CHECKLIST OF REQUIREMENTS FOR RETAIL DRUGSTORE
CHECKLIST OF REQUIREMENTS FOR RETAIL DRUGSTORE
__ Accomplished Petition Form – must be notarized
__ Accomplished Joint Affidavit of Undertaking – must be notarized
__ DTI Business Name/SEC/CDA
__ Franchise Agreement (for franchisee)
__ Barangay Clearance/Mayor’s Permit
__ Accomplished Petition Form – must be notarized
__ Accomplished Joint Affidavit of Undertaking – must be notarized
__ DTI Business Name/SEC/CDA
__ Franchise Agreement (for franchisee)
__ Barangay Clearance/Mayor’s Permit
*note: Brgy. Clearance/Mayor’s Permit must present full details of the
establishment (name & exact address of the establishment)
*note: Brgy. Clearance/Mayor’s Permit must present full details of the
establishment (name & exact address of the establishment)
__ Contract of Lease (must be notarized) / Proof of Ownership
__ Location Plan or Vicinity Map of the establishment
__ Floor Plan with measurements; not less than 15 sq. M
(measurements must be in METERS)
__ Picture of drug outlet
*note: drugstore must be OPEN, has PERMANENT SIGNAGE &
WITHOUT initial STOCKS.
__ Contract of Lease (must be notarized) / Proof of Ownership
__ Location Plan or Vicinity Map of the establishment
__ Floor Plan with measurements; not less than 15 sq. M
(measurements must be in METERS)
__ Picture of drug outlet
*note: drugstore must be OPEN, has PERMANENT SIGNAGE &
WITHOUT initial STOCKS.
Pharmacist Credentials:
__ 3 pieces of 2x2 recent pictures of pharmacist
__ Photocopy of PRC Board Certificate
__ PRC ID (must be valid)
__ PTR (must be valid)
__ Certificate of AO 56 seminar
__ Resignation from the previous employer
__ Notarized Contract of Employment
Pharmacist Credentials:
__ 3 pieces of 2x2 recent pictures of pharmacist
__ Photocopy of PRC Board Certificate
__ PRC ID (must be valid)
__ PTR (must be valid)
__ Certificate of AO 56 seminar
__ Resignation from the previous employer
__ Notarized Contract of Employment
__ White & Red Labels
__ Rubber Stamp
__ List of Products to be sold
__ White & Red Labels
__ Rubber Stamp
__ List of Products to be sold
*note: includes Generic Name, Dosage & Therapeutic Action
*note: includes Generic Name, Dosage & Therapeutic Action
*note: 3 SETS OF REQUIREMENTS must be submitted in YELLOW folder
with FASTENER & EARTAGS. Please arrange the following accordingly.
*note: 3 SETS OF REQUIREMENTS must be submitted in YELLOW folder
with FASTENER & EARTAGS. Please arrange the following accordingly.
SPECIFIC REQUIREMENTS AVAILABLE AT THE TIME OF INSPECTION:
__ Adequate VENTILATED area
__ Permanent Signage
__ Cabinet / Shelves
__ Washing Facilities with adequate water supply
__ Pharmacist PRC Board Certificate & AO 56 Certificate conspicuously
displayed. *note: MUST display the ORIGINAL COPIES
__ Organizational Chart
__ Reference Materials: (choose one only)
*United States Pharmacopoeia/National Formulary (USP-NF)
*Remington’s Pharmaceutical Sciences
*Goodman & Gilman Pharmacological Basis of Therapeutics
__ Copies of Republic Act/s : 3720, 5921, 6675, 8203, 9502, 9711
__ Administrative/Executive Order/s: A.O. 56 s. 89, EO#821,
ACPR#2009-001
__ Standard Operating Procedures: Product Complaint, Product Recall,
Procurement/Distribution of Stocks, Reporting of Adverse Drug
Events/ Reaction, Good Dispensing Practice, Good Storage Practice,
Good Housekeeping (including Garbage Disposal/Pest Control), Cold
Chain Management
__ Generic Posters & Generic Dispensing Flow Chart, MDRP – GMAP
Posters (must be displayed)
__ Generic Menu Cards
__ Prescription Book, Senior Citizen, PWD Record Book
__ Temperature Monitoring Device (Digital) & Temperature Monitoring
Chart
__ Dispensing Apparatus: Tablet Counter with spatula and Graduated
Cylinder
SPECIFIC REQUIREMENTS AVAILABLE AT THE TIME OF INSPECTION:
__ Adequate VENTILATED area
__ Permanent Signage
__ Cabinet / Shelves
__ Washing Facilities with adequate water supply
__ Pharmacist PRC Board Certificate & AO 56 Certificate conspicuously
displayed. *note: MUST display the ORIGINAL COPIES
__ Organizational Chart
__ Reference Materials: (choose one only)
*United States Pharmacopoeia/National Formulary (USP-NF)
*Remington’s Pharmaceutical Sciences
*Goodman & Gilman Pharmacological Basis of Therapeutics
__ Copies of Republic Act/s : 3720, 5921, 6675, 8203, 9502, 9711
__ Administrative/Executive Order/s: A.O. 56 s. 89, EO#821,
ACPR#2009-001
__ Standard Operating Procedures: Product Complaint, Product Recall,
Procurement/Distribution of Stocks, Reporting of Adverse Drug
Events/ Reaction, Good Dispensing Practice, Good Storage Practice,
Good Housekeeping (including Garbage Disposal/Pest Control), Cold
Chain Management
__ Generic Posters & Generic Dispensing Flow Chart, MDRP – GMAP
Posters (must be displayed)
__ Generic Menu Cards
__ Prescription Book, Senior Citizen, PWD Record Book
__ Temperature Monitoring Device (Digital) & Temperature Monitoring
Chart
__ Dispensing Apparatus: Tablet Counter with spatula and Graduated
Cylinder
*note: The Owner / Authorized Representative & Pharmacist must be
present during the inspection.
*note: The Owner / Authorized Representative & Pharmacist must be
present during the inspection.
FDA Reg.3 Tel. No: (045) 8613426 loc. 113
FDA Reg. 3 Hotline: 09228330176/09088925332
FDA website: www.fda.gov.ph
FDA Alabang Reg. I : (02) 807-0725
(02) 807-8275
FDA Reg.3 Tel. No: (045) 8613426 loc. 113
FDA Reg. 3 Hotline: 09228330176/09088925332
FDA website: www.fda.gov.ph
FDA Alabang Reg. I : (02) 807-0725
(02) 807-8275