 

Section 7.  APPEAL

 

Disapproved application(s) may be appealed to the Secretary of Health / Secretary of Agriculture for reconsideration.

 

Section 8. SEPARABILITY CLAUSE

 

In case any provision of this administrative order is declared contrary to law or unconstitutional, other provisions which are not affected hereby shall continue to be in force in effect.

 

Section 9. REPEALING CLAUSE

 

All administrative orders, rules and regulations and other administrative issuance or parts thereof inconsistent with the provisions of this Administrative Order are hereby repealed or modified accordingly.

 

Section 10. EFFECTIVITY

 

This regulation shall take effect fifteen (15) days after its publication in a newspaper of general circulation.

 

 

 

 

 

 

 

(Sgd.) SENEN C. BACANI                                                                    (Sgd.) ALFRED R. A. BENGZON, M.D.

Secretary of Health                                                                                                Secretary of Health

 

 

 

 

 

 

ANNEX A

(LIST A)

 

LIST OF PHARMACEUTICAL PRODUCTS CLASSIFIED AS PROHIBITED DRUGS OR REGULATED DRUGS BY THE DANGEROUS DRUGS BOARD

 

I. Prohibited Drugs

 

1. ALFENTANIL - Rapifen Injectable
2. CODEINE (as sulfate) - Codeine Sulfate H.T.
- Codeine Sulfate T.T.
3. CODEINE (as phosphate) - Dolo-Adamon Suppository
- Dolo-Adamon Tablet
4. DIHYDROCODEINE - NOT AVAILABLE IN THE MARKET
5. FENTANYL (as citrate) - Sublimaze Injectable
6. FENTANYL (as citrate) / Droperidol - Innovar
7. HYDROCODONE (DIHYDROCODEINONE) - Deka Syrup
(as bitartrate) - Raminon Syrup
8. HYDROCODONE (DIHYDROCODEINONE) - Tussinex Suspension
9. HYDROCODONE (DIHYDROCODEINONE) -Codevite Syrup
(as bitartrate) plus Pyrilamine (as maleate) /
Sodium Citrate / Ammonium
Chloride / Potassium
Guaiacolsulfonate
10. HYDROCODONE (DIHYDROCODEINONE) / - Endotussin Syrup
(as bitartrate) plus Pyrilamine (as maleate) /
Homatropine (as methylbromide) /
Phenylephrine (as hydrochloride) /
Ammonium Chloride
11. MORPHINE (as sulfate) - Morphine Sulfate H.T.
- Morphine Sulfate Ampul
- Morphine Sulfate Tablet
12. MORPHINE (as sulfate) / Atropine - Morphine with Atropine
13. OPIUM - Brown Mixture Tablet
- Brown Mixture Liquid
14. OPIUM / ALCOHOL - Elixir Paregoric
15. PETHIDINE (MEPERIDINE) - Demerol Ampul
- Demerol Tablet
- Demerol Vial

II. Regulated Drugs

 

  1. Available in the Market

 

1. AMOBARBITAL (as sodium) - Amytal Sodium Ampul
- Amytal Sodium Capsule
- Amytal Sodium Tablet
2. AMPHETAMINE - Benzedrine Tablet
- Daprisal Tablet
3. APROBARBITAL, BARBITAL, AND - Plexonal
PHENOBARBITAL
4. CHLORAL HYDRATE - Noctec
5. DEXAMPHETAMINE - Dexedrine Spansule
6. EPHEDRINE (excluding exempt preparations)
7. ETHINAMATE - Valamin Tablet
8. FLUNITRAZEPAM - Rohypnol
9. NITRAZEPAM - Mogadon
10. PARALDEHYDE - Paraldehyde Ampule
11. PENTAZOCINE (as hydrochloride) - Sosegon Tablet
12. PENTAZOCINE (as base) - Sosegon Ampule
13. PENTHOTAL (as sodium) - Penthotal Sodium Vial
- Thiopental Sodium Vial
14. PROPOXYPHENE (as hydrochloride) - Doloxene Palin Tablet
15. PROPOXYPHENE (as napsylate), - Doloxene Compound-65
Aspirin, and Caffeine
16. PROPOXYPHENE (as napsylate) - Dologesic - 32
/ Paracetamol
17. PSEUDOEPHEDRINE (excluding exempt preparations)

 

Local suppliers no longer carry these drugs but are still available in some drugstores and hospital pharmacies.

 

  1. Not Available in the Market

 

1. AMOBARBITAL / DEXAMPHETAMINE - Dexamyl Spansule No.1
2. BUTABARBITAL - Butisol Sodium Tablet
- Circuline Forte Tablet
3. ETHCHLORVYNOL - Placidyl Capsule
4. HYDROCODONE (DIHYDROCODEINONE) / - Calcidrine Syrup
PENTOBARBITAL
5. MECLOQUALONE - Nubarene Tablet
6. METHAMPHETAMINE - Desoxyn Tablet
7. METHAQUALONE / Diphenhydramine - Mandrax Tablet
(as hydrochloride)
8. METHYLPRYLON - Noludar Tablet
9. PENTOBARBITAL (as sodium) - Nembutal Sodium Vial
10. PIPRADROL - Gadexyl Tablet
11. SECOBARBITAL - Seconal Sodium Capsule

Local suppliers no longer carry these drugs but are still available in some drugstores and hospital pharmacies.

 

 

 

 

ANNEX B

(LIST B)

 

LIST OF VETERINARY DRUGS AND PRODUCTS REQUIRING STRICT PRECAUTION IN PRESCRIBING, DISPENSING AND USE

 

1. ACEPROMAZINE : TABLET / INJECTABLE
2. AMINOPHYLLINE : SUPPOSITORY / TABLET
3. AMITRAZ : POUR ON
4. AMPHOTERICIN B : INJECTABLE
5. AZAPERONE : INJECTABLE
6. BETAMETHASONE : TABLET
7. BUNAMIDINE : TABLET
8. CARBADOX : PREMIX
9. CHLORAMBUCIL : TABLET
10. CHLORAMPHENICOL : CAPSULE / INJECTABLE
11. CHLORPROPAMIDE : TABLET
12. COLISTIN : INJECTABLE
13. CYCLOPHOSPHAMIDE : TABLET
14. DEXAMETHASONE : TABLET
15. DEXAMETHASONE ACETATE : INJECTABLE
16. DIAZEPAM : TABLET
17. DICHLORVOS : CAPSULE / GRANULES
18. DIETHYLESTILBESTROL (DES) : INJECTABLE
:
19. DIGITOXIN : TABLET
20. DIGOXIN : TABLET
21. DIHYDROSTREPTOMYCIN : INJECTABLE
22. DIMETRIDAZOLE : INJECTABLE
23. DIMINAZINE : INJECTABLE
24. EPINEPHRINE : INJECTABLE
25. ERYTHROMYCIN : INJECTABLE
26. ESTROGENS, CONJUGATED : INJECTABLE
27. ETHINYLESTRADIOL : TABLET
28. ETHOSUXIMIDE : CAPSULE
29. FURAZOLIDONE : SUSPENSION / TABLET
30. FUROSEMIDE : TABLET / INJECTABLE
31. GENTAMACIN : INJECTABLE
32. HALQUINOL : PREMIX
33. HYDROCHLOROTHIAZIDE : TABLET
34. HYDROCORTISONE : INJECTABLE
35. IMIDOCARB : INJECTABLE
36. INSULIN : INJECTABLE
37. IVERMECTIN : TABLET / INJECTABLE
38. KETAMINE : INJECTABLE
39. LASALOCID : PREMIX
40. LEVAMISOLE : INJECTABLE
41. LINDANE : POUR ON
42. LORAZEPAM : ORAL
43. MELARSONYL : INJECTABLE
44. MENADIONE : TABLET
45. MENADIONE SODIUM BISULFATE : TABLET
46. MEPHENYTOIN : TABLET
47. METHDILAZINE HYDROCHLORIDE : TABLET
48. METHOTREXATE : TABLET
49. METHYLERGOMETRINE
(METHYLERGONOVINE) MALEATE : TABLET
50. METRONIDAZOLE : TABLET
51. MONENSIN : PREMIX
52. NEOMYCIN : INJECTABLE
53. NICLOSAMIDE : TABLET
54. NITROFURANTOIN : CAPSULE/SUSPENSION
TABLET
55. OLAQUINDOX : PREMIX
56. OUABAIN : INJECTABLE
57. OXYTETRACYCLINE (LONG-ACTING) : INJECTABLE
58. OXYTOCIN : INJECTABLE
59. PANCURONIUM : INJECTABLE
60. PERPHENAZINE : SUPPOSITORY / SYRUP / TABLET / CR TABLET
61. PHENYLBUTAZONE : CAPSULE / TABLET
62. PHENYTOIN : SUSPENSION
63. PHENYTOIN SODIUM, EXTENDED : CAPSULE
64. PHENYTOIN SODIUM, PROMPT : CAPSULE
65. PRAZIQUANTEL : TABLET
66. PROBENECID : TABLET
67. PROCAINAMIDE HYDROCHLORIDE : CAPSULE/TABLET/CR TABLET
68. PROPIONYL PHENOTHIAZINE : INJECTABLE
69. PROSTAGLANDIN  F2 ALPHA : INJECTABLE POWDER
70. PYRAZINAMIDE : TABLET
71. QUINIDINE SULFATE : CAPSULE/TABLET/CR TABLET
72. SALINOMYCIN : PREMIX
73. SPIRONOLACTONE : TABLET
74. STREPTOMYCIN : INJECTABLE
75. SUCCINYLCHOLINE : INJECTABLE
76. SULFADIAZINE; SULFAMERAZINE
SULFAMETHAZINE : TABLET
77. SULFAMETHIZOLE : SUSPENSION / TABLET
78. SULFISOXAZOLE : SUSPENSION  / TABLET
79. SURAMIN : INJECTABLE

 

 

 

ANNEX C

 

REQUIREMENTS FOR REGISTRATION

 

A. General Requirements

 

1. License To Operate of the veterinary drug and product manufacturer, trader, distributor / importer, distributor / exporter.

 

2.  Technical data which shall include:

 

2.1    Physical description of the veterinary drug and product.

 

2.2    Complete formulation and technical specifications for the raw materials and finished product.

 

2.3    Process of manufacturing including facilities and control used in the manufacturing and packaging of

the veterinary drug and product.

 

2.4    Description of all quality control tests performed stability including Dissolution Test, when applicable,

and results obtained.

 

2.4.1 For antibiotic products, results of batch analysis.

 

2.5   Certificate of analysis and assay procedures for active ingredient(s) and degradation product(s) if

any.

 

2.6   Complete stability studies under local conditions

 

3.   Samples and corresponding reference standards.

 

4.  Two copies of labels or specimens of the proposed label and other labeling materials such as inserts brochures, etc.

 

5.  Relevant literature and/or scientific evidence based on local or foreign studies to show safety, efficacy, potency, and therapeutic value of the veterinary drug and product. Local studies must be based on protocols acceptable to BFAD / BAI.

 

B. Specific Requirements

 

1.  Investigational Veterinary Drug and Product

 

1.1   Veterinary Medical Director / Officer registered with BFAD / BAI.

 

1.2   Laboratory Animal Studies

 

1.2.1    Acute toxicity

 

1.2.2    Sub-chronic toxicity

 

1.2.3    Teratogenicity

 

1.2.4    Other studies, e.g. carcinogenecity

 

1.3   Clinical Pharmacology Studies

 

1.3.1   Phases I and II tolerance and efficacy studies.

 

1.3.2   Phase III clinical trial for target animal species.

 

1.3.2.1   Local

 

1.3.2.2   Foreign when applicable

 

2.  New Veterinary Drug and Product

 

2.1    Veterinary Medical Director / Officer registered with BFAD / BAI.

 

2.2   Results of laboratory animal and clinical studies as required in Section 1.2 and 1.3 of this Annex and

results of carcinogencity test if required by BFAD/BAI.

 

2.3    Results of Ecological or Environmental Impact Assessment (EIA) when applicable.

 

2.4    Phase IV Clinical Use

 

2.4.1 Post-marketing surveillance

 

3.  Tried and Tested Veterinary Drug and Product

 

3.1   Dissolution test for solid oral dosage forms when applicable.

 

3.2   Bioavailability / bioequivalence study for certain veterinary drugs and products determined by BFAD /

BAI when applicable.

 

3.3   Local clinical trial to determine effective therapeutic dose range in target animals when applicable.

 

4.  Established Veterinary Drug and Product

 

4.1  Dissolution test for solid dosage forms when applicable.

 

4.2 Bioavailability / bioequivalence study for certain veterinary drugs and products as determined by BFAD / BAI when applicable.

 

5.  Pharmaceutical and Therapeutic innovation of Tried and Tested or Established Veterinary Drug and Product.

 

5.1   Veterinary Medical Director / Officer registered with BFAD / BAI.

 

5.2   Dissolution test for solid dosage forms when applicable.

 

5.3   Bioavailability / bioequivalence for certain drugs as determined by BFAD/BAI when applicable.

 

5.4  Local clinical and non-clinicals trial to test efficacy, potency, and safety of the therapeutic innovation, when applicable.

 

C. Additional Requirements for Certain Categories.

 

1.  Dangerous Drugs

 

1.1  Certificate of clearance from the Dangerous Drug Board.

 

2.  Branded Drugs

 

2.1  Certificate of trademark from the Bureau of Patents

 

2.2  Certificate of brand name clearance issued by BFAD/BAI

 

3.  Imported Finished Products

 

3.1 Certificate of Free Sale of Veterinary Drug and Product in country of origin authenticated by the territorial Philippine Consulate and/or

 

3.2  Certification from FAO/WHO International Certification Scheme for manufacturers or equivalent.

 

4.  Locally-manufactured Products from Imported Materials.

 

4.1  Certificate of quality of imported raw materials from the Drug Regulatory Authority of the country of origin from the FAO/WHO.

 

4.2   License To Operate of the manufacturer, if different from applicant.

 

4.3   Copy of the contract between applicant and manufacturer, when applicable.

 

4.4   Certificate of Fee Sale for registration of any veterinary drug and product containing said ingredient or raw material in country of origin authenticated by the territorial Philippine Consulate.

