Generics Act of 1988

September 13, 1988

REPUBLIC ACT NO. 6675

AN ACT TO PROMOTE, REQUIRE AND ENSURE THE PRODUCTION OF AN ADEQUATE SUPPLY, DISTRIBUTION, USE AND ACCEPTANCE OF DRUGS AND MEDICINES IDENTIFIED BY THEIR GENERIC NAMES

SECTION 1. Title. — This Act shall be known as the "Generics Act of 1988".

SECTION 2. Statement of Policy. — It is hereby declared the policy of the State:

To promote, encourage and require the use of generic terminology in the importation, manufacture, distribution, marketing, advertising and promotion, prescription and dispensing of drugs;

To ensure the adequate supply of drugs with generic names at the lowest possible cost and endeavor to make them available for free to indigent patients;

To encourage the extensive use of drugs with generic names through a rational system of procurement and distribution; acd

To emphasize the scientific basis for the use of drugs, in order that health professionals may become more aware and cognizant of their therapeutic effectiveness; and

To promote drug safety by minimizing duplication in medications and/or use of drugs with potentially adverse drug interactions.

SECTION 3. Definitions of Terms. — The following terms are herein defined for purposes of this Act:

(1) "Generic Name or Generic Terminology" is the identification of drugs and medicines by their scientifically and internationally recognized active ingredients or by their official generic name as determined by the Bureau of Food and Drugs of the Department of Health.

(2) "Active Ingredient" is the chemical component responsible for the claimed therapeutic effect of the pharmaceutical product.

(3) "Chemical Name" is the description of the chemical structure of the drug or medicine and serves as the complete identification of a compound.

(4) "Drug Product" is the finished product form that contains the active ingredients, generally but not necessarily in association with inactive ingredients.

(5) "Drug Establishment" is any organization or company involved in the manufacture, importation, repacking and/or distribution of drugs or medicines.

(6) "Drug Outlets" means drugstores, pharmacies, and any other business establishments which sell drugs or medicines.

(7) "Essential Drugs List" or "National Drug Formulary" is a list of drugs prepared and periodically updated by the Department of Health on the basis of health conditions obtaining in the Philippines as well as on an internationally accepted criteria. It shall consist of a core list and a complementary list.

(8) "Core List" is a list of drugs that meets the health care needs of the majority of the population. cd

(9) "Complimentary List" is a list of alternative drugs used when there is no response to the core essential drug or when there is a hypersensitivity reaction to the core essential drug or when, for one reason or another, the core essential drug cannot be given.

(10) "Brand Name" is the proprietary name given by the manufacturer to distinguish its product from those of competitors.

(11) "Generic Drugs" are drugs not covered by patent protection and which are labeled solely by their international non-proprietary or generic name.

SECTION 4. The Use of Generic Terminology for Essential Drugs and Promotional Incentives. — (a) In the promotion of the generic names for pharmaceutical products, special consideration shall be given to drugs and medicines which are included in the Essential Drugs List to be prepared within one hundred eighty (180) days from approval of this Act and updated quarterly by the Department of Health on the basis of health conditions obtaining in the Philippines as well as on internationally accepted criteria.

(b) The exclusive use of generic terminology in the manufacture, marketing and sales of drugs and medicines, particularly those in the Essential Drugs List, shall be promoted through such a system of incentives as the Board of Investments jointly with the Department of Health and other government agencies as may be authorized by law shall promulgate in accordance with existing laws, within one hundred eighty (180) days after approval of this Act.

SECTION 5. Posting and Publication. — The Department of Health shall publish annually in at least two (2) newspapers of general circulation in the Philippines the generic names, and the corresponding brand names under which they are marketed, of all drugs and medicines available in the Philippines.

SECTION 6. Who Shall Use Generic Terminology. — (a) All government health agencies and their personnel as well as other government agencies shall use generic terminology or generic names in all transactions related to purchasing, prescribing, dispensing and administering of drugs and medicines.

(b) All medical, dental and veterinary practitioners, including private practitioners, shall write prescriptions using the generic name. The brand name may be included if so desired.

(c) Any organization or company involved in the manufacture, importation, repacking, marketing and/or distribution of drugs and medicines shall indicate prominently the generic name of the product. In the case of brand name products, the generic name shall appear prominently and immediately above the brand name in all product labels as well as in advertising and other promotional materials.

(d) Drug outlets, including drugstores, hospital and non-hospital pharmacies and non-traditional outlets such as supermarkets and stores, shall inform any buyer about any and all other drug products having the same generic name together with their corresponding prices so that the buyer may adequately exercise his option. Within one (1) year after approval of this Act, the drug outlets referred to herein, shall post in conspicuous places in their establishments, a list of drug products with the same generic name and their corresponding prices.

