Regulation on Hydroquinone and Tretinoin Use

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BFAD ADMINISTRATIVE ORDER NO. 13, S. 1999: Regulation on Hydroquinone and Tretinoin Use

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Title Supreme Court: 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.

administrative order

A

Classification of Preparations Containing Tretinoin (Retinoic Acid)

Preparations with ≤ 0.025% Tretinoin are classified as home remedies.
These may be sold without pharmacist supervision, provided proper usage labeling is present.
Preparations with > 0.025% but ≤ 0.05% Tretinoin are classified as OTC drugs.
Preparations with > 0.05% Tretinoin are prescription drugs.
Prescription drugs require labeling indicating proper use and warnings about possible adverse effects.

Classification of Combinations of Hydroquinone and Tretinoin

Combinations are classified as home remedies if each active component does not exceed 2% Hydroquinone and 0.025% Tretinoin.
Such combinations do not require pharmacist supervision.
Proper labeling on usage must be adhered to.

Regulatory Compliance and Amendments

All other administrative issuances or parts inconsistent with this Order are amended, repealed, or modified as appropriate.

Effectivity of the Order

This Order takes effect 15 days after its publication in a newspaper of general circulation.

Legal Authority

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

Labeling Requirements

Proper labeling is essential for all classifications to inform users of correct usage.
Prescription products must explicitly warn about possible adverse effects.

Pharmacist Supervision

Home remedies can be sold without pharmacist supervision.
OTC and prescription drugs entail different levels of control, with prescription drugs requiring dispensing only under supervision.

Penalties and Enforcement

Though not explicitly stated in the Order itself, compliance with classification and labeling is implied as mandatory under the governing statute.

END