 

5.   Locally-manufactured Products from Local Materials.

 

5.1   License To Operate of the manufacturer of the local raw material(s).

 

5.2   License To Operate of the manufacturer of the finished product, if different from applicant.

 

5.3   Copy of contract between applicant and manufacturer of the finished products, when applicable.

 

DA AO #14 series of 2003

Ban On The Use In Food Animals Of Beta-Agonist Drugs
Used In Human As Bronchodilators And Tocolytic Agents.

Republic of the Philippines

DEPARTMENT OF AGRICULTURE

Office of the Secretary

Elliptical Road, Diliman, Quezon City 1100

Philippines

 

 

ADMINISTRATIVE ORDER

No. __24__

Series of 2005

 

 

SUBJECT:            GENERAL GUIDELINES AND REQUIREMENTS ON THE QUALITY CONTROL LABORATORY ACCREDITATION OF COMMERCIAL AND NON-COMMERCIAL DRUG MANUFACTURERS, VETERINARY DRUG MANUFACTURERS AND FOR FEED AND DRUG SERVICE LABORATORIES

 

Pursuant to the implementation of and in support to R.A. 1556, Animal Industry AO No.35 Article IV Sections 9 & 11; AO no. 25 series of 1991, the following requirements for accreditation are hereby promulgated.

I. PURPOSE AND SCOPE

These requirements are to be accomplished by all Quality Control Laboratories of Commercial/Non-Commercial Feed manufacturers, Veterinary Drug manufacturers/Tollers and Purely Service Laboratories.

Applicants will have to provide documentations ion all laboratory activities and must allow inspection of the laboratory premises by the Laboratory Technical Assessors from the Central Animal Feed Analysis and the Pharmaceutical Production Laboratories of the Laboratory Services Division, Bureau of Animal Industry.

II. DEFINITION OF TERMS

When used in the guidelines, the following terms shall mean as follows:

  1. Accreditation - formal recognition of competence
  2. Assessors - Technical Staff of the Central Animal Feed Analysis and the Pharmaceutical Production Laboratories of the Bureau of Animal Industry to carry out inspection/audits and shall provide recommendations.
  3. Audit/Inspection � periodic and systematic assessment of all policies and procedures.
  4. Test Procedures- defined technical procedures of all analyses/assays conducted.
  5. Documentation � written procedures/results.
  6. Reference Books/Materials � references which provide essential traceability and are used to demonstrate the accuracy of the following: procedures/methods, results, monitor performance to validate methods and enable comparison of methods by the set standards.

III. REQUIREMENTS:

  1. Accomplished Application Form for laboratory inspection/accreditation 2. The laboratory shall be legally identifiable.
  2. The owner of the laboratory whether an individual, partnership or corporation must be registered with the Department of Trade and Industry (DTI) or Securities and Exchange Commission (SEC).
  3. The laboratory shall submit certified photocopy of the environmental certificate of compliance/clearance from DENR.
  4. The laboratory shall submit certified photocopy of the license/s, permit/s from other government regulatory bodies.
  5. The laboratory shall submit a clear structure of responsibility. It shall have:a.   Management Staff with authority to discharge dutiesc.   Quality Control Staff responsible for quality control system of production and of analysis
  6. b.   Technical Staff responsible for production and for results
  7. The laboratory shall have the competence to conduct all claimed analyses and assays and deliver results within a prescribed period with traceability.
  8. The laboratory shall submit documented analysis procedures. 8. The laboratory shall submit the following documents to CAFAL-LSD for tabletop evaluation:

a. Duly accomplished and notarized application

b. Organizational structure

c. Photocopy of Chemists� PRC license

d. Affidavit of Quality Control Chemist

e. List of Laboratory analyses conducted

f. Test procedures of all analyses/capabilities conducted

g. List of equipment with specifications (classifying into functional and non-functional)

h. List of chemicals and reagents (no. of bottles, net weight)

i. Prescribed fees (if any)

j. List of reference books/materials

k. Floor plan of the laboratory

l. Ocular inspection and evaluation of laboratory facilities

i. it shall request in writing the schedule for laboratory inspection

ii. it shall convey inspector(s) to and from the site

iii. it shall submit receipt of payment/s (inspection and accreditation fees)

  1. 9. The requesting laboratory shall pay the following corresponding fees per annum:a. Laboratory Inspection Fee ���������................................ P 250.00c. Combination of Feed and VDAP Laboratory Accreditation Fee �. .1,000.00
  2. d. Service Laboratories �����������. ................................1,500.00
  3. b. Feed Laboratory Accreditation Fee ����. .. ................................... 500.00

IV. COMPLAINTS

The laboratory shall have documented policy and procedures for the resolution of complaints received from clients.

The laboratory shall have complete records of all complaints and all the actions taken.

V. VALIDITY

Accreditation shall be valid for a period of one (1) year.

 

The implementation of this ORDER shall be the responsibility of the Laboratory Services Division, Bureau of Animal Industry.

 

 

(Sgd.)  DOMINGO F. PANGANIBAN

                       Secretary

DA AO #60 and DOH AO #91 series of 1990

Declaring A Ban On The Use Of Chloramphenicol
In Food Producing Animals.

DEPARTMENT OF AGRICULTURE                                                                     April 30, 1990

Administrative Order No. 60

Series 1990

 

DEPARTMENT OF HEALTH

Administrative Order No. 91

Series 1990

 

 

SUBJECT     :     DECLARING A BAN ON THE USE OF CHLORAMPHENICOL IN FOOD

                             PRODUCING ANIMALS.

 

Chloramphenicol is an active ingredient of drug products with a proven value as an antibiotic for life threating infections in humans. It is also being used by mixing with feed for animals raised as food.

 

  1. The Subcommittee on Veterinary Drugs of the National Drug Committee at the Department of Health has determined that the use of chloramphenicol in food-producing animals present a clear public health danger resulting from high levels of chloramphenicol residues in meat, milk and eggs. The said subcommittee, therefore, recommends the prohibition in the use of chloramphenicol for such purposes.

 

  1. A task force created by the Department of Agriculture has also come to the same conclusions, and therefore concurs with the same recommendation.

 

  1. Based on the work of these expert committees, the Departments of Agriculture and Health have agreed on the following findings:

 

3.1 Chloramphenicol is a useful drug for treating infections in humans. Its value however, requires that it be used discriminately through physicians prescription after a sound diagnosis.

 

3.2 When used in animals raised for food, chloramphenicol residues build up in animal tissues that are eventually ingested by humans when these are consumed. The human tolerance for such residues cannot be established because the effect may or may not be related to the dose or the duration of exposure. In fact, the joint FAO/WHO Expert Committee on Food Additives has not recommended an acceptable residue level since no assurance can be given that even low residue levels would be safe for certain sensitive individuals.

 

3.3 Indiscriminate or even discriminate use of chloramphenicol in food producing animals can lead to build-up of residues in food derived from such animals causing (a) increased chance of human exposure to possibility of aplastic anemia, one of the rare but fatal conditions associated with chloramphenicol, and (b) alteration of microbial ecology leading to increased chloramphenicol-resistance of human pathogens.

 

Now, therefore, we the Secretariats of Agriculture and Health, jointly and several order the following:

 

  1. Chloramphenicol is banned from use in all food producing animals, including in aquaculture, regardless of the route of administration.
  2. Registration of chloramphenicol products for use in food-producing animals, is withdrawn and future applications for similar registration shall be disapproved.
  3. All concerned personnel are instructed to implement the ban  and educate the public on the reasons for such ban.

 

 

For compliance.

 

 

 

(Sgd.) ALFREDO R.A. BENGZON, M.D.                                                (Sgd.) SENEN C. BACANI

Secretary                                                                                               Secretary

Department of Health                                                                           Department of Health

 

 

DA AO #1 and DOH #4-A series of 2000

Banning And Withdrawal Of Olaquindox
And Carbadox From The Market

Republic of the Philippines

Department of Health

OFFICE OF THE SECRETARY

 

 

January 11, 2000

 

DEPARTMENT OF HEALTH

Administrative Order No. 4-A, s. 2000

 

 

DEPARTMENT OF AGRICULTURE

Administrative Order No. 1, s. 2000

 

 

Subject:          BANNING AND WITHDRAWAL OF OLAQUINDOX AND CARBADOX FROM THE MARKET

 

 

Olaquindox and Carbadox are anti-microbial drugs used in livestock production to reduce Salmonella shedding in animals. Both drugs have long withdrawal period of about 70 days. The parent compounds of both drugs possess genetoxic potential. Absence of specific toxicity studies on the metabolites and the slight increase in the incidence of adrenal cortex adenomas in male mice have prompted the Joint Expert Committee on Food Additives of the Food and Agriculture Organization of the World Health Organization not to establish an acceptable daily intake for these two active ingredients. Studies also indicated that possible exposure of workers handling the product to the parent molecules may pose a real risk of irritation, allergy, anaphylactic shock and other cumulative effects.

 

The Subcommittee on Veterinary Drugs of the National Drug Committee of the Department of Health therefore conclude that the potential hazards in the use of these drugs outweigh the benefits derived from the use of these products.

 

Now, therefore, we, the Secretary of Agriculture and the Secretary of Health, jointly and severally order the following:

 

1.                          Olaquindox and Carbadox shall no longer be allowed for use in all food producing animals, including in aquaculture regardless of the route of administration.

 

2.                          Registration of Olaquindox and Carbadox for use in food producing animals shall be immediately withdrawn and future application for similar registration shall be disapproved.

 

3.                          All existing stocks of both drugs shall be immediately withdrawn from all distribution outlets.

 

4.                          All concerned personnel are instructed to implement the ban and educate the public on the reason to such ban.

 

This Order shall take effect fifteen (15) days after publication in a newspaper of general circulation.

 

 

 

(Sgd.) ALBERTO R. ROMUALDEZ JR., M.D.                            (Sgd.) EDGARDO J. ANGARA

Secretary                                                                                       Secretary

Department of Health                                                             Department of Agriculture

 

 

DA and DOH AO #2 series of 2000

Declaring A Ban/Phase-Out Of The Use Of Nitrofurans
In Food-Producing Animals.

Republic of the Philippines

Department of Health

Department of Agriculture

                                        17 August, 2000

Joint Administrative Order

No. 2 s. 2000

SUBJECT:    DECLARING A BAN/PHASE-OUT OF THE USE OF NITROFURANS IN FOOD-

                        PRODUCING ANIMALS.

The Nitrofurans is a group of synthetic antibacterial compounds that have a broad spectrum of activity, being of value against Gram-positive and Gram-negative bacterial infections. Nitrofurans use today in mainly on topical preparations for the eye, ear and mucous membranes and skin; with a limited use in treating bacterial gastro-intestinal and urinary tract disorders. The major disadvantage of nitrofurans to treat systemic infections is that the concentrations need to reach the Minimum Inhibitory Concentration (MIC) also induce systemic toxicity.

There a have been many reports in the veterinary literature on the toxicities induced when the nitrofurans are used systemically. The toxicity of Furazolidone has been investigated extensively in laboratory, food and companion animals as well as in human and has recently been reviewed. Toxic signs seen with extensive doses of nitrofurans derivatives include central nervous system involvement (excitement, tremors, convulsions, peripherial neuritis), gastrointestinal disturbances, poor weight gain and depression of spermatogenesis. Various sensitivity reactions can also occur. Furazolidone has also been demonstrated to be carcinogenic when used at 0.15% w/w concentration in feed for one year, including mammary tumors in dose-related manner.

Nitrofurans has been recognized by the Food and Drug Administration in United States as both mutagen and a carcinogerr and can no longer be used in the U.S.A. since 1991. In Germany, the Federal Health Office has announced that it has withdrawn approvals of veterinary products containing nitrofurans except furazolidone for food producing animals.

On the basis of the European Commission Regulations 2901/93 of 18 October 1993 and 2377/90 of 26 June 1990 on the establishment of a community procedure for the stipulation of maximum permissible concentrations for veterinary drug residues in foods of animal origin, all nitrofurans except furazolidone were included in the list of pharmacologically active substances for which no maximum permissible concentrations can be stipulated. Nitrofurazone and Furazolidone are banned for use in food-producing animals and are no longer available as feed additives in the U.S.A.

On account of these new evidences, the Subcommittee on Veterinary Drugs of the National Drug Committee of the Department of Health therefore concludes that the nitrofurans should be banned for use in food-producing animals and should no longer be used as feed additives.

Now, therefore, we the Secretary of Agriculture and the Secretary of Health, jointly order the following:

  1. Nitrofurans should be banned for use in all food-producing animals, including aquaculture regardless of the route of administration.

  1. Registration of nitrofurans for use in food-producing animals is withdrawn and future application for similar registrations shall be disapproved.

  1. All concerned personnel are instructed to implement the ban and educate the public on the reasons to such ban.

  1. In order to carry out a smooth implementation of the phase-out, no importation shall be allowed after 29 February 2000; manufacturers may continue producing the product until 31 May 2000. All nitrofurans are not allowed for use in food-producing animals after 31 August 2000.

This Order shall take effect fifteen (15) days from the date of publication in two (2) newspaper.

