Title
FDA Rules on Drugstore Licensing
Law
Fda Circular No. 2014-025
Decision Date
Nov 21, 2014
The FDA Circular No. 2014-025 establishes updated guidelines for the licensing of drugstores and pharmacies, streamlining application processes, enhancing transparency through electronic transactions, and outlining compliance requirements for safety and quality in drug distribution.
licensing
drugstore
pharmacy

Legal basis and covered establishments

  • The Circular is issued to implement Administrative Order No. 2014-0034 dated 13 October 2014, which updates and streamlines licensing approaches for drug establishments.
  • The Circular prescribes requirements for initial and renewal License to Operate (LTO) applications, variation applications, and other guidelines for drugstore/pharmacy/botica and similar outlets, including hospital and institutional pharmacies.
  • The FDA evaluates compliance with administrative and technical requirements for licensing applications through its Regional Field Offices.
  • The FDA may require additional or supplemental documents during evaluation to prove compliance with existing regulations.
  • The Circular recognizes regulatory oversight consistent with the FDA’s regulatory powers under Republic Act No. 9711 and its implementing rules.

Policy rationale and implementation intent

  • Administrative Order 2014-0034 dated 13 October 2014 is implemented to update and streamline regulatory approaches in licensing of drug establishments.
  • Administrative Order 2014-0034 dated 13 October 2014 is implemented to provide faster access of drug products to the public.
  • Administrative Order 2014-0034 dated 13 October 2014 is implemented to promote transparency through the universal use of electronic transaction.
  • The Circular prescribes guidelines that support those objectives for licensing, variations, inspections, and post-licensing compliance.

Core definitions and key concepts

  • A Risk Management Plan (RMP) is a general plan submitted by the establishment describing how risks related to the products it engages with will be identified, characterized, prevented, or minimized, including pharmacovigilance activities and interventions.
  • Good Distribution and Storage Practices (GDP and GSP) govern compliance for drugstore/pharmacy/botica and similar outlets.
  • Good Pharmacy Practices govern compliance for safe and proper pharmacy operations.
  • Good Dispensing governs dispensing requirements in the establishment.
  • Major variation and minor variation categories classify changes to an approved LTO.

License to Operate (LTO) applications

  • An application for LTO must be completely filled out and notarized, and must be signed by the pharmacist and the owner/authorized representative.
  • The establishment must submit proof of business name registration specifying the exact and complete address, including unit number, floor, building, lot, block, phase, street, barangay, city/municipality, and province, where applicable.
  • The proof of business name registration must be in the form required by the establishment’s juridical type:
    • For single proprietorship: Certificate of Business Registration from DTI.
    • For corporation, partnership and other juridical person: Certificate of Registration from SEC and Articles of Incorporation.
    • For cooperative: Certificate of Registration from the Cooperative Development Authority and approved by-laws.
    • For government-owned or controlled corporation: proof of registration supported by the law creating the establishment.
  • The establishment must submit credentials for the pharmacist-in-charge, including:
    • Valid PRC ID
    • Certificate of Attendance to an appropriate FDA Licensing Seminar
    • Resignation letter of the pharmacist from previous employer (if previously employed)
  • If the establishment employs a pharmacy assistant(s), it must identify the responsible pharmacy assistant who will take charge in the absence of the pharmacist-in-charge, and must submit the responsible pharmacy assistant’s credential as a Certificate of Training for Pharmacy Assistants.

Documentary requirements, evaluation, and inspection

  • The establishment must submit a general Risk Management Plan (RMP) describing how risks will be managed, including pharmacovigilance activities and interventions.
  • The establishment must submit a location plan consisting of a sketch for inspection purposes indicating clear directions and identified landmarks to locate the establishment.
  • The establishment must include GPS Coordinates in decimal degrees (DD) [Latitude and Longitude] in its location plan submission.
  • The establishment must submit a picture of the drugstore with signage showing the name of the establishment consistent with its submitted business name proof.
  • The establishment must include proof of payment (e.g., official receipt or authorized bank payment slip) as proof of filing.
  • The establishment must submit a Self-Assessment Toolkit (SATK) to guide submission and serve as the worksheet during FDA evaluation.
  • All applications are initially reviewed by the respective FDA Regional Field Offices to determine compliance with administrative and technical requirements.
  • During evaluation, the FDA may require additional or supplemental documents proving compliance.
  • Drugstore/pharmacy/botica and similar outlets with an approved LTO are subject to routine inspection for compliance with GDP and GSP and other applicable practices.
  • Major variation applications may require post-licensing inspection prior to approval of the variation.
  • Inspections also occur when the establishment is subject to regulatory action triggered by matters such as violations of FDA laws/rules/regulations, adverse drug reactions, and other quality/safety/efficacy issues.
  • During inspection (in addition to documentary requirements), the FDA verifies:
    • Agreement between franchisor and franchisee, where applicable
    • Records/e-file (e.g., distribution records, prescription books, senior citizen and persons with disability record books)
    • Standard Operating Procedures
    • Display of information/education/communication materials
    • Relevant reference materials (e.g., Republic Acts, WHO GDP and GSP Guide, Philippine National Drug Formulary, standard practice guidelines, pharmacovigilance-related references)
  • The FDA issues a report after inspection that serves as the basis for decisions/actions such as approval or disapproval of applications for LTO or other actions.
  • Cold-chain compliance is required for drugstore/pharmacy/botica and similar outlets carrying vaccines, biologics, and other temperature-sensitive products.

