Department of Health 1.

5 Drug Distributor/Wholesaler means any

OFFICE OF THE SECRETARY drug establishment that procures raw materials, active
Manila ingredients and/or finished products from local
establishments for local distribution on wholesale basis.
ADMINISTRATIVE ORDER No. 56 s. 1989
2. Standards and Requirements for License To
January 3, 1989
Operate (LTO)
SUBJECT : Revised Regulations for the Licensing of Drug
Establishments and Outlets 2.1 General Requirements
2.1.1 Application — any person desiring to
Pursuant to Section 26(a) in relation to Section 21(a) operate or establish a drug establishment shall file with the
and 11(k) of Republic Act No. 3720, known as the Foods, BFAD an application supported by the following
Drugs and Devices, and Cosmetics Act as amended by documents:
Executive Order No. 175 s. 1987 and consistent with 2.1.1.1 A standard petition form containing
Republic Act No. 6675, known as the Generic Act of among others the name, age, citizenship and a passport
1988, the following regulations are hereby promulgated size picture (5 x 5 cm.) of the petitioner and other pertinent
governing drug establishments and drug outlets under the circumstances pertaining to the proposed drug
Bureau of Food and Drugs (BFAD). establishment including the place where it is to be
In accordance with Section 3 Paragraphs 5 and 6 of established.
R.A. 6675, any organization, company or business 2.1.1.2 Proof of registration as an establishment,
establishments in the pharmaceutical industry shall fall i.e.:
under the following general classification:
(a) For single proprietorship; an authenticated
I. Drug Establishment means any organization or photocopy of the Certificate of Business Name
company involved in the manufacture, importation, Registration issued by the Bureau of Domestic Trade
repacking and/or distribution of drugs or medicines. This (BDT) of the Department of Trade and Industry.
is covered by Chapter I below.
(b) For partnerships, corporations and other
II. Drug Outlet means drugstore, pharmacy, and other juridical persons; authenticated photocopies of the
business establishment which sells drugs or medicines. Certificate of Registration issued by the Securities and
This is covered by Chapter II below. Exchange Commission (SEC) and the Articles of
CHAPTER I Incorporation or partnership.
Drug Establishment 2.1.1.3 A valid Certificate of Registration of the
establishment's Filipino pharmacist issued by the
1. Definition of Different Types of Drug Professional Regulation Commission (PRC).
Establishments
2.1.1.4 A certificate of attendance to a BFAD-
1.1 Drug Manufacturer means any sponsored accredited Seminar on Licensing of Drug
establishment engaged in operations involved in the Establishments.
production of a drug, including propagation, processing,
compounding, finishing, filling, packing, repacking, 2.1.1.5 An Affidavit of Undertaking providing
altering, ornamenting and labelling with the end in view of that the applicant shall:
storage, distribution or sale of the product; provided that (a) change the establishment's name if there is
for the purpose of this regulation the compounding and already a validly registered name similar to it.
filling of prescriptions in drugstores and hospital
pharmacies shall not be considered as production (b) display the duly approved LTO in a
operations. conspicuous place within the establishment.
1.2 Drug Trader means any establishment (c) notify BFAD in case of any change in the
which is a registered owner of the drug product, procures circumstances described in the application such as: change
the raw materials and packaging components, and provides of location, change of pharmacist, change in drug
the production monographs, quality control standards and products.
procedures, but sub-contracts the manufacture of such 2.1.1.6 List of products to be manufactured or
product to a licensed manufacturer. In addition, a trader distributed identified by their generic names and brand
may also engage in distribution, and/or marketing of its names, if any.
products.
2.1.1.7 An authenticated photocopy of Contract of
1.3 Drug Distributor/Importer means any Lease for the space to be occupied if the applicant does not
establishment that imports raw materials, active own it.
ingredients and/or finished products for its own use or for
wholesale distribution to other drug establishments or 2.1.2 A Certificate of continuing compliance
outlets. with specific technical requirements (to be specified by
BFAD according to section 2.2 below).
1.4 Drug Distributor/Exporter means any drug
establishment that exports raw materials, active ingredients 2.1.3 A Batch Distribution Record Book duly
and/or finished products to another country. registered with BFAD.

