Republic act no.

3720
REPUBLIC ACT NO. 3720
 Food, Drug, and Cosmetic Act

 approved: June 22, 1963

 establish standards and adopt quality measures to

ensure pure and safe supply of food, drug, and

cosmetic in the country

Food and Drug Administration (FDA)
Functions, Powers, and Duties:

 administer and supervise the implementation of this Act;

 provide for the collection of samples of food, drug, and

cosmetic;

 analyze and inspect food, drug, and cosmetic;

 establish analytical data to serve as basis for the preparation

of food, drug, and cosmetic standards;

 issue certificate of compliance

Food and Drug Administration (FDA)
Functions, Powers, and Duties:

levy, assess and collect fees for inspection,

analysis and testing of products and materials

certify batches of antibiotic and antibiotic

preparations
Food and Drug Administration (FDA)
Divisions of FDA:
1.Inspection and Licensing Division

2.Laboratory Division
Prohibited Acts and Penalties
Prohibited Acts

 manufacture, sale, offering for sale or transfer of adulterated

or misbranded food, drug, and cosmetic;

 refusal to permit entry or inspection;

 giving of a guaranty or undertaking containing the name and

address of the person from whom he received in good faith

the food, drug, device or cosmetic;

 Prohibited Acts and Penalties
Prohibited Acts

 forging, counterfeiting, simulating, or falsely representing or without proper

authority using any mark, stamp, tag label, or other identification device;

 using by any person to his own advantage any information acquired or

concerning any method or process which as a trade secret is entitled to

protection;

 alteration, mutilation, destruction, obliteration, or removal of the whole or

any part of the labeling of a food, drug, device or cosmetic;

Prohibited Acts and Penalties
Prohibited Acts

use of any representation or suggestion that an

application with respect to such drug is effective

Prohibited Acts and Penalties
Penalties

any person who violates any of the provisions shall

be subject to imprisonment of not less than 6 months

and 1 day, but not more than 5 years, or a fine of not

less than Php 1,000.00 or both such imprisonment

and FINE.
 Adulterated Drugs and Devices
A drug or device shall be deemed to be adulterated:

consists of any filthy, putrid, decomposed substance;

manufactured, prepared, packed, or held under insanitary

conditions;

composed of any poisonous or deleterious substance;

contains any color other than permissible one;

Adulterated Drugs and Devices
A drug or device shall be deemed to be adulterated:

 purports to be an official drug and its strength differs from, or

its quality or purity falls below, the standard;

 a substance has been mixed or packed to reduce its quality

or strength or substituted wholly or in part; and

 methods, facilities or controls used do not conform to current

good manufacturing practices

Misbranded Drugs and Devices
A drug or device shall be deemed to be misbranded:

 labeling is false or misleading;

 did not contain the name and place of business of the

manufacturer, packer, or distributor; and an accurate

statement of the quantity of the contents in terms of weight,

measure, or numerical count;

 any word, statement, or other information required is not

prominently placed with such conspicuousness;

 Misbranded Drugs and Devices
A drug or device shall be deemed to be misbranded:

 for use by man that contain any quantity of narcotic or hypnotic substance;

 not designated solely by a name recognized in an official compendium;

 unless its labeling bears adequate directions for use and warnings against use;

 purports to be the drug the name of which recognized in an official

compendium;

 found to be a drug liable to deterioration unless its label bears a statement of

precautions;
Misbranded Drugs and Devices
A drug or device shall be deemed to be misbranded:

 drug and its container is so made, formed, or filled as to be misleading;

