AMENDING BOARD REGULATION NO. 6, S. 1972 BY ADDING EPHEDRINE, PSEUDOEPHEDRINE, AND ANY OF THEIR SALTS AS WELL AS PREPARATIONS CONTAINING ANY OF SAID DRUGS IN THE LIST OF REGULAT…

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