FDA Focus On cGMP Compliance By Compounders

Updated June 10, 2022

Some of the links broke.

You might also be interested in:

• Compounding Oversight and Compliance Actions - FDA.gov
• Human Drug Compounding - FDA.gov

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The FDA continues to focus on pharmacy compounders.

This is evidenced by the growing number of the FDA's Form 483s (Inspectional Observations) that are being posted:  FDA - 2013 Pharmacy Inspections

Earlier this month, the FDA sent a "Warning Letter" to Medi-Fare Drug and Home Health Center 3/7/13.  It highlights the myriad touchpoint issues, including pharmacy regulations, and the FDA's regulations on current good manufacturing practices (i.e., the FDA's cGMPs).

You might also be interested in:
21 CFR 211: Pure, Safe, and Effective - Online training - An orientation to the FDA's cGMPs

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