(Sgd.) ALBERTO R. ROMUALDEZ JR., M.D.                            (Sgd.) EDGARDO J. ANGARA

Secretary                                                                                        Secretary

  Department of Health                                                               Department of Agriculture

DA AO #39 and DOH AO #111-B series of 1991

Rules And Regulations To Implement Prescribing Requirements
For The Veterinary Drugs And Products

Republic of the Philippines

Department of Health

OFFICE OF THE SECRETARY

                                                                                                                                                                  15 October 1991

  

DEPARTMENT OF AGRICULTURE

Administrative Order No. 39

Series 1991

 

DEPARTMENT OF HEALTH

Administrative Order No. 111-B

Series 1991

 

SUBJECT   :  RULES AND REGULATIONS TO IMPLEMENT PRESCRIBING  REQUIREMENTS FOR

 THE VETERINARY DRUGS AND PRODUCTS

Pursuant to R.A. No. 3720, as amended by Executive Order No. 175 otherwise known as the �Foods, Drugs and Devices and Cosmetics Act�. R.A. No. 6675, otherwise known as the �Generics Act of 1988�, R.A. 382 known as the �Veterinary Practice Act�. R.A. 5921 known as the �Pharmacy Act�, R.A. 6425 known as the �Dangerous Drugs Act of 1972� as amended, R.A. 1556, otherwise known as �Livestock and Poultry Feeds Act�, R.A. 1071, an Act to regulate the sale of veterinary biologics and medicinal preparation and R.A. 3101, an Act authorizing the Director of the Bureau of Animal Industry, subject to the approval of the Secretary of Agriculture and Natural Resources to promulgate regulations for the preparation, sale, traffic in, shipment and importation of viruses, sera, toxins or analogous products used for the treatment of domestic animals, the following are hereby promulgated for the information, guidance and compliance of all concerned:

Section 1. DEFINITION OF TERMS:

1.1  �Prescription� refers to the written order and instruction to the pharmacist by a duly-licensed veterinarian for the use of a specific veterinary drug and product for a specific species of animal. For the purpose of these Rules and Regulations, the Veterinary Drug Order (VDO) for the use of specific drug(s) shall be considered a prescription.

1.2   �Generic Prescribing� refers of the prescribing of veterinary drugs and products or medicines using their generic name(s) or generic terminology.

1.3   �Dispensing� refers to the act by a duly-licensed pharmacist and/or veterinarian of filling a prescription or veterinary drug order.

1.4   �Generic Dispensing� refers to dispensing the client�s/buyer�s choice from among generic equivalents.

1.5   �Generic Name or Generic Terminology� refers to the identification of drugs and medicines by their scientifically and internationally recognized active ingredients or by their official names as determined by the Bureau of Food and Drugs of the Department of Health and the Bureau of Animal Industry of the Department of Agriculture.

1.6  �Veterinary Drugs� refer to: (1) articles recognized in the current official United States Pharmacopeia (USP), National Formulary (NF), official homeophatic pharmacopeia of the United States, official Philippine National Veterinary Drug Formulary (PNVDF), or any supplement to any of them; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in terrestial and aquatic animals; and (3) articles (other than food) intended to affect the structure or function of the animal body; and (4) articles intended for use as a component of any article specified in clauses (1), (2) or (3) but do not include devices or their components, parts or accessories,.

1.6.1       �Prescription or Ethical Veterinary Drugs and Products� refers to any drug preparation that is to be dispensed only upon written order of a duly-licensed veterinarian for the treatment of a condition or a diagnosed disease of animals. Such preparation are labeled Rx. The general list of prescription or ethical veterinary drugs and product is found in List C (Annex C).

1.6.2       �Non-prescription Veterinary Drugs� or �Over-the-Counter Veterinary Drugs (OTC)� or �Self-Service Veterinary Drugs (SS)� refer to drug preparations that can be approved for animal use, even without the written order of a duly-licensed veterinarian.

1.7  �Veterinary Drug Products� refer to the finished forms that contain the active ingredient(s), generally, but not necessarily in association with inactive ingredients.

1.8   �Dangerous Drugs� refer to either prohibited drugs or regulated drugs which require a special prescription form, the use of which is monitored by the Dangerous Drugs Board.

1.8.1       �Prohibited Drugs� refer to opium and its derivatives such as heroin and morphine; cocoa leaf and its derivatives, principally cocaine, alpha and beta eucaine; hallucinogenic drugs, such as mescaline, lysergic acid diethylamide (LSD) and other substances producing similar effects; Indian hemp and its derivatives; all preparations made from any of the foregoing and other drugs, whether natural or synthetic, with the physiological effects of a narcotic drug.

 

1.8.2       �Regulated Drugs� refers to sleep-inducing sedatives, such as secobarbital, Phenobarbital, barbital, amobarbital and other drugs which contain a salt or derivative of a salt of barbituric acid; any salt, isomer or salt of an isomer of amphetamine, such as Benzedrine or Dexedrine, or any drug which produces a pharmacologic action similar to amphetamine; and hypnotic drugs such as methaqualone, or any other compound producing similar pharmacologic effects.

1.9  Definitions of different types of veterinary drug and product outlets.

1.9.1       Drugstore, pharmacy and botica are drug outlets where registered veterinary drugs and products, chemical products, active principles, proprietary medicines or pharmaceutical specialties are compounded and/or dispensed and sold excluding veterinary hospitals, clinic and farm storage areas where drugs and products are stored for their exclusive use.

1.9.2       Veterinary and Agricultural Supply Store, Livestock and Poultry Supply Store are outlets selling prescription veterinary drugs and products.

1.9.3       Retail-outlet for non-prescription drugs including non-traditional outlets such as supermarkets and stores, means a drug outlet where registered non-prescription or over-the-counter (OTC) or self-service (SS) veterinary drugs and products are sold in their original packages, bottle or containers or in smaller quantities not in their original containers.

Standards and requirements for License to Operate (LTO) a veterinary and product outlet are found in D.A. A.O. No. 138 and DOH A.O. No. 100 Regulations for the Licensing of Veterinary Drug and Product Establishments and Outlets.

1.10         �Veterinarian-Client-Patient Relationship (VCPR)�, (Annex F) the VCPR is a written agreement between the client and veterinarian wherein the following conditions have been met:

a.      The veterinarian has assumed the responsibility for making clinical judgments regarding the health of animal(s) and the need for medical treatment, and the client has agreed to follow the veterinarian�s instructions.

b.      The veterinarian has sufficient knowledge of the animal(s) to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s). This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of examination of the animal(s) or by medically appropriate and timely visits to the premises where the animal(s) are kept.

c.      Veterinary Drug Order (Annex F) is a written instruction (prescription) to pharmacist or of veterinary drug establishment to fill a veterinary prescription of large quantities a specific veterinary drug and product provided that there is an accompanying VCPR letter (Annex F) from the prescribing veterinarian. VCPR is required when prescribing for ten (10) or more animal units.

Section 2. GUIDELINES ON PRESCRIBING BASED ON PRIOR LAWS

Prior to the Generics Act of 1988, the following general guidelines on prescribing have been operative. In order to have an integrated implementation of all relevant guidelines on prescribing, these guidelines based on prior laws are restated hereunder:

2. 1 Only duly-licensed veterinarians, whether in private practice or employed in a private institution/corporation or in the government, are authorized to prescribe drugs. Prescribing by unauthorized persons constitutes illegal practice of veterinary medicine punishable under R.A. 382 or the Veterinary Practice Act.

2.2 In accordance with R.A. 5921, or the Pharmacy Act as amended, all prescriptions (Annex G) must contain the following information: name of prescriber, office and address. In addition to the above requirements the following shall be included: professional registration number, professional tax receipt number, patient�s/client�s name, date of prescription, species and number of animal treated and: name(in generic), strength, unit size and quantity of the veterinary drug product to be delivered/dispensed.

2.3 For drugs in List A (Annex A) containing the list of Prohibited Drugs and Regulated Drugs as approved by the Dangerous Drugs Board (DDB), the following are required:

2.3.1 The prescriber must have an S-2 license.

2.3.2 The special DDB prescription form must be used.

2.3.3 A recording system following pertinent DDB regulations must be observed.

Section 3. ADDITIONAL GUIDELINES ON PRESCRIBING

In addition to the guidelines contained in section 2, the following shall specifically guide prescribing under the Generics Act of 1988;

3.1 Generic names shall be used in all prescriptions.

3.1.1 For veterinary drugs and products with a single active ingredient, the generic name of that active ingredient shall be used in prescribing.

3.1.2 For drugs with two or more active ingredients, the generic name as determined by BFAD/BAI shall be used in prescribing.

3.2 The generic name must be written in full but the salt or chemical form may be abbreviated.

3.3 The generic name of the veterinary drug and product ordered must be clearly written on the prescription immediately after the Rx symbol.

3.3.1 If written on a prescription pad, the brand name enclosed in parenthesis may be written after the generic name.

3.4 In prescribing veterinary drugs and products enumerated in List B (Annex B) which need strict precaution in their use, the prescriber must comply with the following:

3.4.1 After the Rx symbol but before the generic name, he must write clearly �(list B)�.

3.4.2 He must ensure that the following informations are accurately written on the prescription:

3.4.2.1 The generic name of the active ingredient(s) and the specific salt or chemical form.

3.4.2.2 The manufacturer

3.4.2.3 The brand name, if so desired

3.4.2.4 The strength or dose level using units of the metric system (see Annex D).

.3.4.2.5 The delivery mode or delivery system: quick-dissolve, sustained release, etc. and the corresponding appropriated dose frequency or dose interval.

Section 4. SPECIFIC GUIDELINES OF PRESCRIBING

In addition to the guidelines contained in section 2 and 3, the following shall guide prescribing to food and aquatic animals under the Generics Act of 1988.

In prescribing veterinary drugs and products the prescriber must comply with the following conditions:

4.1 The veterinarian has assumed the responsibility for making clinical judgments regarding the health of the animal(s) and the need for medical treatment, and the client has agreed to follow the veterinarian instructions.

4.2 The veterinarian has sufficient knowledge of animal(s) to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s). This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of examination of the animal(s) or by medically appropriated and timely visits to the premises where the animal(s) are kept.

4.3 The veterinarian is readily available for follow-up evaluation in the event of adverse reactions or failure of the treatment regimen.

4.4 In prescribing for non-food animals, the sample standard prescription (Annex G) is sufficient.

4.5 In prescribing for food animals the following guidelines should be followed.

4.5.1 When prescribing for individual animals a simple standard prescription is sufficient.

4.5.2 When prescribing for 10 or more animal units (Annex E) a VCPR letter accompanying a Veterinary Drug Order (VDO) is required.

The VCPR letter must contain the following:

a.      Name and address of the client

b.      Statement that the client has agreed to follow the veterinarian�s instructions and directions.

c.      Statement that the veterinarian is readily available for follow-up and evaluation in the event of adverse reactions or failure of the treatment regimen.

d.      Statement that the veterinarian has assumed the responsibility for making clinical judgments regarding the health of the animal and the need for medical treatment.

e.      The veterinarian�s name, signature, PRC number and address.

f.        Withdrawal period if there is any, of drug and product prescribed.

Section 5. VIOLATIVE, ERRONEOUS AND IMPOSSIBLE PRESCRIPTIONS

5.1 Violative Prescriptions:

5.1.1 Where generic name is not written;

5.1.2 Where the generic name is not legible and a brand name which is legible is written.

5.1.3 Where the brand name is indicated and instructions added (such as the phrase �no substitution�) which tend to obstruct, hinder or prevent proper generic dispensing.

5.2 What to do with violative prescriptions.

Violative prescription shall not be filled by the pharmacist/veterinarian. They shall be kept and reported by the pharmacist/veterinarian of the veterinary drug and product outlet or nay other interested party to the nearest DOH/DA Office for appropriate action. The pharmacist or veterinarian shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription.

5.3 Erroneous Prescriptions.

5.3.1 Where the brand name precedes the generic name.

5.3.2 Where the generic name is the one in parenthesis.

5.3.3 Where the brand name is not in parenthesis.

5.4 What to do with erroneous prescriptions

Erroneous prescriptions shall be filled. Such prescription shall also be kept and reported by the pharmacist/veterinarian of the veterinary drug and product outlet or any other interested party to the nearest DOH/DA Office for appropriate action.

5.5 Impossible Prescriptions

5.5.1 When only the generic name is written but it is not legible.

5.5.2 When the generic name does not correspond to the brand name.

5.5.3 When the veterinary drug and product prescribed is not registered with the BFAD/BAI.

5.6 What to do with impossible prescriptions.

Prescriptions mentioned in 5.5 shall not be filled. They shall be kept and reported by the pharmacist/veterinarian of the veterinary drug and product outlet or any other interested party to the nearest DOH/DA office for appropriate action. The pharmacist/veterinarian shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription.

5.7 In all cases enumerated in 5.1 and 5.5 the local DOH Office shall be responsible for giving written notice to the erring veterinarian concerned and for transmitting through channels the report of violation/error to the Professional Regulation Commission (PRC) or to the fiscal�s or to the Council of Ethics of the Philippine Veterinary Medical Association office for appropriate action.

Section 6. ADMINISTRATIVE SANCTIONS

For violations of Section 4 of these Rules and Regulations, the Secretary of Health shall recommend the imposition of appropriate administrative sanctions by the PRC.

Section 7. CRIMINAL LIABILITY

The imposition of the above sanctions does not preclude the institution of appropriate criminal proceedings pursuant to Section 12 of R.A. 6675 known as the �Generics Act of 1988�, R.A. 3720 known as �Food, Drug and Devices and Cosmetics Act� as amended, and R.A. 5921 known as �Pharmacy Law� as amended, R.A. 382 or the Veterinary Practice Act, R.A. 6425 known as the �Dangerous Drugs Act of 1972� as amended, R.A. 1556 known as the �Livestock and Poultry Feed Act�, R.A. 1071, R.A. 3101, and other relevant laws, upon receipt of complaints or reports of violations.

Section 8. TIMETABLE OF IMPLEMENTATION

In order to give all affected parties adequate time for learning and adjustment, the implementation of these Rules and Regulations shall be in three phases, as follows:

Phase 1 Education Drive and Information Dissemination

This phase shall be accomplished within six months from the date of the effectivity of these Rules and Regulations. During this period, the DOH/DA-BAI in cooperation with the Department of Education, Culture and Sports, the Department of Local Government, Philippine Information Agency, academic veterinary institutions, Philippine Veterinary Medical Association (PVMA) and its affiliates shall undertake information dissemination and education drive concerning the provisions of these Rules and Regulations as well as the Generics Act of 1988.

Phase 2 Monitoring of Compliance Without Sanctions or Penalties

Within twelve months the DOH/DA-BAI shall monitor voluntary compliance with the provisions of the Rules and Regulations on Prescribing and Dispensing. During this period, the associations of affected professionals are enjoined to promote compliance in order to achieve a smooth transition to the next phase of full implementation.

