Section 3Sec./Art. 3

Definition of Terms. For purposes of this Act, the terms:

a. Drugs shall refer to any chemical compound or biological substance, other than food, intended for use in the treatment, prevention or diagnosis of disease in man or animals, including but not limited to:

1. any article recognized in the official United States Pharmacopoeia-National Formulary (USP-NF), official Homeopathic Pharmacopoeia of the United States, Philippine National Drug Formulary, British Pharmacopoeia, any National Compendium or any supplement to any of them;

2. any article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals;

3. any article other than food intended to affect the structure or any function of the body of man or animals;

4. any article intended for use as a component of any articles specified in clauses (1), (2), (3) not including devices or their components, parts, or accessories; and

5. herbal and/or traditional drugs which are articles of plant or animal origin used in folk medicine which are: (a)recognized in the Philippine National Drug Formulary; (b) intended for use in the treatment or cure or mitigation of disease symptoms, injury or bodily defect in man; (c) other than food, intended to affect the structure or any function of the body of man; (d) in finished or ready-to-use dosage form; and (e) intended for use as a component of any of the articles specified in clauses (a), (b), (c) and (d).

b. Counterfeit drug/medicine refers to medicinal products with the correct ingredients but not in the amounts as provided hereunder, wrong ingredients, without active ingredients, with insufficient quantity of active ingredient, which results in the reduction of the drug's safety, efficacy, quality, strength or purity. It is a drug which is deliberately and fraudulently mislabeled with respect to identity and/or source or with fake packaging, and can apply to both branded and generic products. It shall also refer to:

1. the drug itself, or the container or labeling thereof or any part of such drug, container or labeling bearing without authorization the trademark, trade name or other identification mark or imprint or any likeness to that which is owned or registered in the Bureau of Patent, Trademark and Technology Transfer (BPTTT) in the name of another natural or juridical person;

2. a drug product refilled in containers by unauthorized persons if the legitimate labels or marks are used;

3. an unregistered imported drug product, except drugs brought in the country for personal use as confirmed and justified by accompanying medical records; and

4. a drug which contains no amount of, or a different active ingredient; or less than eighty percent (80%) of the active ingredient it purports to possess, as distinguished from an adulterated drug including reduction or loss of efficacy due to expiration.

c. Brokering shall refer to any act of facilitating the disposal or sale of counterfeit drugs, including acts of agency.

d. Bureau shall refer to the Bureau of Food and Drugs (BFAD) of the Department of Health (DOH).

e. Department shall refer to the Department of Health.

f. Business establishment shall refer to any entity, whether a single proprietorship, partnership or corporation engaged in, or doing business in the Philippines.

g. Owner shall refer to a person or group of persons who is the registered owner of a license to operate a business or business undertaking in the Philippines or the branch manager or operator, licensee, franchisee, or any person acting on behalf of the corporate entity.

h. Residence shall refer to a private dwelling or abode where a person lives, either as owner or lessee, or usufructuary including, for purposes of this Act, its yard, garage, storage rooms or premises.