SECTION 7. Provision of Quality, Manufacturer's Identity and Responsibility. — In order to assure responsibility for drug quality in all instances, the label of all drugs and medicines shall have the following: name and country of manufacture, dates of manufacture and expiration. The quality of such generically labeled drugs and medicines shall be duly certified by the Department of Health.

SECTION 8. Required Production. — Subject to the rules and regulations promulgated by the Secretary of Health, every drug manufacturing company operating in the Philippines shall be required to produce, distribute and make available to the general public the medicine it produces, in the form of generic drugs.

SECTION 9. Rules and Regulations. — The implementation of the provisions of this Act shall be in accordance with the rules and regulations to be promulgated by the Department of Health. Rules and regulations with penal sanctions shall be promulgated within one hundred eighty (180) days after approval of this Act and shall take effect fifteen (15) days after publication in the Official Gazette or in two (2) newspapers of general circulation.

SECTION 10. Authority to Import. — Within three (3) years from the effectivity of this Act, extendible by the President for another two (2) years and during periods of critical shortage and absolute necessity, the Department of Health is hereby authorized to import raw materials of which there is a shortage for the use of Filipino-owned or controlled drug establishments to be marketed and sold exclusively under generic nomenclature. The President may authorize the importation of raw materials tax and duty-free. The Secretary of Health shall ensure that the imported raw materials are allocated fairly and efficiently among Filipino-owned or controlled drug establishments. He shall submit to the Office of the President and to Congress a quarterly report on the quantity, kind and value of the raw materials imported.

SECTION 11. Education Drive. — The Department of Health jointly with the Department of Education, Culture and Sports, Philippine Information Agency and the Department of Local Government shall conduct a continuous information campaign for the public and a continuing education and training for the medical and allied medical professions on drugs with generic names as an alternative of equal efficacy to the more expensive brand name drugs. Such educational campaign shall include information on the illnesses or symptoms which each generically named drug is supposed to cure or alleviate, as well as its contraindications. The Department of Health with the assistance of the Department of Local Government and the Philippine Information Agency shall monitor the progress of the education drive, and shall submit regular reports to Congress.

SECTION 12. Penalty. — (A) Any Person who shall violate Section 6(a) or 6(b) of this Act shall suffer the penalty graduated hereunder, viz:

(a) for the first conviction, he shall suffer the penalty of reprimand which shall be officially recorded in the appropriate books of the Professional Regulation Commission.

(b) for the second conviction, the penalty of fine in the amount of not less than two thousand pesos (P2,000.00) but not exceeding five thousand pesos (P5,000.00) at the discretion of the court.

(c) for the third conviction, the penalty of fine in the amount of not less than five thousand pesos (P5,000.00) but not exceeding ten thousand pesos (P10,000.00) and suspension of his license to practice his profession, for thirty (30) days at the discretion of the court.

(d) for the fourth and subsequent conviction, the penalty of fine not less than ten thousand pesos (P10,000.00) and suspension of his license to practice his profession for one year or longer at the discretion of the court.

(B) Any juridical person who violates Section 6(c), 6(d), 7 or 8 shall suffer the penalty of a fine of not less than five thousand pesos (P5,000.00) nor more than ten thousand pesos (P10,000.00) and suspension or revocation of license to operate such drug establishment or drug outlet at the discretion of the Court: Provided, That its officers directly responsible for the violation shall suffer the penalty of fine and suspension or revocation of license to practice profession, if applicable, and by imprisonment of not less than six (6) months nor more than one (1) year or both fine and imprisonment at the discretion of the Court; and Provided, further, That if the guilty party is an alien, he shall be ipso facto deported after service of sentence without need of further proceedings.

(C) The Secretary of Health shall have the authority to impose administrative sanctions such as suspension or cancellation of license to operate or recommend suspension of license to practice profession to the Professional Regulation Commission as the case may be for the violation of this Act.

SECTION 13. Separability Clause. — If any provision of this Act is declared invalid, the remainder or any provision hereof not affected thereby shall remain in force and effect.

SECTION 14. Repealing Clause. — The provisions of any law, executive order, presidential decree or other issuances inconsistent with this Act are hereby repealed or modified accordingly.

SECTION 15. Effectivity. — This Act shall take effect fifteen (15) days after its complete publication in the Official Gazette or two (2) newspapers of general circulation.

Approved: September 13, 1988

Published in the Official Gazette, Vol. 84 No. 38 page 5588 on September 19, 1988.