1
 2.1.4 A contingency plan or procedure for a 2.2.3.1.1 Foreign Agency Agreement between the
systematic, effective and prompt recall in case any of its Philippine importer and foreign supplier duly authenticated
products is found violative and ordered recalled from the by the territorial Philippine Consulate.
market by BFAD.
2.2.3.1.2 A certificate that the manufacturer of the
2.1.5 An orderly and secure system of filing up raw material, active ingredient and/or finished product is
to date invoices from suppliers and buyers identifying lot registered in the country of origin, duly authenticated by
numbers or batch numbers of manufacturer's stock the territorial Philippine Consulate, and evidence that the
pursuant to BFAD Memo Circular No. 001 s. 1983. manufacturer meets BFAD standards for local
manufacturers. If inspection of the foreign manufacturer is
2.2 Specific Requirements:
necessary, the cost of inspection shall be borne by the
Any entity applying for a LTO as a drug applicant establishment.
manufacturer, drug trader or drug distributor shall be
2.2.3.1.3 In case of finished products, Certificate of
required to demonstrate its capacity to perform adequately
Free Sale of the products in the country of origin, duly
as such in a manner that satisfactorily assures the safety,
authenticated by the territorial Philippine Consulate and
efficacy and quality of its drug products. It shall be
evidence that such certificate is issued in substantial
required to conform with the following relevant standards
compliance with BFAD standards.
and requirements specific for each category, in addition to
the above general requirements: 2.2.3.2 Exporters
2.2.1 Drug Manufacturers 2.2.3.2.1 A valid contract with BFAD-licensed
manufacturer in addition to other requirements set by other
2.2.1.1 Guidelines on Current Good
competent authorities.
Manufacturing Practices provided for under A.O No. 220
s. 1974, including location, building and floor plans, and 2.2.3.3 Wholesalers
any additional guidelines issued by BFAD;
2.2.3.3.1 A valid contract with a BFAD licensed
2.2.1.2 Minimum standards for pharmaceutical manufacturer, trader or distributor.
manufacturing equipment/machines described in Annex A;
2.2.3.3.2 A certification that the products it sells are
2.2.1.3 Minimum standards for quality control registered with BFAD.
facilities described in Annex B;
2.3 Other Additional Requirements
2.2.1.4 If importing raw materials, active
In addition to the above standards and requirements,
ingredients and/or finished products for use in manufacture
BFAD in the course of evaluating an application may
of drug products, a certificate that the manufacturer is
require other additional documentation or evidence to
registered in the country of origin, duly authenticated by
satisfactorily ascertain the capability of the drug
the territorial Philippine Consulate, and evidence that the
establishment.
manufacturer meets BFAD standards for local
manufacturers. If inspection of the foreign manufacturer 3. Renewal of License To Operate (LTO)
by BFAD is necessary, the cost of inspection shall be 3.1 The License To Operate shall have the
borne by the applicant establishment. following validities for all categories of drug
2.2.2 Drug Traders establishments.
2.2.2.1 A valid contract agreement with a BFAD- 3.1.1 Initial Period (Initial Application) 1 year
Licensed manufacturer containing a stipulation that both 3.1.2 Subsequent Period (Renewal Application)
the drug trader and the manufacturer are jointly 2 years
responsible for the quality of the product;
3.2 At least one month prior to the expiration
2.2.2.2 If importing raw materials, active of the LTO, drug establishments shall apply to renew their
ingredients and/or finished products for the use in the license.
manufacture of drug products, a certificate that the
manufacturer is registered with the country of origin, duly 3.3 In considering the renewal application,
authenticated by the territorial Philippine Consulate, and BFAD shall ascertain the continued compliance by the
evidence that the manufacturer meets BFAD standards for establishment with the standards and requirements
local manufacturers. If inspection of the foreign stipulated in section 2.1 and 2.2.
manufacturer by BFAD is necessary, the cost of inspection 3.4 The following grounds shall be basis for
shall be borne by the applicant establishment; non-renewal of LTO:
2.2.2.3 A description of the production process 3.4.1 Failure to comply with BFAD standards
and quality control procedures to be followed by the and requirements.
contracted manufacturer, jointly certified by the owner and
the pharmacist of the establishment. 3.4.2 Serious, repeated or rampant violation of
existing laws, rules and regulations.
2.2.3 Drug Distributors
3.4.3 Persistent shortcomings in demonstrating
2.2.3.1 Importers a capacity to perform in a manner that satisfactorily
assures the safety, efficacy and quality of its drug
products.

