Expiration dating of unit dose Repackaged Solid Oral Dosage Form


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 27 CFR parts 210 and 211.3 
The guidance does not address repackaging involving the following: 
• Other dosage forms (e.g., sterile, liquid, topical). 
For more details login at below link to download the guideline
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070278.pdf

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