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Consent Decree Entered Against Specialty Compounding

In mid-March, FDA announced that a consent decree had been reached with Specialty Compounding based on the agency’s inspection findings of bacterial contamination in 2013. Under the decree the company is prohibited from manufacturing or handling sterile drugs. [For an in-depth analysis of FDA inspection findings at sterile compounding pharmacies see IPQ April 14, 2014.]

Public Docket on Compounding

FDA opened a public docket on compounding in early March. The docket is designated to receive comments, research, and information that is not specific to other compounding-related dockets. [For more on compounding developments and guidance related to the implementation of the 2013 Drug Quality and Safety Act see IPQ January 23, 2014.]

Compounding Advisory Committee Meeting

In late February, FDA’s Compounding Advisory Committee held a meeting on implementing the compounding provisions (Title 1) of the Drug Quality and Security Act (DQSA). The first part of the meeting discussed proposed revisions to the list of drug products that may not be compounded, while the second part focused on the criteria for developing […]

Draft Guidances on Compounding

In mid-February, FDA issued five draft guidances on policies for compounding and repackaging. One draft covers whether a company should register as an outsourcing facility, while another discusses regulations around repackaging by outsourcing facilities. A draft on biologics repackaging covers when the agency will not take action against facilities lacking a BLA. The other two […]

FDA Creates Compounding Pharmacy Advisory Committee

FDA created a compounding pharmacy advisory committee in mid-December. The committee consists of 12 voting and two non-voting members and is designed to give advice and recommendations relating to regulatory changes for compounding manufacturers and the implementation of the compounding provisions in Title 1 of the Drug Quality and Security Act (DQSA) (see IPQ December […]

Consent Decree at Compounder Main Street Family Pharmacy

In early December, FDA completed legal actions against compounding pharmacy “Main Street Family Pharmacy” that followed from mid-2013 FDA inspection findings of insanitary conditions and numerous other deviations from cGMPs. The company and its co-owner pleaded guilty to misdemeanor criminal violations of the FD&C act and entered into a civil consent decree

Final Guidances on Compounding Facilities

FDA issued two final guidances and one draft revision relating to compounding outsourcing facilities in late November. The final guidances address the Registration of Human Drug Compounding Outsourcing Facilities, including the process for registering, re-registering, and de-registering as an outsourcing facility, and the Fees for Human Drug Compounding Outsourcing Facilities, respectively. Also issued was a […]

More Warning Letters to Compounders

Two more compounding facilities received warning letters in mid-August for cGMP violations – Florida-based The Compounding Shop and Arizona-based Zions Rx Formulations Services. Five out of six citations in the two letters focus on the same problem areas: ● environmental monitoring ● microbial SOPs ● stability testing ● appropriate personnel clothing, and ● determination of […]

More Out-of-Compliance Sterile Drug Compounders

A warning letter and two alerts issued during July show FDA’s continuing crackdown on sterile practices at drug compounders, including inadequate sterility procedures, environmental monitoring and gowning (IPQ April 14, 2014). The warning letter was issued to Dallas-based Abrams Royal Pharmacy following an inspection in December. FDA also alerted healthcare professionals during July to avoid […]

GMP Warning Letters Continue to Compounding Pharmacies

In June, two more compounding pharmacies received warning letters from FDA – Sunnymede Pharmacy, doing business as Lee and Company and Lee Pharmacy, and Pharmacy Creations. Both letters include citations involving contamination SOPs and environmental monitoring – the most common problems FDA is finding at sterile compounding facilities (IPQ April 14, 2014).
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