IMPLEMENTATION OF ADMINISTRATIVE ORDER NO. 13, S. 1999, “USE OF HYDROQUINONE AND/OR TRETINOIN (RETINOIC ACID)
dated April 6, 1999 and with subject “Use of Hydroquinone and/or
Tretinoin (Retinoic Acid)”, provides the classification of preparations
containing hyrdoquinone and/or tretinoin and the type of establishment
where they may be sold. A summary of the provisions in the said A.O. is
presented in the table below:
|
Concentration of Active |
Dispensing Classification |
Type of Outlet/ Ingredient Restriction |
|
|
|
|
|
Less than or equal to 2.0% Hyrdroquinone |
Household Remedy |
Any establishment; to be placed in a segregated area |
|
More than 2.0% but less than3.0% Hydroquinon |
Over-the-Counter(OTC) Drug |
Drug outlets; without need for Doctor’s prescription |
|
More than 3.% Hydroquinone |
Prescription (Rx) Drug |
Drug outlets; Requires Doctor’s prescription |
|
Less than or equal to 0.025% Tretinoin (Retinoic Acid) |
Household Remedy |
Any establishment; to be placed in a segregated area |
|
More than 0.025% but less than or equal to 0.05% Tretinoin |
Over-the Counter(OTC) Drug |
Drug outlets; without need for Doctor’s prescription |
|
More than 0.05% Tretinoin |
Prescription (Rx) Drug |
Drug outlets; Requires Doctor’s prescription |
|
Combination of Hydroquinone(less than or equal to 2%) and Tretinoin (Less than or equal to 0.025%) |
Household Remedy |
Any establishment; to be placed in a segregated area |
In the interest of public health and safety, all Regional Food and
Drug Regulation Officers are hereby directed to strictly implement the
provisions of the above stated Order.
Your full cooperation and concern on this matter will ensure the efficient and effective discharge of the Bureau’s mandate.
Adopted: 14 June 2000
(SGD.) WILLIAM D. TORRES, Ph.D.
Director
[*] See NAR 10/2, page 366