March 19, 2014

FDA has recently issued several "referral letters" (RLs) to state boards of pharmacy based on year-old pre-Compounding Quality Act Form 483 Inspectional Observations. FDA counts RLs as new instruments of oversight designed to strengthen their power over both state boards of pharmacies and state-regulated pharmacies.

The RLs, issued to the Oklahoma, Florida, New Jersey, and Missouri boards, "turned in" the pharmacies for "deviations from appropriate sterile practices," but did not specify whether those practices are state USP or federal GMP.

Click here to view the full alert.