Phase 3 Full Implementation

Beginning January 1, 1993 the DOH/DA and the other relevant agencies of government shall monitor compliance with these Rules and Regulations and all violations shall be subject to the appropriate sanction and penalties provided for under these Rules and Regulations and the Generics Act of 1988 and prior laws.

The funding of the 3 phases will be provided by the DOH / DA.

Section 9. SEPARABILITY CLAUSE

In case any provision of this Administrative Order is declared contrary to law or unconstitutional, other provisions which are not affected thereby shall continue to be in force and in effect.

Section 10. REPEALING CLAUSE

All Administrative Orders, Rules and Regulations and other Administrative issuances or parts thereof, inconsistent with the provisions of the Administrative Order are hereby repealed and modified accordingly.

Section 11. EFFECTIVITY

This Order shall take effect fifteen (15) days after its publication in a newspaper of general circulation.

 

(Sgd.) SENEN C. BACANI                                                            (Sgd.) ALFREDO R.A. BENGZON, M.D.

Secretary of Agriculture                                                                                     Secretary of Health

 

 

 

ANNEX A

(LIST A)

LIST OF PHARMACEUTICAL PRODUCTS CLASSIFIED AS PROHIBITED DRUGS OR REGULATED DRUGS BY THE DANGEROUS DRUGS BOARD 

I.  Prohibited Drugs

 

1. ALFENTANIL - Rapifen Injectable
2. CODEINE (as sulfate) - Codeine Sulfate H.T.
- Codeine Sulfate T.T.
3. CODEINE (as phosphate) - Dolo-Adamon Suppository
- Dolo-Adamon Tablet
4. DIHYDROCODEINE - NOT AVAILABLE IN THE MARKET
5. FENTANYL (as citrate) - Sublimaze Injectable
6. FENTANYL (as citrate) / Droperidol - Innovar Injectable
7. HYDROCODONE (DIHYDROCODEINONE) - Deka Syrup
(as bitartrate) - Raminon Syrup
8. HYDROCODONE (DIHYDROCODEINONE) - Tussionex Suspension
9. HYDROCODONE (DIHYDROCODEINONE) - Codevite Syrup
(as bitartrate) plus Pyrilamine (as maleate) /
Sodium Citrate / Ammonium Chloride /
Potassium Guaiacolsulfonate
10. HYDROCODONE (DIHYDROCODEINONE) - Endotussin Syrup
(as bitartrate) plus Pyrilamine (as maleate) /
Homatropine (as methylbromide) /
Phenyllephrine (as hydrochloride) /
Ammonium Chloride
11. MORPHINE (as sulfate) - Morphine Sulfate H.T.
- Morphine Sulfate Ampul
- Morphine Sulfate Tablet
12. MORPHINE (as sulfate) / Atropine - Morphine with Atropine
13. OPIUM - Brown Mixture Tablet
- Brown Mixture Liquid
14. OPIUM / ALCOHOL - Elixir Paregoric
15. PETHIDINE (MEPERIDINE) - Demerol Ampul
- Demerol Tablet
- Demerol Vial

II.  Regulated Drugs

A. Available in the Market

1. AMOBARBITAL (as sodium) - Amytal Sodium Ampul
- Amytal Sodium Capsule
- Amytal Sodium Tablet
2. AMPHETAMINE - Benzedrine Tablet
- Daprisal Tablet
3. APROBARBITAL, BARBITAL AND - Plexonal
PHENOBARBITAL
4. CHLORAL HYDRATE - Noctec
5. DEXAMPHETAMINE - Dexedrine Spansule
6. EPHEDRINE (excluding exempt preparations)
7. ETHINAMATE - Valamin Tablet
8. FLUNITRAZEPAM - Rohypnol
9. NITRAZEPAM - Mogadon
10. PARALDEHYDE - Paraldehyde Ampule
11. PENTAZOCINE (as hydrochloride) - Susegon Tablet
12. PENTAZOCINE (as base) - Susegon Ampule
13. PENTOTHAL (as sodium) - Pentothal Sodium Vial
- Thiopental Sodium Vial
14. PROPOXYPHENE (as hydrochloride) - Doloxene Plain Tablet
15. PROPOXYPHENE (as napsylate), Aspirin - Doloxene Compound -65
and Caffeine
16. PROPOXYPHENE (as napsylate) / - Dologesic -32
Paracetamol
17. PSEUDOEPHEDRINE (excluding exempt preparations)

Local suppliers no longer carry these drugs but are still available in some drugstores and hospital pharmacies.

B. Not Available in the Market

1. AMOBARBITAL / DEXAMPHETAMINE - Dexamyl Spansule No. 1
2. BUTABARBITAL - Butisol Sodium Tablet
- Circuline Forte Tablet
3. ETHCHLORVYNOL - Placidyl Capsule
4. HYDROCODONE (DIHYDROCODEINONE) - Calcidrine Syrup
/ PENTOBARBITAL
5. MECLOQUALONE - Nubarene Tablet
6. METHAMPHETAMINE - Desoxyn Tablet
7. METHAQUALONE / Diphenhydramine - Mandrax Tablet
(as hydrochloride)
8. METHYPRYLON - Moludar Tablet
9. PENTOBARBITAL (as sodium) - Nembutal Sodium Vial
10. PIPRADOL - Gadexyl Tablet
11. SECOBARBITAL - Seconal Sodium Capsule

Local suppliers no longer carry these drugs but are still available in some drugstores and hospital pharmacies.

 

 

ANNEX B

(LIST B)

 

LIST OF VETERINARY DRUGS AND PRODUCTS REQUIRING STRICT PRECAUTION IN PRESCRIBING, DISPENSING AND USE

td width="42%" height="18">POUR ON

1. ACEPROMAZINE : TABLET / INJECTABLE
2. AMINOPHYLLINE : SUPPOSITORY / TABLET
3. AMITRAZ :
4. AMPHOTERICIN B : INJECTABLE
5. AZAPERONE : INJECTABLE
6. BETAMETHASONE : TABLET
7. BUNAMIDINE : TABLET
8. CARBADOX : PREMIX
9. CHLORAMBUCIL : TABLET
10. CHLORAMPHENICOL : CAPSULE / INJECTABLE
11. CHLORPROPAMIDE : TABLET
12. COLISTIN : INJECTABLE
13. CYCLOPHOSPHAMIDE : TABLET
14. DEXAMETHASONE : TABLET
15. DEXAMETHASONE ACETATE : INJECTABLE
16. DIAZEPAM : TABLET
17. DICHLORVOS : CAPSULE/GRANULES
18. DIETHYLESTILBESTROL (DES) : INJECTABLE
19. DIGITOXIN : TABLET
20. DIGOXIN : TABLET
21. DIHYDROSTREPTOMYCIN : INJECTABLE
22. DIMETRIDAZOLE : INJECTABLE
23. DIMINAZINE : INJECTABLE
24. EPINEPHRINE : INJECTABLE
25. ERYTHROMYCIN : INJECTABLE
26. ESTROGENS, CONJUGATED : INJECTABLE
27. ETHINYLESTRADIOL : TABLET
28. ETHOSUXIMIDE : CAPSULE
29. FURAZOLIDONE : SUSPENSION / TABLET
30. FUROSEMIDE : TABLET / INJECTABLE
31. GENTAMICIN : INJECTABLE
32. HALQUINOL : PREMIX
33. HYDROCHLOROTHIAZIDE : TABLET
34. HYDROCORTISONE : INJECTABLE
35. IMIDOCARB : INJECTABLE
36. INSULIN : INJECTABLE
37. IVERMECTIN : TABLET / INJECTABLE
38. KETAMINE : INJECTABLE
39. LASALOCID : PREMIX
40. LEVAMISOLE : INJECTABLE
41. LINDANE : POUR ON
42. LORAZEPAM : ORAL
43. MELARSONYL : INJECTABLE
44. MENADIONE : TABLET
45. MENADIONE SODIUM BISULFATE : TABLET
46. MEPHENYTOIN : TABLET
47. METHDILAZINE HYDROCHLORIDE : TABLET
48. METHOTREXATE : TABLET
49. METHYLERGOMETRINE : TABLET
(METHYLERGONOVINE) MALEATE
50. METRONIDAZOLE : TABLET
51. MONENSIN : PREMIX
52. NEOMYCIN : INJECTABLE
53. NICLOSAMIDE : TABLET
54. NITROFURANTOIN : CAPSULE / SUSPENSION /TABLET
55. OLAQUINDOX : PREMIX
56. OUABAIN : INJECTABLE
57. OXYTETRACYCLINE (LONG-LASTING0 : INJECTABLE
58. OXYTOCIN ; INJECTABLE
59. PANCURONIUM : INJECTABLE
60. PERPHENAZINE : SUPPOSITORY/SYRUP/TABLET/CR
TABLET
61. PHENYLBUTAZONE : CAPSULE / TABLE
62. PHENYTOIN : SUSPENSION
63. PHENYTOIN SODIUM, EXTENDED : CAPSULE
64. PHENYTOIN SODIUM, PROMPT : CAPSULE
65. PRAZIQUANTEL : TABLET
66. PROBENECID : TABLET
67. PROCAINAMIDE HYDROCHLORIDE : CAPSULE / TABLET / CR TABLET
68. PROPIONYL PHENOTHIAZINE : INJECTABLE
69. PROSTAGLANDIN F2 ALPHA : INJECTABLE POWDER
70. PYRAZINAMIDE : TABLET
71. QUINIDINE SULFATE : CAPSULE / TABLET / CR TABLET
72. SALINOMYCIN : PREMIX
73. SPIRONOLACTONE : TABLET
74. STREPTOMYCIN : INJECTABLE
75. SUCCINYLCHOLINE : INJECTABLE
76. SULFADIAZINE; SULFAMERAZINE : TABLET
SULFAMETHAZINE
77. SULFAMETHIZOLE : SUSPENSION / TABLET
78. SULFISOXAZOLE : SUSPENSION / TABLET
79. SURAMIN : INJECTABLE
80. THEOPHYLLINE : TABLET / CR CAPSULE (SPRINKLES /
: SUSPENSION / CR TABLET
81. THIACETARSAMIDE : INJECTABLE
82. THIORIDAZINE HYDROCHLORIDE : TABLET
83. THYROGLOBULIN : TABLET
84. TOLBUTAMIDE : TABLET
85. TRIAMCINOLONE : TABLET
86. XYLAZINE : INJECTABLE

 

 

LIST C

A. ALL ANTI-INFECTIVES EXCEPT TOPICAL FORMS

B. ALL ACARICIDES

C. ALL INSECTICIDES EXCEPT CARBAMATES, PYRETHIOIDS AND REPELLANTS

D. ALL BIOLOGICALS AND IMMUNOLOGICALS

E. ALL CARDIOVASCULAR DRUGS

F. ALL HORMONES

G. ALL ANTINEOPLASTICS

H. ALL PARENTERAL FLUIDS

I. ALL CORTICOSTEROIDS

J. ALL EUTHANIZING AGENTS

K. ALL ANABOLICS

 

 

ANNEX D

STANDARD ABBREVIATIONS AND PRACTICE IN THE USE OF METRIC UNITS

 

1 grain                                    =                      60 mg

 

� grain                                   =                      30 mg

 

Quantities of 1 gram or more should be written as 1 g, etc.

Quantities less than 1 gram should be written in milligrams, e.g. 500 mg. Not 0.5 g.

Quantities less than 1 milligram should be written in micrograms, e.g. 100 mcg, not 0.1 mg.

When decimals are unavoidable, a zero should be written in front of the decimal point when there is no other figure, e.g. 0.5 ml, not .5 ml.

The term millimeter (ml) should be used and not cubic centimeters or cm.3

 

 

 

 

ANNEX E

 ANIMAL UNITS

  

No. of Animals                                                         No. of Animal Unit

1 Carabao                                                                 1 Animal Unit

1 Cattle                                                                       1 Animal Unit

1 Horse                                                                      1 Animal Unit

5 pigs                                                                         1 Animal Unit

100 Chickens                                                            1 Animal Unit

 

 

 

 

ANNEX F

VETERINARY DRUG ORDER (VDO) 

NAME OF VETERINARY INSTITUTION

 

Address:

Telephone Number:

 

Veterinarian-Client-Patient-Relationship (VCPR)

 

I, ________________________, the manager / owner of _____________________________________

(name of establishment)

Located at ______________________________________________ have contracted.

(address)

Dr. ______________________________ of ______________________________________

(name veterinarian)                                                              (address)

 

To diagnose and treat disease problems of the animals described as follows:

1. Species :   _________________________

2. Breed : ____________________________

3. No. of Animals ______________________

I agree to follow the veterinarian�s instructions and directions including withdrawal period.

I, Dr. _____________________________ have agreed to assume the responsibility for making clinical judgments regarding the health of the animals described above and their need for medical treatment. I further agree to be readily available for follow-up and evaluation in the event of adverse reactions or failure of the treatment regimen.

 

___________________                                         __________________

Owner                                                                                 Veterinarian

 

TIN: ________________                                        PRC No. ____________

PTR: _______________

TIN: ________________

 

______________________                                   ______________________

Date                                                                                 Date

DA AO #11 and DOH AO #105 series of 1991

Requirement For Labelling Materials Of Veterinary Drugs And Products

Annex A

Pharmacological Categories Of
Veterinary Drugs And Products

Annex B

List Of Veterinary Drugs And Products
Requiring Strict Precautions In Prescribing
Dispensing And Use

* Administrative Order No. 114-B

Transitional Remedial Labeling In Compliance With R.A. 6675

Republic of the Philippines

Department of Health

OFFICE OF THE SECRETARY

                                                                                                                                            April 15, 1991

DEPARTMENT OF AGRICULTURE

Administrative Order No. 11

Series of 1991

 

DEPARTMENT OF HEALTH

Administrative Order No. 105

Series of 1991

SUBJECT  :    REQUIREMENT FOR LABELLING MATERIALS OF VETERINARY DRUGS AND

                           PRODUCTS

             Pursuant to R.A. No. 3720, as amended by Executive Order No. 175 otherwise known as the �Foods, Drugs and Devices and Cosmetics Act�. R.A. No. 6675, otherwise known as the �Generics Act of 1988�, R.A. No. 1556, otherwise known as the �Livestock and Poultry Feeds Act�, R.A. 1071, an act to regulate the sale of veterinary biologics and medicinal preparation and R.A. 3101, an Act authorizing the Director of Animal Industry, subject to the approval of the Secretary of Agriculture and Natural Resources to promulgate regulations for the preparation, sale, traffic in shipment and importation of viruses, sera, toxins or analogous products used for the treatment of domestic animals, the following requirements for the labeling of veterinary drugs and products are hereby promulgated for the information, guidance and compliance of all concerned;

 Section 1. DEFINITION OF TERMS:

For purposes of this Regulation the terms:

1.1    �Labelling materials� refer to the label on the immediate container and package and other printed materials that are made available with the veterinary drug and product at the time of purchase and/or where the veterinary drug and product is used, such as the outer wrapper cartons, leaflet/package insert accompanying the product, which provide the accurate and necessary detailed information for the identification and proper use of the veterinary drug and product.

