Reclassification of Hydroquinone and Tretinoin Use

The Order is issued in accordance with the provisions of Republic Act No. 3720, as amended, otherwise known as the Food, Drugs, Devices and Cosmetics Act.
The reclassification of Hydroquinone and Tretinoin preparations is anchored on the authority to regulate the use, dispensation, and controls over drugs and drug products under Republic Act No. 3720.

The Order rationalizes existing rules and regulations governing Hydroquinone and/or Tretinoin preparations.
The Order re-examines and reviews the rules in the light of recent clinical studies.
The Order also revises the rules in response to changing consumer preferences and practices.

The Order provides a classification framework that assigns drug products into these dispensing categories: Household Remedies, Over-the-Counter Drugs, Prescription Drugs, and Not-Registrable.
Household Remedies are dispensable without the supervision of a licensed pharmacist when the specified concentration and product type requirements are met.
Over-the-Counter Drugs must be dispensed under the supervision of a licensed pharmacist when the specified concentration and product type requirements are met.
Prescription Drugs must be dispensed only by licensed pharmacists of registered drug outlets upon the presentation of a proper prescription when the specified concentration and product type requirements are met.
Not-Registrable applies to Hydroquinone-only preparations at five percent (5%) or more, and these are prohibited from being registered.

All preparations containing Hydroquinone as the only active ingredient with specified concentrations are classified under the following thresholds:
Household Remedies apply when the preparation contains less than or equal to two percent (2%) Hydroquinone; such preparations can be dispensed without supervision of a licensed pharmacist.
Over-the-Counter Drugs apply when the preparation contains more than two percent (2%) but less than or equal to four percent (4%) Hydroquinone; such preparations must be dispensed under supervision of a licensed pharmacist.
Prescription Drugs apply when the preparation contains more than four percent (4%) but less than five percent (5%) Hydroquinone; such preparations must be dispensed only by licensed pharmacists of registered drug outlets upon presentation of a proper prescription.
Not-Registrable applies when the preparation contains five percent (5%) or more Hydroquinone; such preparations are not allowed and are prohibited from being registered.

All preparations containing Tretinoin (Retinoic Acid) as the only active ingredient with specified concentrations are classified as follows:
Household Remedies apply when the preparation contains less than or equal to 0.025% Tretinoin for gels and lotions, and 0.05% Tretinoin for creams; such preparations can be dispensed without supervision of a licensed pharmacist.
Prescription Drugs apply when the preparation contains more than 0.025% Tretinoin for gels and lotions, and 0.05% Tretinoin for creams; such preparations must be dispensed only by licensed pharmacists of registered drug outlets upon presentation of a proper prescription.

All preparations containing combinations of Hydroquinone and Tretinoin (Retinoic Acid) as active ingredients with specified concentrations are classified under the following thresholds:
Household Remedies apply when the combination contains:
- less than or equal to two percent (2%) Hydroquinone, and
- less than or equal to 0.025% Tretinoin for gels and lotions, and 0.05% Tretinoin for creams;
- such preparations can be dispensed without supervision of a licensed pharmacist.
Over-the-Counter Drugs apply when the combination contains:
- more than two percent (2%) but less than or equal to four percent (4%) Hydroquinone, and
- less than or equal to 0.025% Tretinoin for gels and lotions, and 0.05% Tretinoin for creams;
- such preparations must be dispensed under supervision of a licensed pharmacist.
Prescription Drugs apply when the combination contains:
- more than four percent (4%) but less than five percent (5%) Hydroquinone, and
- more than 0.025% Tretinoin for gels and lotions, and 0.05% Tretinoin for creams;
- such preparations must be dispensed only by licensed pharmacists of registered drug outlets upon presentation of a proper prescription.

All approved products with Hydroquinone, Tretinoin (Retinoic Acid), or any combinations thereof must have appropriate labeling showing their proper use.
All approved products with Hydroquinone, Tretinoin (Retinoic Acid), or any combinations thereof must include adequate warnings about their possible local or systematic adverse effects or reactions.
The labeling and warnings must be clearly indicated for all approved products covered by the Order.

All other administrative issuances or parts thereof that are inconsistent with the provisions of the Order are amended, modified, repealed, and/or revoked accordingly.
The Order implements its reclassification and dispensing controls through the concentration thresholds and dispensing categories stated for Hydroquinone-only, Tretinoin-only, and combination preparations.
The operative effect begins after fifteen (15) days from publication in at least two (2) newspapers of general circulation.