 Imitation of another drug;

 offered for sale under the name of another drug;

 dangerous to health when used in the dosage recommended or

suggested in the labeling;

 purports to be, or is represented as a drug composed wholly or partly

Misbranded Drugs and Devices
A drug or device shall be deemed to be
misbranded:

purports to be a drug containing an antibiotic

drug, unless a certificate of release has been

issued and such certificate of release is in

effect with respect to such drug

AO NO. 220 s. 1974
 June 13, 1974

 Drugs: Current Good Manufacturing Practice in Manufacture,

Processing, Packing or Holding

 prescribes the conditions and requirements for good

manufacturing practice applied to premises, equipment,

personnel, product and warehousing

Current Good Manufacturing Practice
(cGMP)

determine whether methods used in, or the facilities

or controls used for, the manufacture, processing,

packing, or holding of a drug conform to or are

operated or administered in conformity with cGMP

Current Good Manufacturing Practice
(cGMP)
Buildings

 adequate space for equipment and materials; holding and storage of

rejected and approved for use components; manufacturing and

processing, packaging and labeling, and control and production-

laboratory operations;

 adequate lighting and ventilation for air-pressure, microbiological, dust,

screening, filtering, humidity and temperature control;

Current Good Manufacturing Practice
(cGMP)
Buildings

 adequate locker facilities and hot and cold water washing

facilities;

 adequate supply of potable water;

 suitable housing and space for laboratory animals;

 space for safe and sanitary disposal of sewage and trash

Current Good Manufacturing Practice
(cGMP)
Equipment

 not reactive, additive or absorptive when in contact with the drug;

 lubricants and coolants do not come in contact with the drug;

 facilitate adjustment, disassembly, cleaning and maintenance;

 be of suitable type, size, and accuracy for testing, measuring, mixing,

weighing or other processing operations

 Current Good Manufacturing Practice
(cGMP)
Personnel

 adequate in number and background of education and experience;

 shall have the capabilities commensurate with the assigned function;

 thorough understanding of the manufacturing or control operations;

 shall have periodic health checks, and shall be free of communicable

disease and open lesions

 Current Good Manufacturing Practice
(cGMP)
Components (Raw Materials)

 containers shall be examined visually for damage or

contamination;

 adequate number of samples shall be taken and subjected to

identity tests;

 representative samples shall be examined for evidence of filth,

insect infestation or other extraneous contamination

Current Good Manufacturing Practice
(cGMP)
Components (Raw Materials)

active ingredients shall be tested to determine strength;

approved components shall be marked and retested;

reserve sample shall be retained

Current Good Manufacturing Practice
(cGMP)
Master Formula and Batch Production Records

Master Formula Record

 prepared, endorsed, and dated to assure drug batch uniformity;

 record shall include:

 name of the drug product, description dosage form, and copy of
label;
 name and weight of each ingredient;
 complete list of ingredients;
 description of containers, closures, and packaging materials;
 manufacturing and control instructions, procedures, specifications,
special notations, and precautions to be followed
Current Good Manufacturing Practice
(cGMP)
Master Formula and Batch Production Records

Batch Production Record

 record shall include:

 appropriate reproduction of the master formula record;
 records of each step in the manufacturing, processing, packaging,
labeling, testing, and controlling of the batch;
 batch number that permits determination of all laboratory control
procedures;
 complete investigative history of any mix-ups, errors, and
unsatisfactory drug products
Current Good Manufacturing Practice
(cGMP)
Production and Control Procedures

include all reasonable precautions to assure that the

drugs produced have the safety, identity, strength,

quality and purity they purports to possess

Current Good Manufacturing Practice
(cGMP)
Product Containers

suitable specifications, test methods, cleaning

procedures, and sterilization procedures shall be

performed to assure that the containers and closures

are suitable for their intended use

Current Good Manufacturing Practice
(cGMP)
Packaging and Labeling

 adequately controlled to assure that only those who have

met standards and specifications shall be distributed; correct

labels and labeling are employed; and to identify finished

product with a control number

Current Good Manufacturing Practice
(cGMP)
Laboratory Controls

include the establishment of specifications,

standards and test procedures to assure that

components, drug preparations and finished

product conform to standards

Current Good Manufacturing Practice
(cGMP)
Finished-Goods Warehouse Control Distribution Records
 include an adequate inventory control system so that the distribution of each lot

