Question & AnswerQ&A (BFAD ADMINISTRATIVE ORDER NO. 23-C, S. 2000)
OTC drugs are drug products that can be dispensed without the written order or prescription of a licensed physician or dentist for human use, for the symptomatic relief of minor or self-limiting ailments, and are sold only in BFAD licensed drug outlets under the direct supervision of a registered and licensed pharmacist.
A drug must be time-tested with thorough investigation and extensive clinical use; contain active ingredients with proven safety and efficacy without professional supervision; and must not have bioequivalence problems nor be classified as prohibited or regulated by the Dangerous Drugs Board or controlled by the INCB.
They must submit documents showing the product is safe and effective under recommended use, active ingredient concentrations are clinically safe and do not exceed approved limits, ADR incidence is low and insignificant, years of international and Philippine market presence, and classification as OTC in the country of origin and at least two designated countries.
The drug product must have been sold internationally for at least 20 years and in the Philippine market for at least 10 years.
Canada, United Kingdom, United States of America, Japan, Australia, and Sweden.
Application is filed with BFAD, referred to the Technical Advisory Committee for evaluation, upon approval the applicant complies with standards for reclassification, a Certificate of Product Registration is issued, and pharmaceutically equivalent products are similarly classified.
The Secretary of Health through the Director of the Bureau of Food and Drugs.
If there are documented and verified adverse reactions endangering public health and safety or if the drug is reclassified as an internationally controlled drug product by the INCB after due notice.
It repeals or modifies all prior Administrative Orders, Rules, Regulations, or issuances inconsistent with the provisions of this Administrative Order.
It took effect fifteen (15) days after its publication in two newspapers of general circulation following its adoption on March 3, 2000.