TEMPORARY EXCLUSION OF PENTAZOCINE FROM THE LIST OF REGULATED DRUGS SUBJECT TO CERTAIN CONDITIONS

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