drug can be readily determined to facilitate its recall

AO NO. 55 s. 1988
 December 7, 1988

 Requirements for Labelling Materials of Pharmaceutical Products

 generic name shall be the one with the highest point size among the printed

elements of the label, printed in full and enclosed exclusively by an outlined box
AO NO. 55 s. 1988
General Requirements
 minimum mandatory information:
 name of the product;
 dosage form and strength;
 pharmacologic category;
 Rx symbol;
 name and complete address of manufacturer and trader;
 net content;
 formulation;
 indication(s);
 contraindications;
 mode of administration;
AO NO. 55 s. 1988
General Requirements
 minimum mandatory information:
 batch and lot number;
 expiry/expiration date and date of manufacture;
 registration number;
 storage conditions;
 “Foods, Drugs, Devices, and Cosmetic Act prohibits dispensing without prescription.” (for
Rx products)
AO NO. 56 s. 1989
 January 3, 1989

 Revised Regulations for the Licensing of Drug Establishments and Outlets

AO NO. 56 s. 1989
 Drug Establishment

 Drug Outlet
AO NO. 56 s. 1989
Standards and Requirements For License to Operate (LTO) For
Drug Establishments
 General Requirements
 standard petition form
 proof of registration (single proprietorship or partnership/corporations)
 certificate of registration of establishment’s Filipino pharmacist
 certificate of attendance of BFAD-sponsored/accredited seminar on licensing of drug
establishments
 affidavit of undertaking
 list of products to be manufactured or distributed
AO NO. 56 s. 1989
Standards and Requirements For License to Operate (LTO)
 General Requirements
 authenticated copy of contract of lease
 certificate of continuing compliance with specific technical requirements
 batch distribution record book
 contingency plan
 system of filling up to date invoices
AO NO. 56 s. 1989
Standards and Requirements For License to Operate (LTO)
 Specific Requirements
 drug manufacturer

 drug trader

 drug distributor
 importers
 exporters
 wholesalers
AO NO. 56 s. 1989
Renewal of LTO
 initial period (initial application) – 1 year

 subsequent period (renewal) – 2 years

 at least 1 month prior to the expiration of LTO

AO NO. 56 s. 1989
Administrative Sanctions
 Grounds for Revocation of LTO
 misrepresentation of any material fact in the application of LTO;
 deficiency in GMP resulting in adulterated, misbranded, substandard or unsafe products
(manufacturers and traders);
 distribution of fake, misbranded, adulterated or unsafe drug products (distributor);
 violation of BFAD standards;
 sale or distribution of antibiotics without batch certification;
 failure to keep up-to-date records that would indicated continued compliance with
standards
AO NO. 56 s. 1989
Administrative Sanctions
 Grounds for Suspension of LTO
 minor deficiencies in GMP that are not likely to result in adulterated, misbranded,
substandard or unsafe products;
 lapses in keeping invoices, receipts or distribution records

 Re-application of after Revocation

 no establishments may apply for an LTO within 5 years after revocation
AO NO. 56 s. 1989
Schedule of Fees
Initial Renewal
Drug Manufacturer (DM) Php 5,000.00 Php 10,000.00
Drug Trader (DT) Php 3,000.00 Php 6,000.00
Drug Distributor Php 2,000.00 Php 4,000.00
(DW/DE/DI)
AO NO. 56 s. 1989
Types of Drug Outlets
 Drugstores, Pharmacy or Botica (Hospital Pharmacy/Dispensary)

 Retail Outlet for Non-Prescription Drugs

AO NO. 56 s. 1989
Standards and Requirements For License to Operate (LTO) For
Drug Outlets
 General Requirements
 standard petition form
 proof of registration (single proprietorship or partnership/corporations)
 certificate of registration of establishment’s Filipino pharmacist
 certificate of attendance of BFAD-sponsored/accredited seminar on licensing of drug
establishments
 affidavit of undertaking
 tentative list of products to be sold
 authenticated copy of contract of lease
AO NO. 56 s. 1989
Standards and Requirements For License to Operate (LTO) For
Drug Outlets
 Specific Requirements

1. Drugstore, Pharmacy or Botica

 Premises
 signboard;
 well-ventilated area not less than 15 sq. m.;
 place for compounding prescription;
 place for storage of drugs and biologicals;
 cabinet for hanging poisons and dangerous drugs
AO NO. 56 s. 1989
Standards and Requirements For License to Operate (LTO) For
Drug Outlets
 Specific Requirements

