Pharmacy Compounding Legislation Introduced in Both Houses of Congress Provides for FDA Regulatory Flexibility and Inspection Authority

Legislation has been introduced in both houses of Congress that would provide FDA with the power and flexibility it needs to define the regulatory requirements for high-risk compounding operations and the authority to inspect those that engage in interstate commerce.

The similarity of the bills reflects the time both houses have had to do a thorough vetting of the issues and listen to the concerns of the various constituencies, as well as to frame and compare initial proposals, in the effort to develop a viable legislative pathway.

Both bills provide the agency with some latitude in deciding how best to achieve the specified goals.

The House bill is sponsored by Rep. Edward Markey (D-MA), who represents the district in which the New England Compounding Center (NECC) was located.  NECC was responsible for the major crisis that broke out last fall when tainted injectable methylprednisilone acetate caused an outbreak of fungal meningitis that has resulted in 55 deaths and more than 740 illnesses in 20 states (see IPQ November Special Report).

Markey is currently running for the Senate seat vacated when Massachusetts Senator John Kerry was confirmed as Secretary of State.  Markey built his new legislation on the bill he proposed last fall in the immediate wake of the emerging crisis, which did not have time to work its way forward as the Congressional session ended.

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See related IPQ stories:

Compounder Recalls, 483s and Warning Letters Continue in Wake of FDA Inspection Blitz

The Sterility Risks in Pharmacy Compounding Can Be Limited, Not Eliminated, Experts Stress at USP Forum

Pharmacy Compounding Will Remain Center Stage as FDA’s Focus Intensifies on Drug Quality, Hamburg Tells FDLI

FDA Inspection Blitz Reveals Weakness in Sterile Practices at Large Compounders

Letter from CDER’s Woodcock to PharMEDium Serves as Notice to Compounders and Hospitals on Need for Product/Patient Linkage

Iowa, Massachusetts, California and Virginia Intensify Compounding Pharmacy Crackdown

Mass. Closes More Compounders; Grand Jury Probes NECC; New Infection Types Reported; FDA Reaches out to States

FDA Inspection Findings of Sterile Practice Breeches at Ameridose Mirror Those at NECC

Congressional Hearings Expand Meningitis/NECC Probe; More Light Shed on Regulatory Gaps

IPQ November 2012 Special Report on the Crisis in Pharmacy Compounding and its Implications