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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.

The FDA holds that when a compounding pharmacy does that, it has crossed the line into acting like a drug manufacturer and should be regulated by the agency. But many practices remain in a gray area.

FDA officials say that uncertainty — and a lack of resources — has led them to be less aggressive with questionable compounding pharmacies. The bipartisan Senate bill aims to address both of those issues by explicitly putting the FDA in charge of regulating compounding manufacturers that make sterile products without a prescription and sell them across state lines. It also would charge those manufacturers annual fees to offset the cost of inspections and other oversight.

Where Do the Bills Stand Now?

Fueled by strong bipartisan support, the Senate Health, Education, Labor and Pensions Committee approved its bill by voice vote in May. Chairman Tom Harkin, D-Iowa, and ranking Republican Lamar Alexander of Tennessee attempted to hotline the bill with a substitute amendment before the August recess, but Oklahoma Republican Tom Coburn said more time was needed to review the measure.

The Senate bill did not get a warm reception at first from House Republicans, who were unconvinced that the FDA needed additional authorities. But Virginia Republican Morgan Griffith crafted a proposal aiming to clarify how the FDA should work with state boards of pharmacy in overseeing compounding pharmacies and allowing compounders to engage in traditional practices.

Griffith’s bill also would put some limitations on the volume of drugs a pharmacy can compound and allow the FDA to make a list of drugs that cannot be used in compounding because of safety or efficacy concerns.

The bill has yet to be formally introduced, but aides say the Senate panel and the House Energy and Commerce Committee are working together and hope to reach an agreement and put legislation on the floor this fall.

What About This ‘Track and Trace’ Provision in the Senate Bill?

This is another prescription drug issue that both committees have been working on for a long time. The Senate combined this drug-distribution security measure with its compounding pharmacy bill, while the House passed a stand-alone measure (HR 1919) in June.

Both bills share a goal: moving to an interoperable, nationwide, electronic, unit-level tracing system throughout the drug supply chain. The Senate bill would set 10 years to transition to that system. The House bill would set standards for a lot-level tracing system but allow the FDA until 2027 to propose regulations on a unit-level system. Lots can contain thousands of units.

Lawmakers tried to include drug supply chain provisions in a 2012 FDA user fee reauthorization bill (PL 112-144) but couldn’t include them in the final version. Supporters including Sens. Michael Bennet, D-Colo., and Richard M. Burr, R-N.C., have been working on it since then.

“Right now, we know more from the barcode on a gallon of milk than we do from the barcode on a bottle of pills,” Bennet said in a statement.

Have There Been Any Incidents With Compounded Drugs Since Last Fall?
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