1. Drugstore, Pharmacy or Botica

 Reference Books and Documents
 PNDF;
 USP-NF (latest edition);
 RA 3720;
 RA 6675;
 RA 5921;
 Remington’s Pharmaceutical Sciences (latest edition);
 Goodman and Gilman Pharmacological Basis of Therapeutics (latest edition)
AO NO. 56 s. 1989
Standards and Requirements For License to Operate (LTO) For
Drug Outlets
 Specific Requirements

1. Drugstore, Pharmacy or Botica

 Record Books
 prescription book;
 dangerous drug book;
 exempt preparation book;
 poison book;
 record book for selected non-prescription drugs (subject to abuse)
AO NO. 56 s. 1989
Standards and Requirements For License to Operate (LTO) For
Drug Outlets
 Specific Requirements

1. Drugstore, Pharmacy or Botica

 Utensils, Apparatus and Other Equipment

 refrigerator for biologicals;
 prescription balance, glass volumetric, mortar and pestle (hospital pharmacy only)
 Others
 invoices indicating the lot/batch number of manufacturer’s stock;
 file of prescriptions filled numbered consecutively;
 dry seal or rubber stamp;
 red and white labels
AO NO. 56 s. 1989
Standards and Requirements For License to Operate (LTO) For
Drug Outlets
 Specific Requirements

2. Retail Outlets for Non-Prescription Drugs

 Premises
 Signboard with non-Rx;
 well-ventilated area;
 place for storage of non-prescription drugs
 Reference Books and Documents
 PNDF
 RA 3720;
 RA 6675;
 RA 5921;
AO NO. 56 s. 1989
Standards and Requirements For License to Operate (LTO) For
Drug Outlets
 Specific Requirements

2. Retail Outlets for Non-Prescription Drugs

 Others
 record book for selected non-prescription drugs;
 invoices indicating the lot/batch number of manufacturer’s stock;
 dry seal or rubber stamp
AO NO. 56 s. 1989
Renewal of LTO
 history of satisfactory performance with BFAD standards and requirements without

any case of serious violation of law, rules and regulations

AO NO. 56 s. 1989
Administrative Sanctions
 Temporary Closure
 absence of pharmacist on 3 inspections by BFAD inspectors;

 Suspension of LTO
 failure to produce invoices and receipts;
 failure to record and file all prescriptions;
 refusal to allow entry of BFAD inspectors
AO NO. 56 s. 1989
Administrative Sanctions
 Revocation of LTO
 sale or offer for sale of drugs marked “Not for Sale”;
 failure to record dangerous drugs;
 lack of pharmacist;
 failure to take necessary remedial or corrective measures within prescribed period
directed by BFAD
AO NO. 56 s. 1989
Validity
Initial Validity Subsequent Validity
Drugstore, Pharmacy or
Botica 1 year 2 years
Retail Outlet

Schedule of Fees
Initial Renewal
Drugstore, Pharmacy or
Php 500.00 Php 1,000.00
Botica
Retail Outlet Php 200.00 Php 400.00
AO NO. 64 s. 1989
 March 13, 1989

 Amendments of AO No. 55 s. 1988 Otherwise Known as Requirements for Labelling

Materials of Pharmaceutical Products

AO NO. 64 s. 1989
Amendments
 Caution for Prescription Drugs
 “Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.”
(List A, B and all other prescription drugs);

 for products contained in a strip or blister packs, strength, expiry date, company

name and batch number must appear for every standard strip;

 Effectivity
 July 1, 1989 – acquiring of the new labels for drug establishments (from April 1, 1989)
AO NO. 67 s. 1989
 March 15, 1989

 Revised Rules and Regulations on Registration of Pharmaceutical Products

AO NO. 67 s. 1989
General Standards
 establishments applying to register are required to full disclose all pertinent

documentation and information;

 action on registration application is based on complete set of specifications in

the label and classification of the drug product;