1.2    �Veterinary drugs and products� refer to any substance, including biological products, applied or administered to food producing, companion, aquatic, laboratory and exotic animals, whether used for therapeutic, prophylactic or diagnostic purposes or for modification of physiological functions or behavior.

1.3    �Brand name� refers to the proprietary/trade name assigned to the veterinary drugs and products by the veterinary drug and product establishment.

1.4    �Generic Terminology� refers to the identification of veterinary drugs and products by their scientifically and internationally recognized active ingredient as determined by the Bureau of Food and Drugs of the DOH/Bureau of Animal Industry of the DA. In case of feed products containing veterinary drugs and products, generic name refers to the internationally recognized technical name of the feeds as determined by the Bureau of Animal Industry of the Department of Agriculture.

1.5    �Philippine National Veterinary Drug Formulary (PNVDF)� refers to the classiication and listings of the veterinary drug and product.

1.6    �Formulation� refers to the name(s) and amount(S) of ingredients per unit quantity expressed in the metric system.

1.7    �Indication� refers to the approved clinical and non-clinical use of the veterinary drug and product in terrestial and aquatic animals based on substantial scientific evidence of the safety and efficacy in the given dosage form.

1.8    �Dosage Form� refers to the pharmaceutical form of the preparation based on an official pharmacopeia.

1.9    �Mode of Administration� refers to the site and manner by which the product is to be introduced to animal.

1.10    �Warning� refers to statements regarding the withdrawal period of the product before the animal is slaughtered for food and/or the occurrence of potential hazard and side effects associated with the use of the product and the limitation of its use.

1.11    �Contraindications� refer to statements of conditions under which veterinary drug and product should not be used.

1.12    �Caution� refers to the instructions and special procedures required in the use and handling of the veterinary drug and product to avoid undesired effects and to ensure the safety and effective use of the veterinary drugs and products.

1.13    �Antidote� refers to a specific substance or combination of substances that would counteract the effect of any undue reaction and overdosage.

1.14   �Veterinary Prescription or Ethical Drugs� refer to any drug preparation that is to be dispensed only upon written order of a duly-licensed veterinarian for the treatment of a condition or a diagnosed disease of animals.

1.15    �Medicated Feed� refers to any feed which contains drug ingredients intended or represented for the cure, mitigation, treament or prevention of diseases of animal other than man or which contains drug ingredients intended to affect the structure or any function of the body of animal other than man.

1.16    �Medicated Feed Premix� refers to a uniform mixture of one or more drug micro-ingredients with diluent and/or carrier. Premixes are used to facilitate uniform dispension of the micro-ingredients in a larger mix.

1.17    �Medicated Feed Supplement� refers to a drug ingredient or mixture of drug ingredients intended to supply the deficiencies in a ration or improve the nutritive balance or performance of the total mixture. It is intended to be:

  1. a)fed undiluted as a supplement to other feeds;
  2. b)offered free choice with other parts of the ration separately available; and
  3. c) further diluted and mixed to produce a complete feed.

1.18  �Medicated Feed Additive� refers to a drug ingredient or combination of drug ingredients added to the basic feed mix or parts thereof to fulfill a specific need. Usually mixed in micro quantities and requires careful handling and mixing.

1.19  �Medicated Water Additive� refers to a drug ingredient or combination of drug ingredients added to basic drinking water or parts thereof fulfill a specific need.

1.20    �Date of Manufacture of Veterinary Drugs and Products other than Veterinary Biological Products and Medicated Feeds� refers to the month and year during which the processing of the bulk product, from which the veterinary drug and product are packaged, is completed. �Bulk product� refers to the batch of the finished product.

                   1.21 �Batch Number� refers to any distinctive combination of letters and/or numbers, assigned to a

                            particular batch herein defined as any product produced during a given cycle of manufacture.

                   1.22  �Lot Number� refers to any distinctive combinations of letters and/or numbers assigned to a             

                             particular lot herein defined as a portion of batch. 

1.23 �Expiration or Expiry date� refers to the date after which the product is not expected to retain its claimed safety, efficacy, quality and potency and after which it is not permissible to sell, distribute or use said products.

1.24 �Net Content� refers to the total amount/quantity/number of the dosage form in a certain container of a veterinary drug and product expressed in metric system.

1.25 �Storage Conditions� refer to the specified temperature, humidity and other environmental factors within which optimal stability of the veterinary drug and product is ensured.

1.26  �Principal display panel� refers to the part of the label that is most likely to be displayed, presented, shown or examined under customary conditions of display for retail sale.

1.27  �Area of the principal display panel� refers to the area of surface of the container/package where the principal display panel is located.

1.28  �Primary Pack� refers to the first pack sustaining the individually wrapped products, strip or blister packs.

1.29   �Information Panel� refers to that part of the label other than the principal display panel.

Section 2. GENERAL REQUIREMENTS

            2.1 The minimum mandatory information that shall be included in the labeling materials are:

                         2.1.1 Name of the product (Generic name alone or with Brand name, as the case may be)

                         2.1.2 Dosage form and strength

                         2.1.3 Pharmacologic category

                         2.1.4 Rx symbol, In case of prescription drugs

                         2.1.5 Name and  complete address of manufacturer and when applicable the trader.

                         2.1.6 Registration number (BFAD and/or BAI)

                         2.1.7 For veterinary use only

                         2.1.8 Net content

                         2.1.9 Formulation

                         2.1.10 Indication(s)

                         2.1.11 Contraindication(s)

                         2.1.12 Precaution(s)

                         2.1.13 Warning(s)

                        2.1.14 Antidote (if any)

                        2.1.15 Mode of administration/direction of use

                        2.1.16 Batch and lot number

                        2.1.17 Expiry/Expiration date and date of manufacture

                        2.1.18 Storage conditions

                        2.1.19 For Rx products, Foods, Drugs and Devices and Cosmetics Act prohibits dispensing without prescription of a duly-licensed Veterinarian.

            2.2 All information required to appear on the label must be:

                        2.2.1 Written in English or Filipino.

                        2.2.2 Readable with normal vision without straining. The color contrast, the position and spacing of the

                                  information must be taken into consideration in complying with the labeling requirements. 

2.3     The principal display panel must:

2.3.1  Contain the particulars required under 2.1.1 to 2.1.8

2.3.2  Comprise 40% of the total surface of the container, except in the case of a rectangular container where the total area of the principal display panel must be equal to the product of the height and width of the entire side of the container. For any other shaped container presenting an obvious principal display panel such as the top of a triangular or circular container, the size of the area shall consist of the entire top surface.

2.4     On the information panel of the label the following shall appear:

2.4.1   Formulation

2.4.2   Indication(s)

2.4.3   Mode of administration/direction for use

2.4.4   Batch and lot number

2.4.5   Expiry/expiration date and date of manufacture

2.4.6   Storage conditions

2.4.7   (For Rx) Foods, Drug and Devices and Cosmetics Act prohibits dispensing without prescription by a licensed veterinarian.

2.4.8   Warning/caution statements (if necessary)

2.5 Other information and additional details shall (i.e. warning(s), precaution(s) and antidote(s) appear on the other labeling materials such as inserts/leaflets or wrapper cartons.

Section 3. SPECIFIC REQUIREMENTS

            3.1 Name of the product

                        3.1.1 In all cases, the generic name shall be the prominently printed element on the label, defined as

                                the one with the highest point size among the various printed elements on the label. It shall be

                                enclosed exclusively by an outlined box rendered in the same color as the generic name. The

                                background  color inside the box, against which the generic name is rendered, should be same

                                color as the background color outside the box, against which the brand name is rendered. 

 

                        3.1.2 In all cases, the generic name shall be printed in full, not abbreviated and in accordance with the

                                  International Non-proprietary Name (INN). In case the salt is to be indicated this must be included

                                  inside the box but in smaller point size. 

 

                        3.1.3 If a product is identified by generic name together with its brand name to be the following shall be

                                  required in addition to 3.1.1 and 3.1.2 

 

  3.1.3.1 The generic name and brand name shall be rendered using the same typeface,

                                                boldness, font and color, with the generic name appearing immediately above the brand

                                                name and rendered in a point size bigger than the brand name. 

 

                                    3.1.3.2 If a brand name is presented using a special typeface exclusively designed and used for

                                                it, the generic name shall be rendered in Helvetica or Universe typeface while complying

                                                with the other pertinent provisions above. 

 

            3.2 Dosage from shall be specified such as tablets, suspensions, ointments including special delivery system

                   such as sustained release, etc. 

            3.3 Pharmacologic category shall conform to the category used in the Philippine National Veterinary Drug Formulary (PNVDF) attached as Annex �A� provided that drugs which cannot be classified under these categories may be given a pharmacologic category other than what appears in the Annex, subject to the approval of BFAD/BAI taking into consideration current acceptable standards for therapeutic categories.

            3.4 Rx symbol

                        3.4.1 The Rx symbol must be printed in a contrasting color to the background on which it appears.

                        3.4.2 Over printing or superimposition of the Rx symbol is allowed provided that such will not result in obliterating or rendering less legible the other required label requirements.

                        3.4.3 The Rx symbol shall be printed in a type size no less than one-fifth (1/5) of the height of the principal display panel.

                        3.4.4 The Rx symbol shall appear conspicuously on the principal display panel.

            3.5 Complete Name and address of manufacturer and also trader, when applicable, must appear on the principal display panel of the label.

            3.6 Net content shall indicate the total amount/quantity/number of the dosage form in a given container of the product expressed in metric system.

            3.7 Formulation

                        3.7.1 Active ingredient(s) must be stated in their generic names (INN).

                        3.7.2 The amount(s) of the active ingredient(s) shall be expressed in the metric system or units of potency, when applicable, as specified in an official compendium.

                        3.7.3 The salt or chemical form(s) of active ingredient(s) must be stated, when applicable.

                        3.7.4 The coloring agent and other excipients used in the formulation that may cause hypersensitivity and/or other adverse reaction(s) must be indicated.

                        3.7.5 The alcohol content when present must be expressed in percent (%).

            3.8 Indication(s)

                        3.8.1 Indications shall state only approved clinical/non-clinical use(s) and the approved use on species and/or classes of animals such as stated in the approved BFAD/BAI registration.

                        3.8.2 For anti-infectives and biological products disease conditions shall be indicated by scientific names of the causative agent to be printed on the product insert or accompanying labeling material.

            3.9 Contraindication(s), Precaution(s) and warning(s)

                        3.9.1 Full information regarding contraindication(s) to the use of drugs, as well as precaution(s) to be observed in its administration and use must be provided.

                        3.9.2 Caution statements, as required; and specified by BFAD/BAI must be stated (ANNEX B).

                        3.9.3 In case of Biological products, warning statements on the proper disposal of container shall be stated.

                        3.9.4 Warnings: Withdrawal period must be stated based on the PNVDF.

                        3.9.5 Antidote shall indicated the specific drug to be given to the animal to immediately counteract the drug reaction and/or overdosage.

            3.10 Directions for Use.

                        3.10.1 Full information must be provided for the recommended dosage, including the initial dose, the optimal use or usual dose, route of administration and frequency interval, the duration of treatment, dosage adjustment or other pertinent aspects of drug therapy.

                        3.10.2 Relevant information regarding dilution, reconstitution, preparation and administration must be included.

            3.11 Batch/Lot Number

                        3.11.1 If the entire batch is marketed under one company, only the batch number needs to be indicated. If however, a batch is divided into several lots and the lots are marketed by different companies, the lot number and its corresponding batch number shall be indicated for every lot.

                        3.11.2 The batch number must be printed or embossed on the wrapper for every ten (10) blister units and the lot number must be printed on the wrapper for every two (2) blister units.

            3.12 Expiry/Expiration Date

                        3.12.1 The expiry or expiration date shall be expressed in terms of the month and the year. In such cases, the last day of the month is assumed as the expiration date.

                        3.12.2 For a drug that is reconstituted prior to use, a period of guaranteed efficacy must be specified at a given storage condition.

                        3.12.3 The expiration date shall be printed or embossed on the tin foil, blister and/or strip packages.

            3.13 Registration number shall indicate the drug registration number and code assigned by BFAD/BAI.

            3.14 Storage conditions appropriate for the product must be stated. 

Section 4. BIOLOGICAL PRODUCTS

            For biological products, the label must include, an addition the requirements of Section 2 and 3:

            4.1 The name and proportion of any antimicrobial agent in the product.

            4.2 The name of any adjuvant in the product or any substance which, when administered with an antigen, modifies the immune response to that antigen.

            4.3 The name of the species of animal or organism from which the product has been prepared.

            4.4 For monoclonal antisera, the name of the species source or name of the species of origin of the hybridoma cell line used in the preparation of the product.

            4.5 For viral vaccines produced in animal cells or cell cultures, the name of the cell culture substrate or the name of the species of animal and tissue used in the manufacture of the product, as well as the name of any residual antibiotic present in the product, must be stated when applicable.

            4.6 The potency of biological products which needs to be prepared before use, shall be expressed as potency units or weight of active substance per dose or unit volume or the volume which contains the recommended dose.

