Question & AnswerQ&A (EXECUTIVE ORDER NO. 175)
The new title is '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 shall protect and promote the right to health of the people, instill health consciousness among them, establish and maintain an effective food and drug regulatory system, and undertake appropriate health manpower development and research responsive to the country's health needs and problems.
The Bureau of Food and Drugs (BFAD) under the Department of Health is responsible for administering and enforcing these laws.
A 'drug' means articles recognized in official pharmacopeias, articles intended for diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals, articles other than food intended to affect the structure or function of the body, and components of these articles excluding devices or their parts.
A 'new drug' includes drugs whose composition is not generally recognized for safety and efficacy, drugs used under new conditions, drugs containing newly discovered active ingredients, new fixed combinations, new indications, new modes of administration, or new dosages or strengths.
Prohibited acts include manufacturing, importing, selling adulterated or misbranded products; adulteration or misbranding; refusing inspection; false guarantees; forgery or false representation; unauthorized use of trade secrets; label alterations causing adulteration; false claims of drug approval; and unregistered drug or device distribution.
Violators face imprisonment of not less than one year but not more than five years, or a fine between five thousand to ten thousand pesos, or both, at the court's discretion. If committed by a juridical person, responsible officers shall be penalized.
Drugs or devices are adulterated if they contain filthy or decomposed substances, are contaminated due to unsanitary manufacturing, have poisonous containers, contain unauthorized colors, differ from official standards, have substances that reduce quality, or do not conform to good manufacturing practice.
Misbranding occurs if labeling is false or misleading, lacks required information, does not provide adequate directions or warnings, is misleading in container appearance, imitates another drug, is dangerous under labeled usage, or lacks certification for antibiotic drugs.
An effective application for the drug or device must be filed and approved by the Secretary of Health through the Bureau, including submission of reports demonstrating safety, efficacy, composition, manufacturing methods, samples, labeling, and other requirements.
No person may manufacture, sell, import, export, or distribute any drug or device without first securing a license to operate and registering the product with the Bureau in accordance with rules and regulations promulgated by the Secretary.
After notice and hearing, the Secretary may impose administrative fines ranging from one thousand to five thousand pesos in addition to other sanctions.
The Commissioner must deliver samples of imported food, drugs, devices, and cosmetics to the Bureau for inspection, refuse admission of non-compliant products, cause destruction or export of such products, and cooperate with the Bureau for enforcement.
Yes, the Secretary may promulgate regulations exempting drugs and devices that are processed, labeled, or repacked in establishments other than those originally processing or packing, provided they are not adulterated or misbranded upon removal.
The applicant is given notice of an opportunity for a hearing to challenge the disapproval based on grounds such as inadequate tests, unsafe or inefficacious results, inadequate manufacturing methods, insufficient information, lack of evidence for claims, or false labeling.