[ DDB BOARD REGULATION NO. 14, s. 1973, October 02, 1973 ]

EXCLUSION OF DOLONIL FROM THE LIST OF REGULATED DRUGS, AND CONDITIONS UNDER WHICH IT MAY BE DISPENSED



Pursuant to the powers vested in the Dangerous Drugs Board under Sections 36(a) of R.A. 6425, as amended, the pharmaceutical preparation Dolonil containing Pyridium (phenzopyridine HCL, 150 mg. per tablet) hyoscymine HBr, and butabarbital (15 mg. per tablet), is hereby excluded from the list of regulated drugs.  Such drug, however, shall be dispensed through the ordinary prescription required under R.A. 3720, otherwise known as the Food, Drug and Cosmetic Act, and only under the following conditions.

1.  That the name, address, number of the Privilege Tax Receipt and the Opium license of the prescribing physician, as well as the name and address of the patient shall be indicated on the prescription;

2.  That the sale shall be recorded in the Record Book for Exempt Prescriptions Containing Negligible Amounts of Dangerous Drugs not exceeding the limits set under Board Regulation No. 1, series of 1973; and

3.  That the manufacture and importation of the same shall be made only upon approval of a permit duly signed by the Food and Drug Administrator.

This regulation amends Board Regulation No. 6, series of 1972 and shall take effect immediately.

Adopted: 2 Oct. 1973

(SGD.)CLEMENTE. S. GATMAITAN, M.D. M.P.H.
Chairman