Administrative Orders

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

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

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

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

II. Regulated Drugs

1. Available in the Market

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

1. Not Available in the Market

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

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.

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.  
7. b.   Technical Staff responsible for production and for results
8. The laboratory shall have the competence to conduct all claimed analyses and assays and deliver results within a prescribed period with traceability.
9. 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

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

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

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

II.  Regulated Drugs

A. Available in the Market

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

B. Not Available in the Market

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

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