Question & AnswerQ&A (FDA Circular No. 2014-025)
The primary purpose is to update and streamline regulatory approaches in licensing drug establishments, provide faster public access to drug products, and promote transparency through the use of electronic transactions.
Applicants must submit a notarized application form, proof of business name registration, credentials of the pharmacist-in-charge and responsible pharmacy assistant, a Risk Management Plan, location plan with GPS coordinates, a picture of the establishment with signage, proof of payment, and a Self-Assessment Toolkit.
The application form must be signed by both the pharmacist-in-charge and the owner or authorized representative.
The pharmacist-in-charge must submit a valid PRC ID, certificate of attendance to an FDA licensing seminar, and if previously employed, a resignation letter from the previous employer.
The RMP outlines how the establishment will identify, characterize, prevent, or minimize risks related to drugs, including pharmacovigilance activities and interventions to manage such risks.
Activities requiring prior FDA approval include online ordering and delivery of drugs, sterile and complex non-sterile compounding, mobile pharmacy operations, and any other specified activities.
They are jointly responsible for ensuring drug safety, efficacy, quality, supervising operations, enforcing good pharmacy practices, proper dispensing, patient counseling, inventory monitoring, handling adverse drug reactions, cooperating in product recalls, and compliance with FDA regulations.
Yes, drugstores or pharmacies may continue their business operations provided they have already filed an application for the minor variation.
Variations include Major Variation (change of ownership, transfer of location, additional activity), Minor Variation a Prior Approval (expansion of establishment, change of business name, zonal change in address), and Minor Variation a Notification (change of pharmacist or pharmacy assistant, deletion of activity).
LGUs are enjoined to monitor licensed drugstores/pharmacies within their localities for compliance with laws and regulations and report violations inconsistent with FDA rules for regulatory action.