 

Department of HealthOFFICE OF THE SECRETARY

 January 3, 1989

ADMINISTRATIVE ORDER

No. 56 s. 1989

SUBJECT. :. Revised Regulations for the Licensing of Drug Establishments and Outlets

Pursuant to Section 26(a) in relation to Section 21(a) and 11(k) of Republic Act No. 3720, known as the Foods, Drugs and Devices, and Cosmetics Act as amended by Executive Order No. 175 s. 1987 and consistent with Republic Act No. 6675, known as the Generic Act of 1988, the following regulations are hereby promulgated governing drug establishments and drug outlets under the Bureau of Food and Drugs (BFAD). casia

In accordance with Section 3 Paragraphs 5 and 6 of R.A. 6675, any organization, company or business establishments in the pharmaceutical industry shall fall under the following general classification:

I. Drug Establishment means any organization or company involved in the manufacture, importation, repacking and/or distribution of drugs or medicines. This is covered by Chapter I below. casia

II. Drug Outlet means drugstore, pharmacy, and other business establishment which sells drugs or medicines. This is covered by Chapter II below.

CHAPTER I

Drug Establishment

1. Definition of Different Types of Drug Establishments

1.1. Drug Manufacturer means any establishment engaged in operations involved in the production of a drug, including propagation, processing, compounding, finishing, filling, packing, repacking, altering, ornamenting and labelling with the end in view of storage, distribution or sale of the product; provided that for the purpose of this regulation the compounding and filling of prescriptions in drugstores and hospital pharmacies shall not be considered as production operations.

1.2. Drug Trader means 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 sub-contracts the manufacture of such product to a licensed manufacturer. In addition, a trader may also engage in distribution, and/or marketing of its products.

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

1.4. Drug Distributor/Exporter means any drug establishment that exports raw materials, active ingredients and/or finished products to another country.

1.5. Drug Distributor/Wholesaler means any drug 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 drug establishment shall file with the BFAD 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 drug establishment 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 partnerships, corporations and other juridical 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 pharmacist issued by the Professional Regulation Commission (PRC).

2.1.1.4. A certificate of attendance to a BFAD-sponsored accredited Seminar on Licensing of Drug Establishments.

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) notify BFAD in case of any change in the circumstances described in the application such as: change of location, change of pharmacist, change in drug products.

2.1.1.6. List of products to be manufactured or distributed identified by their generic names and brand names, if any.

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

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

2.1.4. A contingency plan or 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.

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 manufacturer's stock pursuant to BFAD Memo Circular No. 001 s. 1983.

2.2. Specific Requirements:

Any entity applying for a LTO as a drug manufacturer, drug trader or drug distributor shall be required to demonstrate its capacity to perform adequately as such in a manner that satisfactorily assures the safety, efficacy and quality of its drug products. It shall 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. Drug Manufacturers

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

2.2.1.2. Minimum standards for pharmaceutical manufacturing equipment/machines described in Annex A;

2.2.1.3. Minimum standards for quality control facilities described in Annex B;

2.2.1.4. If importing raw materials, active ingredients and/or finished products for use in manufacture of drug 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 standards for local manufacturers. If inspection of the foreign manufacturer by BFAD is necessary, the cost of inspection shall be borne by the applicant establishment.

2.2.2. Drug Traders

2.2.2.1. A valid contract agreement with a BFAD-Licensed manufacturer containing a stipulation that both the drug trader and the manufacturer are jointly responsible for the quality of the product;

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

2.2.2.3. 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 establishment.

2.2.3. Drug Distributors

2.2.3.1. Importers

2.2.3.1.1. Foreign Agency Agreement between the Philippine importer and foreign supplier duly authenticated by the territorial Philippine Consulate.

2.2.3.1.2. 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, and evidence that the manufacturer meets BFAD standards for local manufacturers. If inspection of the foreign manufacturer is necessary, the cost of inspection shall be borne by the applicant establishment.

2.2.3.1.3. In case of finished products, Certificate of Free Sale of the products in the country of origin, duly authenticated by the territorial Philippine Consulate and evidence that such certificate is issued in substantial compliance with BFAD standards.

2.2.3.2. Exporters

2.2.3.2.1. A valid contract with BFAD-licensed manufacturer in addition to other requirements set by other competent authorities.

2.2.3.3. Wholesalers

2.2.3.3.1. A valid contract with a BFAD licensed manufacturer, trader or distributor.

2.2.3.3.2. A certification that the products it sells are registered with BFAD.

2.3. Other Additional Requirements

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

3. Renewal of License To Operate (LTO)

3.1. The License To Operate shall have the following validities for all categories of drug 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, drug establishments shall apply to renew their license.

3.3. In considering the renewal application, BFAD shall ascertain the continued compliance by the establishment with the standards and requirements stipulated in section 2.1 and 2.2.