2
 4. Administrative Sanctions
4.1 Grounds for Revocation of LTO 5.2 If a drug establishment engages in
activities belonging to more than one of the above
4.1.1 Misrepresentation of any material fact in
categories, applicant must apply for LTO for each of the
the application for LTO and in any documentation used as
category and pay the corresponding fees.
basis for issuing the LTO.
5.3 Only upon payment of application fees
4.1.2 For manufacturers and traders: any
may the application be processed. A surcharge of fifty
deficiency in GMP that is likely to result in adulterated,
percent (50%) of the above fees shall be imposed on
misbranded, substandard or unsafe products as determined
applications for renewal filed after the validity of the
by BFAD. This includes, among others, grossly inadequate
license has lapsed. Any change in the category of drug
premises, lack of key technical and professional personnel,
establishment or change in ownership shall require a new
lack of key equipment in production or quality control,
application.
poor or inadequate process control and inadequate or
improper documentation of the production process. CHAPTER II
4.1.3 For distributors: distribution of fake, Drug Outlets
misbranded, adulterated or unsafe drug products.
1. Definitions of Different Types of Drug Outlets
4.1.4 Violation of BFAD standards of quality,
1.1 Drugstore, Pharmacy or Botica, including
efficacy, purity and safety of drug products.
Hospital Pharmacy/Dispensary means a drug outlet where
4.1.5 Sale or distribution of antibiotic products registered drugs, chemical products, active principles,
without batch certification by BFAD. proprietary medicines or pharmaceutical specialties and
dental, medicinal, galenical, or veterinary preparations are
4.1.6 Failure to take adequate remedial or
compounded and/or dispensed.
corrective measures for deficiencies identified in
accordance with requirements of BFAD. 1.2 Retail outlet for non-prescription drugs
including non- traditional outlets such as supermarkets and
4.1.7 Failure to keep up to date, secure, orderly,
stores, means a drug outlet where registered non-
and easily inspected records that would indicate continued
prescription or over-the-counter (OTC) drugs are sold in
compliance with standards.
their original packages, bottles or containers or in smaller
4.2 Grounds for Suspension of LTO quantities not in their original containers.
4.2.1 Minor deficiencies in GMP or material 2. Standards and Requirements for License To
management that need to be corrected but are not Operate (LTO)
immediately or likely to result in adulterated, misbranded,
2.1 General Requirements
substandard or unsafe products as determined by BFAD.
This includes, among others, poor housekeeping, 2.1.1 Applications — any person desiring to
inadequate storage facilities, lack of minor equipment or operate or establish a drug establishment shall file with the
requirement, and other minor shortcomings. BFAD an application supported by the following
documents:
4.2.2. Lapses in record keeping of invoices,
receipts or distribution records. 2.1.1.1 A standard petition form containing
among others the name, age, citizenship and a passport
4.3 Re-application After Revocation
size (5 x 5 cm) photo of the petitioner and other pertinent
No establishment whose LTO was revoked may apply circumstances pertaining to the proposed drug
for an LTO within 5 years after the revocation of its establishment including the place where it is to be
license. established.
5. Schedule of Fees 2.1.1.2 Proof of registration as an establishment,
5.1 Upon application for a license to operate i.e.:
as a drug establishment, the following non-refundable fees (a) For single proprietorship, an authenticated
shall be charged for each application: photocopy of the Certificate of Business Name
Registration issued by the Bureau of Domestic Trade
(BDT) of the Department of Trade and Industry.
Renewal
(b) For partnership, corporations and other
Initial (good for 2 years) juridical persons; authenticated photocopies of the
Certificate of Registration issued by Securities and
Exchange Commission (SEC) and the Articles of
Drug Manufacturer (Code: DM) P5,000.00 Incorporation or Partnership.
P10,000.00
2.1.1.3 A valid Certificate of Registration of the
Drug Trader (Code: DT) P3,000.00 establishment's Filipino pharmacist issued by the
P6,000.00 Professional Regulation Commission (PRC).
Drug Distributor (Code: DW/
DE/DI P2,000.00 P4,000.00