            4.7 The potency unit to be used shall be the International Unit established by the FAO/World Health Organization or where no such International Unit has been established, the potency unit to be used shall be that approved by the BAI taking into consideration current acceptable standards.

Section 5. INJECTIONS

            In addition to the requirements referred to in Section 2 and 3, when the product  is an injection, the label shall include:

            5.1 The name and quality of all excipients in the product except where Section 6 applies.

5.2      A statement of the recommended route or routes of administration, such as �intravenous�, �intramuscular�, �subcutaneous�, or �for intramuscular use only�, or �for subscutaneous use only�.

5.3      When applicable the statement �use only once� or �discard any remaining portion� or �use within 24 hours� or words to that effect must be included.

5.4      Where the contents of the container are to be used on one occasion only, the words �single use� or �single dose� must be included.

5.5      Where the product consists of a concentrated solution for injection, a direction not to administer the solution undiluted and a direction to dilute the solution with the specified diluent to the appropriate volume before use must be included.

Section 6. LARGE VOLUME INJECTION

            In addition to the requirements referred to in Section 2 and 3, the label shall include:

            6.1 The names and quantities of all excipients and active substances in the nominal volume of fluid in the container, listed in descending order of magnitude within each group of chemically similar substances.

            6.2 Where one or more substances are amino acids and/or protein, a statement of the total amount of nitrogen in the nominal volume of fluid in the container.

            6.3 The nominal osmolality.

            6.4 A statement which specifies whether the solution is nominally �hypotonic� or �hypertonic�.

            6.5 The nominal pH range of the solution.

            6.6 The words �single use� or �single dose�.

Section 7. MEDICATED FEED PRODUCTS

            In addition to the requirement refered to in Section 2 and 3, when the product is a medicated feed, the label shall include:

            7.1 The definite guarantee of the manufacturer relative to the quality of the veterinary drug and product.

            7.2 The accepted or official name of each ingredient used in the manufacture. The percent of such ingredients as corn cobs, oat hulls, rice hulls, barley hulls, mongo bean hulls, cocoa shells, or similar materials when such constitute a portion of the feed or feedstuffs in quantities in excess of what is normally found in such feedstuffs.

Section 8. TOPICAL PRODUCTS

            In addition to the requirements referred to in Section 2 and 3, the label shall include the name and proportion of any antimicrobial agent present in the product.

Section 9. PRODUCTS FOR EXTERNAL USE

            In addition to the requirements referred to in Section 2 and 3, statement �FOR EXTERNAL USE ONLY� printed in red color must appear on the principal display panel of the label.

Section 10. SMALL CONTAINERS

            Where the product is enclosed in a container which has a capacity of 10 millimeters or less and the container is enclosed in a primary pack;

            10.1 The label of the container must contain the requirement of 2.11, company logo, strength, mode of administration, species and type of animal indication batch number, expiry date and registration number of BAI/BFAD.

            10.2 The label of the primary pack or other labeling materials must contain the requirements referred to in Section 2 and 3, and Section 4 and 5, when applicable.

            10.3 When it is not practical to set out particulars in full on the label of the container, the particulars referred to 10.1 may be abbreviated, upon the approval of the BAI/BFAD.

Section 11. INDIVIDUALLY WRAPPED PRODUCTS, STRIP AND BLISTER PACKS

            Where the product consists of individual dosage units, and each such dosage unit is individually wrapped or contained in strip or blister packs, after which each individual dosage unit is enclosed in a primary pack:

            11.1 The individual wrapper unit must contain the requirement of 2.1.1, company name or logo, strength, expiry date, lot number and for veterinary use only.

            11.2 For products contained in strip or blister packs, the requirements of 2.1.1, strength, expiry date, lot number for every 2 units and company name and batch number for strip 10 units.

            11.3 The primary pack or other labeling materials must contain the requirements referred to in Section 2 and 3.

Section 12. EXEMPTIONS

            12.1 Where products are made up or compounded by a pharmacist in accordance with the individual prescription of a veterinarian.

            12.2 Where products are used solely for investigational purpose.

            12.3 Where products are donated by foreign agencies/persons, the requirements of generic labeling may be waived except that the expiry date must be indicated.

            The requirements of this Regulation do not apply in relation to goods under 12.2, 12.3 and in exceptional cases where the labeling provisions of this regulation are not appropriate, but in these cases exemption must be applied for and approved by BFAD/BAI on a case to case basis.

Section 13. VIOLATIVE / PROHIBITED ACTS

13.1      Any product that is not labeled in accordance with the requirement of this Regulation shall be deemed misbranded.

13.2      The following acts and the causing thereof are hereby prohibited:

13.2.1  The manufacture, sale, offering for sale or transfer of any product that is misbranded.

13.2.2   Forging/counterfeiting, simulating or falsely representing or using any mark, stamp, label or other identification device required under the Regulation without proper authority.

13.2.3   The alteration, mutilation, destruction, obliteration or removal of the whole or any part of the labeling of product, if such act is done while such product is held for sale and results in such article being misbranded.

13.2.4  The use in labeling of reference to any BFAD/BAI Report or documents (analysis) without clearance from BFAD and or BAI.

Section 14. SANCTIONS

            For violation of this Regulation, any or all of the following sanctions after due notice and summary hearing may be imposed by the Secretary of Health/Secretary of Agriculture, whenever applicable.

            14.1 Suspension or revocation of the License to Operate (LTO) of veterinary drug and product establishments and outlets and cancellation of Certificate of Product Registration.

            14.2 Imposition of administrative fines of not less than P1,000.00 not more than P5,000.00

            14.3 Recall from the market of misbranded product(s)

            14.4 Confiscation of the violative product(s)

Section 15. CRIMINAL LIABILITY

            The imposition of the above sanctions does not preclude the institution of appropriate criminal proceeding pursuant to Section 26 of R.A. No. 3720, as amended, Section 12 of R.A. No. 6675, Section 10 of R.A. No. 1556 and Section 3 of R.A. 1071 and Section 5 of R.A. 3101.

Section 16. PROCEDURE FOR CHANGING OVER TO NEW LABELS

            The procedure and timetable for changing over to the new labels will be as follows:

            16.1 All drug establishments that own registered drug products with single active ingredients covered by this A.O. shall present the above for review and approval by BFAD  not later than June 15, 1991. Multiple active ingredient products will follow the guidelines and timetable which shall be the subject of another subsequent A.O.

            16.2 All satisfactory applications for new generic labels covered by this A.O. submitted within June 15, 1991 deadline shall be approved by BFAD no later than August 15, 1991.

            16.3 Starting sixty (60) days after approval but not later than October 15, 1991, only such approved generic labels shall be used for these products in new production. The drug establishment is required to submit the last batch number bearing the old and first batch number bearing the new generic label before the start of actual production with the new label.

            16.4 After December 31, 1991 all covered products with the old labels shall be deemed misbranded and subject to seizure by BFAD.

            16.5 It shall be the responsibility of the drug establishment to ascertain the coverage of this A.O. on its products.

            16.6 Remedial generic labeling according to the provisions of A.O. 79 s. 1989 is available to products covered by this A.O.

Section 17. SEPARABILITY CLAUSE

            In case of any provision of these rules and regulations is declared contrary to law or unconstitutional, other provisions which are not affected thereby shall continue to be in force and in effect.

Section 18. REPEALING CLAUSE

            All administrative orders, Rules and Regulations and other administrative issuances or parts thereof, inconsistent with the provisions of this Regulation, are hereby repealed and modified accordingly.

Section 19. EFFECTIVITY

            This regulation shall take effect fifteen (15) calendar days after publication in two newspapers of general circulation or in Official Gazette.

(Sgd.) SENEN C. BACANI                                                            (Sgd.) ALFREDO R.A. BENGZON, M.D.

   Secretary of Agriculture                                                                                      Secretary of Health

ANNEX A 

PHARMACOLOGICAL CATEGORIES OF VETERINARY DRUGS AND PRODUCTS 

  1. DRUGS ACTING ON THE CENTRAL NERVOUS SYSTEM

            1.0 Analgesics

1.1  Non-Opioids

1.2  Opioid Analgesics

2.0 Anesthetics

            2.1 General Anesthetics

                        2.1.1 Inhalation

                                    2.1.1.1 Gases

                                    2.1.1.2  Volatile Agents

                        2.1.2 Intravenous Agents

                        2.1.3 Adjuvants

                                    2.1.3.1 Opioid Analgesics

                                    2.1.3.2 Muscle Relaxants

                                    2.1.3.3 Anticholinergics

                                    2.1.3.4 Sedatives / Tranquilizers

            2.2 Local Anesthetics

3.0 Antipyretics

4.0 Anticonvulsants

  1. ANTI-INFECTIVES

            1.0 Antibiotics

1.1  Cell Wall Inhibitors

1.1.1 Penicillins

1.1.2 Ampicillins

1.1.3 Carboxypenicillins

1.1.4 Cephalosporins

1.1.5 Polymixins

1.2  Protein Synthesis Inhibitors

1.2.1 Aminoglycosides

1.2.2 Tetracyclines

1.2.3 Chloramphenicol

1.2.4 Macrolides

1.2.5 Lincosamides

1.2.6 Diterpenes

1.3  Energy Metabolism Inhibitors

1.4  Folate Synthesis Inhibitors

1.4.1 Sulfonamides

1.4.2 Trimethoprims / Sulfonamides

1.5  Nucleic Acid Inhibitors

1.5.1 Imidazole

1.5.2 Quinolones

            2.0 Antivirals

            3.0 Antifungals

                        3.1 Systemic

                        3.2 Topical

            4.0 Antiparasitics

                        4.1 Anthelmintics

                        4.2 Antiprotozoal

III. ACARICIDES / INSECTICIDES

            1.0 Avermectins

            2.0 Carbamates

            3.0 Formamidines

            4.0 Organochlorines

            5.0 Organophosphates

            6.0 Pyrethroids

            7.0 Rotenones

            8.0 Repellants

            9.0 Insect Growth Regulators

            10.0 Synergists

  1. BIOLOGICALS / IMMUNOLOGICALS

            1.0 Vaccines

            2.0 Diagnostic Reagents

            3.0 Antisera

            4.0 Immunoenhancers

            5.0 Immunosuppressors

  1. CARDIOVASCULAR DRUGS

            1.0 Antiarrhythmic Agents

            2.0 Inotropic Agents

            3.0 Diuretics

  1. DRUGS ACTING ON THE URINARY SYSTEM

            1.0 Urinary Acidifiers

            2.0 Urinary Alkalinizers

            3.0 Urinary Antiseptics

            4.0 Diuretics

            5.0 Cholinergics

  1. DRUGS ACTING ON REPRODUCTIVE SYSTEM

            1.0 Androgens

            2.0 Androgen Antagonists

            3.0 Estrogens

            4.0 Estrogen Antagonists

            5.0 Progestins

            6.0 Oxytocics

            7.0 Tocolytics

VIII. DRUGS ACTING ON THE RESPIRATORY SYSTEM

            1.0 Antihistamines

            2.0 Antitussives

            3.0 Bronchodilators

            4.0 Corticosteroids

            5.0 Expectorants

            6.0 Mucolytics

  1. ANTI-ALLERGICS

            1.0 Antihistamines

            2.0 Corticosteroids

            3.0 Epinephrine

  1. ANTIEOPLASTICS

            1.0 Cytotoxic Agents

            2.0 Immunomodulators

            3.0 Immunosupressants

  1. DRUGS AFFECTING THE BLOOD

            1.0 Anti-Anemics

            2.0 Anticoagulants

            3.0 Hemostatics

XII. ANTIDOTES/THERAPIES FOR TOXINS

XIII. DRUGS ACTING ON THE GASTRO-INTESTINAL TRACT

            1.0 Adsorbents

            2.0 Antacids

            3.0 Antiemetics

            4.0 Antisecretory

                        4.1 Anticholinergics

                        4.2 Opioids

                        4.3 Phenothiazine Derivatives

                        4.4 Prostaglandin Inhibitors

            5.0 Astringents

            6.0 Carminatives

            7.0 Cathartics

            8.0 Emetics

            9.0 Motility Modifiers

                        9.1 Anticholinergics

                        9.2 Cholinergic Agonists

                        9.3 Opioids

            10.0 Protectants

XIV. HORMONES, HORMONE ANTAGONISTS AND RELATED DRUGS

            1.0 Adrenal Corticosteroids

            2.0 Anabolic Steroids

            3.0 Anterior Pituitary / Hypothalamic Hormones

            4.0 Gonadal Hormones and Antagonists

                        4.1 Androgens

                        4.2 Androgen Antagonists

                        4.3 Estrogens

                        4.4 Estrogen Antagonists

                        4.5 Progestins

            5.0 Glycemic Hormone / Glucagon

            6.0 Insulins

            7.0 Oral Hypoglycemic

            8.0 Posterior Pituitary Hormones

            9.0 Prostaglandins and Analogues

            10.0 Thyroid Hormones

            11.0 Thyroid Antagonists

  1. SOLUTIONS CORRECTING WATER ELECTROLYTES, ACID-BASE AND CALORIC DISTURBANCES

            1.0 Sugars

            2.0 Electrolytes

            3.0 Amino Acids

XVI. DIAGNOSTIC AGENTS 

XVII. DERMATOLOGICAL AGENTS

            1.0 Anti-Infectives

            2.0 Anti-inflammatory / Antipruritic Drugs

            3.0 Antiseptics

            4.0 Astringents

XVIII. CAUTERIZING AND DEBRIDING AGENTS 

XIX. OPTHTHALMOLOGICAL PREPARATIONS 

  1. OTIC PREPARATIONS

XXI. VITAMINS AND MINERALS

XXII. ANTISEPTICS AND DISINFECTANTS 

XXIII. ANTI-INFLAMMATORY DRUGS

            1.0 Non-Steroidal Anti-Inflammatory Drugs

            2.0 Corticosteroids

XXIV. BEHAVIOR MODIFIERS 

XXV. PERFORMANCE ENHANCERS

            1.0 Antibacterials

            2.0 Anabolics

            3.0 Non-Specific Chemicals

XXVI. EUTHANIZING AGENTS

            1.0 Gases

            2.0 Chemicals

            3.0 Anesthetics

XXVII. DRUGS FOR AQUATIC ANIMALS

ANNEX B

(LIST B)

