Law Summary
License to Operate (LTO) Application Documentary Requirements
- Completed, notarized application form signed by pharmacist and owner/authorized representative
- Proof of Business Name Registration:
- Single proprietorship: DTI registration certificate
- Corporation/partnership: SEC registration and Articles of Incorporation
- Cooperative: Cooperative Development Authority certificate and by-laws
- Government-owned/controlled corporations: legal creation document
- Credentials of Pharmacist-in-Charge:
- Valid PRC ID
- Certificate of attendance at FDA licensing seminar
- Resignation letter from previous employer if applicable
- Pharmacy assistants' Certificate of Training if they act in pharmacist's absence
- Submission of a general Risk Management Plan outlining risk identification, prevention, and management including pharmacovigilance
- Location plan sketch with clear landmarks and GPS coordinates
- Photo of establishment with signage matching business name
- Proof of payment for application
- Self-Assessment Toolkit as compliance worksheet
Evaluation and Inspection Procedures
- Initial review by FDA Regional Field Offices for administrative and technical compliance
- Possible requirement of additional supporting documents
- Routine post-licensing inspections to ensure adherence to Good Distribution and Storage Practices
- Inspections triggered by violations, adverse drug events, or quality concerns
- Verification of additional documents such as franchise agreements, distribution records, SOPs, and IEC materials
- Compliance report issued after inspection to determine actions on LTO applications
- Cold-chain management required for temperature-sensitive products
Variations to License to Operate
- Major Variations:
- Change of ownership
- Transfer of establishment location
- Addition of new activities
- Minor Variations requiring prior approval:
- Establishment expansion
- Change of business name
- Address zonal changes
- Minor Variations requiring notification:
- Change of pharmacist or pharmacy assistant
- Deletion of an activity
- All variations require notification to FDA, additional types can be regulated
- Fees apply except for location transfer which pays initial 2-year license fee
- Minor variation applicants may continue business during application processing
Activities Requiring Prior FDA Approval
- Online ordering and delivery of drugs
- Sterile and non-sterile complex compounding
- Mobile pharmacies
- Other newly identified activities
- Authorization may be secured during initial or variation application
Licensing Requirements for Institutional Pharmacies
- Non-drug establishments that procure drugs for employee dispensing
- Drug establishments dispensing drugs not registered under their name
Responsibilities of Pharmacist and Owner
- Joint responsibility for drug safety, efficacy, and quality
- Ensure compliance with Good Storage, Distribution, Dispensing, and Pharmacy Practices
- Promote rational drug use; dispense prescription drugs only on valid prescriptions
- Provide patient counseling
- Monitor inventory and expiry dates
- Manage and report adverse drug reactions to FDA
- Cooperate during product recalls
- Keep abreast of FDA regulations and advisories
- Ensure only FDA-registered drugs from licensed suppliers are sold
- Develop and maintain Standard Operating Procedures to formalize responsibilities
Role of Other Implementing Offices
- FDA and Regional Offices may enlist assistance from government bodies
- Local Government Units (LGUs) monitor compliance of licensed establishments
- LGUs must report violations inconsistent with FDA rules to FDA for action
Transition Provisions
- Existing licensed establishments must submit Risk Management Plan, GPS Coordinates, and credentials of pharmacists and pharmacy assistants upon license renewal
Repealing and Separability Clauses
- Previous inconsistent FDA issuances are repealed or revoked
- If any provision is invalidated, others remain effective
Effectivity
- Circular takes effect immediately upon approval and signature by FDA Director General