LTO variations and required prior approvals

  • The Circular classifies LTO changes into major variation, minor variation requiring prior approval, and minor variation requiring notification.
  • Major variation includes:
    • Change of Ownership
    • Transfer of Location
    • Additional Activity
  • Minor variation—prior approval includes:
    • Expansion of Establishment
    • Change of Business Name
    • Zonal Change in Address
  • Minor variation—notification includes:
    • Change of the Pharmacist or Pharmacy Assistant
    • Deletion of Activity
  • The establishment must inform the FDA of any changes to the approved LTO, whether or not the changes fall within the listed variation categories.
  • Other changes may be added to the variation classifications through appropriate regulation.
  • All variations are subject to the existing variation/amendment fee.
  • A transfer of location variation is subject to initial payment for two (2) years validity of LTO.
  • Drugstore/pharmacy/botica and similar outlets applying for minor variations may continue business operations if an application for that minor variation has already been filed.

Activities requiring prior FDA approval

  • The following activities require FDA application and prior approval:
    • Online ordering and delivery
    • Sterile compounding as well as non-sterile complex compounding, as defined under the United States Pharmacopeia, latest edition
    • Mobile pharmacy
    • Any other activities
  • The authorization for these activities must be secured during initial application or filed as a variation application.

Institutional pharmacies requiring LTO

  • Institutional pharmacies must secure an LTO when they meet these criteria:
    • They are non-drug establishments that regularly procure drugs to be dispensed to their employees.
    • They are drug establishments that procure drugs other than those registered to their names to be dispensed, whether at a cost or as part of employee benefits and/or for its dependents.

Responsibilities of pharmacists and owners

  • The pharmacist and the owner must jointly ensure the safety, efficacy, and quality of drug products.
  • The pharmacist and owner are responsible for:
    • Monitoring/supervision of all establishment operations
    • Observing Good Storage, Good Distribution, Good Dispensing, and Good Pharmacy Practices
    • Promoting rational use of drugs and ensuring that prescription drugs are dispensed only to patients with a written order or prescription from a licensed physician or dentist
    • Ensuring patient counseling is conducted to the extent possible
    • Monitoring inventory of products, including expiry dates
    • Ensuring adverse drug reactions/events experienced by patients/consumers are properly handled, documented, and reported to the FDA
    • Initiating removal of drug products from shelves and cooperating with market authorization holders if FDA orders a product recall
    • Ensuring the establishment is updated with the latest FDA issuances and advisories
    • Ensuring all drug products offered for sale/made available are registered with the FDA and purchased from licensed establishments
    • Ensuring the establishment complies with existing regulations
  • These responsibilities must be translated into a Standard Operating Procedure (SOP) validated during post-licensing inspection.

Implementation roles of FDA offices and LGUs

  • The FDA and its Regional Field Offices, through the Director General, may call on assistance of any department office and/or government agency for effective implementation consistent with regulatory powers under Republic Act No. 9711 and its implementing rules.
  • Local Government Units (LGUs) are enjoined to monitor licensed drugstore/pharmacy/botica and similar outlets in their localities for compliance with existing laws and local rules and regulations.
  • Any violation found by an LGU inconsistent with FDA rules and regulations must be reported to the FDA for regulatory action.

Transitory provisions and renewal requirements

  • Existing licensed establishments must submit upon renewal of their LTO:
    • Their Risk Management Plan
    • Their GPS Coordinates
    • Their credentials of their pharmacist and responsible pharmacy assistants

Repeal and separability; electronic access

  • Provisions of previous FDA circulars and memoranda inconsistent with the Circular are withdrawn, repealed, and/or revoked accordingly.
  • If any part, term, or provision is declared contrary to law or unconstitutional, the other provisions remain in force and effect.
  • All electronic fillable forms must be accessible at the FDA Website.

Annexes on documentary requirements and supplements

  • Documentary requirements for initial and renewal LTO, reissuance of lost or destroyed LTO, and voluntary cancellation are set out in Annex A.
  • Documentary requirements for variations are set out in Annex B.

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