3
 2.1.1.4 A Certification of Attendance to a BFAD- 2.2.1.2.3 R.A. 3720, otherwise known as the Foods,
sponsored/accredited Seminar on Licensing of Drug Drugs and Devices and Cosmetics Act as amended and
Outlets. relevant implementing rules and regulations.
2.1.1.5 An Affidavit of undertaking providing that 2.2.1.2.4 R.A. 6675, Generics Act of 1988 and
the applicant shall: relevant implementing rules and regulations.
(a) change the establishments' name if there is 2.2.1.2.5 R.A. 5921 Pharmacy Law, as amended
already a validly registered name similar to it. and relevant implementing rules and regulations.
(b) display the duly approved LTO in a 2.2.1.2.6 Remington's Pharmaceutical Sciences
conspicuous place within the establishment. (latest edition).
(c) notify BFAD in case of any change in the 2.2.1.2.7 Goodman & Gilman — Pharmacological
circumstances described in the application such as: change Basis of Therapeutics (latest edition).
of location or change of pharmacist.
2.2.1.3 Record Books Duly Registered with the
2.1.1.6 Tentative list of products intended to be BFAD
sold using generic names with brand names when
2.2.1.3.1 Prescription Book
applicable.
2.2.1.3.2 Dangerous Drug Book
2.1.1.7 An authenticated photocopy of Contract of
Lease of the space to be occupied if the applicant does not 2.2.1.3.3 Exempt Preparation Book
own it. 2.2.1.3.4 Poisons Book
2.2 Specific Requirements: 2.2.1.3.5 Record Book for Selected Non-
Any entity applying for a license to operate a Prescription Drugs, subject to abuse as determined by
drugstore, pharmacy or botica or retail outlet shall be BFAD and/or Dangerous Drugs Board (DDB).
required to demonstrate its capacity to perform adequately 2.2.1.4 Utensils, Apparatus and Other Equipment
its functions to inform its clientele in accordance with
Section 6(d) of R.A. 6675 and sell drugs and medicines, 2.2.1.4.1 For all drugstores including hospital
which are safe, effective, and of good quality to the public. pharmacies, refrigerator for biologicals and other drug
It shall be required to conform with relevant standards and products needing refrigeration.
requirements specific for each category, in addition to the 2.2.1.4.2 For hospital pharmacy only:
foregoing general requirements.
2.2.1.4.2.1 Prescription balance of one centigram
2.2.1 Drugstores, Pharmacy or Botica sensitivity and a set of weights.
2.2.1.1 Premises 2.2.1.4.2.2 Glass volumetric measures a set of not
2.2.1.1.1 A signboard in front of the place of less than six pieces from 15 ml to 1000 ml capacity.
business bearing the registered name of the drug store. For 2.2.1.4.2.3 Mortar and pestle — a set of not less than
hospital pharmacy, the sign "Pharmacy" is sufficient. For three in assorted sizes.
drug outlet selling exclusively non-prescription or Over
the Counter (OTC) drug product, the signboard should 2.2.1.5 A full-time validly registered pharmacist
indicate so by putting the symbol non-Rx or its equivalent. physically present while the drugstore is open to business.
2.2.1.1.2 A well-ventilated area not less than 15 sq. 2.2.1.6 Other Additional Requirements:
m. in floor area with concrete, tile or wooden flooring. 2.2.1.6.1 Invoices indicating the lot number or
2.2.1.1.3 A place suitable for compounding batch number of the manufacturer's stock pursuant to
prescription and for washing and sterilizing bottles BFAD Memo. Circular no. 001 s. 1983.
(compulsory only for hospital pharmacy). 2.2.1.6.2 File of prescription filled, consecutively
2.2.1.1.4 A suitable and proper place for the numbered.
adequate storage of drugs and biological products as 2.2.1.6.3 Dry Seal or Rubber Stamp containing the
specified on the label. name and address of the drug outlet.
2.2.1.1.5 A suitable cabinet for keeping poisons 2.2.1.6.4 Red and White labels indicating name and
and/or dangerous drugs. address of drugstore.
2.2.1.1.6 An adequate water supply. 2.2.2 Requirements for a Retail Outlet for Non-
2.2.1.2 Reference Books and Documents Prescription Drugs
2.2.1.2.1 Philippine National Drug Formulary 2.2.2.1 Premises
(when available) 2.2.2.1.1 A signboard in front of the place of
2.2.1.2.2 United States Pharmacopeia/National business bearing the registered name of retail outlet and
Formulary (USP-NF) (latest edition). the symbol non-Rx or equivalent.
2.2.2.1.2 An adequate, well-ventilated area with
concrete, tile, or wooden flooring.

