Question & AnswerQ&A (BFAD BUREAU CIRCULAR NO. 04, S. 2000)
It provides the classification of preparations containing hydroquinone and/or tretinoin (retinoic acid) and the type of establishment where they may be sold.
Hydroquinone with concentration less than or equal to 2.0% is classified as a Household Remedy.
They may be sold in any establishment but must be placed in a segregated area.
It is classified as an Over-the-Counter (OTC) Drug.
No, OTC drugs with more than 2.0% but less than 3.0% hydroquinone can be sold without a doctor's prescription.
Such preparations are classified as Prescription (Rx) Drugs requiring a doctor's prescription.
Tretinoin with concentration less than or equal to 0.025% is a Household Remedy.
Tretinoin with concentration more than 0.025% but less than or equal to 0.05% is classified as an OTC drug.
When its concentration is more than 0.05%, it requires a doctor's prescription.
Combination of hydroquinone (less than or equal to 2%) and tretinoin (less than or equal to 0.025%) is classified as a Household Remedy.
All Regional Food and Drug Regulation Officers are directed to strictly implement the provisions.
To ensure public health and safety by controlling accessibility and preventing misuse.
No, OTC and Prescription drugs must be sold only in drug outlets.
The text does not specify penalties, but strict enforcement is mandated to ensure public health and safety.
To ensure efficient and effective discharge of the Bureau's mandate in regulating these substances.