FDA CIRCULAR NO. ____ Guidelines on the Classification of Deficiencies Observed During Inspection of Drug Distributors, Drugstores, Hospital Pharmacies and Retail Outlet for Non-Prescription Drugs (RONPD)

Protection of human health or safety (TBT)

Pharmaceutical products

Link to ePing

11.120 - Pharmaceutics

Human health

These guidelines shall apply to all local drug establishments engaged in distribution, importation, exportation, and retailing of drug products including household remedy, medicinal gas, traditional and herbal medicines, non-sterile and sterile vaccines, biologicals and raw materials used to produce pharmaceutical products for human and animal use.  These guidelines shall also apply to Good Distribution and Storage Practices (GDSP) inspectorate service of the FDA’s Field Regulatory Operations Office (FROO) for uniformity of regulatory understanding consistent with the provisions of RA No. 3720, as amended by RA No. 9711, RA no. 11032, and relevant national and international standards and policies.

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EN:File here

FR:File here

ES:File here

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