Pursuant to the powers vested in the Dangerous Drugs Board under Section 36(a) of RA 6425, as amended, Board Regulation No. 6, S. 1972 is hereby amended as follows:

SECTION 1.       Classification as Regulated Drugs - All raw materials of ephedrine, pseudoephedrine, or any of their salts, as well as preparations containing any of the said drugs are hereby classified as regulated drugs.

SECTION 2.       Exception - Section 1 hereof does not apply to a preparation containing any of the above named drugs when such preparation:

a.       Is so compounded as to present no, or negligible risk of abuse and none of the above named drugs that it contains can be recovered by readily applicable means in a quantity liable to abuse,

b.       Contains one or more non-narcotic or non-psychotropic active medicinal ingredients in proportion sufficient to prevent enhancement, or potentiation or synergism of the abuse liability of the ephedrine, pseudoephedrine, or any of its salts,

c.       Is devoid of any prohibited drug, or another regulated drug, or a psychotropic substance under Schedule I of the 1971 Convention on Psychotropic Substances or another psychoactive drug not under domestic or international control but with known abuse potential, and

d.       Is not in injectable form.

SECTION 3.       Effect of Presence of Prohibited Drug - When the contents of the subject preparation is in association with a prohibited drug, the preparation shall be deemed to be a prohibited drug.

SECTION 4.       Prohibition Against Over-the-Counter Sale and Distribution as Physician's Samples - In no case shall a preparation in any form and in whatever physical state containing ephedrine, pseudoephedrine, or their salts be sold as over-the-counter items or distributed as physician's samples.

SECTION 5.       This Regulation shall take effect fifteen (15) days after the completion of its publication once a week for two consecutive weeks in a newspaper of general circulation.

Adopted: 17 March 1988

(SGD.) TOMAS P. MARAMBA, JR., MD., MHA.
(Undersecretary of Health for Standards and Regulation)
Chairman