BFAD Bureau Circular No. 04 (2000)

(NAR) VOL. 11 NO.2 / APRIL – JUNE 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 Type of Outlet/ Classification Ingredient Restriction Less than or equal to 2.0% Household Any establishment; to Hyrdroquinone Remedy be placed in a segregated area More than 2.0% but less than3.0% Over-the- Drug outlets; without Hydroquinon Counter(OTC) need for Doctor’s Drug prescription More than 3.% Hydroquinone Prescription (Rx) Drug outlets; Requires Drug Doctor’s prescription Less than or equal to 0.025% Tretinoin Household Any establishment; to (Retinoic Acid) Remedy be placed in a segregated area More than 0.025% but less than or Over-the Drug outlets; without equal to 0.05% Tretinoin Counter(OTC) need for Doctor’s Drug prescription More than 0.05% Tretinoin Prescription (Rx) Drug outlets; Requires Drug Doctor’s prescription Combination of Hydroquinone(less Household Any establishment; to than or equal to 2%) and Tretinoin Remedy be placed in a (Less than or equal to 0.025%) 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