AMENDING BOARD REGULATION NO. 1-A, SERIES OF 1983 BY REMOVING CERTAIN PREPARATIONS CONTAINING LIMITED QUANTITIES OF PHENTERMINE RESIN OR PHENTERMINE HCL FROM THE LIST OF REGULAT…

Pursuant to the powers vested in the Dangerous Drugs Board under
Section 36(a) of RA 6425, as amended, and in conformity with the
decision of the said Body arrived at in its meeting of October 19, 1983,
Board Regulations No. 1-A, series of 1983 is hereby amended by removing
from the list of Regulated Drugs certain preparations containing not
more than 30 mg. of Phentermine Resin or not more than 15 mg. of
Phentermine HCL and placing them in the category of exempt preparations
as follows:

SECTION 1.       All preparations containing
not more than 30 mg. of Phentermine Resin are hereby removed from the
list of Regulated Drugs and placed under the category of exempt
preparation which may be prescribed through ordinary prescription
without indicating therein the S-2 license of the prescribing
physician.  The prescription shall, however, indicate the name and
address of the physician as well as the name and address of the patient.

SECTION 2.       All combination preparations
containing not more than 15 mg. of Phentermine HCL are hereby removed
from the list of Regulated Drugs and categorized as exempt preparation
which may be prescribed through ordinary prescription wherein shall be
indicated the S-2 license of the prescribing physician. his name and
address as well as the name and address of the patient.

SECTION 3.       The products herein classified as exempt preparations shall remain subject to the following requirements:

1.       Registration — In all cases, the products shall be
subject to registration with the Bureau of Food and Drug. In the cases
of exempt preparations subject to ordinary prescription in which shall
be indicated the S-2 license of the prescribing physician, the retailers
dealing in preparations of the category shall secure an S-1 license
from the Dangerous Drugs Board if they do not as yet possess an S-3
license.

2.       Records-keeping — a. If classified as an exempt
preparation subject to ordinary prescription without need of indicating
the S-2 license of the prescribing physician, each sale thereof shall be
recorded by the retail drug establishment in the ordinary prescription
book.

b.       If classified as exempt preparation subject to
ordinary prescription which shall indicate the S-2 license of the
prescribing physician, each sale thereof shall be recorded by the retail
drug establishment in the additional opium book.

3.       Inspection of wholesale and retail trade — All products
falling within the classification herein made are subject to inspection
by the authorized officers of the Bureau of Food and Drug and the
Dangerous Drugs Board insofar as regards the purposes and functions of
each of the said officers.

4.       Limitations of imports and exports.

5.       Reports to be furnished by the importers/manufacturers.

SECTION 4.       This Regulation shall take effect fifteen
(15) days after completion of its publication in a newspaper of general
circulation once a week for two consecutive weeks.

Adopted: 19 Oct. 1983

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