QuestionsQuestions (BFAD ADMINISTRATIVE ORDER NO. 23-C, S. 2000)
OTC drugs are drug products that can be dispensed even without a written order or prescription of a licensed physician or dentist, for the symptomatic relief of minor or self-limiting ailments.
OTC drugs shall be sold only in BFAD-licensed drug outlets under the direct supervision of a registered and licensed pharmacist.
It is pursuant to Section 26 of Republic Act No. 3720, as amended.
It must: (1) be time-tested with thorough investigation and extensive clinical use; (2) have active ingredients with proven safety and efficacy even without professional supervision, supported by ADR monitoring; and (3) not have bioequivalence problems (List B) and not be prohibited/regulated by the Dangerous Drugs Board (List A) or internationally controlled by INCB (as internationally controlled drug product).
Because OTC classification assumes safety for self-use without a physician’s prescription; therefore, drugs that are prohibited or heavily regulated/controlled (by DDB or INCB) are not meant to be sold over the counter.
They must submit: (1) proof of safety and effectiveness under recommended conditions of use; (2) that concentrations are clinically safe and effective and do not exceed the approved maximum limits for symptomatic relief of minor/self-limiting ailments; (3) worldwide incidence data showing ADRs and interactions are low and clinically insignificant; (4) years of international release (at least 20 years for originally registered strength/form) and at least 10 years in the Philippine market; and (5) if imported, certification that it is classified/marketed as OTC or non-prescription in the country of origin and marketed in at least two specified countries (Canada, UK, USA, Japan, Australia, Sweden).
The originally registered strength and form must have been released in at least 20 years internationally, and at least 10 years in the Philippine market.
It must be classified and marketed as OTC or non-prescription in the country of origin, and it must be marketed in at least two of: Canada, UK, USA, Japan, Australia, Sweden.
The Director refers the application to the Technical Advisory Committee of BFAD for evaluation and recommendation.
The applicant must comply with the current standards and requirements for reclassification of pharmaceutical products as OTC.
Pharmaceutically equivalent drug products shall be similarly classified as OTC or prescription drug, as the case may be.
The Secretary of Health retains authority to recall and withdraw the approval of the classification as OTC if there are documented and verified adverse reactions endangering public health and safety, or if the drug is reclassified as internationally controlled by INCB, after due notice to the manufacturer/trader/importer.
Recall/withdrawal can also be triggered if the drug is reclassified as internationally controlled by the INCB after due notice to the registered manufacturer, trader, or importer.
Due notice must be given to the registered drug manufacturer, trader, or importer.
It takes effect fifteen (15) days after its publication in two (2) newspapers of general circulation.
All administrative orders, rules and regulations, and other administrative issuances or parts inconsistent with the Order are repealed and modified accordingly.