AO NO. 67 s. 1989
General Standards
 standards of product registration and evaluating application are subject to

revisions;

 establishment with LTO under AO 56 s. 1989 can only apply to register a drug

product
AO NO. 67 s. 1989
Classification of Drug Products
 number of active ingredient;

 available scientific evidence and experience of drug’s use;

 pharmacologic/therapeutic category specified in PNDF;

 source or circumstances of drug production;

 brand identification and patent protection of the drug;

 prescribing and dispensing regulations applicable

AO NO. 67 s. 1989
Initial Product Registration
 application;

 evaluation by review of submitted data;

 evaluation by testing of submitted samples;

 assessment of findings;

 action on registration application;

AO NO. 67 s. 1989
Renewal of Registration
 drug products registered for general and restricted use;

 application shall be made on a form promulgated by BFAD;

 reviewed and evaluated based on the product and applicant meeting the

current BFAD standards;

AO NO. 67 s. 1989
Schedule of Registration
Initial Registration
Investigational Drug Application
New Drug Application (provisional
monitored release)
New Drug Application (general/restricted
use)
Tried and Tested, Established Drug,
Pharmaceutical or Therapeutic Innovations
Generic Drug
Branded Drug
Fee
Php 1,000.00/year
Php 2,000.00/year or Php 6,000.00/3
years + Laboratory Analysis
Php 2,000.00/year or Php 10,000.00/3
years + Laboratory Analysis
Php 500.00/year or Php 2,500.00/5 years
+ Laboratory Analysis
Php 1,000.00/year or Php 5,000.00/5
years + Laboratory Analysis
AO NO. 67 s. 1989
Schedule of Registration

 For renewal
 Php 300.00/year or Php 1,500.00/5 years + Laboratory Analysis
AO NO. 79 s. 1989
 September 18, 1989

 Transitional Remedial Labelling in Compliance with RA 6675

AO NO. 79 s. 1989
 drug manufacturers may be granted with a remedial labeling relief if they have

specific plan for implementing any of the remedial labeling options

AO NO. 79 s. 1989
Remedial Labeling Options
 Drug Products in Bottles (vials containing more than 20mL)
 new package insert approved by BFAD;
 immediate container must be identified by a remedial stick-on label added on the old
label;
 secondary container should use new label approved by BFAD
AO NO. 79 s. 1989
Remedial Labeling Options
 Drug Products in Blister Packs or Aluminum Foil Packs, Vials containing less than
20mL and all Ampules
 new package insert approved by BFAD;
 clarificatory leaflet containing the labeling information;
 secondary container should use new label approved by BFAD;
AO NO. 85 s. 1990
 February 15, 1990

 Requirements for Labelling Materials of Certain Categories of Products Containing

Two or More Active Ingredients

AO NO. 85 s. 1990
 Applicability of the Provisions of AO 55 s. 1989

 all pertinent provisions of AO 55 for labelling materials of pharmaceutical products shall

apply to products with 2 or more active ingredients

AO NO. 85 s. 1990
 Coverage
 products with 2 or more active ingredients with a single International Non-Proprietary
Name (INN);
 products with 2 and 3 active ingredients without a single (INN);
 fluid replacement and special solution products;
 multivitamins;
 multivitamins with non-vitamin components
AO NO. 85 s. 1990
 Coverage
 products with 2 or more active ingredients with a single International Non-Proprietary
Name (INN);
 products with 2 and 3 active ingredients without a single (INN);
 fluid replacement and special solution products;
 multivitamins;
 multivitamins with non-vitamin components
AO NO. 99 s. 1990
 December 3, 1990

 Requirements for Labelling Materials of Categories of Pharmaceutical Products

Containing Four or More Active Ingredients Outside the Coverage of A.O. 85 s,

1990
AO NO. 99 s. 1990
 Applicability of the Provision of AO 55 s. 1989

 all pertinent provisions of AO 55 for labelling materials of pharmaceutical products shall

apply to products with 4 or more active ingredients

 Coverage

 all pharmaceutical products containing for or more active ingredients not covered by

AO 85 s. 1990
AO NO. 99 s. 1990
 Generic Labelling

 generic name for each active ingredient shall be printed within the outline box on the

principal display panel

 trade/brand name is printed in smaller letters