Policies on Over the Counter Drugs

Section 26 of Republic Act No. 3720, as amended authorizes the promulgation of policies and guidelines to govern the registration and classification of drugs and medicines in the market.
The Secretary of Health—through the Director of the Bureau of Food and Drugs (BFAD)—retains authority over OTC classification approval and withdrawal.
The BFAD Director evaluates and, upon recommendation, approves the classification of a drug product as an OTC drug product.
The Technical Advisory Committee of BFAD evaluates the application and provides a corresponding recommendation to the Director.

The Order establishes policies and guidelines on over the counter (OTC) drug products to govern their registration and classification for market use.
OTC drugs are defined as drug products that can be dispensed without the written order or prescription of a licensed physician or dentist for human use.
OTC drugs are limited to symptomatic relief of minor or self-limiting ailments.
OTC drugs must be sold only in BFAD licensed drug outlets under the direct supervision of a registered and licensed pharmacist.
The classification system requires a drug product to meet OTC criteria and requires BFAD action before an OTC Certificate of Product Registration is issued.

Over the Counter (OTC) drugs are drug products dispensed without a written physician or dentist prescription for human use.
OTC drugs are for symptomatic relief of minor or self-limiting ailments.
OTC drug products must be sold only in BFAD licensed drug outlets.
OTC drug products must be sold under the direct supervision of a registered and licensed pharmacist.

A drug product is classified as an OTC drug only if it meets the general criteria below.
The drug product must be time-tested and have undergone thorough investigation and extensive clinical use.
The drug product must contain active ingredient(s) with proven safety and efficacy, supported by a wide margin of safety and high therapeutic index, and must be safe even without professional supervision as proven by adverse drug reaction (ADR) monitoring.
The drug product must not have a bioequivalence problem (List B).
The drug product must not be prohibited or regulated by the Dangerous Drugs Board (List A).
The drug product must not be an internationally controlled drug product by the International Narcotics Control Board (INCB).

To determine conformity with the general criteria, the manufacturer or importer must submit documents demonstrating the following:
Under recommended conditions of use, the product is safe and effective.
The concentration(s) of the active ingredient(s) are clinically safe and effective and do not exceed the maximum limit approved by the Secretary of Health for symptomatic relief of minor or self-limiting ailments.
The worldwide incidence of reported adverse drug reactions (ADRs) and interactions is low and clinically insignificant.
The drug product has been released in the international market for at least twenty (20) years and the sale of the originally registered strength and form has been in the Philippine market for at least ten (10) years.
If imported, the drug product is classified and marketed as an OTC or non-prescription drug in the country of origin and is marketed in at least two (2) of these countries: Canada, United Kingdom, United States of America, Japan, Australia, and Sweden.

The manufacturer or trader or importer must file an application with BFAD for classification of the drug product as an OTC drug.
The Director refers the application to the Technical Advisory Committee of BFAD for evaluation and corresponding recommendation.
After the BFAD Director approves the classification as OTC, the applicant must comply with the current standards and requirements for reclassification of pharmaceutical products as OTC.
A Certificate of Product Registration as an OTC drug product is issued after BFAD determines the product’s compliance with the standards and requirements for registration.
Pharmaceutically equivalent drug products must be similarly classified as OTC or prescription drug, as the case may be.

The Secretary of Health, through the Director of BFAD, may retain authority to recall and withdraw approval of OTC classification of a drug product when:
- documented and verified adverse reactions endanger public health and safety; and
- the drug product has been reclassified as an internationally controlled drug product by the INCB, following due notice to the registered drug manufacturer, trader, or importer.

All Administrative Orders, Rules and Regulations, and other administrative issuances or parts thereof, inconsistent with the provisions of Administrative Order No. 23-C, s. 2000 are repealed and modified accordingly.