Question & AnswerQ&A (DOH ADMINISTRATIVE ORDER NO. 90, SERIES OF 2003)
The reclassification and revision are based on the provisions of Republic Act No. 3720, as amended, known as the Food, Drugs, Devices and Cosmetics Act.
Preparations containing Hydroquinone are classified as Household Remedies (≤2%), Over-the-Counter Drugs (>2% to ≤4%), Prescription Drugs (>4% to <5%), and Not Registrable (≥5%).
They are classified as Over-the-Counter Drugs and must be dispensed under the supervision of a licensed pharmacist.
Such preparations are classified as Not-Registrable and are prohibited from being registered.
Tretinoin preparations are classified as Household Remedies if the concentration is ≤0.025% for gels and lotions, and ≤0.05% for creams; and as Prescription Drugs if above these concentrations.
They must be dispensed only by licensed pharmacists at registered drug outlets upon presentation of a proper prescription.
They are classified as Household Remedies if Hydroquinone ≤2% with Tretinoin ≤0.025% (gels/lotions) or ≤0.05% (creams); Over-the-Counter Drugs if Hydroquinone >2% to ≤4% with the same Tretinoin limits; and Prescription Drugs if Hydroquinone >4% to <5% with Tretinoin above these limits.
All approved products must have appropriate labeling indicating proper use and clear warnings about possible local or systemic adverse effects or reactions.
They are amended, modified, repealed, and/or revoked accordingly.
It takes effect fifteen (15) days after its publication in at least two newspapers of general circulation.