Question & AnswerQ&A (FDA Circular No. 2014-028)
The main purpose of FDA Circular No. 2014-028 is to provide guidelines on the implementation of new rules and regulations on the licensing of retail outlets for non-prescription drugs (RONPDs) following Administrative Order No. 2014-0034 to update regulatory approaches, provide faster access to drug products, and promote transparency through electronic transactions.
The documentary requirements include: 1) A completely filled-out and notarized application form signed by the pharmacist and owner/authorized representative; 2) Proof of Business Name Registration; 3) Credentials of the Supervising Pharmacist; 4) A general Risk Management Plan (RMP); 5) Location Plan with GPS coordinates; 6) Picture of the drugstore with signage; 7) Proof of Payment; 8) Self-Assessment Toolkit (SATK).
A single pharmacist can supervise multiple RONPDs provided they dedicate at least two hours per week at each establishment, all establishments are within the same provincial local government unit, the distance between the farthest RONPDs does not exceed 25 km, the establishments are within a circumferential area, and the pharmacist supervises a maximum of 15 RONPDs.
The supervising pharmacist must ensure observance of Good Storage Distribution, Good Dispensing, and Good Pharmacy Practices; monitor product inventory including expiry dates; handle, document, and report adverse drug reactions/events to FDA; keep the establishment updated with FDA advisories; ensure all drugs sold are FDA-registered; and ensure compliance with regulations, documented in a Standard Operating Procedure.
Variations are classified as major and minor. Major variations include change of ownership and transfer of location. Minor variations requiring prior approval include expansion of establishment, change of business name, and zonal change in address. Minor variations by notification include change of supervising pharmacist.
The FDA must be informed of any changes to the approved LTO, regardless of whether they fall under classified variations. Failure to do so may subject the RONPD or pharmacist to legal actions.
Documents include agreements between franchisor and franchisee, records (distribution, senior citizen/persons with disability records, supervising pharmacist schedule, location plans), Standard Operating Procedures, display of information/education materials, and relevant reference materials such as Republic Acts and WHO GDP and GSP guides.
LGUs are tasked to monitor the licensed drug RONPDs in their localities for compliance with existing laws and regulations. Any violation inconsistent with FDA rules should be reported to the FDA for regulatory action.
Only selected registered non-prescription drugs such as household remedies, selected traditional medicines, herbal and other over-the-counter drugs allowed based on current evidence of safety and efficacy can be sold. The official list is posted and regularly updated on the FDA website.
RONPDs or pharmacists that violate the rules on supervision, such as exceeding the number of supervised drugstores or breach of procedural requirements, are subject to appropriate legal actions as determined by the FDA.