Department
of Health
OFFICE OF
THE SECRETARY
Manila
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).
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.
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)
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.
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.
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:
*
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:
*
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.
*
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.
