RECLASSIFICATION AND REVISION IN THE USE OF HYDROQUINONE AND/OR TRETINOIN (RETINOIC ACID) PREPARATIONS

The existing rules and regulations governing
the use of Hydroquinone
and/or Tretinoin (Retinoic Acid) Preparations were rationalized,
re-examined and reviewed in the light of recent clinical studies and
changing consumer preferences and practices.

Therefore, in accordance with the provisions of Republic Act No. 3720,
as amended, otherwise known as the Food, Drugs, Devices and Cosmetics
Act, the use of Hydroquinone and/or Tretinoin (Retinoic Acid)
Preparations are hereby reclassified and revised as follows:

A. All preparations containing Hydroquinone as the only active
ingredient with the corresponding concentrations are classified as:

1. HOUSEHOLD REMEDIES – for preparations
   containing less than or
   equal to two percent (2%) Hydroquinone. They can be dispensed without
   the supervision of a licensed pharmacist;

2. OVER-THE-COUNTER DRUGS – for preparations
   containing more than
   two percent (2%) but less than or equal to four percent (4%)
   Hydroquinone. They must be dispensed under the supervision of a licensed
   pharmacist;

3. PRESCRIPTION DRUGS – for preparations containing
   more than four
   percent (4%) but less than five (5%) Hydroquinone. They must be
   dispensed only by licensed pharmacists of registered drug outlets upon
   the presentation of proper prescription;

4. NOT-REGISTRABLE – for preparations containing
   five percent (5%)
   or more Hydroquinone. They are not allowed and are prohibited from being
   registered.

B. All preparations containing Tretinoin (Retinoic Acid) as the only
active ingredient with the corresponding concentrations are classified
as:

1. HOUSEHOLD REMEDIES – for preparations
   containing less than or
   equal to 0.025% Tretinoin for gels and lotions, and 0.05% Tretinoin for
   creams. They can be dispensed without the supervision of a licensed
   pharmacist;

2. PRESCRIPTION DRUGS – for preparations containing
   more than 0.025%
   Tretinoin for gels and lotions, and 0.05% Tretinoin for creams. They
   must be dispensed only by licensed pharmacists of registered drug
   outlets upon the presentation of proper prescription;

C. All preparations containing combinations of Hydroquinone and
Tretinoin (Retinoic Acid) as the active ingredients with the
corresponding concentrations are classified as:

1. HOUSEHOLD REMEDIES – for preparations
   containing combinations of:

   (a)	less than or equal to two percent (2%) Hydroquinone, and
   (b)	less than or equal to 0.025% Tretinoin for gels and lotions, and 0.05% Tretinoin for creams.

They can be dispensed without the supervision of a licensed
pharmacist;

2. OVER-THE-COUNTER DRUGS – for preparations containing combination of:

   (a)	more than two percent (2%) but less than or equal to four percent (4%) Hydroquinone, and
   (b)	less than or equal to 0.025% Tretinoin for gels and lotions, and 0.05% Tretinoin for creams.

   They must be dispensed under the supervision of a
   licensed
   pharmacist;

3. PRESCRIPTION DRUGS – for preparations containing combinations of:

(a)	more than four percent (4%) but less than five percent (5%) Hydroquinone, and
(b)	more than 0.025% Tretinoin for gels and lotions, and 0.05% Tretinoin for creams.

They must be dispensed only by licensed pharmacists of
registered
drug outlets upon the presentation of proper prescription.

Appropriate labeling as to their proper use, and adequate warnings as to
their possible local or systematic adverse effects or reactions, must
be clearly indicated for all approved products with Hydroquinone,
Tretinoin (Retinoic Acid), or any combinations thereof.

All other administrative issuances or parts thereof, inconsistent with
the provisions of this Order are hereby amended, modified, repealed
and/or revoked accordingly.

This Order shall take effect fifteen (15) days after its publication in
at least two (2) newspapers of general circulation.

Adopted: 18 September 2003

(SGD.) MANUEL M. DAYRIT, M.D., MSc.

Secretary of Health