3.4. The following grounds shall be basis for non-renewal of LTO:

3.4.1. Failure to comply with BFAD standards and requirements.

3.4.2. Serious, repeated or rampant violation of existing laws, rules and regulations.

3.4.3. Persistent shortcomings in demonstrating a capacity to perform in a manner that satisfactorily assures the safety, efficacy and quality of its drug products.

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 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. This includes, among others, grossly inadequate premises, lack of key technical and professional personnel, lack of key equipment in production or quality control, poor or inadequate process control and inadequate or improper documentation of the production process.

4.1.3. For distributors: distribution of fake, misbranded, adulterated or unsafe drug products.

4.1.4. Violation of BFAD standards of quality, efficacy, purity and safety of drug products.

4.1.5. Sale or distribution of antibiotic products without batch certification by BFAD.

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

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 products as determined by BFAD. This includes, among others, poor housekeeping, inadequate storage facilities, lack of minor equipment or requirement, and other minor shortcomings.

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

4.3. Re-application After Revocation

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

5. Schedule of Fees

5.1. Upon application for a license to operate as a drug establishment, the following non-refundable fees shall be charged for each application:

			Renewal
		Initial	(good for 2 years)
Drug Manufacturer	(Code: DM)	P5,000.00	P10,000.00
Drug Trader	(Code: DT)	P3,000.00	P6,000.00
Drug Distributor	(Code: DW/
	DE/DI	P2,000.00	P4,000.00

5.2. If a drug establishment engages 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 drug establishment or change in ownership shall require a new application.

CHAPTER II

Drug Outlets

1. Definitions of Different Types of Drug Outlets

1.1. Drugstore, Pharmacy or Botica, including Hospital Pharmacy/Dispensary means a drug outlet where registered drugs, chemical products, active principles, proprietary medicines or pharmaceutical specialties and dental, medicinal, galenical, or veterinary preparations are compounded and/or dispensed.

1.2. 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) drugs are sold in their original packages, bottles or containers or in smaller quantities not in their original containers.

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

2.1. General Requirements

2.1.1. Applications — any person desiring to operate or establish a drug establishment shall file with the BFAD 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 (5 x 5 cm) photo of the petitioner and other pertinent circumstances pertaining to the proposed drug establishment 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, corporations and other juridical persons; authenticated photocopies of the Certificate of Registration issued by 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 pharmacist issued by the Professional Regulation Commission (PRC).

2.1.1.4. A Certification of Attendance to a BFAD-sponsored/accredited Seminar on Licensing of Drug Outlets.

2.1.1.5. An Affidavit of undertaking providing that the applicant shall:

(a) change the establishments' 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) notify BFAD in case of any change in the circumstances described in the application such as: change of location or change of pharmacist.

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

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

2.2. Specific Requirements:

Any entity applying for a license to operate a 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 drugs and medicines, 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. Drugstores, Pharmacy or Botica

2.2.1.1. Premises

2.2.1.1.1. A signboard in front of the place of business bearing the registered name of the drug store. For hospital pharmacy, the sign "Pharmacy" is sufficient. For drug outlet selling exclusively non-prescription or Over the Counter (OTC) drug product, the signboard should indicate so by putting the symbol non-Rx or its equivalent.

2.2.1.1.2. A well-ventilated area not less than 15 sq. m. in floor area with concrete, tile or wooden flooring.

2.2.1.1.3. A place suitable for compounding prescription and for washing and sterilizing bottles (compulsory only for hospital pharmacy).

2.2.1.1.4. A suitable and proper place for the adequate storage of drugs and biological products as specified on the label.

2.2.1.1.5. A suitable cabinet for keeping poisons and/or dangerous drugs.

2.2.1.1.6. An adequate water supply.

2.2.1.2. Reference Books and Documents

2.2.1.2.1. Philippine National Drug Formulary (when available)

2.2.1.2.2. United States Pharmacopeia/National Formulary (USP-NF) (latest edition).

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

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

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

2.2.1.2.6. Remington's Pharmaceutical Sciences (latest edition).

2.2.1.2.7. Goodman & Gilman — Pharmacological Basis of Therapeutics (latest edition).

2.2.1.3. Record Books Duly Registered with the BFAD

2.2.1.3.1. Prescription Book

2.2.1.3.2. Dangerous Drug Book

2.2.1.3.3. Exempt Preparation Book

2.2.1.3.4. Poisons Book

2.2.1.3.5. Record Book for Selected Non-Prescription Drugs, subject to abuse as determined by BFAD and/or Dangerous Drugs Board (DDB).

2.2.1.4. Utensils, Apparatus and Other Equipment

2.2.1.4.1. For all drugstores including hospital pharmacies, refrigerator for biologicals and other drug products needing refrigeration.

