RA 5921

Section 25
No medicine, pharmaceutical, or drug of whatever
nature and kind or device shall be compounded,
dispensed, sold or resold, or otherwise be made available
to the consuming public except through a prescription
drugstore or hospital pharmacy, duly established in
accordance with the provisions of this Act.

Pharmaceutical, drug or biological manufacturing

establishments, importers and wholesalers of drugs,
medicines, or biologic products are authorized to sell their
products only at wholesale to duly established retail
drugstore or hospital pharmacies.

Section 26

No sample of any drug, biological product, device or

proprietary medicine, given or intended to be given for
free to the physician and other qualified person by any
manufacturer or distributor of its representative or
detailman as part of its program or promotion, may be
sold.

The statement "Sample, not for sale" shall appear

conspicuously on the container, package or carton of the
drug or device to be given.

Section 27

Every pharmacy, drugstore or hospital pharmacy

whether owned by the government or a private person
or firm shall at all times when open for business be
under the personal and immediate supervision of a
registered pharmacist

RA 3720
Section 11(a) of Republic Act 3720 as amended provides:
The following acts and the causing thereof are hereby
prohibited: (a) the manufacture, sale, offering for sale
or transfer of any food, drug, device or cosmetic that is
adulterated or misbranded.

Section 11(j)
The following acts and the causing thereof are hereby
prohibited: xxx (j) the manufacture, importation,
exportation, sale, offering for sale, distribution, or
 transfer of any drug or device which is not registered
with the Bureau pursuant to this Act.

Section 11(k);
The following acts and the causing thereof are hereby
prohibited: xxx (k) the manufacture, importation,
exportation, sale, offering for sale, distribution, or
transfer of any drug or device by any person without
the license from the Bureau required under this Act.

Section 27
Every pharmacy, drugstore or hospital pharmacy
whether owned by the government or a private person
or firm shall at all times when open for business be
under the personal and immediate supervision of a
registered pharmacist

RA 8203
Section 4(a) in relation to Section 3(b)(3) of Republic Act 8203;
The following acts are declared unlawful and therefore
prohibited: (a) the manufacture, sale, or offering for
sale, donation, distribution, trafficking, brokering,
exportation, or importation or possession of counterfeit
drugs as defined in Section 3 hereof xxx

Administrative Order No. 55 s. 1988;

Section 3.1.1
In all cases, the generic name shall be the prominently
printed element on the label, defined as the one with
the highest point size among the various printed
elements on the label.

Administrative Order No. 56 s 1989

Section 4.2.1 Minor deficiencies in GMP or material
management that need to be corrected but are not
immediately or likely to result in adulterated,
misbranded, substandard or unsafe products as
determined by BFAD. This includes, among others, poor
housekeeping, inadequate storage facilities, lack of
minor equipment or requirement, and other minor
shortcomings.

Section 4.2.2 of Administrative Order 56 s. 1989

provides that: Lapses in record keeping of invoices,
receipts or distribution records would result in
administrative sanctions.
 Section 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.

Section 2.2.1.2 Reference Books and Documents are

specific requirements for a drugstore, pharmacy or botica

Section 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.

Section 2.2.1.1.2 A well-ventilated area not less than

15 sq. m. in floor area with concrete, tile or wooden
flooring.

Section 2.21.6.2 File of prescription filled,

consequently numbered.

Section 2.2.1.6.3 Dry Seal or Rubber Stamp containing

the name and address of the drug outlet.

Section 2.2.1.6.4 Red and White labels indicating name

and address of drugstore are other additional
requirements for a drugstore, pharmacy or botica.

Section 2.2.2.5.1 of Administrative Order No. 56 s. 1989

which likewise include invoices indicating the lot
number or batch number of the manufacturers stock
pursuant to BFDA Memo. Circular No. 001 s. 1983 as
additional requirements.

Administrative Order 37 s. 1979

Section 1
Any person desiring to import or export food and food
products shall file an application for the registration of
each and every food items to be imported or exported
with the Food and Drug Administration

Memorandum Circular No. 8 s. 1990

Section 3
A handbook or directory and Menu Cards or poster
containing the list of drug products using generic names
with their brand names, if any, and their corresponding
current prices for the top 25 selling products, readily
accessible by the patient/buyer shall be considered
substantial compliance with Section 3.1.1.2 of
Administrative Order 63 s. 1989
Bureau Circular 19 s. 1999 reiterating Section 20(b)
(1)(B) of Republic Act 3720 as amended provides that: Drugs
intended for use by man xxx shall be dispensed only upon a
written prescription of a practitioner license by law to administer
such drug xxx