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    Regulations Overview - Rx to OTC
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    Regulations Overview - Rx to OTC

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    Regulatory Overview - Rx to OTC Switch
    Philippines

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    Version Number
    Content Creation Date
    		Publishing DateSection(s) Updated & Reason(s) for Update
    V0
    15 December 2023
    		29 February 2024N/A (new report)
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    1. Product Classifications in the Philippines

    According to Administrative Order No. 2023 [1], medicines may be classified according to one of the following categories:

    Category

    Definition

    Prescription Drugs

     

    Drug products that can only be dispensed by a pharmacist to a patient, upon presentation of a valid prescription from a physician, dentist, or veterinarian and for which a pharmacist's advice is necessary. 

     

    A product shall be classified as a prescription drug if: 

    1. It is likely to present a risk either directly or indirectly, even when used correctly if utilized without medical supervision, or
    2. It is frequently used incorrectly, likely to present a direct or indirect risk to human health; or
    3. It contains substances or preparations thereof, the activity and/or adverse reactions of which require further investigation or additional monitoring; or
    4. The product is prescribed for parenteral administration. 

    Prescription Drugs with special requirements

     

    1. Dangerous drug preparation requiring an S2 license and dangerous drugs board prescription as listed in the latest version of the List of Scheduled Controlled Substances released by DDB. 
    2. Advanced therapy Drug Products (ATTMPs) for implantation, transplantation, infusion or transfer into human recipients to be performed only in hospitals and non-hospital-based stem cell facilities that are licensed by the DOH.
    3. Radiopharmaceuticals refer to a chemical compound labeled with radioisotopes and administered to patients for diagnosis and/or therapy. Only Authorized Nuclear Pharmacists are allowed to prepare and dispense radiopharmaceuticals. 

    Pharmacist Only Non-Prescription drugs

     

    Drug products can be dispensed even without the prescription of a licensed physician, or dentist, for symptomatic relief of minor or self-limiting ailments; and to be obtained from a Licensed pharmacist, with mandatory pharmacist’s advice on its selection and proper use. These drugs shall only be sold in FDA-licensed drug outlets under the direct supervision of a registered and licensed pharmacist. 


    A drug shall be classified as a pharmacist-only prescription drug if: 

    1. Consultation with a pharmacist is necessary to confirm the appropriate choice of therapy;
    2. The contraindications, drug interactions, precautions, or warnings need reinforcement by a pharmacist or are not easily recognized by the patient;
    3. Special precautions are needed in the storage and handling of the product; or
    4. It does not conform to any of the conditions for a prescription drug product.

    General Sales List Drugs 

     

    Non-prescription drug products which may be dispensed without a prescription and only be sold by retail, offered, or exposed for sale either at licensed drugstores or retail outlets for non-prescription drugs. 


    A product shall be classified as general sales non-prescription drugs if

    1. The product is reasonably safe and can be sold or supplied without the need for supervision by a registered physician, dentist, or pharmacist. 
    2. The contraindications, drug interactions, precautions, and warnings are easily recognized by the patient; and 
    3. The hazard to health, the risk of misuse, the risk of misdiagnosis, and the need to take special precautions in the storage and handling of the product are minimal. 
    4. It does not conform with any of the conditions for a prescription drug product and pharmacist-only non-prescription drug product. 

    The FDA shall provide and publish an updated list of drug molecules with corresponding market access classifications. Products with drug substances not yet included on the list shall be assigned with market access classification prior to issuance of a Certificate of Product Registration. 

    The sponsor may request for reclassification of a drug product from the prescription drugs list to the pharmacist-only non-prescription drugs list or from the pharmacist-only non-prescription drugs list to the general sales non-prescription drug list by applying for a Post Approval Change. 

    No prescription drug is allowed to be directly switched to a general sales non-prescription drug. The FDA has the right to reclassify a drug product without requests from the MAH.

    2. Process to Switch from Rx to OTC in the Philippines

    The process for applying to be considered as an OTC product is described in Administrative Order No. 23-C s. 2000 [2]. 

    In order for a drug product to be classified as an OTC medicine, it must meet the following criteria: 

    1. The drug product is time-tested and has undergone thorough investigation and extensive clinical use. 
    2. The drug product is recognized to contain active ingredient(s) with proven safety and efficacy (wide margin of safety and high therapeutic index) even without professional supervision as proven by adverse drug reactions (ADR) monitoring; and 
    3. The drug is neither with bioequivalence problem (List B) nor classified as prohibited or regulated by the Dangerous Drugs Board (List A) or as an internationally controlled drug product by the International Narcotics Control Board (INCB)

    The manufacturer or importer must provide documents showing that: 

    1. Under recommended conditions of use, the product is safe and effective. 
    2. The concentrations of the active ingredient(s) have been found to be clinically safe and effective and do(es) not exceed the maximum limit approved by the Secretary of Health for symptomatic relief of minor or self-limiting ailments;
    3. The worldwide incidence of reported adverse drug reactions (ADRs) and interactions with the drug is low and clinically insignificant;
    4. The number of years the drug product has been released to the international market and the sale of the originally registered strength and form is at least twenty years and in the Philippine market for at least 10 years; and 
    5. The drug product, if imported is classified and marketed as an OTC or non-prescription drug in the country of origin and marketed in at least two of the following countries; Canada, United Kingdom, United States of America, Japan, Australia, and Sweden. 

    In order to obtain reclassification as an OTC product, the sponsor or manufacturer must submit an application containing the above for evaluation. 

    Upon approval, the applicant shall then proceed to comply with the current standards and reclassification as an OTC medicine. A. Certificate of Product Registration as an OTC product shall then be issued. 

    It should be noted that pharmaceutically equivalent drug products may be similarly classified as OTC products.

    Conclusion
    Based on the review conducted of the drug classification regulations in the Philippines, it has been confirmed that medicines may be supplied without a prescription if they are classed as Pharmacist Only Non-Prescription drugs.

    3. References

    1. Administrative Order No. 2023

    https://www.fda.gov.ph/wp-content/uploads/2023/07/Draft-AO-as-of-2023-07-05.pdf


    2. Administrative Order No. 23-C-s. 2000. 

    https://www.fda.gov.ph/wp-content/uploads/2021/04/Administrative-Order-No.-23-C-s.-2000.pdf


    3. Philippines FDA Website

    https://www.fda.gov.ph/


    4. FDA Verification Portal

    https://verification.fda.gov.ph/Home.php


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