Title: REVISED REGULATIONS FOR THE LICENSING OF DRUG
ESTABLISHMENTS AND OUTLETS
Types of Drug Establishments:
- Drug Manufacturer – any establishment engaged in operations involved in the production of drug, including propagation, processing, compounding, finishing, filling, packing, repacking, altering, ornamenting, and labeling with the end in view of storage, distribution, or sale of the product.
- Drug Trader – any establishment which is registered owner of the drug product, procures the raw materials and packing components, and provides the production monographs, quality control standards and procedures, but sub-contract the manufacturer of such product to a licensed manufacturer. It may engage in distribution and/or marketing of its products.
- Drug Distributor/Exporter – any drug establishment that exports raw materials, active ingredients and/or finished products to another country.
- Drug Distributor/Wholesaler – any drug establishment that procures raw materials, active ingredients and/or finished products from local establishments in wholesale basis.
Requirements for Drug Outlets:
A. Premises
- A signboard in front of the place of the business bearing registered name of the drugstore
- A well-ventilated area not less than 15 sq m in floor area with concrete tile or wooden flooring
- A place suitable for compounding prescription and for washing and sterilizing bottles (compulsory only for hospital pharmacy)
- A suitable and proper place for the adequate storage of drugs and biological products as specified on the label
- A suitable cabinet for keeping poisons and/or dangerous drugstores
- An adequate water supply
B. References/Documents
- Philippine National Drug Formulary (when available)
- USP/NF (latest edition)
- RA 3720, RA 6675, RA 5921
- Remington's Pharmaceutical Sciences (latest edition)
- Goodman and Gilman: Pharmacological Basis of Therapeutics (latest edition)
C. Record Books duly registered with BFAD
- Prescription Book
- Dangerous Drug Book
- Exempt Preparation Book
- Poisons Book
- Record Book for Selected Non-prescription Drugs
D. A full-time validity registered pharmacist
physically present while drugstore is open for business
E. Others
- Invoices indicating the lot number or batch number of the manufacturer's stock
- File of prescription filled, consecutively numbered
- Dry seal or rubber containing the name and address of the drug outlet
- Red and white labels indicating the name and address of drugstore
