A Primer on Compounding Pharmacies and Regulation by Congress

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 year’s 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 — 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 FDA’s 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 Can’t 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 — making large batches of compounded drugs meant for interstate commerce in advance of receiving a patient’s prescription. That’s what the NECC was doing.
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?

Yes, although not on the same scale as the NECC outbreak. In May, a pharmacy in Florida recalled its sterile products following an FDA inspection. And in August, the FDA issued a voluntary nationwide recall of all sterile products made by a compounding pharmacy in Texas after reports of bacterial infection affecting 15 patients in two Texas hospitals.

Alexander called the recall “deeply troubling” and said it showed the need for action on his bill. “Senators on the health committee have worked carefully to put together the best possible legislation, because we knew that the lack of accountability over compounding businesses would lead to another crisis like last year’s meningitis outbreak,” he said in a statement in August.

What Will Happen Next?

Aides say that members in both chambers are continuing to work on details of the legislation and are aiming to pass a final version this fall. The drug distribution security provision in particular has strong bipartisan support in both chambers.

But bill sponsors in the Senate say they are committed to trying to pass compounding pharmacy legislation as well, as soon as possible. An aide for Harkin said he is eager to move the bill, especially in light of the compounded drug problems that continue to occur.

The biggest obstacle is for House Republicans and senators to agree on how much authority the FDA should have over compounding pharmacies. If they can work that out, it will go a long way to helping the legislation succeed. And if the two committees can hammer out the details in their own negotiations, that would increase the bills’ chances on the floor of their respective chambers — and make reconciliation much easier.

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