Classification and Regulation of Tretinoin (Retinoic Acid) Preparations
- Tretinoin preparations are classified according to their concentration levels.
- Concentrations less than or equal to 0.025% are classified as Household Remedies.
- Concentrations more than 0.025% but less than or equal to 0.05% are classified as OTC Drugs.
- Concentrations above 0.05% are classified as Prescription (Rx) Drugs.
Classification of Combination Preparations
- Preparations combining Hydroquinone (≤ 2%) and Tretinoin (≤ 0.025%) are classified as Household Remedies.
Dispensing and Outlet Restrictions
- Household Remedies can be sold in any type of establishment but must be placed in a segregated area.
- OTC Drugs containing Hydroquinone or Tretinoin must be sold in drug outlets only; no doctor’s prescription required.
- Prescription Drugs require dispensing through drug outlets and the presentation of a doctor’s prescription.
Implementation and Enforcement
- Regional Food and Drug Regulation Officers are mandated to strictly enforce these classifications and dispensing regulations.
- The directive emphasizes public health and safety as the foundation of these regulations.
- The Bureau expects full cooperation from all concerned parties to ensure effective enforcement.
Administrative and Legal Authority
- The provisions are encapsulated in Administrative Order No. 13, s. 1999, implemented pursuant to Bureau Circular No. 04, s. 2000.
- Issued by the Bureau of Food and Drugs to regulate the use of Hydroquinone and Tretinoin in various preparations.
- Effective as of June 14, 2000, under the authority of the BFAD Director.