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...more
Today Senator Lamar Alexander (R-TN), member of the Senate HELP Committee asked FDA Commissioner Margaret Hamburg what FDA's policy was with regard to asserting jurisdiction over 503A traditional compounding pharmacies. He...more
On January 17, FDA issued its opening sally in the new compounding pharmacy enforcement regime by issuing a Warning Letter to Avella of Deer Valley in Phoenix, AZ. The letter is based on a nearly year-old inspection (February...more
Following enactment of the Drug Quality and Security Act last month, FDA has quickly issued a new guidance for compounding pharmacies that choose to not register as "outsourcing facilities" and subject themselves to federal...more
On Wednesday, December 4, FDA will publish six key documents in the implementation of the Compounding Quality Act, signed into law by President Obama on Monday, December 2. In addition, FDA has withdrawn its current guidance...more