2.2.1.4.2. For hospital pharmacy only:

2.2.1.4.2.1. Prescription balance of one centigram sensitivity and a set of weights.

2.2.1.4.2.2. Glass volumetric measures a set of not less than six pieces from 15 ml to 1000 ml capacity.

2.2.1.4.2.3. Mortar and pestle — a set of not less than three in assorted sizes.

2.2.1.5. A full-time validly registered pharmacist physically present while the drugstore is open to business.

2.2.1.6. Other Additional Requirements:

2.2.1.6.1. Invoices indicating the lot number or batch number of the manufacturer's stock pursuant to BFAD Memo. Circular no. 001 s. 1983.

2.2.1.6.2. File of prescription filled, consecutively numbered.

2.2.1.6.3. Dry Seal or Rubber Stamp containing the name and address of the drug outlet.

2.2.1.6.4. Red and White labels indicating name and address of drugstore.

2.2.2. Requirements for a Retail Outlet for Non-Prescription Drugs

2.2.2.1. Premises

2.2.2.1.1. A signboard in front of the place of business bearing the registered name of retail outlet and the symbol non-Rx or equivalent.

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

2.2.2.1.3. A suitable and proper place for the adequate storage of non-prescription drugs. When there are products sold other than drugs, an area exclusively for drug products shall be allocated within the premises.

2.2.2.2. Reference Books and Documents

2.2.2.2.1. Philippine National Drug Formulary (when available);

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

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

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

2.2.2.3. Record Books as required by BFAD for selected non-prescription drugs subject to abuse as determined by BFAD and/or DDB

2.2.2.4. A full-time validly registered pharmacist physically present while the retail outlet is open for business.

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. Dry seal or Rubber Stamp containing the name and address of the drug outlet.

3. Renewal of License to Operate (LTO)

In case of renewal of LTO the drug outlet must have a history of satisfactory performance, consistent with BFAD standards and requirements, without any case of serious violation of existing laws, rules and regulations.

4. Administrative Sanctions

4.1. Temporary Closure

Absence of pharmacist on three (3) inspections by BFAD inspector.

4.2. Suspension of License to Operate

4.2.1. Failure to produce invoices and receipts together with lot numbers, expiry dates for the drugs 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 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 drugs or products marked "Not for Sale."

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

4.3.3. Lack of pharmacist.

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

5. Validity

The license to operate shall have the following validities:

	Initial Period	Validity of
	of validity	Subsequent
		Renewal
Drugstore, Pharmacy or
Botica	1 year	2 years
Retail Outlet	1 year	2 years

 

6. Schedule of Fees

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

		Renewal
	Initial	(good for two years)
P500.00 per drugstore, pharmacy
	or botica outlet	P1,000.00
P200.00 per retail outlet
	carrying only OTC drugs	P400.00

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 and in effect.

REPEALING CLAUSE

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

EFFECTIVITY

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

* The foregoing Administrative Order was published in the Daily Globe issue of January 17, 1989.

ANNEX A

MINIMUM STANDARDS FOR PHARMACEUTICAL MANUFACTURING EQUIPMENT/MACHINES

1.0. General Machinery and Equipment

1.1. Weighing Scale

 

1.1.1. 1 g. sensitivity

1.1.2. 1 kg. sensitivity

 