LIST OF VETERINARY DRUGS AND PRODUCTS REQUIRING STRICT PRECAUTIONS IN PRESCRIBING DISPENSING AND USE

1. ACEPROMAZINE : TABLET/INJECTABLE
2. AMINOPHYLLINE : SUPPOSITORY/TABLET
3. AMITRAZ : POUR ON
4. AMPHOTERICIN B : INJECTABLE
5. AZAPERONE : INJECTABLE
6. BETASMETHASONE : TABLET
7. BUNAMIDINE : TABLET
8. CARBADOX : PREMIX
9. CHLORAMBUCIL : TABLET
10. CHLORAMPHENICOL : CAPSULE/INJECTABLE
11. CHLORPROPAMIDE : TABLET
12. COLISTIN : INJECTABLE
13. CYCLOPHOSPHAMIDE : TABLET
14. DEXAMETHASONE : TABLET
15. DEXAMETHASONE ACETATE : INJECTABLE
16. DIAZEPAM : TABLET
17. DICHLORVOS : CAPSULE/GRANULES
18. DIETHYSTILBESTROL (DES) : INJECTABLES
19. DIGITOXIN : TABLET
20. DIGOXIN : TABLET
21. DIHYDROSTREPTOMYCIN : INJECTABLE
22. DIMETRIDAZOLE : INJECTABLE
23. DIMETHAZINE : INJECTABLE
24. EPINEPHRINE : INJECTABLE
25. ERYTHROMYCIN : INJECTABLE
26. ESTROGEN, CONJUGATED : INJECTABLE
27. ETHINYLESTRADIOL : TABLET
28. ETHOSUXIMIDE : CAPSULE
29. FURAZOLIDONE : SUSPENSION/TABLET
30. FUROSEMIDE : TABLET/INJECTABLE
31. GENTAMICIN : INJECTABLE
32. HALQUINOL : PREMIX
33. HYDROCHLOROTHIAZIDE : TABLET
34. HYDROCORTISONE : INJECTABLE
35. IMIDOCARB : INJECTABLE
36. INSULIN : INJECTABLE
37. IVERMECTIN : TABLET/INJECTABLE
38. KETAMINE : INJECTABLE
39. LASALOCID : PREMIX
40. LEVAMISOLE : INJECTABLE
41. LINDANE : POUR ON
42. LORAZEPAM : ORAL
43. MELARSONYL : INJECTABLE
44. MENADIONE : TABLET
45. MENADIONE SODIUM BISULFATE : TABLET
46. MEPHENYTOIN : TABLET
47. METHDILAZINE HYDROCHLORIDE : TABLET
48. METHOTREXATE : TABLET
49. METHYLERGOMETRINE
(METHYLERGONOVINE) MALEATE : TABLET
50. METRONIZADOLE : TABLET
51. MONENSIN : PREMIX
52. NEOMYCIN : INJECTABLE
53. NICLOSAMIDE : TABLET
54. NITROFURANTOIN : CAPSULE/SUSPENSION/TABLET
55. OLAQUINDOX : PREMIX
56. OUABAIN : INJECTABLE
57. OXYTETRACYCLINE (LONG-ACTING) : INJECTABLE
58. OXYTOCIN : INJECTABLE
59. PANCURONIUM : INJECTABLE
60. PERPHENAZINE : SUPPOSITORY/SYRUP/TABLET/CR TABLET
61. PHENYLBUTAZONE : CAPSULE/TABLET
62. PHENYTOIN : SUSPENSION
63. PHENYTOIN SODIUM, EXTENDED : CAPSULE
64. PHENYTOIN SODIUM, PROMPT : CAPSULE
65. PRAZIQUANTEL : TABLET
66. PROBENECID : TABLET
67. PROCAINAMIDE HYDROCHLORIDE : CAPSULE/TABLET/CR TABLET
68. PROPIONYL PHENOTHIAZINE : INJECTABLE
69. PROSTAGLANDIN F2 ALPHA : INJECTABLE POWDER
70. PYRAZINAMIDE : TABLET
71. QUINIDINE SULFATE : CAPSULE/TABLET/CR TABLET
72. SALINOMYCIN : PREMIX
73. SPIRONOLACTONE : TABLET
74. STREPTOMYCIN : INJECTABLE
75. SUCCINYLCHOLINE : INJECTABLE
76. SULFADIAZINE; SULFAMERAZINE; : TABLET
SULFAMETHAZINE
77. SULFAMETHIZOLE : SUSPENSION/TABLET
78. SULFISOXAZOLE : SUSPENSION/TABLET
79. SURAMIN : INJECTABLE
80. THEOPHYLLINE : TABLET/CR CAPSULE (SPRINKLES/SUSPENSION/CR TABLET)
81. THIACETARSAMIDE : INJECTABLE
82. THIORIDAZINF HYDROCHLORIDE : TABLET
83. THYROGLOBULIN : TABLET
84. TOLBUTAMIDE : TABLET
85. TRIAMCINOLONE : TABLET
86. XYLAZINE : INJECTABLE

Republic of the Philippines

Department of Health

OFFICE OF THE SECRETARY

                                                                                                            7 November 1991

 

DEPARTMENT OF HEALTH

Administrative Order No. 114-B

Series of 1991

 

DEPARTMENT OF AGRICULTURE

Administrative Order No. 38

Series of 1991

 

SUBJECT      :           TRANSITIONAL REMEDIAL LABELLING IN COMPLIANCE WITH R.A. 6675

In response to various inquiries by veterinary drug and product manufacturers and outlets regarding the implementation of joint Administrative Order DOH No. 105 s. 1991 and DA No. 11 s. 1991 the following clarification are hereby issued:

  1. The Bureau of Food and Drugs and the Bureau of Animal Industry shall implement the provisions and deadlines for the joint Administrative Order DOH No. 105 s. 1991 and DA No. 11 s. 1991. All parties engaged in manufacturing, distributing or selling veterinary drug products using labels not in compliance with joint Administrative Order DOH No. 105 s. 1991 and DA 11 s.1991 are advised to observed the deadlines.
  2. Veterinary drugs and product manufacturers carrying substantial inventories of veterinary drugs and products whose labels do not comply with the requirements of joint Administrative Order DOH No. 105 and DA No. 11 s. 1991 may be granted by BFAD/BAI remedial labeling options described below during the transition period only. The specific plan shall indicate the veterinary drugs and products for which it would adopt relabelling, estimated quantity to be relabeled and the kind of relabelling option to be adopted.
  3. Upon compliance with the conditions described in Section 2 above and upon approval by BFAD/BAI, any of the following remedial relabelling options may be availed of by veterinary drug and product manufacturers seeking to comply with the generics labeling requirements of R.A. 6675 for a specific lot of veterinary drugs and products already produced under old labeling rules. The essence of these options is that the identification of the generic name of the veterinary drugs and products shall be made as far as feasible under the circumstances.

3.1 For a veterinary drugs and products in bottles, including, vials containing more than 220 ml.

                        3.1.1 A new package insert approved by BFAD/BAI as complying with joint Administrative Order DOH

                                 No. 105 s.1991 and DA No. 11 s. 1991 must be provided. 

 

                      3.1.2 The immediate container must be identified by a remedial stick-on label added to the old label

                              may be any of the following (a) the new label approved by BFAD/BAI under joint Administrative

                             Order DOH No. 105 s.1991 and DA No. 11 s.1991; (b) a label containing only the generic name

                             derived from the label approved by BFAD/BAI under joint Administrative Order DOH No. 105 s.

                             1991 and DA No. 11 s. 1991.

 

3.1.3 The secondary container should use a new label approved by BFAD/BAI under joint Administrative

                           Order No. 105 s. 1991 and DA No. 11 s. 1991; or alternatively a remedial stick on label on the

                           principal display panel containing the generic name as approved by BFAD/BAI complying joint

                            Administrative Order DOH No. 105 s. 1991 and DA No. 11 s. 1991. 

            3.2 For veterinary drugs and products in blister packs or aluminum foil packs, vials containing not more than 20 mL and all ampules.

                        3.2.1 A new package insert approved by BFAD/BAI as complying with joint Administrative Order DOH No. 105 s.1991 and DA No. 11 s.1991 must be provided.

                        3.2.2 A clarificatory leaflet containing the labeling information required by joint Administrative Order DOH No. 105 s.1991 and DA No. 11 s.1991 must be provided. The leaflet must be approximately the same size as the basic blister pack or aluminum foil pack. There should be about one leaflet for every four tablets or capsules. This leaflet shall be distributed upon dispensing the product.

                        3.2.3 A secondary container should use a new label approved by BFAD/BAI under joint Administrative Order DOH No. 105 s.1991 and DA No. 11 s.1991 or alternatively a remedial stick on label on the principal display panel containing the generic name as approved by BFAD/BAI complying with joint Administrative Order DOH No. 105 s.1991 and DA No. 11 s.1991.

  1. This remedial labeling shall be available only for products produced prior to October 1, 1992, the starting date when all new veterinary drug and production is required to use the new approved labels under joint Administrative Order DOH No. 105 s.1991 and DA No. 11 s.1991.
  2. This regulation shall take effect fifteen (15) calendar days after publication in a newspaper of general circulation or in the official Gazette.

(Sgd.) SENEN C. BACANI                                                            (Sgd.) ALFREDO R.A. BENGZON, M.D.

   Secretary of Agriculture                                                                                     Secretary of Health

DA AO #41 and DOH AO #111-D series of 1990

Guidelines On Advertisement And Promotions Of
Veterinary Drugs And Products

Republic of the Philippines

Department of Health 

OFFICE OF THE SECRETARY

  

                                                                                                            August 1, 1990

DEPARTMENT OF AGRICULTURE

Administrative Order No. 41

Series of 1990

 

DEPARTMENT OF HEALTH

Administrative Order No. 111-D

Series of 1990

SUBJECT  :   GUIDELINES ON ADVERTISEMENT AND PROMOTIONS OF VETERINARY DRUGS

                        AND PRODUCTS

             Pursuant to Section 6 (c) of R.A. 6675 known as �Generics Act of 1988� Section 3 (c) of R.A. 3720 known as �Foods, Drugs and Devices and Cosmetics Act�, and Executive Order No. 119 dated January 30, 1987, the following rules and regulations on the advertisement and promotions of veterinary drugs and products are hereby promulgated.

 Section 1. DEFINITION OF TERMS:

1.1  �Advertisement� refers to any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any veterinary drug and product.

1.2   �Promotion� refers to the practice of giving temporary additional value to brand, product or service to achieve specific marketing objectives. �Promotion� includes the distribution of free sample of veterinary drugs and products.

1.3   �Veterinary drugs and products� refer to any substance, including biological products, applied or administered to food producing, companion, aquatic, laboratory and exotic animals, whether used for therapeutic, prophylactic or diagnostic purpose or for modification of physiological functions or behavior.

1.4   �Veterinary Prescription or Ethical Drugs� refer any drug preparation that is to be dispensed only upon written order of a duly-licensed veterinarian for the treatment of a condition or a diagnosed disease of animals.

1.5   �Veterinary Non-prescription Drug� or �Veterinary Over-the-Counter Drugs� refer to drug preparations that can be dispensed even without the written order of a duly-licensed veterinarian, for the use of animals for the self-limiting animal diseases.

1.6  �Mass Media� refer to any publication, book, notice, handbill, poster, circular, pamphlet, letter, billboard, print media, radio, television, cinema, mobile audiovisual units or any other widespread medium of information directed to the lay public.

Section 2. GUIDELINES ON ADVERTISEMENT AND PROMOTION TO BASED ON PRIOR LAWS.

 

2. 1 No person shall advertise or promote veterinary drug and product unless such products are duly-

        registered with the Bureau of Food and Drugs (BFAD) and/or the Bureau of Animal Industry (BAI). 

 

2.2 All therapeutic claims for veterinary drugs and product made in advertising or promotional materials must

     be based on adequate scientific, pharmacological, technical and clinical evidence, responsible veterinary

    medical opinion or long experience demonstrating their safety, efficacy and therapeutic indications

     approved by the BFAD and or the BAI. 

 

2.3 Veterinary drugs and products classified by BFAD/BAI as Prescription of Ethical Drugs can be advertised

     or promoted in any form of mass media provided a veterinarian should be prescribing the veterinary drugs

    and products. This form of advertisement shall be only for a period of one (1) year or until such time that in

    the rural areas certified by the Philippine Veterinary Medical Association (PVMA) / Veterinary Practitioners

    Association of the Philippines (VPAP).

 

2.4 The Veterinary drug and product company which owns the veterinary drugs and products, and its

     Veterinary Medical Director/Officer shall be responsible and accountable for the content and form of their

     advertisement and promotion materials.

            IMPLEMENT SECTION 6 (C) OF THE GENERICS ACT OF 1988 (R.A. 6675)

Section 3. GUIDELINES ON ADVERTISEMENT AND PROMOTION TO IMPLEMENT SECTION 6 (C) OF THE

                   GENERICS ACT OF 1988 (R.A. 6675)

            3.1 General Principle

            Consistent with section 6 (c) of R.A. 6675, all advertising and promotional materials, whether print, visual or

            auditory, shall feature prominently the generic name of the veterinary drugs and products designated by

            BFAD/BAI. In the case of branded products, the prominence of the generic name shall be insured in all print,

            visual or auditory materials but can feature the brand name.

            3.2 Print and Static Visual Materials, (e.g. Posters, Billboards)

            The pertinent provisions of Administrative Order No.  _____ on Requirements for Labelling Materials of

            Veterinary Drugs and Products quoted hereunder shall apply with the exception that the word �label� shall be

            substituted by �advertising and other promotional material�. 

 

3.2.1 In all cases, the generic name shall be the prominently printed element on the advertising and

                              other promotional material defined as the one with the highest point size among the various

                              printed elements on the advertising and other promotional materials. It shall be enclosed exclusively

                              by a outlined box rendered in the same color as the generic name. The background color inside the

                              box, against which the generic name is rendered, should be the same color as the background

                              color outside the box, against which the brand name is rendered. 

