PERSPEC - FURTHER CLASSIFICATION OF ESTABLISHMENTS as DEFINED in AO 2014-0034 of DOH

The Administrative Order was issued by DOH on ____________, entitled, "Rules and Regulations on the Licensing of Establishments Engaged in the Manufacture, Conduct of Clinical Trial, Distribution, Importation, Exportation, and Retailing of Drug Products, and Issuance of Other Related Authorizations".

October 13, 2014

__________________ refers to any establishment engaged in any or all operations involved in the production of drug products including preparatory processing, compounding, formulating, filling, packaging, repackaging, altering, ornamenting, finishing, and labeling with the end 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. A drug manufacturer can distribute and/or export wholesale its own drug products and import raw materials for its own production. 

Drug manufacturer

________________ 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, and 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 purpose of dispensing. 

Drug manufacturer - Repacker

______________ 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- Packer

________________ refers to any establishment which is a registered owner of a drug 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. 

Drug manufacturer- Trader

A __________ may also engage in the distribution and/or exportation in wholesale of its own drug products and importation of raw materials for the production by its contract manufacturer. In cases where the contract manufacturer procures the raw materials and packing components, a________________ must be provided.

Trader
Quality agreement

_________________ refers to any establishment that exports raw materials, active ingredients and finished products for distribution to other drug establishments outside the country.  

Drug distributor- Exporter

_________________ refers to any establishment that imports raw materials, active ingredients and/or finished products for wholesale distribution to other local FDA-licensed drug establishments. 

Drug distributor - Importer

_____________ 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. 

Drug distributor - wholesaler

_________________/ ___________/ __________ refers to a drug outlet or drug establishment where registered drugs, chemical products, dental, medicinal, and household remedies are dispensed directly to the general public on a retail basis. This includes hospital pharmacy, community pharmacy and institutional pharmacy.  

Drugstore
Pharmacy
Botica

________________________ refers to drug establishments such as a supermarket, convenient store and other similar retail establishment authorized to sell only identified OTC and household remedy products directly to the general public on a retail basis.

Retail outlet for Non Prescription Drugs (RONPD)

_____________ is an individual, company, institution, organization, or an entity which takes the responsibility for the initiation, management, and or financing of a clinical trial. 

Sponsor

_________________ refers to a person or an organization (commercial, academic, or other entities) contracted by the sponsor to perform one or more of the sponsor's trial-related duties and functions. 

Contract Research Organization