Reclassification of Hydroquinone and Tretinoin Use

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DOH ADMINISTRATIVE ORDER NO. 90, SERIES OF 2003: Reclassification of Hydroquinone and Tretinoin Use

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Title Supreme Court: Reclassification of Hydroquinone and Tretinoin Use

Law: Doh Administrative Order No. 90, Series Of 2003

Decision Date: Sep 18, 2003

DOH Administrative Order No. 2003-0090 reclassifies and revises the use of Hydroquinone and Tretinoin preparations, setting guidelines for their dispensing and labeling based on concentration levels, in accordance with Republic Act No. 3720.

reclassification

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Reclassification of Tretinoin (Retinoic Acid) Preparations

Classification depends on concentration and formulation:
- Household Remedies: 0.025% for gels and lotions, 0.05% for creams, no pharmacist supervision needed.
- Prescription Drugs: Above these limits, dispensed only upon prescription by licensed pharmacists.

Reclassification of Combined Hydroquinone and Tretinoin Preparations

Classification based on combined concentrations:
- Household Remedies: 2% Hydroquinone and 0.025% Tretinoin (gels, lotions) or 0.05% (creams), no pharmacist supervision needed.
- Over-the-Counter Drugs: >2% to 4% Hydroquinone and within tretinoin limits, dispensed under pharmacist supervision.
- Prescription Drugs: >4% to <5% Hydroquinone and above tretinoin limits, dispensed only upon prescription.

Labeling and Warnings

All approved products with Hydroquinone, Tretinoin, or combinations must:
- Bear clear labeling on proper use.
- Include adequate warnings regarding potential local or systemic adverse effects.

Legal and Implementation Provisions

Inconsistent prior administrative issuances are amended or revoked.
Effective fifteen (15) days after publication in two newspapers of general circulation.

This comprehensive approach ensures consumer safety through regulation based on concentration, controls dispensing modes, and mandates proper labeling and warnings to mitigate risks associated with Hydroquinone and Tretinoin preparations.

END