Philippines Drafts Unified Classification of Pharmaceutical Products Intended for Human Use

Manila, November 2025. The Philippine Food and Drug Administration (FDA) has released a draft Circular that standardizes how human medicines are classified and reclassified nationwide. The proposal replaces legacy “ethical/OTC” labels with a risk-based framework comprising prescription products and two non-prescription tiers: pharmacist-only and general-sales (which includes household remedies). The draft implements the FDA Act of 2009 and the Philippine Pharmacy Act and aligns with Department of Health Administrative Order 2024-0013 on registration rules.

Scope and policy basis

The Circular applies to all FDA-licensed pharmaceutical establishments handling medicines for human use. It links classification to product risk and intended patient access, and sets operational rules for both initial classification and subsequent reclassification.

The three access categories

a. Prescription pharmaceutical products

Assigned where medical supervision is necessary due to risks such as misuse or dependency, the need for additional safety monitoring, parenteral administration, or radiation-emitting characteristics. Dispensing requires a valid prescription and a licensed pharmacist.

b. Pharmacist-only non-prescription products

Covers medicines that do not meet prescription criteria but still require professional oversight. Supply is restricted to licensed retail pharmaceutical establishments under a pharmacist’s direct supervision.

c. General-sales non-prescription products (including household remedies)

Intended for self-selection when warnings are readily understood and the risk of misuse or misdiagnosis is minimal. A subset may be designated household remedies if they contain common actives used for minor ailments.

Classification at registration

Applications must indicate the correct class at submission; filings under the wrong class are not accepted because documentation differs. New actives not yet on FDA’s list are assigned a class during pre-assessment. Fixed-dose combinations are classified conservatively based on the most stringent active, and drug kits/combination packs follow the most stringent item they contain.

Reclassification rules

Movement to a less stringent class proceeds stepwise. FDA may up-classify without a company request where safety evidence warrants it, considering international classifications, post-marketing safety data, and the risk of inappropriate use without supervision. Following any reclassification, Market Authorization Holders must file a post-approval change (PAC) so labels and records reflect the new class; a new Certificate of Product Registration (CPR) is issued. Stockpiling in anticipation of changes is prohibited.

Active-ingredient master list

FDA will publish and update a list of active ingredients with their assigned classes. Where an active spans multiple classes, the applicable class is distinguished by dosage strength, dosage form, indication, and related criteria. Updates occur annually or when reclassification decisions are finalized.

Labelling, storage, and advertising

Pharmacist-only products must display “PHARMACIST-ONLY” prominently on the principal display panel. All non-prescription products require a Patient Information Leaflet (PIL); if no PIL is provided, equivalent information must appear on the inner panel of the outer carton when dispensed with such packaging.

Placement rules mirror access tiers: prescription and pharmacist-only medicines are stored out of direct public reach (e.g., behind the counter), while general-sales items are displayed in a segregated section. Only non-prescription medicines may be advertised to the public; prescription products are limited to professional channels.

Transition and enforcement

For products affected by reclassification, PAC submissions follow staged timelines, and a one-year manufacturing-level exhaustion period applies to labelling updates after approval. Stickering is permitted when moving to a more stringent class, subject to FDA approval. Non-compliance can result in disapproval, suspension or cancellation of registrations, findings of misbranding/adulteration, and penalties under the Consumer Act for stockpiling.