Seminar on A.O. # 56 s. 1989 April 29, 2014 – Cagayan de Oro City April 30, 2014 – Misamis Oriental and Camiguin CLASSIFICATION OF DRUG ESTABLISHMENTS Drug Manufacturer shall refer to any establishment engaged in any and all operations involved in the production of pharmaceutical products including preparatory processing, compounding, formulating, filling, packaging, repackaging, altering, ornamenting, finishing and labeling with the end in view of its storage, sale or distribution; provided, that the term shall not apply to the compounding and filling of prescriptions in drugstores and hospital pharmacies. Sub-classification of Drug Manufacturer Drug Manufacturer-Repacker - – refers to any establishment that repacks a finished drug product into smaller quantities in a separate container and/or into secondary packaging, including but not limited to relabeling, stickering, & bundling for promo packs with the end view of storage, distribution, or sale of the product. Provided, it shall not cover repacking of drugs at the time of purchase for purposes of dispensing. Sub-classification of Drug Manufacturer Drug Manufacturer-Packer - refers to any establishment that packages a bulk drug product into its immediate container with the end view of storage, distribution, or sale of the product Drug Manufacturer-Trader – refers to any establishment which is a registered owner of a pharmaceutical product and the formulation and procures the raw materials and packing components, and provides the production monographs, quality control standards and procedures, but subcontracts the manufacture of such product to a licensed manufacturer. In addition, a trader may also engage in the distribution and or marketing of its products. A trader shall be categorized as a manufacturer. Drug Distributor-Exporter refers to any establishment that exports raw materials, active ingredients and finished products for distribution to other drug establishments outside the country. Drug Distributor-Importer refers to any establishment that imports raw materials, active ingredients and/or finished products for wholesale distribution to other local FDA- licensed drug establishment. Drug Distributor-Wholesaler refers to any establishment that procures raw materials, active ingredients and/or finished products from a local FDA licensed drug establishment for local distribution on wholesale basis. Drugstore/Pharmacy/Botica, including hospital pharmacy and institutional pharmacy shall refer to drug establishment where registered drugs, chemical products, specialty pharmaceutical and dental, medicinal and household remedies are dispensed directly to the general public on a retail basis. Botika ng Barangay and its variants that sell prescription product shall be reclassified and required to secure LTO as a drugstore. Retail Outlet for Non-Prescription Drugs shall refer to drug establishments such as supermarkets, convenient stores and other similar retail establishments licensed to sell registered non-prescription or Over-the-Counter (OTC) drugs which are sold in their individual original and primary packaging and are dispensed directly to the general public on a retail basis. Botika ng Barangay and its variants that sell non-prescription or OTC product only shall be reclassified and required to secure LTO as a RONPD. REQUIREMENTS FOR SECURING A LICENSE TO OPERATE Any qualified natural or juridical person desiring to engage or operate in the manufacture, packing, repacking, importation, exportation, sale, offer for sale, distribution or transfer of pharmaceutical products shall comply with the requirements that FDA is authorized to promulgate through the appropriate issuance including amendments thereto. GENERAL REQUIREMENTS ( Opening or Initial) 1.Notarized Petition form 2.Notarized Joint Affidavit of Undertaking 3.Proof of Registration as an Establishment 4.Franchise Agreement ( If applicable) 5.Pharmacist’s credentials 2- (2x2) d picture Board Certificate Valid PRC ID Current PTR Duties and Responsibilities Seminar Certificate (AO 56 and FDA -Updates) 6.Contract of Lease/ Proof of ownership/Certification of Occupancy 7. Vicinity Map with Landmark/ Location Map 8. Floor Plan with Dimension in meters( not less than 15 sq. meters) 9. Tentative List of products 10. Any one of the following: United state Pharmacopoeia/ National Drug Formulary ( USP/NF) Remington’s Pharmaceutical Science Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 11. Reference Materials: Philippine National Drug Formulary (PNDF) latest edition R.A. 3720R.A, 5921 R.A. 6675 R.A. 8203 R.A. 9502 E.O. # 821 MDRP and ACPR#2009-001 GMAP 12. Prescription Book 13.Senior Citizen’s Record Book 14.Generics Menu Cards 15.MDRP/GMAP posters 16. Drugstore Seal 17. Generics White Label, Partial Filling, Red Label 18. Pictures of Drugstore with permanent Signboard RENEWAL OF LICENSE TO OPERATE (LTO) Application for regular renewal of license may be filed within six months from its expiration. An application received after expiration of the LTO shall be subject to a surcharge or penalty equivalent to twice the renewal licensing fee and an additional ten percent (10%) per month or a fraction thereof of continuing nonsubmission of such application up to a maximum of one hundred twenty (120) days. A. Any application for renewal of license filed beyond the 120 days after the original expiration shall be considered expired and shall be subject to a fee equivalent to the total surcharge or penalty plus the initial license fee. Such application shall undergo the initial filing and evaluation procedure. For applications for renewal filed within one hundred twenty (120) days from its original expiry, the LTO shall be considered valid and existing until a decision or resolution by the FDA is rendered on the application for renewal. B. Automatic renewal shall apply to the following conditions: 1. The application is filed before the expiration date; 2. The prescribed renewal fee is paid upon filing of the Application; 3. A sworn statement indicating no change or variation whatsoever in the establishment is attached to the application. C. In considering both renewal application, FDA shall ascertain the continued compliance by the establishment with the existing standards and requirements. In either case above, the instances provided in Section 4, Article I, Book II of the IRR of RA 9711(Paragraph E, Item VI above) shall be grounds for non-renewal of application. Thank You!