1.2. Labelling machine

1.3. Coding machine

1.4. Facility for washing and drying bottles

1.5. Laboratory apparatus including measuring glasswares, chemical supplies, filter paper.

2.0. Additional Machine and Equipment needed for each dosage form:

2.1. Liquid/Suspension

2.1.1. Stainless Steel tank with stirrer of appropriate capacity

2.1.2. Jacketed kettle

2.1.3. Homogenizer

2.1.4. Stainless steel pail, assorted sizes

2.1.5. Deionizer or distilling apparatus

2.1.6. Stainless steel storage tank 500 L

2.1.7. Filter assembly

2.1.8. Filling machine

2.1.9. Pilfer-proof capper

2.2. Tablet

2.2.1. Mixer/blender

2.2.2. Mill

2.2.3. Granulator

2.2.4. Drying Oven or fluidized-bed dryer

2.2.5. Sifter/Sieves

2.2.6. Tablet Press

2.2.7. Dust collector/exhaust system

2.2.8. Dehumidifier

2.3. Capsule

2.3.1. Mixer

2.3.2. Dehumidifier

2.3.3. Encapsulating machine

2.3.4. Dust collector/exhaust system

2.4. Powder/Granule Preparation

2.4.1. Blender

2.4.2. Powder filling machine

2.4.3. Tamper-proof machine

2.4.4. Dehumidifier

2.5. Sterile products (Ophthalmic, etc.)

2.5.1. Stainless steel tank with stirrer

2.5.2. Stainless steel storage tank

2.5.3. Membrane filter assembly

2.5.4. Laminar flow system

2.5.5. Filling machine

2.5.6. Capping machine

2.6. Ointment/Cream

2.6.1. Mill

2.6.2. Stainless tank with stirrer, jacketed

2.6.3. Filling machine

2.6.4. Crimper

2.7. Small Volume Parenteral Products

2.7.1. Vial washer/rinser

2.7.2. Pyrogen-free distilling apparatus

2.7.3. Storage tank s.s.

2.7.4. Stainless steel tank with stirrer

2.7.5. Membrane filter assembly

2.7.6. Laminar flow system

2.7.7. Ampule filter and sealer

2.7.8. Vial filter and sealer/crimper

2.7.9. Filling machine for liquid

2.7.10. Sterilizer/autoclave

2.7.11. Depyrogenating oven

 

2.8. Large Volume Parenteral Products

 

2.8.1. Water softener

2.8.2. Carbon filter

2.8.3. Deionizer

2.8.4. Distilling unit

2.8.5. Stainless steel tank with stirrer

2.8.6. Stainless steel storage tank

2.8.7. Membrane filter assembly

2.8.8. Bottle/stopper washer

2.8.9. Laminar flow assembly

2.8.10. Filter and sealer/crimper

2.8.11. Vacuum equipment

2.8.12. Autoclave/sterilizer

2.8.13. Depyrogenating oven

2.9. Penicillin Preparation

2.9.1. Separate areas, separate area and entrance from non-penicillin products.

2.9.2. Separate equipment outlay based on specific dosage form.

2.10. Optional equipment and Machine

2.10.1. Coating Pan.)

2.10.2. Mill.) for sugar coated tablet

2.10.3. Polishing Pan.)

2.10.4. Sprayer — for film coating

2.10.5. Sachet filler

2.10.6. Strip sealing machine

2.10.7. Blister pack machine

2.10.8. Tablet/capsule Counter

ANNEX B

MINIMUM STANDARDS FOR QUALITY CONTROL

FACILITIES

(DRUG MANUFACTURERS)

1.0. GENERAL REQUIREMENTS

1.1. Physico-Chemical Assay

1.1.1. UV spectrophotometer

1.1.2. Fluorphotometer (for vitamin preparation)

1.1.3. Titrimeter

1.1.4. Thin layer chromatography

1.1.5. Analytical balance

1.1.6. pH meter

1.1.7. Drying oven

1.1.8. Oven for stability testing

1.1.9. Water bath

1.1.10. Magnetic stirrer

1.1.11. Mechanical shaker

1.1.12. Pycnometer

1.1.13. Desiccators/vacuum desiccators

1.1.14. Hot plate

1.1.15. Furnace

1.1.16. Glasswares

1.1.16.1. Buret (4)

1.1.16.2. Volumetric flask (6)

1.1.16.3. Separatory funnel (3)

1.1.16.4. Erlenmeyer flask (3)

1.1.16.5. Beaker (assorted sizes, 2 pcs. of each size)

1.1.16.6. Graduated cylinder (assorted sizes, 2 pcs. of each size)

1.1.16.7. Pipette (6)

1.1.16.8. Thermometer (2)

1.1.16.9. Test Tube (24)

1.1.16.10. Funnel (4)

1.1.16.11. Stirring rod (6)

1.1.16.12. Crucible (6)

Laboratory supplies/chemical/reagents/reference standards, etc.

1.2. Biological Assay

1.2.1. Micro Assay

1.2.1.1. Autoclave

1.2.1.2. Centrifuge

1.2.1.3. Colony counter

1.2.1.4. Incubator

1.2.1.5. Refrigerator

1.2.1.6. Bunsen burner

1.2.1.7. Petri Dishes (24 pieces)

1.2.1.8. Microscope

1.2.1.9. Laboratory supplies/glasswares/chemicals/ culture/media etc.

1.2.2. Animal House and Laboratory Animals i.e. mice for safety test; rabbits for pyrogen test

1.3. Reference Books

1.3.1. Latest United States Pharmacopeia/National Formulary

1.3.2. British Pharmacopeia Latest Edition

1.3.3. Remington's Pharmaceutical Sciences

1.3.4. Merck Index

1.3.5. Drug Reference Manual

1.3.6. BFAD Regulations/Pharmacy Laws

1.3.7. Official Philippine National Drug Formulary

1.4. Optional Requirements

NOTE:. If product to be manufactured requires the use of any of the following then it becomes mandatory. casia

