License to Operate (LTO) Application Requirements
- Application form: filled, notarized, signed by pharmacist and owner/authorized representative.
- Proof of Business Name Registration: varies with business type (DTI, SEC, Cooperative Development Authority, or government law).
- Credentials of Supervising Pharmacist: valid PRC ID, FDA seminar attendance, resignation letter if applicable, list of other RONPDs supervised.
- Risk Management Plan: detailing how risks are managed, including pharmacovigilance.
- Location Plan: detailed sketch with landmarks and GPS coordinates.
- Picture of Drugstore with signage matching business name.
- Proof of Payment of application fees.
- Self-Assessment Toolkit (SATK) to facilitate submission and evaluation.
Evaluation and Post-Licensing Inspection
- Initial review by FDA Regional Field Offices for compliance.
- FDA may require supplemental documents.
- Routine inspections for Good Distribution and Storage Practices compliance.
- Inspections triggered by regulatory actions or adverse drug reactions.
- Verification of franchise agreements, records, Standard Operating Procedures (SOPs), displayed materials, and reference manuals.
- Post-inspection report influences approval or regulatory action.
Application for Variation of LTO
- Major Variations:
- Change of Ownership.
- Transfer of Location.
- Minor Variations Prior Approval:
- Expansion of Establishment.
- Change of Business Name.
- Zonal Address Change.
- Minor Variations Notification:
- Change of Supervising Pharmacist.
- FDA must be informed of all changes.
- Variation fees apply except transfer of location which requires initial 2-year payment.
- Business may continue during minor variation application processing.
Accessibility of Electronic Forms
- All fillable forms available on FDA Website for accessibility.
Multiple RONPD Supervision Rules
- One pharmacist may supervise multiple RONPDs if:
- Minimum of two (2) hours weekly physical presence per RONPD.
- All RONPDs within the same provincial LGU; NCR treated as single area.
- Maximum distance between farthest RONPDs is 25 km.
- All supervised locations lie within a circumferential area between farthest outlets.
- Maximum 15 RONPDs supervised per pharmacist.
- Exceptions possible for geographically disadvantaged areas.
- Violations subject to legal action.
Responsibilities of Supervising Pharmacist
- Ensure safety, efficacy, and quality of drug products.
- Observe Good Storage Distribution, Good Dispensing, and Good Pharmacy Practices.
- Monitor inventory and expirations.
- Properly handle and report adverse drug reactions.
- Keep establishment updated on FDA issuances and advisories.
- Ensure all drugs sold are FDA-registered.
- Ensure compliance with existing regulations.
- These responsibilities reflected in a validated Standard Operating Procedure (SOP).
List and Control of Non-Prescription Drugs Allowed in RONPDs
- Only selected registered non-prescription drugs allowed based on safety and efficacy evidence.
- Includes household remedies, selected traditional medicines, herbal, and over-the-counter drugs.
- Official list posted on FDA website and regularly reviewed.
Responsibilities of Other Implementing Offices and LGUs
- FDA can request assistance from other government departments/agencies.
- Local Government Units (LGUs) assist in monitoring compliance locally.
- LGUs must report violations inconsistent with FDA rules for regulatory action.
Transitory Provisions for Existing Licensed Establishments
- Existing establishments must submit Risk Management Plan, GPS coordinates, and supervising pharmacist credentials upon LTO renewal.
Repealing and Separability Clauses
- Previous inconsistent FDA circulars/memoranda are repealed or revoked.
- If any provision is declared unconstitutional or unlawful, remaining provisions stay effective.
Effectivity
- Circular takes effect upon approval and signature by FDA Director General.