Requirements in setting up a drug store retail outlet for non prescription drugs



So...you have decided to put up a drug store. The requirements as posted in the BFAD (Bureau of Food and Drugs) are as follows:

1. Notarized Petition Form / Joint affidavit of undertaking duly accomplished ( format can be obtained from the BFAD website).

2. Tentative list of Products using generic names and brand names, if any

3. Floor area, not less than 15 square meters

4. Generic white labels and red labels

5. Rubber stamp of outlets

6. Pharmacist board Registration Certificate, PRC-ID, Valid PTR, ID Picture (2 x 2) 2 pcs. And Certificate of attendance of owner / pharmacist to a BFAD sponsored /accredited Seminar on Licensing of Drug Establishments and Outlets

7. If Single Proprietorship, Certificate of Business Name Registration with the Bureau of Trade Regulation and Consumer Protection (BTRCP) formerly Bureau of Domestic Trade.

8. If Corporation, copy of Registration with SEC and Articles of Incorporation or Partnership

9. Contract of Lease for the space to be occupied if the owner doest not own it

10. Picture of drugstore with signboard

11. Location Plan and Floor Plan with dimension

12. Free for LTO (valid for 1 year) – P1,000

UPON INSPECTION THE FF. MUST BE PRESENT :

Reference Books:

• Philippine National Drug Formulary (PNDF)
• RA 3720 otherwise known as Food, Drugs & Devices & Cosmetics Act
• RA 6675 Generics Act of 1988 and relevant implementing rules and regulations
• RA 5921 Pharmacy Law as amended and relevant implementing rules and regulations
• RA 8203 Special Law on Counterfeit Drugs

Any one of the following reference books (latest edition):

• United States Pharmacopoeia / National Formulary (USP/NF)
• Remington's Pharmaceutical Sciences
• Goodman and Gilman Pharmacological Basis of Therapeutics
Record Books duly registered with BFAD (Prescription book)

Source: BFAD, photo courtesy www.sanfelipe.com.mx

Popular Posts