RETAIL DRUGSTORE
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
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