EXEMPT REGULATED PREPARATIONS

Pursuant to the powers of the Dangerous Drugs Board under Section
36(a), Article VIII of R.A. 6425, as amended, the following regulation
is hereby prescribed:

SECTION 1.       Definition of Terms —

a.      Dangerous Drug Preparation — refers to any solution or mixture, in whatever physical state, containing:

a.1       one or more dangerous drugs: or

a.2       one or more dangerous drugs in dosage form.

          As herein construed a dangerous drug preparation is in
dosage form when it consists of a measured, small quantity of dangerous
drugs or a combination of dangerous drugs in whatever form (tablet or
pill, ampul or powder) ready for consumption by, or administration to, a
patient or animal, whether orally or parenterally or through other
routes.

b.      Exempt Dangerous Drug Preparation — is
any dangerous drug preparation which is compounded in such a way that it
presents no, or a negligible, risk of abuse and the dangerous drug it
contains cannot be recovered by readily applicable means in a quantity
liable to abuse, so that the preparation does not give rise to a public
health and social problem; and has high therapeutic value a wide use for
legitimate purposes and is a much needed medicine required to be easily
available to the public in medical need thereof.  The word compounded
as herein used means the process of combining a controlled drug with a
non-controlled ingredient counteractive of the abuse liability of the
controlled drug present.

b.1       Exempt Regulated Drug Preparation — is any dangerous drug preparation which:

b.1.1    contains only one regulated drug internationally
controlled under Schedule III or IV of the 1971 Convention on
Psychotropic Substances and not exceeding the quantitative limits for
such as determined by the Board:

b.1.2    is not a combination of a regulated drug with a prohibited drug:

b.1.3    is not a combination of a psychotropic drug under
international control with an uncontrol drug having similar psychotropic
properties;

b.1.4    does not contain any psychotropic substance listed
in Schedule II annexed to the 1971 Convention on Psychotropic
Substances;

b.1.5    includes one or more non-narcotic or
non-psychotropic active medicinal ingredients in proportion sufficient
to confer upon the preparation valuable medicinal properties other than
those possessed by the regulated drug alone and to prevent enhancement
potentiation or synergism of the abuse liability of the regulated drug
(or any of its salts) that it contains; or if it consists of a single
psychotropic substance in dosage form, is compounded with a
counteracting non-psychotropic or non-narcotic material;

b.1.6    is devoid of any prohibited drug under Schedule IV
of the 1961 Convention on Narcotic Drugs or another psychotropic drug
not under domestic or international control but with known abuse
potential; and

b.1.7    is not in injectable form.

This last criterion does not apply when the preparation has high
therapeutic usefulness. As herein construed, a preparation in injectable
form is deemed to have high therapeutic usefulness if it is very
effective for the indicated use, is safely administered by skilled
professionals and is widely used in medicine.

SECTION 2.       Jurisdiction . — The Dangerous
Drugs Board has jurisdiction and control over all exempt dangerous drug
preparations except where registration of the product and determination
of its efficacy, purity and safety are concerned which are within the
functions of the Bureau of Food and Drugs under R.A. 3720, as amended.

SECTION 3.       Control Masures Not Required for Exempt Regulated Preparations. — Exempt regulated preparations are not subject to the following control measures:

a.       Compulsory use of DDB Form 1-72 or Yellow Prescription.

The preparation shall, however, be prescribed through an Ordinary
Prescription wherein the S-2 license of the practitioner shall be
indicated.

b.       Recording in the Dangerous Drugs Record Book.

The preparation should, however, be recorded in the Additional Dangerous Drugs Record Book.

SECTION 4.       Effect of the Presence of a Prohibited Drug
. — When the exempt regulated preparation is compounded with a
prohibited drug, the preparation shall be deemed to be a prohibited
drug.

SECTION 5.       Prohibition Against Sample Distribution. —

SECTION 6.       Advertising . — Exempt dangerous
drug preparations may be advertised in scientific journals. In no case,
however, shall such preparations be advertised to the general public.

SECTION 7.       Sanctions . — Any individual or
entity found, after notice and hearing, guilty of violating this
regulation shall be penalized with the sanctions embodied in Section
36(1), Article VIII of Republic Act No. 6425, as amended, without
prejudice to the institution of criminal proceedings if circumstances so
warrant.

SECTION 8.       Repealing Clause . — All regulations inconsistent herewith are hereby repealed or modified accordingly.

SECTION 9.       Effectivity . — This Regulation
shall take effect after the completion of its publication in the
Official Gazette and in a newspaper of general circulation once a week
for two (2) consecutive weeks, whichever is earlier.

Adopted: 19 Oct. 1989

(SGD.) THOMAS P. MARAMBA, JR., M.D., M.H.A.
Vice-Chairman
(Undersecretary of Health for Standard and Regulation)

Effective: November 28, 1989