BFAD BUREAU CIRCULAR NO. 04, S. 2000, June 14, 2000

[ BFAD BUREAU CIRCULAR NO. 04, S. 2000, June 14, 2000 ]

IMPLEMENTATION OF ADMINISTRATIVE ORDER NO. 13, S. 1999, “USE OF HYDROQUINONE AND/OR TRETINOIN (RETINOIC ACID)

Administrative Order No. 13, s. 1999 [*] , 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