FDA Guidance for Industry: Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products

Titel:
FDA Guidance for Industry: Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products
Herkunft/Verlag:

FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070278.pdf

Inhalt:
This guidance addresses repackaging of prescription and over-the-counter solid oral dosage form drugs into unit-dose containers by commercial pharmaceutical repackaging firms that are required to register with FDA under section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and to comply with current good manufacturing practice (CGMP) regulations in 21 CFR parts 210 and 211.

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