From The Designated Representative and Exemptee Blog-- March 15, 2013 FDA Focus on cGMP Compliance by Compounders

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

Source:  The Designated Representative and Exemptee Blog