4
 2.2.2.1.3 A suitable and proper place for the 5. Validity
adequate storage of non-prescription drugs. When there
The license to operate shall have the following
are products sold other than drugs, an area exclusively for
validities:
drug products shall be allocated within the premises.
Initial Period Validity of
2.2.2.2 Reference Books and Documents
of validity Subsequent
2.2.2.2.1 Philippine National Drug Formulary
(when available); Renewal
2.2.2.2.2 R.A. 5921, Pharmacy Law and its Drugstore, Pharmacy or
implementing rules and regulations; Botica 1 year 2 years
2.2.2.2.3 R.A. 6675, the Generics Act of 1988 and Retail Outlet 1 year 2 years
relevant implementing rules and regulations;
6. Schedule of Fees
2.2.2.2.4 R.A. 3720 as amended or Foods, Drugs
and Devices and Cosmetics Act; Upon application for a license to operate as a drug
outlet, the following non-refundable fees shall be charged
2.2.2.3 Record Books as required by BFAD for for each application:
selected non-prescription drugs subject to abuse as
determined by BFAD and/or DDB Renewal
2.2.2.4 A full-time validly registered pharmacist Initial (good for two years)
physically present while the retail outlet is open for
business.
P500.00 per drugstore, pharmacy
2.2.2.5 Other Additional Requirements
or botica outlet P1,000.00
2.2.2.5.1 Invoices indicating the lot number or
batch number of the manufacturer's stock pursuant to P200.00 per retail outlet
BFAD Memo. Circular No. 001 s. 1983. carrying only OTC drugs P400.00
2.2.2.5.2 Dry seal or Rubber Stamp containing the Only upon payment of application fees may the
name and address of the drug outlet. application be processed. A surcharge of fifty percent
3. Renewal of License to Operate (LTO) (50%) of the above fees shall be imposed on applications
for renewal filed after the validity of the license has
In case of renewal of LTO the drug outlet must have a lapsed.
history of satisfactory performance, consistent with BFAD
standards and requirements, without any case of serious SEPARABILITY CLAUSE
violation of existing laws, rules and regulations. In case any provision of this rules and regulations is
4. Administrative Sanctions declared contrary to law or unconstitutional other
provisions which are not affected thereby shall continue to
4.1 Temporary Closure be in force and in effect.
Absence of pharmacist on three (3) inspections by REPEALING CLAUSE
BFAD inspector.
All administrative orders, rules and regulations and
4.2 Suspension of License to Operate other administrative issuances or parts thereof, inconsistent
4.2.1 Failure to produce invoices and receipts with the provisions of this Regulation are hereby repealed
together with lot numbers, expiry dates for the drugs in or modified accordingly.
stock. EFFECTIVITY
4.2.2 Failure to properly record and keep a file This Regulation shall take effect fifteen (15) days
of all prescriptions filled in the last two years. after its publication in a newspaper of general circulation.
4.2.3 Refusal to allow entry of BFAD *
inspectors. * The foregoing Administrative Order was
4.3 Revocation of License to Operate published in the Daily Globe issue of January 17, 1989.
4.3.1 Sale or offer for sale of adulterated, ANNEX "A"
misbranded, sub-standard, unregistered, expired and/or MINIMUM STANDARDS FOR
unsafe drugs or products marked "Not for Sale." PHARMACEUTICAL MANUFACTURING
4.3.2 Failure to properly record dangerous drugs EQUIPMENT/MACHINES
as determined by DDB. 1.0General Machinery and Equipment
4.3.3 Lack of pharmacist. 1.1 Weighing Scale
4.3.4 Failure to take necessary remedial or
corrective measures within the prescribed period as
directed by BFAD. 1.1.1 1 g. sensitivity

5
 1.1.2 1 kg. sensitivity 2.4.3. Tamper-proof machine
2.4.4. Dehumidifier
1.2. Labelling machine
1.3. Coding machine 2.5. Sterile products (Ophthalmic, etc.)
1.4. Facility for washing and drying bottles
1.5. Laboratory apparatus including measuring 2.5.1. Stainless steel tank with stirrer
glasswares, chemical supplies, filter paper.
2.5.2. Stainless steel storage tank
2.0. Additional Machine and Equipment
2.5.3. Membrane filter assembly
needed for each dosage form:
2.5.4. Laminar flow system
2.1. Liquid/Suspension
2.5.5. Filling machine
2.5.6. Capping machine
2.1.1. Stainless Steel tank with stirrer of
appropriate capacity
2.1.2. Jacketed kettle 2.6. Ointment/Cream
2.1.3. Homogenizer
2.1.4. Stainless steel pail, assorted sizes 2.6.1 Mill
2.1.5. Deionizer or distilling apparatus 2.6.2 Stainless tank with stirrer, jacketed
2.1.6. Stainless steel storage tank 500 L 2.6.3 Filling machine
2.1.7. Filter assembly 2.6.4 Crimper
2.1.8. Filling machine
2.1.9. Pilfer-proof capper 2.7. Small Volume Parenteral Products

2.2. Tablet 2.7.1. Vial washer/rinser

2.7.2. Pyrogen-free distilling apparatus
2.2.1. Mixer/blender 2.7.3. Storage tank s.s.
2.2.2. Mill 2.7.4. Stainless steel tank with stirrer
2.2.3. Granulator 2.7.5. Membrane filter assembly
2.2.4. Drying Oven or fluidized-bed dryer 2.7.6. Laminar flow system
2.2.5. Sifter/Sieves 2.7.7. Ampule filter and sealer
2.2.6. Tablet Press 2.7.8. Vial filter and sealer/crimper
2.2.7. Dust collector/exhaust system 2.7.9. Filling machine for liquid
2.2.8. Dehumidifier 2.7.10. Sterilizer/autoclave
2.7.11. Depyrogenating oven
2.3Capsule
2.8. Large Volume Parenteral Products
2.3.1. Mixer
2.3.2. Dehumidifier 2.8.1. Water softener
2.3.3. Encapsulating machine 2.8.2. Carbon filter
2.3.4. Dust collector/exhaust system 2.8.3. Deionizer
2.8.4. Distilling unit
2.4. Powder/Granule Preparation 2.8.5. Stainless steel tank with stirrer
2.8.6. Stainless steel storage tank
2.4.1. Blender 2.8.7. Membrane filter assembly
2.4.2. Powder filling machine 2.8.8. Bottle/stopper washer

