Legal basis: Administrative Order No. 13, s. 1999
- Administrative Order No. 13, s. 1999 provides classification of preparations containing hydroquinone and/or tretinoin (retinoic acid).
- Administrative Order No. 13, s. 1999 provides the type of establishment where such preparations may be sold.
- BFAD Bureau Circular No. 04, s. 2000 mandates strict implementation of the Administrative Order No. 13, s. 1999 provisions by regional officers.
Policy and public-health purpose
- The regulatory framework is imposed in the interest of public health and safety.
- The classification and dispensing restrictions are enforced to govern where preparations containing hydroquinone and/or tretinoin (retinoic acid) may be sold.
Core classification for hydroquinone
- Hydroquinone less than or equal to 2.0% is classified as a Household Remedy, and it may be sold in any establishment if it is placed in a segregated area.
- Hydroquinone more than 2.0% but less than 3.0% is classified as an Over-the-Counter (OTC) Drug, and it may be sold in drug outlets without need for Doctor’s prescription.
- Hydroquinone more than 3.0% is classified as a Prescription (Rx) Drug, and it may be sold in drug outlets requiring Doctor’s prescription.
Core classification for tretinoin (retinoic acid)
- Tretinoin (Retinoic Acid) less than or equal to 0.025% is classified as a Household Remedy, and it may be sold in any establishment if it is placed in a segregated area.
- Tretinoin (Retinoic Acid) more than 0.025% but less than or equal to 0.05% is classified as an Over-the-Counter (OTC) Drug, and it may be sold in drug outlets without need for Doctor’s prescription.
- Tretinoin (Retinoic Acid) more than 0.05% is classified as a Prescription (Rx) Drug, and it may be sold in drug outlets requiring Doctor’s prescription.
Classification for combined formulations
- A combination of Hydroquinone (less than or equal to 2%) and Tretinoin (less than or equal to 0.025%) is classified as a Household Remedy.
- The combined Hydroquinone + Tretinoin preparation may be sold in any establishment if it is placed in a segregated area.
- The combined classification is imposed in the interest of public health and safety.
Implementation directives and enforcement responsibility
- BFAD Bureau Circular No. 04, s. 2000 directs all Regional Food and Drug Regulation Officers to strictly implement the dispensing and outlet rules in Administrative Order No. 13, s. 1999.
- Regional officers are responsible for ensuring that the classification by concentration and the corresponding type of outlet are followed.
- The circular emphasizes that efficient and effective discharge of BFAD’s mandate depends on full cooperation and concern from implementing officers.