1.4.1. Colorimeter

1.4.2. Column Chromatography

1.4.3. Gas-liquid chromatography

1.4.4. Infrared spectrophotometer

1.4.5. Polarimeter

1.4.6. Polarograph

1.4.7. High pressure liquid chromatography

1.4.8. Ultra-sonic bath

1.4.9. Kjeldahl assembly

2.0. Additional Requirements based on dosage form to be manufactured

2.1. Tablet Preparation

2.1.1. Disintegration tester

2.1.2. Dissolution rate assembly

2.1.3. Friabilator

2.1.4. Hardness tester

2.1.5. Caliper

2.1.6. Moisture balance

2.1.7. Torsion balance/analytical balance

2.1.8. Melting point apparatus

2.2. Capsule Preparation

2.2.1. Dissolution rate assembly

2.2.2. Moisture balance

2.2.3. Melting point apparatus

2.2.4. Torsion balance/analytical balance

2.3. Liquid/Suspension

2.3.1. Viscosimeter

2.3.2. Refractometer

2.3.3. Visual inspection assembly

2.3.4. pH meter

2.4. Powder and Granules

2.4.1. Moisture balance

2.4.2. Torsion balance/analytical balance

2.4.3. See 2.3 requirements for liquid/suspension

2.5. Parenteral

2.5.1. Visual Inspection system

2.5.2. Leaker Test (Set-up) for ampules

2.5.3. Pyrogen test Set-up

2.5.4. Particle counter

2.6. Ointment/Cream

2.6.1. Viscosimeter

2.6.2. pH meter

2.7. Penicillin Preparation

2.7.1. Separate equipment from that of non-penicillin products depending on the dosage form to be manufactured.

 

PURSUANT TO THE GENERICS ACT OF 1988 AND ITS

IMPLEMENTING GUIDELINES, DOCTORS AND

PHARMACISTS ARE URGED TO BEGIN GENERIC

PRESCRIBING AND DISPENSING TODAY, JUNE

1, 1989

June 1 to August 31 is the designated learning and practice period for all medical, dental, veterinary and pharmaceutical professionals. Beginning September 1, the Generics Act of 1988 will be in full effect.

 

GUIDELINES ON PRESCRIBING MEDICINES

BASED ON PRIOR LAWS

 

* Only validly-registered medical, dental and veterinary practitioners, whether in private practice or employed in a private institution/corporation or in the government, are authorized to prescribe drugs.

* All prescriptions must contain the name of the prescriber, office address, professional registration number, professional tax receipt number, patient's/client's name, age and sex, and date of prescription.

* For prohibited and regulated drugs, the following are required:

The prescriber must have an S-2 license.

The special Dangerous Board prescription form must be used.

A recording system following pertinent Dangerous Drugs Board regulations must be observed.

 

ADDITIONAL GUIDELINES ON PRESCRIBING

MEDICINES PURSUANT TO THE

GENERICS ACT OF 1988

 

* Generic names shall be used in all prescriptions for:

Drugs with a single active ingredient, the generic name of the active ingredient shall be used in prescribing.

Drugs with two or more active ingredients, the generic name of the active ingredients as determined by the Bureau of Food and Drugs shall be used in prescribing.

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

* The generic name of the drug ordered must be clearly written on the prescription immediately after the Rx symbol, or on the order chart.

In addition to the generic name, a brand name may also be indicated. In such cases, the following shall be observed:

* If written on a prescription pad, the brand name enclosed in parenthesis shall be written below the generic name.

* If written on a patient's chart, the brand name enclosed in parenthesis shall be written after the generic name.

* Only one drug product shall be prescribed on one prescription form.

* In prescribing drugs which need strict precaution in their use, the prescriber must comply with the following:

After the Rx symbol but before the generic name he must write clearly "(List B)". Refer to attached appendix for details.

The prescriber must ensure that the following information are accurately written on the prescription:

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

* The manufacturer.

* The brand name, if so desired.

* The strength or dose level using units of the metric system. Example: 1 grain — 60 mg.

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

 

VIOLATIVE, ERRONEOUS AND IMPOSSIBLE

PRESCRIPTIONS

 

Violative Prescription

* Where the generic name is not written.

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

* 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.

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

Erroneous Prescription

* Where the brand name precedes the generic name.

* Where the generic name is the one in parenthesis.

* Where the brand name is not in parenthesis.

* Where more than one drug product is prescribed on one prescription form.

Erroneous prescriptions shall not be filled. Such prescriptions shall also be kept and reported by the pharmacist of the drug outlet or any other interested party to the nearest Department of Health office for appropriate action.

Impossible Prescriptions

* When only the generic name is written but is not legible.

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

* When both the generic and the brand names are not legible.

* When the drug product prescribed is not registered with the Bureau of Food and Drugs.

Impossible prescriptions shall not be filled. They shall be kept and reported by the pharmacist of the drug outlet or any other interested party to the nearest Department of Health office for appropriate action. The pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription.