6
 2.8.9. Laminar flow assembly 1.1.16.2. Volumetric flask (6)
2.8.10. Filter and sealer/crimper 1.1.16.3. Separatory funnel (3)
2.8.11. Vacuum equipment 1.1.16.4. Erlenmeyer flask (3)
2.8.12. Autoclave/sterilizer 1.1.16.5. Beaker (assorted sizes, 2 pcs. of each size)
2.8.13. Depyrogenating oven 1.1.16.6. Graduated cylinder (assorted sizes, 2 pcs.
of each size)
2.9. Penicillin Preparation
1.1.16.7. Pipette (6)
2.9.1. Separate areas, separate area and entrance from
non-penicillin products. 1.1.16.8. Thermometer (2)
2.9.2. Separate equipment outlay based on specific 1.1.16.9. Test Tube (24)
dosage form.
1.1.16.10. Funnel (4)
2.10. Optional equipment and Machine
1.1.16.11. Stirring rod (6)
2.10.1. Coating Pan )
1.1.16.12. Crucible (6)
2.10.2. Mill ) for sugar coated tablet
Laboratory supplies/chemical/reagents/reference
2.10.3. Polishing Pan ) standards, etc.
2.10.4. Sprayer — for film coating 1.2. Biological Assay
2.10.5. Sachet filler 1.2.1. Micro Assay
2.10.6. Strip sealing machine 1.2.1.1. Autoclave
2.10.7. Blister pack machine 1.2.1.2. Centrifuge
2.10.8. Tablet/capsule Counter 1.2.1.3. Colony counter
ANNEX "B" 1.2.1.4. Incubator
MINIMUM STANDARDS FOR QUALITY 1.2.1.5. Refrigerator
CONTROL
1.2.1.6. Bunsen burner
FACILITIES
1.2.1.7. Petri Dishes (24 pieces)
(DRUG MANUFACTURERS)
1.2.1.8. Microscope
1.0. GENERAL REQUIREMENTS
1.2.1.9. Laboratory supplies/glasswares/chemicals/
1.1 Physico-Chemical Assay culture/media etc.
1.1.1. UV spectrophotometer 1.2.2. Animal House and Laboratory Animals i.e.
mice for safety test; rabbits for pyrogen test
1.1.2. Fluorphotometer (for vitamin preparation)
1.3. Reference Books
1.1.3. Titrimeter
1.3.1. Latest United States
1.1.4. Thin layer chromatography
Pharmacopeia/National Formulary
1.1.5. Analytical balance
1.3.2. British Pharmacopeia Latest Edition
1.1.6. pH meter
1.3.3. Remington's Pharmaceutical Sciences
1.1.7. Drying oven
1.3.4. Merck Index
1.1.8. Oven for stability testing
1.3.5. Drug Reference Manual
1.1.9. Water bath
1.3.6. BFAD Regulations/Pharmacy Laws
1.1.10. Magnetic stirrer
1.3.7. Official Philippine National Drug
1.1.11. Mechanical shaker Formulary
1.1.12. Pycnometer 1.4. Optional Requirements
1.1.13. Desiccators/vacuum desiccators NOTE: If product to be manufactured requires the
1.1.14. Hot plate use of any of the following then it becomes mandatory.

