Requirements for Drugstores, Pharmacy or Botica

2.2.1.1 Premises

2.2.1.1.1 A signboard in front of the place of business bearing the registered name of the
drug store. For hospital pharmacy, the sign “Pharmacy” is sufficient. For drug outlet selling
exclusively non-prescription or Over the Counter (OTC) drug product, the signboard should
indicate so by putting the symbol non-Rx or its equivalent.

2.2.1.1.2 A well-ventilated area not less than 15 sq. m. in floor area with concrete, tile or
wooden flooring.

2.2.1.1.3 A place suitable for compounding prescription and for washing and sterilizing
bottles (compulsory only for hospital pharmacy).

2.2.1.1.4 A suitable and proper place for the adequate storage of drugs and biological
products as specified on the label.

2.2.1.1.5 A suitable cabinet for keeping poisons and/or dangerous drugs.

2.2.1.1.6 An adequate water supply.

2.2.1.2 Reference Books and Documents

2.2.1.2.1 Philippine National Drug Formulary (when available)

2.2.1.2.2 United States Pharmacopeia/National Formulary (USP-NF) (latest edition).

2.2.1.2.3 R.A. 3720, otherwise known as the Foods, Drugs and Devices and Cosmetics
Act as amended and relevant implementing rules and regulations.

2.2.1.2.4 R.A. 6675, Generics Act of 1988 and relevant implementing rules and
regulations.

2.2.1.2.5 R.A. 5921 Pharmacy Law, as amended and relevant implementing rules and
regulations.

2.2.1.2.6 Remington’s Pharmaceutical Sciences (latest edition).

2.2.1.2.7 Goodman & Gilman — Pharmacological Basis of Therapeutics (latest edition).

2.2.1.3 Record Books Duly Registered with the BFAD

2.2.1.3.1 Prescription Book

2.2.1.3.2 Dangerous Drug Book

2.2.1.3.3 Exempt Preparation Book

2.2.1.3.4 Poisons Book

2.2.1.3.5 Record Book for Selected Non-Prescription Drugs, subject to abuse as

determined by BFAD and/or Dangerous Drugs Board (DDB).

2.2.1.4 Utensils, Apparatus and Other Equipment

2.2.1.4.1 For all drugstores including hospital pharmacies, refrigerator for biologicals
and other drug products needing refrigeration.

2.2.1.4.2 For hospital pharmacy only:

2.2.1.4.2.1 Prescription balance of one centigram sensitivity and a set of weights.

2.2.1.4.2.2 Glass volumetric measures a set of not less than six pieces from 15 ml to 1000
ml capacity.

2.2.1.4.2.3 Mortar and pestle — a set of not less than three in assorted sizes.

2.2.1.5 A full-time validly registered pharmacist physically present while the

drugstore is open to business.

2.2.1.6 Other Additional Requirements:

2.2.1.6.1 Invoices indicating the lot number or batch number of the manufacturer’s stock
pursuant to BFAD Memo. Circular no. 001 s. 1983.

2.2.1.6.2 File of prescription filled, consecutively numbered.

2.2.1.6.3 Dry Seal or Rubber Stamp containing the name and address of the drug outlet.

2.2.1.6.4 Red and White labels indicating name and address of drugstore.

Requirements for a Retail Outlet for Non-Prescription Drugs

2.2.2.1 Premises

2.2.2.1.1 A signboard in front of the place of business bearing the registered name of
retail outlet and the symbol non-Rx or equivalent.

2.2.2.1.2 An adequate, well-ventilated area with concrete, tile, or wooden flooring.

2.2.2.1.3 A suitable and proper place for the adequate storage of non-prescription drugs.
When there are products sold other than drugs, an area exclusively for drug products shall be
allocated within the premises.

2.2.2.2 Reference Books and Documents

2.2.2.2.1 Philippine National Drug Formulary (when available);

2.2.2.2.2 R.A. 5921, Pharmacy Law and its implementing rules and regulations;

2.2.2.2.3 R.A. 6675, the Generics Act of 1988 and relevant implementing rules and
regulations;

2.2.2.2.4 R.A. 3720 as amended or Foods, Drugs and Devices and Cosmetics Act;

2.2.2.3 Record Books as required by BFAD for selected non-prescription drugs

subject to abuse as determined by BFAD and/or DDB

2.2.2.4 A full-time validly registered pharmacist physically present while the retail
outlet is open for business.

2.2.2.5 Other Additional Requirements

2.2.2.5.1 Invoices indicating the lot number or batch number of the manufacturer’s stock
pursuant to BFAD Memo. Circular No. 001 s. 1983.

2.2.2.5.2 Dry seal or Rubber Stamp containing the name and address of the drug outlet.

3. Renewal of License to Operate (LTO)

In case of renewal of LTO the drug outlet must have a history of satisfactory performance,
consistent with BFAD standards and requirements, without any case of serious violation of
existing laws, rules and regulations.

4. Administrative Sanctions

4.1 Temporary Closure

Absence of pharmacist on three (3) inspections by BFAD inspector.

4.2 Suspension of License to Operate

4.2.1 Failure to produce invoices and receipts together with lot numbers, expiry dates for the
drugs in stock.

4.2.2 Failure to properly record and keep a file of all prescriptions filled in the last two years.

4.2.3 Refusal to allow entry of BFAD inspectors.

4.3 Revocation of License to Operate

4.3.1 Sale or offer for sale of adulterated, misbranded, sub-standard, unregistered, expired
and/or unsafe drugs or products marked “Not for Sale.”

4.3.2 Failure to properly record dangerous drugs as determined by DDB.

4.3.3 Lack of pharmacist.

4.3.4 Failure to take necessary remedial or corrective measures within the prescribed period
as directed by BFA