In cases of violative, erroneous and impossible prescriptions, the local Department of Health office shall be responsible for giving written notice to the erring doctor concerned and for transmitting through channels the report for violation/error to the Professional Regulation Commission or to the fiscal's office for appropriate action.

 

GUIDELINES ON DISPENSING OF MEDICINES

BASED ON PRIOR LAWS

 

* Ethical drugs can only be dispensed upon a written order of a validly-registered physician, dentist or veterinarian.

* Non-prescription or over-the-counter drugs may be dispensed even without a written order of a validly-registered physician, dentist or veterinarian in duly licensed drug outlets. When dispensing over-the-counter drugs without a doctor's prescription, the pharmacist shall give the necessary information and direction for use of the drug.

* All prescriptions dispensed in the drugstore, botica or hospital pharmacy shall be kept in file for two years and recorded in a prescription book duly registered with the Bureau of Food and Drugs which shall be opened for inspection to Food and Drugs Inspectors any time during business hours of the outlet. The prescription book shall be kept for two years after the last entry. cd i

 

ADDITIONAL GUIDELINES ON DISPENSING

TO IMPLEMENT THE GENERICS ACT OF 1988

 

* All drug outlets are required to practice dispensing of drugs using generic names with some exceptions, modifications or qualifications in certain cases or circumstances prescribed herein.

Drugstores, boticas, and other drug outlets.

To ensure the informed choice and use of drugs by patient/buyer, the drug outlet is required to:

* Inform the patient/buyer of all available drug products generically equivalent to the one prescribed with their corresponding prices. In so doing, the drug outlet shall not favor or suggest any particular product so that the patient/buyer may fully and adequately exercise his option to choose.

* For this purpose, all drug outlets shall post in a conspicuous place in their respective establishments a list of drug 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 patient/buyer shall be considered substantial compliance.

Hospital Pharmacies The following shall govern generic dispensing in hospital pharmacies, in the case of in-patients only:

* Upon admission, the patient or his/her responsible relative shall indicate in writing whether he/she shall submit to the hospital drug policies or reserve the option to buy drugs and medicines outside of the hospital pharmacy.

* Hospital pharmacies operating on an acceptable formulary system and pricing policy as determined by the Department of Health, and using generic terminology in procurement, prescribing, dispensing, and recording of drugs shall be exempted from the following: casia

* Recording of prescription filled in the prescription book, provided such prescriptions shall be kept in file for two years.

* Individually informing the in-patient/buyer on available generic equivalents and their corresponding prices. However, a handbook or directory containing the required drug information must be made available in the wards for patients, responsible relatives of patients and professional staff.

* In dispensing to the buyer, the drug products in the unit dose or 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 shall place legibly on the required drug outlet's label the following information:

Name of patient	Dosage strength
Generic name of the drug	Expiry date
Brand name, if any	Directions for use
Manufacturer	Name of Pharmacist

The partially-filled prescription shall be returned to the buyer after recording the partial filling in the prescription book. The drugstore which completes the filling of the prescription shall keep the prescription in file.

Dispensing prohibited and Regulated Drugs (List) and Drugs Requiring Strict Precautions (List B) (Please see attached Lists)

* In dispensing prohibited and regulated drugs requiring strict precautions in their use, the following shall be observed:

Dispensing must be done by the pharmacist who shall affix his/her signature on the prescription filled.

The order and instructions of the doctor as written on the prescription, must be precisely followed.

Partial filling of prescription for prohibited and regulated drugs (List A) shall not be allowed.

Guidelines on what to do with Violative, Erroneous, and

Impossible Prescriptions

* Violative and impossible prescriptions as defined in A.O. 62 (Generic Prescribing) shall not be filled. The pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription. These violative and impossible prescriptions shall be kept and reported by the pharmacist or other interested parties to the nearest Department of Health office for appropriate action.

* Erroneous prescription shall be filled, but they shall also be kept and reported to the nearest Department of Health office for appropriate action.

Violations on the part of Dispensers and Outlets

The following acts or omissions are considered violations of these rules and regulations: cd

* Imposing a particular brand or product on the buyer.

* Inaccurate dispensing i.e. dispensing a drug product which does not meet the prescription as to any or all the following: active ingredient, dosage form and strength.

* Failure to post or make accessible the required up-to-date information on drug products.

* Failure to indicate the generic name/official name designated by the Bureau of Food and Drugs and other required information on the drug outlet's label of the dispensed drug.

* Failure to record and keep prescriptions filled. aisa dc

* Failure to report to the nearest Department of Health office cases of violative, erroneous, and/or wrong prescriptions within three months after receipt of such prescriptions.