QuestionsQuestions (FDA Circular No. 2014-025)
To update and streamline licensing of drug establishments, provide faster access of drug products to the public, and promote transparency through universal use of electronic transaction, consistent with Administrative Order No. 2014-0034.
Among others: (1) completely filled-out and notarized application form signed by the pharmacist and owner/authorized representative; (2) proof of business name registration (DTI/SEC/Coop Dev Authority/governing law); (3) credentials of pharmacist-in-charge (PRC ID, certificate of attendance to appropriate FDA seminar, and resignation letter if previously employed); (4) risk management plan (RMP); (5) location plan with sketch and GPS coordinates; (6) picture of drugstore with signage; (7) proof of payment; and (8) self-assessment toolkit (SATK).
Single proprietorship: DTI Certificate of Business Registration; corporation/partnership/other juridical person: SEC Certificate of Registration and Articles of Incorporation; cooperative: CDA Certificate of Registration and approved by-laws; government-owned/controlled corporation: law/provision creating the establishment.
Valid PRC ID; Certificate of Attendance to the appropriate FDA licensing seminar; and a resignation letter of the pharmacist from previous employer if previously employed.
The responsible pharmacy assistant must be identified and must submit the Certificate of Training for Pharmacy Assistants.
A general RMP for the establishment describing how it will identify, characterize, prevent or minimize risks related to the products it engages with, including pharmacovigilance activities and interventions to manage risks.
A sketch indicating clear directions with identified landmarks for locating the establishment, and GPS coordinates in decimal degrees (latitude and longitude).
Examples include: franchisor-franchisee agreement (where applicable); records/e-file such as distribution records and prescription books plus senior citizen and PWD record books; Standard Operating Procedures (SOPs); display of information/IEC materials; and relevant reference materials (including RA provisions, WHO GDP/GSP guide, Philippine National Drug Formulary, and pharmacovigilance-related references).
All approved establishments shall be subject to routine inspection for compliance with GDP and GSP and other applicable practices; further, major variations may require post-licensing inspection prior to approval, and inspections may be triggered by violations or quality/safety/efficacy issues.
Because drugstore/pharmacy/botica and similar outlets carrying vaccines, biologics, and other temperature-sensitive products must comply with cold-chain management.
Major Variation includes: change of ownership, transfer of location, and additional activity. Minor Variation with prior approval includes: expansion of establishment, change of business name, and zonal change in address. Minor Variation with notification includes: change of pharmacist or pharmacy assistant, and deletion of activity.
Yes. Drugstore/pharmacy/botica and similar outlets applying for minor variations may continue business operations provided that the application for such variation has already been filed.
All variations are subject to the existing variation/amendment fee, except transfer of location, which is subject to initial payment for two (2) years validity of LTO.
Online ordering and delivery; sterile compounding and non-sterile complex compounding (as defined by the latest USP edition); mobile pharmacy; and any other activities (as may be required to secure authorization).
Institutional pharmacies required to secure LTO are those that: (1) are non-drug establishments that regularly procure drugs to be dispensed to employees; or (2) drug establishments procuring drugs other than those registered to their names to be dispensed whether at a cost or as employee benefits and/or for dependents.
Examples: monitor/supervise all operations; observe Good Storage/Good Distribution/Good Dispensing and Good Pharmacy Practices; ensure rational use of drugs and dispense prescription drugs only with a written order/prescription from a licensed physician or dentist; ensure patient counseling to the extent possible; monitor inventory including expiry dates; handle/document/report adverse drug reactions/events to FDA; initiate removal of recalled products and cooperate with market authorization holders if recall is ordered; ensure establishment is updated with FDA issuances/advisories; ensure all products offered are registered with FDA and purchased from licensed establishments; and ensure compliance with existing regulations.
The responsibilities of the pharmacist and owner should be properly translated into a Standard Operating Procedure (SOP), which shall be duly validated during post-licensing inspection.
The FDA and Regional Field Offices may call on assistance of any department office and/or government agency for effective implementation. LGUs are enjoined to monitor licensed drugstore/pharmacy/botica and similar outlets for compliance with existing laws and their local rules; any LGU violation inconsistent with FDA rules shall be reported to FDA for regulatory action.
Existing licensed establishments must submit their Risk Management Plan, GPS coordinates, and credentials of their pharmacist and responsible pharmacy assistants upon renewal of their LTO.