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(NAR) VOL. 1 NO.1 / JANUARY - MARCH 1990

[ DDB BOARD REG. NO. 7, October 19, 1989 ]

PROVIDING GUIDELINES FOR THE IMPLEMENTATION OF BOARD REGULATIONS WHEREIN CERTAIN PROVISIONS OF THE GENERICS ACT OF 1988 (R.A. 6675) ARE APPLICABLE



Pursuant to the powers of the Board under Section 36(a) of R.A. 6425 as amended in relation to Section 9 and Section 6(a) and (b) of The Generics Act of 1988 the following guidelines are hereby prescribed:

SECTION 1.       For Practitioners . — In issuing a prescription, a duly authorized practitioner shall indicate therein the generic name of the dangerous drug or exempt dangerous drug preparation prescribed.  He shall also comply with the conditions set forth in Section 3 of Administrative Order No. 62, Series of 1989 of the Department of Health.

SECTION 2.       For Manufacturers, Compounders , Exporters and Importers . — They shall indicate the generic name on the label of the dangerous drugs or exempt dangerous drug preparations which they deal on.  They shall also comply with Administrative Order No. 55, Series of 1989 of the Department of Health.

SECTION 3.       For Drug Outlets . — Drug outlets dispensing dangerous and exempt dangerous drug preparations shall practice generic dispensing and shall comply with the conditions set forth in Section 3 of Administrative Order No. 63, S. 1989 of the Department of Health, except, the provision of Section 3, paragraph 3.1.1.2 which is, posting in a conspicuous place in their establishment a list of drug products using generic names with their brand names.

They shall also comply with the provisions of Board Regulation No. 11, Series of 1973 governing the partial filling of dangerous drugs.

SECTION 4.       Prohibition Against Advertising. — Dangerous drugs and exempt dangerous drug preparations shall not be advertised to the general public.  They may, however, be advertised in scientific journals.

SECTION 5.       Prohibition Against Distribution of Samples. — Dangerous drugs and exempt dangerous drug preparations shall not be distributed as samples.

SECTION 6.       Report of Violations . — Violations of this Regulation shall be reported to the Department of Health for appropriate action.

SECTION 7.       Repealing Clause . — All rules and regulations inconsistent herewith shall be deemed repealed or modified accordingly.

SECTION 8.       Effectivity . — This Regulation shall take effect after its publication in the Official Gazette and in a newspaper of general circulation once a week for two (2) consecutive weeks, whichever is earlier.

Adopted: 19 Oct. 1989

(SGD.) THOMAS P. MARAMBA, JR., M.D., M.H.A.
Vice Chairman
(Undersecretary of Health for Standards and Regulation)

Effective: 22 November 1989

 

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