 

3.2.2 In all cases, the generic name shall be printed in full, not abbreviated and in accordance with the

                               International Non-Proprietary Name (INN). In case the salt or the specific chemical form of the drug

                               needs to be indicated, this must be included inside the box but in small point size. 

 

                     3.2.3 If veterinary drug and product are identified by brand names together with their generic names, the

                               following shall be required in addition to 3.2.1 and 3.2.2. 

 

                                  3.2.3.1 The generic name and brand name shall be rendered using the same typeface,

                                              boldness, font and color, with the generic name, appearing immediately above the brand

                                              name and rendered in a point size bigger than the brand name. 

 

3.2.3.2 If a brand name is presented using a special typeface exclusively designed and used for

                                             it, the generic name shall be rendered in Helvetica or Universe typeface while complying

                                             with the other pertinent provisions above.

            3.3 Other Visual Materials

            For other forms of visual materials, such as television, cinema or movies, etc. the general principle in 3.1 shall be applied, and consistent with the generic name designated by BFAD/BAI, shall appear prominently within the outlined box, immediately above and in larger point-size than the brand name, if any.

            3.4 Auditory Materials

            For auditory materials used in radio or other media, the general principle in 3.1 shall be adopted according to the convention of the medium.

Section 4. MONITORING AND ENFORCEMENT

            4.1 The veterinary drug and product establishment under which name the veterinary drug and product is

                registered shall be responsible for ensuring that its advertisement and other promotional materials comply

               with these guidelines. It shall establish suitable mechanism for internally reviewing such materials

               specifically with the participation of its veterinary medical director/officer. 

 

            4.2 In addition, the veterinary drug and product establishment may participate in other industry-wide

                mechanism for self or voluntary regulation. Such participation, however, shall not in anyway diminish the

                fundamental responsibility and accountability of the veterinary drug and product establishment with respect

                to compliance with these regulations. 

 

            4.3 No prior clearance from BFAD/BAI is required for initial printing and broadcast or dissemination of

               advertisement and other promotional materials for veterinary drugs and products. However, it is incumbent

              upon the advertiser of the veterinary drug or product to obtain the approval of the Veterinary Technical

              Committee of the Board of Advertisers of the Philippines. 

 

            4.4 BFAD/BAI shall monitor advertisement and promotion of veterinary drugs and products as well as receive

               complaints regarding these. On the basis of its monitored finding or complaints, BFAD/BAI shall determine

               if any advertising or promotional material violates these guidelines. 

 

4.5 Any advertising or promotional material found to be violative of these guidelines shall be identified and the

               veterinary drug and product establishment responsible shall be notified. BFAD/BAI shall issue a cease and

              desist order stopping the further release, printing broadcast or dissemination of the violative advertising or

               promotional material. 

 

            4.6 If the veterinary drug and product  establishment wishes to contest BFAD/BAI findings, a formal hearing

                  shall be conducted. From the finding after the hearing, BFAD/BAI shall decide along the following

                  possibilities: 

                        4.6.1 The initial finding was found untenable and the cease and desist order is then lifted.

                        4.6.2 The initial finding was found valid so the cease and desist order remains.

 

            4.7 Repeated or serious violations of these guidelines may be regarded by BFAD/BAI as indicative of the

                  subject veterinary drug and product establishment�s inability to perform adequately in a manner that

                  assures the proper use of its veterinary drugs and products. Under such condition and after due hearing,

                  BFAD/BAI may impose the following sanctions: 

 

                        4.7.1 Withdrawal by BFAD/BAI of the accreditation of the establishment�s Veterinary Medical

                                  Director/Officer. 

                        4.7.2 Suspension of the license to operate the veterinary drug and product establishment.

                        4.7.3 Cancellation of the certification of product registration.

                        4.7.4 Revocation of the license to operate the veterinary drug and product establishment.

Section 5. SEPARABILITY CLAUSE

            In case any provision of this A.O. is declared contrary to law or unconstitutional, other provisions which are not affected thereby shall continue to be in force and in effect.

Section 6. REPEALING CLAUSE

            All administrative orders, rules and regulations and other administrative issuances or parts thereof inconsistent with the provisions of this A.O. are hereby repealed or modified accordingly.

Section 7. EFFECTIVITY

            This A.O. shall take effect fifteen days after its publication in two newspaper of general circulation.

 

(Sgd.) SENEN C. BACANI                                                            (Sgd.) ALFREDO R.A. BENGZON, M.D.

   Secretary of Agriculture                                                                                    Secretary of Health

DA AO #17 series of 2004

Amendment To Da-Bai Ao No. 12 S. 1992 On The Classification Of
Animal Diseases.

Republic of the Philippines

Department of Health

OFFICE OF THE SECRETARY

    

DEPARTMENT OF AGRICULTURE

Administrative Order No. 17

Series of 2004

SUBJECT  :    AMENDMENT TO DA-BAI AO NO. 12 S. 1992 ON THE CLASSIFICATION OF ANIMAL DISEASES

             In order to provide the basis for monitoring, prevention, control and eradication of animal diseases and in the regulation of animals, animal products and by-products, animal feeds, veterinary drugs and products, the following classification of diseases affecting animals is hereby amended:

  1. FIRST PRIORITY DISEASES � are communicable diseases which have the potential for very serious and rapid spread; are of serious socio-economic and/or public health importance, are of major importance in the international trade of animals, animal products and by-products, animal feeds, veterinary drugs and products and; are presently the priority of the government for prevention, control and eradication programs.

Foot and mouth disease (O1, A24,C3)

Hemmorhagic septicemia

Hog cholera

Newcastle disease

Rabies

Anthrax

Aujeszky�s disease (Pseudorabies)

Infectious Bursal Disease (Gumboro disease)

  1. SECOND PRIORITY DISEASES - are communicable diseases which are considered to be of socio-economic and/or public health importance and which are significant in the international trade of animals, animal products and by-products, animal feeds, veterinary drugs and products.

Blackleg

Bovine anaplasmosis

Bovine babesiosis

Bovine tuberculosis

Brucellosis

Fasciolosis

Leptospirosis

Pullorum disease

Surra (Trypanosomiasis)

  1. EMERGING DISEASES � are communicable diseases which have been recently detected to be present in the country but still confined in limited areas or farms.

Caprine arthritis/encephalitis

Equine Influenza

Japanese encephalitis

Mucosal disease/Bovine virus diarrhea

Porcine dermatitis nephritis syndrome

Porcine multisystemic wasting syndrome

Swine influenza

Transmissible gastroenteritis

  1. DISEASES OF FARM CONCERN � are diseases which commonly affect farm animals and their prevention and control are of primary concern of the farm.
  2. Hogs

Actinobacillus pleuropneumonia

Atrophic rhinitis

Glasser�s disease

Porcine parvovirus

Porcine reproductive & respiratory syndrome

Swine erysipelas

Swine enzootic pneumonia

Swine plague

  1. Poultry

Avian encephalomyelitis/encephalitis

Avian infectious bronchitis

Avian infectious laryngotracheitis

Avian leucosis

Avian malaria (Leukocytozoonosis)

Bacillary white diarrhea

Chlamydiosis

Coccidiosis

Egg drop syndrome

Fowl cholera (Avian pasteurellosis)

Fowl pox

Infectious chicken anemia

Infectious coryza

Malabsorption syndrome

Marek�s disease

Viral arthritis (Tenosynovitis)

 

  1. Sheep/Goat

Orf

Parasitic gastroenteritis

 

  1. Multispecies

Colibacillosis

Ephemeral fever

Keratoconjunctivitis (Pink eye disease)

Mycoplasmosis

Mycotoxicosis

Salmonellosis

Screwworm (Myiasis)

  1. DISEASES OF COMPANION ANIMALS � are diseases of horses, dogs, cats, and exotic pets which are present in the country.

Canine babesiosis (Babesia canis)

Canine coronavirus enteritis

Canine distemper

Canine herpes

Canine infectious hepatitis

Canine parainfluenza

Canine parvovirus enteritis

Erlichiosis

Equine infectious anemia

Feline

Herpes

Feline panleukopenia

Glanders

Psittacosis/Ornithosis

Strangles

  1. EXOTIC DISEASES � are diseases of animals which are no longer present in the country based on the classification of OIE listings of diseases, A and B.

African swine fever

Avian influenza

Bluetongue

Bovine spongiform encephalopathy

Contagious bovine pleuropneumonia

Dermatophilosis

Duck virus enteritis

Duck virus hepatitis

Enterovirus encephalomyelitis (Teschen disease)

Enzootic abortion of ewes

Enzootic bovine leucosis

Equine viral enteritis

Foot and mouth disease (Asia 1, SAT1, SAT2, SAT3)

Heartwater

Horse pox

Infectious bovine rhinotracheitis

Johne�s disease (Paratuberculosis)

Lumpy skin disease

Maedi-visna

Nairobi sheep disease

Nipah virus

Peste des petits ruminants

Pulmonary adenomatosis

Q fever

Rinderpest

Scrapie

Venezuelan equine encephalomyelitis

Vesicular exanthema

Vesicular stomatitis

Done in Quezon City, this 13th day of August in the year two thousand and four.

 

This Order shall take effect immediately.

 

(Sgd.) ARTHUR C. YAP

Officer-in-Charge

Office of the Secretary

Recommending Approval

(Sgd.) JOSE Q. MOLINA

           Director IV

DA AO #24 series of 2005

General Guidelines And Requirements On The Quality Control
Laboratory Accreditation Of Commercial And Non-Commercial
Drug Manufacturers, Veterinary Drug Manufacturers And
For Feed And Drug Service Laboratories.

Republic of the Philippines

DEPARTMENT OF AGRICULTURE

Office of the Secretary

Elliptical Road, Diliman, Quezon City 1100

Philippines

ADMINISTRATIVE ORDER

No. __24__

Series of 2005

SUBJECT:            GENERAL GUIDELINES AND REQUIREMENTS ON THE QUALITY CONTROL LABORATORY ACCREDITATION OF COMMERCIAL AND NON-COMMERCIAL DRUG MANUFACTURERS, VETERINARY DRUG MANUFACTURERS AND FOR FEED AND DRUG SERVICE LABORATORIES

 

Pursuant to the implementation of and in support to R.A. 1556, Animal Industry AO No.35 Article IV Sections 9 & 11; AO no. 25 series of 1991, the following requirements for accreditation are hereby promulgated.

  1. PURPOSE AND SCOPE

These requirements are to be accomplished by all Quality Control Laboratories of Commercial/Non-Commercial Feed manufacturers, Veterinary Drug manufacturers/Tollers and Purely Service Laboratories.

Applicants will have to provide documentations ion all laboratory activities and must allow inspection of the laboratory premises by the Laboratory Technical Assessors from the Central Animal Feed Analysis and the Pharmaceutical Production Laboratories of the Laboratory Services Division, Bureau of Animal Industry.

  1. DEFINITION OF TERMS

When used in the guidelines, the following terms shall mean as follows:

  1. Accreditation - formal recognition of competence
  2. Assessors - Technical Staff of the Central Animal Feed Analysis and the Pharmaceutical Production Laboratories of the Bureau of Animal Industry to carry out inspection/audits and shall provide recommendations.
  3. Audit/Inspection � periodic and systematic assessment of all policies and procedures.
  4. Test Procedures- defined technical procedures of all analyses/assays conducted.
  5. Documentation � written procedures/results.
  6. Reference Books/Materials � references which provide essential traceability and are used to demonstrate the accuracy of the following: procedures/methods, results, monitor performance to validate methods and enable comparison of methods by the set standards.

III. REQUIREMENTS:

  1. Accomplished Application Form for laboratory inspection/accreditation 2. The laboratory shall be legally identifiable.
  2. The owner of the laboratory whether an individual, partnership or corporation must be registered with the Department of Trade and Industry (DTI) or Securities and Exchange Commission (SEC).
  3. The laboratory shall submit certified photocopy of the environmental certificate of compliance/clearance from DENR.
  4. The laboratory shall submit certified photocopy of the license/s, permit/s from other government regulatory bodies.
  5. The laboratory shall submit a clear structure of responsibility. It shall have:a.   Management Staff with authority to discharge dutiesc.   Quality Control Staff responsible for quality control system of production and of analysis
  6. b.   Technical Staff responsible for production and for results
  7. The laboratory shall have the competence to conduct all claimed analyses and assays and deliver results within a prescribed period with traceability.
  8. The laboratory shall submit documented analysis procedures. 8. The laboratory shall submit the following documents to CAFAL-LSD for tabletop evaluation:
  1. Duly accomplished and notarized application
  2. Organizational structure
  3. Photocopy of Chemists� PRC license
  4. Affidavit of Quality Control Chemist
  5. List of Laboratory analyses conducted
  6. Test procedures of all analyses/capabilities conducted
  7. List of equipment with specifications (classifying into functional and non-functional)
  8. List of chemicals and reagents (no. of bottles, net weight)
  9. Prescribed fees (if any)
  10. List of reference books/materials
  11. Floor plan of the laboratory
  12. Ocular inspection and evaluation of laboratory facilities
  13. it shall request in writing the schedule for laboratory inspection
  14. it shall convey inspector(s) to and from the site

iii. it shall submit receipt of payment/s (inspection and accreditation fees)

  1. 9. The requesting laboratory shall pay the following corresponding fees per annum:a. Laboratory Inspection Fee ���������................................ P 250.00c. Combination of Feed and VDAP Laboratory Accreditation Fee �. .1,000.00
  2. d. Service Laboratories �����������. ................................1,500.00
  3. b. Feed Laboratory Accreditation Fee ����. .. ................................... 500.00
  1. COMPLAINTS

The laboratory shall have documented policy and procedures for the resolution of complaints received from clients.

The laboratory shall have complete records of all complaints and all the actions taken.

  1. VALIDITY

Accreditation shall be valid for a period of one (1) year.

 

The implementation of this ORDER shall be the responsibility of the Laboratory Services Division, Bureau of Animal Industry.

(Sgd.)  DOMINGO F. PANGANIBAN

                       Secretary