BFAD BUREAU CIRCULAR NO. 5

Legal Principle: Republic Act 5921, known as the Food, Drug and Devices and Cosmetic Act, governs the regulation of pharmaceuticals and medical devices in the Philippines.
Purpose: To ensure that medicines and medical devices are available to the public only through licensed channels, thereby protecting public health.

Provision: No medicine, pharmaceutical, or device may be compounded, dispensed, sold, or made available to the public except through a licensed prescription drugstore or hospital pharmacy.
Key Definitions:
- Prescription Drugstore: A retail establishment legally permitted to dispense prescription medicines.
- Hospital Pharmacy: A pharmacy within a hospital, compliant with the provisions of RA 5921.

Authorized Sellers: Pharmaceuticals, drugs, or biological manufacturing establishments, importers, and wholesalers are only permitted to sell products wholesale to licensed drugstores or hospital pharmacies.
Requirements:
- All drug manufacturers, traders, and distributors must be licensed.
- Sales and distributions must strictly comply with the stipulations of RA 5921.

Consequences: Individuals or entities found in violation of this provision may face:
- Fines: Ranging from one thousand pesos (₱1,000) to four thousand pesos (₱4,000).
- Imprisonment: A penalty of imprisonment for a term not less than six months and one day, up to four years, at the court's discretion.
Additional Liabilities: Violations may also constitute grounds for revocation of the manufacturer’s or wholesaler/distributor’s license as defined in Administrative Order No. 56, series of 1989.

Directive: All licensed drug manufacturers, traders, and distributors are reminded to adhere strictly to the law to ensure compliance and safeguard public health.

Medicines and devices can only be sold through licensed drugstores or hospital pharmacies.
Strict licensing requirements are in place for manufacturers and distributors.
Violations attract significant fines and potential imprisonment.
Compliance is essential for maintaining licenses and ensuring public safety.