Title
Regulation on Hydroquinone and Tretinoin Use
Law
Bfad Administrative Order No. 13, S. 1999
Decision Date
Apr 6, 1999
Regulating the sale of Hydroquinone and Tretinoin, this order classifies products based on their concentration, allowing those with lower percentages to be sold as home remedies without pharmacist supervision, while imposing stricter controls and labeling requirements for higher concentrations.
A

Q&A (BFAD ADMINISTRATIVE ORDER NO. 13, S. 1999)

Hydroquinone preparations containing less than or equal to 2.0% are classified as home remedies and can be sold without the supervision of a pharmacist, provided proper labeling is adhered to.

These preparations are classified as over-the-counter (OTC) drugs.

They are considered prescription drugs and must have appropriate labeling regarding proper use and warnings of possible adverse effects.

They are classified as home remedies and can be sold without pharmacist supervision, given that proper labeling is observed.

They are classified as over-the-counter (OTC) drugs.

They are considered prescription drugs requiring proper labeling and warnings about possible adverse effects.

Combinations where Hydroquinone does not exceed 2% and Tretinoin does not exceed 0.025% are classified as home remedies and need not be dispensed under pharmacist supervision, provided proper labeling is followed.

Proper labeling as to the preparation's proper use and warnings of possible adverse effects must be indicated on preparations, especially those classified as prescription or OTC drugs.

It is promulgated in accordance with Republic Act No. 3720, known as the Foods, Drugs, Devices and Cosmetics Act, as amended.

It took effect fifteen (15) days after its publication in a newspaper of general circulation.


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