Republic Act No. 3720 “Foods,
Drugs, Devices and Cosmetics Act” as
amended by E.O. 175
Title: AN ACT TO ENSURE THE SAFETY
AND PURITY OF FOODS AND COSMETICS, AND THE PURITY, SAFETY, EFFICACY
AND QUALITY OF DRUGS AND DEVICES BEING MADE AVAILABLE TO THE PUBLIC,
VESTING THE BUREAU OF FOOD AND DRUGS WITH AUTHORITY TO ADMINISTER AND
ENFORCE THE LAWS PERTAINING THRETO, AND FOR OTHER PURPOSES.
Objectives:
a. Establish standards and quality
measures for foods, drugs, and devices and cosmetics.
b. Adopt measures to ensure pure and
safe supply of foods and cosmetics, and pure, safe, efficacious and
good quality drugs and devices in the country.
c. Adopt measures to ensure the
rational use of drugs and decives, such as, but not limited to,
banning, recalling or withdrawing from the market drugs and devices
which are not registered, unsafe, inefficacious or of doubtful
therapeutic value, the adoption of an National Drug Formulary, and
the use of generic names in the labeling of drugs.
d. Strengthen the Bureau of Food and Drug
FDA Functions:
a. To administer and supervise the implementation of
this Act and of rules and regulation issued pursuant to the same.
b. To provide for the collection of samples of food,
drug and cosmetic.
c. To analyze and inspect food, drug and cosmetic in
connection with the implementation of this Act.
d. To establish analytical data to serve as basis
for the preparation of food, drug and cosmetic standards, and
recommend standards of identity, purity, quality and fill of
container.
e. To issue certificate of compliance with technical
requirements to serve as bases for the issuance of license and
spot-check for compliance with regulations regarding operation of
food, drug and cosmetics manufacturers and establishments.
f. To levy, assess and collect fees for inspection,
analysis and testing of products and materials submitting in
compliance with the provisions of this Act.
g. To certify batches of antibiotics and antibiotic
preparations
FDA Divisions:
- Inspection and Licensing Division
- Laboratory Division
Adulterated Drugs or Devices:
- If it consists in whole or part of any filthy, or decomposed substances
- It has been manufactured, prepared or held under unsanitary conditions
- It is composed of any poisonous or deleterious substances
- It contains any color other than a permissible one
- It purports to be an official drug and its strength differs from, or its safely, efficacy, quality or purity falls below the standards set forth
- It has been mixed or packed or substituted so as to reduce safety, efficacy, quality, strength or purity
- Methods, facilities or controls used do not conform to current good manufacturing practices
Misbranded Drugs and Devices:
- Labeling is false or misleading
- It did not contain (a) the name and place of business of the manufacturer, importer, packer, or distributor, and (b) an accurate statement of the quantity of contents in terms of weight, measure or numerical count.
- If any word or information required is not prominently placed with conspicuousness
- If it is for use of man and contains any quantity of narcotic or hypnotic substances
- It is not designated solely by a name recognized in an official compedium
- Unless its labeling bears (a) adequate directions for use, and (b) such adequate warnings against use
- It purports to be the drug the name of which recognized in an official compendium
- It has been found to be a drug liable to deterioration unless its label bears a statement of precautions
- Its container is so made, formed of filled as to be misleading
- It is an imitation of another drug
- It is offered for sale under the name of another drug
- It is dangerous to health when use in dosage recommended or suggested in the labeling
- If it purports to be, or is represented as a drug composed wholly or partly
