Declaration of Policies
- The State protects and promotes the right to health and health consciousness (Art II, Sec 15, 1987 Constitution).
- The State establishes and maintains an effective food and drug regulatory system (Art XIII, Sec 12, 1987 Constitution).
- Health manpower development and research responsive to country’s needs must be undertaken.
Government Responsibilities under the Act
- Establish standards and quality measures for foods, drugs, devices, and cosmetics.
- Ensure a pure and safe supply of foods and cosmetics; ensure drugs and devices are pure, safe, efficacious, and of good quality.
- Promote rational drug and device use, including bans, recalls, and adopting a national formulary.
- Strengthen the Bureau of Food and Drugs.
Key Definitions
- "Bureau" means the Bureau of Food and Drugs.
- "Drugs" includes articles recognized in official pharmacopeias; articles for diagnosis, cure, mitigation, treatment, or prevention of disease in humans/animals; agents affecting body structure or function excluding devices.
- "New drugs" are those not generally recognized by experts or used extensively under new conditions, including newly discovered ingredients or combinations.
- Additional terms defined include "batch," "batch number," "director," "distribute," "expiry date," "export," "import," "manufacture," and "new veterinary drugs."
Prohibited Acts
- Manufacturing/importing/exporting/selling adulterated or misbranded foods, drugs, devices, or cosmetics.
- Adulteration or misbranding.
- Refusal of inspections or sample collection.
- False guarantees or undertakings.
- Forgery or misuse of identification marks.
- Unauthorized use or disclosure of protected trade secrets.
- Altering or removing labeling to cause adulteration or misbranding.
- False drug efficacy claims or unauthorized reference to official reports.
- Manufacture, sale, or distribution of unregistered or unlicensed drugs/devices.
- Selling beyond expiration or releasing uncertified batches as required.
Penalties for Violations
- Imprisonment of 1 to 5 years, or fines from ₱5,000 to ₱10,000, or both.
- Penalties apply to corporate officers responsible.
- Protection against penalties for good faith sales provided cooperation for information is given.
Criteria for Adulteration
- Containing filthy, putrid, or decomposed substances.
- Manufactured under unsanitary conditions.
- Containing poisonous substances in containers.
- Use of unauthorized coloring agents.
- Failing to meet prescribed standards for strength, safety, efficacy, quality, or purity.
- Mixing or substitution of substances reducing safety or quality.
- Non-conformance with good manufacturing practices.
Criteria for Misbranding
- False or misleading labeling.
- Labeling omissions concerning manufacturer, contents, directions, warnings.
- Inadequate disclosure of habit-forming substances or narcotics.
- Improper packaging or misleading container.
- Dangerous under prescribed usage.
- Uncertified antibiotic drugs.
Labeling and Packaging Regulations
- Exemptions allowed for drugs processed or repacked in other establishments if compliance is assured.
- Habit-forming, toxic, or new investigational drugs require prescription.
- Violations in dispensing or labeling are acts of misbranding.
Licensing, Registration, and Product Approval
- No manufacture, sale, import, export, distribution or transfer of drugs/devices without license and registration.
- Application for registration includes safety, efficacy, composition, manufacturing methods, labeling, and samples.
- Secretary must approve or deny application within 180 days or grant a hearing.
- Authority to suspend effectiveness of approval if safety or truthfulness issues arise.
- Regulations exempt investigational use drugs.
Certification of Antibiotic Drug Batches
- Certification required for safety, identity, strength, quality, and purity.
- Provisions for issuing releases before certification regulations are in place.
- Exemptions for certain drug classes and investigational drugs.
Administrative Provisions and Sanctions
- Secretary empowered to issue necessary rules and regulations.
- Customs and Health Officials coordinate to enforce import regulations.
- Hearings and proceedings conducted by the Bureau.
- Secretary authorized to impose administrative fines from ₱1,000 to ₱5,000.
Importation and Customs Control
- Customs to sample imported shipments for compliance.
- Refused goods destroyed or exported within a prescribed time.
- Relabeling or other compliance measures allowed under supervision.
- Costs for destruction, storage, or supervision charged to owner or consignee.
- Exported products are exempt from adulteration/misbranding if properly labeled and meet foreign requirements.
Repeal and Effectivity
- Repeals inconsistent laws, orders, or rules.
- The executive order takes effect 15 days after publication in the Official Gazette.