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A Primer on Compounding Pharmacies and Regulation by Congress

Douglas Graham/CQ Roll Call File Photo
Griffith crafted a proposal aiming to clarify in the Senate bill how the FDA should work with state boards of pharmacy in overseeing compounding pharmacies and allowing compounders to engage in traditional practices.

Senators hope that they will soon get a chance to quickly pass legislation that would give the Food and Drug Administration more authority over compounding pharmacies. For months, lawmakers in both chambers have been working on the best way to respond to last yearís fatal fungal meningitis outbreak linked to a contaminated compounded drug.

Although the House has yet to produce a full bill, sponsors are hoping that negotiations will smooth the path to compromise ó and that continued problems with the drugs will bring urgency to the cause.

Following are answers to some questions about the problems that have cropped up in connection with compounding pharmacies, current regulatory policy, the fatal outbreak and the solutions for better oversight that are under consideration.

How Did This All Get Started?

Last fall, authorities linked an outbreak of fungal meningitis to an injectable steroid drug made by a Massachusetts compounding pharmacy. The Food and Drug Administration, Centers for Disease Control and Prevention and state authorities investigated the outbreak, and officials confirmed the presence of a fungal contaminant in multiple sealed vials of an injectable drug made at the pharmacy.

To date, contaminated drugs from the New England Compounding Center have led to 750 cases of fungal meningitis in 20 states and 64 deaths, according to the CDC.

In Congress, lawmakers requested documents, information and inspection records related to the NECC, which recalled all of its products and eventually suspended operations. As congressional committees held hearings to determine how the outbreak happened and who was responsible, the FDA began to highlight the NECC incident as a case study for what was wrong with its current oversight system. Conflicting court decisions had led to regulatory confusion, making it unclear when oversight of a compounding pharmacy is the FDAís responsibility, agency officials said.

FDA Commissioner Margaret Hamburg told Congress she regretted the way her agency oversaw the NECC but also said the FDA needed more authority to prevent similar incidents.

Why Canít the FDA Handle This on Its Own?

Several conflicting court decisions regarding a 1997 law (PL 105-115) have left the FDA uncertain about its authority. Traditionally, compounding pharmacy oversight has been left up to the states, with the FDA reserving the right to step in under certain circumstances.

Today, some compounding pharmacies are blurring the lines between traditional practices and wholesale manufacturing ó making large batches of compounded drugs meant for interstate commerce in advance of receiving a patientís prescription. Thatís what the NECC was doing.

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