1.1.15. Furnace 1.4.1. Colorimeter

1.1.16. Glasswares 1.4.2. Column Chromatography

1.4.3. Gas-liquid chromatography

1.1.16.1. Buret (4) 1.4.4. Infrared spectrophotometer

1.4.5. Polarimeter

7
 1.4.6. Polarograph PHARMACISTS ARE URGED TO BEGIN
GENERIC
1.4.7. High pressure liquid chromatography
PRESCRIBING AND DISPENSING TODAY, JUNE
1.4.8. Ultra-sonic bath
1, 1989
1.4.9. Kjeldahl assembly
June 1 to August 31 is the designated learning and
2.0. Additional Requirements based on dosage
practice period for all medical, dental, veterinary and
form to be manufactured
pharmaceutical professionals. Beginning September 1, the
2.1. Tablet Preparation Generics Act of 1988 will be in full effect.
2.1.1. Disintegration tester
2.1.2. Dissolution rate assembly GUIDELINES ON PRESCRIBING MEDICINES
2.1.3. Friabilator BASED ON PRIOR LAWS
2.1.4. Hardness tester
2.1.5. Caliper * Only validly-registered medical, dental and
2.1.6. Moisture balance veterinary practitioners, whether in private practice or
employed in a private institution/corporation or in the
2.1.7. Torsion balance/analytical balance government, are authorized to prescribe drugs.
2.1.8. Melting point apparatus * All prescriptions must contain the name of the
2.2. Capsule Preparation prescriber, office address, professional registration
number, professional tax receipt number, patient's/client's
2.2.1. Dissolution rate assembly name, age and sex, and date of prescription.
2.2.2. Moisture balance * For prohibited and regulated drugs, the following
2.2.3. Melting point apparatus are required:

2.2.4. Torsion balance/analytical balance The prescriber must have an S-2 license.

2.3. Liquid/Suspension The special Dangerous Board prescription form must

be used.
2.3.1. Viscosimeter
A recording system following pertinent Dangerous
2.3.2. Refractometer Drugs Board regulations must be observed.
2.3.3. Visual inspection assembly
2.3.4. pH meter ADDITIONAL GUIDELINES ON PRESCRIBING
2.4. Powder and Granules MEDICINES PURSUANT TO THE
2.4.1. Moisture balance GENERICS ACT OF 1988
2.4.2. Torsion balance/analytical balance
2.4.3. See 2.3 requirements for liquid/suspension * Generic names shall be used in all prescriptions
2.5. Parenteral for:

2.5.1. Visual Inspection system Drugs with a single active ingredient, the generic
name of the active ingredient shall be used in prescribing.
2.5.2. Leaker Test (Set-up) for ampules
Drugs with two or more active ingredients, the
2.5.3. Pyrogen test Set-up generic name of the active ingredients as determined by
2.5.4. Particle counter the Bureau of Food and Drugs shall be used in prescribing.
2.6. Ointment/Cream * The generic name must be written in full but the
salt or chemical form may be abbreviated.
2.6.1. Viscosimeter
* The generic name of the drug ordered must be
2.6.2. pH meter clearly written on the prescription immediately after the
2.7. Penicillin Preparation Rx symbol, or on the order chart.
2.7.1. Separate equipment from that of non- In addition to the generic name, a brand name may
penicillin products depending on the dosage form to be also be indicated. In such cases, the following shall be
manufactured. observed:
* If written on a prescription pad, the brand name
enclosed in parenthesis shall be written below the generic
PURSUANT TO THE GENERICS ACT OF 1988 name.
AND ITS
IMPLEMENTING GUIDELINES, DOCTORS AND

8
 * If written on a patient's chart, the brand name * When only the generic name is written but is not
enclosed in parenthesis shall be written after the generic legible.
name.
* When the generic name does not correspond to the
* Only one drug product shall be prescribed on one brand name.
prescription form.
* When both the generic and the brand names are
* In prescribing drugs which need strict precaution not legible.
in their use, the prescriber must comply with the
* When the drug product prescribed is not registered
following:
with the Bureau of Food and Drugs.
After the Rx symbol but before the generic name he
Impossible prescriptions shall not be filled. They shall
must write clearly "(List B)". Refer to attached appendix
be kept and reported by the pharmacist of the drug outlet
for details.
or any other interested party to the nearest Department of
The prescriber must ensure that the following Health office for appropriate action. The pharmacist shall
information are accurately written on the prescription: advise the prescriber of the problem and/or instruct the
customer to get the proper prescription. cda
* The generic name of the active ingredient(s) and
the specific sat or chemical form. In cases of violative, erroneous and impossible
prescriptions, the local Department of Health office shall
* The manufacturer.
be responsible for giving written notice to the erring doctor
* The brand name, if so desired. concerned and for transmitting through channels the report
* The strength or dose level using units of the metric for violation/error to the Professional Regulation
system. Example: 1 grain — 60 mg. Commission or to the fiscal's office for appropriate action.

