Question & AnswerQ&A (EXECUTIVE ORDER NO. 175)
The amended Republic Act No. 3720 is titled '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 Thereto, And For Other Purposes.'
The State policies under this law, as embodied in the 1987 Constitution, include protecting and promoting the right to health of the people, instilling health consciousness among them, establishing and maintaining an effective food and drug regulatory system, and undertaking appropriate health manpower development and research responsive to the country's health needs and problems.
The Department of Health through the Bureau of Food and Drugs (BFAD) is responsible for implementing this Act, establishing standards for foods, drugs, devices, and cosmetics, and enforcing its provisions.
A 'drug' means: (1) Articles recognized in official pharmacopeias; (2) Articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease; (3) Articles (other than food) intended to affect the structure or function of the body; and (4) Articles intended as components of the foregoing, excluding devices or their parts.
A 'new drug' is any drug whose composition is not generally recognized by experts as safe, effective, and of good quality under prescribed conditions; or a drug used under new conditions or for new indications, containing new active ingredients or combinations, new modes of administration, or new dosage forms.
Prohibited acts include manufacturing, importing, exporting, selling, distributing adulterated or misbranded foods, drugs, devices, or cosmetics; refusal of inspection; false guarantees; counterfeit labeling; misuse of trade secrets; alteration of labeling; using false claims regarding approvals; and selling expired or unregistered drugs or devices without proper licenses.
Violations are punishable by imprisonment from one to five years, a fine from five thousand to ten thousand pesos, or both, at the court's discretion. If committed by a juridical person, responsible officers such as the chairman, president, or partners are liable.
A drug or device is adulterated if it contains filthy or decomposed substances; is prepared in unsanitary conditions; has poisonous containers; contains unauthorized color additives; deviates from official compendium standards without proper labeling; contains substituted substances reducing quality; or is manufactured not conforming to good manufacturing practices.
Labels must not be false or misleading and must include: the manufacturer's or distributor's name and address, an accurate statement of quantity, prominent information that an ordinary individual can understand, listing of active ingredients, adequate directions and warnings, and must comply with packaging standards for drugs recognized in official compendiums.
A person must file an application with the Secretary through the Bureau, submitting full reports on safety, efficacy, and quality from clinical studies in the Philippines; detailed composition; manufacturing methods; samples; proposed labeling; and other requirements. Approval is given after evaluation, and disapproval can occur after due hearing if the drug or device fails safety or efficacy criteria.
No drug or device can be manufactured, sold, imported, exported, distributed, or transferred without a license to operate issued by the Bureau, and the drug or device must be registered accordingly. The Secretary shall set fees for certificate of product registration and licenses.
The Secretary may impose administrative fines ranging from one thousand to five thousand pesos for violations of the Act, following notice and hearing procedures.
The Commissioner of Customs must deliver random samples of imported items to the Bureau for inspection. Items found adulterated, misbranded, or unregistered shall be refused admission and destroyed unless exported within the prescribed period. The law allows for relabeling under supervision and collection of related expenses from the owner or consignee.
Batches of drugs containing antibiotics must be certified to meet identity, strength, quality, and purity standards to ensure safety and efficacy. The Secretary may exempt certain drugs or classes from certification if requirements are unnecessary. The law defines 'antibiotic drug' specifically for these purposes.
A 'batch' means a quantity of any drug or device produced in a given manufacturing cycle. A 'batch number' is a label designation identifying the batch and allowing the traceability of its production history including all manufacturing and control stages.