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