Declaration of Policies
- The State shall protect and promote the right to health of the people and instill health consciousness.
- The State shall establish an effective food and drug regulatory system and promote health manpower development and research.
Government Responsibilities in Implementation
- The Department of Health shall set standards and adopt measures for the purity and safety of foods, cosmetics, drugs, and devices.
- Measures include banning, recalling, or withdrawing unregistered, unsafe, inefficacious, or therapeutically doubtful drugs and devices.
- Establishment of an official National Drug Formulary and use of generic names on labels.
- Strengthening the Bureau of Food and Drugs.
Definitions
- "Bureau": Refers to the Bureau of Food and Drugs.
- "Drugs": Includes articles recognized in official pharmacopeias and those intended for diagnosis, cure, mitigation, treatment, prevention of disease, or to affect body structure/function, excluding devices.
- "New Drugs": Any drug not generally recognized by qualified experts for safety, efficacy, and quality; includes drugs with new active ingredients, combinations, indications, administration modes, or dosages.
- Additional definitions added include batch, batch number, director, distribute, expiry date, export, import, manufacture, and new veterinary drugs.
Prohibited Acts
- Manufacturing, importing, exporting, selling, distributing adulterated or misbranded food, drugs, devices, or cosmetics.
- Adulteration or misbranding itself.
- Preventing authorized inspection or sample collection.
- False guaranties or undertakings.
- Forgery or unauthorized use of identification devices.
- Disclosure of protected trade secrets except as authorized.
- Alteration or mutilation of labeling causing adulteration or misbranding.
- Misuse of regulatory claims in labeling or advertising.
- Manufacturing, selling, distributing unregistered or unlicensed drugs or devices.
- Sale of expired drugs or devices and release without batch certification when required.
Penalties
- Violations carry imprisonment from 1 to 5 years or fines from Php 5,000 to Php 10,000, or both.
- Corporate officers and responsible partners may be held liable.
- Good faith purchase or possession may provide defenses if cooperation is given.
Adulteration of Drugs or Devices
- Occurs if contaminated, filthy, prepared under unsanitary conditions, contains poisonous containers, or unauthorized coloring.
- Failing to meet official compendium standards unless deviations are approved and labeled.
- Presence of substituted substances or ineffective manufacturing practices.
Misbranding of Drugs or Devices
- False or misleading labeling.
- Missing required label information such as manufacturer, quantity, or conspicuousness of required statements.
- Failure to disclose habit-forming or controlled substances with warnings.
- Incorrect or absent ingredient listings.
- Missing direc... (truncated, full summary follows)