* The delivery mode or delivery system: quick-

dissolve, sustained release, etc., and the corresponding GUIDELINES ON DISPENSING OF MEDICINES
appropriate dose frequency or dose interval.
BASED ON PRIOR LAWS

VIOLATIVE, ERRONEOUS AND IMPOSSIBLE

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

Violative Prescription * Non-prescription or over-the-counter drugs may

be dispensed even without a written order of a validly-
* Where the generic name is not written. registered physician, dentist or veterinarian in duly
* Where the generic name is not legible and a brand licensed drug outlets. When dispensing over-the-counter
name which is legible is written. drugs without a doctor's prescription, the pharmacist shall
give the necessary information and direction for use of the
* Where the brand name is indicated and drug.
instructions added (such as the phrase "no substitution")
which tend to obstruct, hinder or prevent proper generic * All prescriptions dispensed in the drugstore, botica
dispensing. or hospital pharmacy shall be kept in file for two years and
recorded in a prescription book duly registered with the
Violative prescription shall not be filled. They shall Bureau of Food and Drugs which shall be opened for
be kept and reported by the pharmacist of the drug outlet inspection to Food and Drugs Inspectors any time during
or any other interested party to the nearest Department of business hours of the outlet. The prescription book shall be
Health Office for appropriate action. The pharmacist shall kept for two years after the last entry. cd i
advise the prescriber of the problem and/or instruct the
customer to get the proper prescription.
Erroneous Prescription ADDITIONAL GUIDELINES ON DISPENSING

* Where the brand name precedes the generic name. TO IMPLEMENT THE GENERICS ACT OF 1988

* Where the generic name is the one in parenthesis.

* Where the brand name is not in parenthesis. * All drug outlets are required to practice dispensing
of drugs using generic names with some exceptions,
* Where more than one drug product is prescribed modifications or qualifications in certain cases or
on one prescription form. circumstances prescribed herein.
Erroneous prescriptions shall not be filled. Such Drugstores, boticas, and other drug outlets.
prescriptions shall also be kept and reported by the
pharmacist of the drug outlet or any other interested party To ensure the informed choice and use of drugs by
to the nearest Department of Health office for appropriate patient/buyer, the drug outlet is required to:
action. * Inform the patient/buyer of all available drug
Impossible Prescriptions products generically equivalent to the one prescribed with

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their corresponding prices. In so doing, the drug outlet Dispensing must be done by the pharmacist who shall
shall not favor or suggest any particular product so that the affix his/her signature on the prescription filled.
patient/buyer may fully and adequately exercise his option
The order and instructions of the doctor as written on
to choose.
the prescription, must be precisely followed.
* For this purpose, all drug outlets shall post in a
Partial filling of prescription for prohibited and
conspicuous place in their respective establishments a list
regulated drugs (List A) shall not be allowed.
of drug products using generic names with their brand
names, if any, and their corresponding current prices. A Guidelines on what to do with Violative, Erroneous,
handbook or directory containing the above required and
information, readily accessible to the patient/buyer shall be Impossible Prescriptions
considered substantial compliance.
* Violative and impossible prescriptions as defined
Hospital Pharmacies The following shall govern in A.O. 62 (Generic Prescribing) shall not be filled. The
generic dispensing in hospital pharmacies, in the case of pharmacist shall advise the prescriber of the problem
in-patients only: and/or instruct the customer to get the proper prescription.
* Upon admission, the patient or his/her responsible These violative and impossible prescriptions shall be kept
relative shall indicate in writing whether he/she shall and reported by the pharmacist or other interested parties
submit to the hospital drug policies or reserve the option to to the nearest Department of Health office for appropriate
buy drugs and medicines outside of the hospital pharmacy. action.
* Hospital pharmacies operating on an acceptable * Erroneous prescription shall be filled, but they
formulary system and pricing policy as determined by the shall also be kept and reported to the nearest Department
Department of Health, and using generic terminology in of Health office for appropriate action.
procurement, prescribing, dispensing, and recording of Violations on the part of Dispensers and Outlets
drugs shall be exempted from the following:
The following acts or omissions are considered
* Recording of prescription filled in the prescription violations of these rules and regulations:
book, provided such prescriptions shall be kept in file for
two years. * Imposing a particular brand or product on the
buyer.
* Individually informing the in-patient/buyer on
available generic equivalents and their corresponding * Inaccurate dispensing i.e. dispensing a drug
prices. However, a handbook or directory containing the product which does not meet the prescription as to any or
required drug information must be made available in the all the following: active ingredient, dosage form and
wards for patients, responsible relatives of patients and strength.
professional staff. * Failure to post or make accessible the required up-
* In dispensing to the buyer, the drug products in the to-date information on drug products.
unit dose or products which are not in their original * Failure to indicate the generic name/official name
containers but transferred to small bottles, tin cans, boxes, designated by the Bureau of Food and Drugs and other
plastic and/or paper envelopes and the like, the pharmacist required information on the drug outlet's label of the
shall place legibly on the required drug outlet's label the dispensed drug.
following information:
* Failure to record and keep prescriptions filled.
aisa dc
Name of patient Dosage strength * Failure to report to the nearest Department of
Generic name of the drug Expiry date Health office cases of violative, erroneous, and/or wrong
prescriptions within three months after receipt of such
Brand name, if any Directions for use prescriptions.
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:

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