Pursuant to the powers vested in it under Section 36(a) of RA 6425, as amended, and following its decision arrived at in a meeting on this date, the Dangerous Drugs Board hereby temporarily excludes from the list of Regulated Drugs, the drug Pentazocine (1, 2, 3, 4, 5, 6- hexahydro-6, 11-dimethyl-3-(3-methyl-2 butenyl)-2, 6-methano-3-benzazocin-8-ol).

As so excluded, the subject drug shall be subject to the following requirements:

a.       It shall be prescribed through the ordinary prescription form wherein shall be stated the name, address, S-2 license number, and privilege tax receipt number of the prescribing physician as well as the name and address of the patient.

b.       Its sale by the retail drug establishment shall be recorded in the additional opium book.

c.       It shall continue to be governed by the provisions under Article 12 concerning Control of the International Trade, and Article 13 concerning the Prohibition of and Restriction on Export and Import under the 1971 Convention on Psychotropic Substances.

d.       That the importers, manufacturers, compounders, producers, and distributors (wholesalers) thereof shall:

1.         render semi-annual and annual reports to the Dangerous Drugs Board specifying therein the quantities of the drugs to be exported, imported or distributed locally as well as of the drugs used for manufacture;

2.         record such sales in the dangerous drugs book;

3.         monitor all distributions closely and submit to the Board periodic report thereof. All cases of reported drug abuse obtained during such monitor shall be fully documented and submitted to the Board.

4.         submit properly filled up DDB Form No. 8-72 (Local Purchase) in every case where purchase of the drug is to be made locally, DDB Form No. 11-72 (Export Authorization) if exportation of the drug is intended, or Form No. 10-72 (Import Permit) if importation is contemplated.

e.       That the drug product will be distributed by the manufacturers, importers, compounders, producers, and distributors (wholesalers) only to hospitals (including medical clinics) and reputable outlets.

This temporary exclusion shall cover a period of one year from the date of effectivity of this regulation, upon expiration of which, the drug shall automatically revert to the category of a regulated drug unless the life of the regulation is extended by the Board.

This Regulation shall take effect 15 days after completion of its publication in a newspaper of general circulation once a week for two consecutive weeks.

Adopted: 14 Nov. 1984

(SGD.) J.C. AZURIN
(Minister of Health)
Chairman