Senators Finalizing Drug Compounding Regulation Bill

By | May 13, 2013

U.S. senators appeared close to finalizing a bill that would require pharmacies that compound and sell sterile drugs across state lines to submit to greater federal regulation.

The proposed legislation comes in the wake of a meningitis outbreak last fall that killed 53 people and sickened more than 700. The outbreak was linked to a tainted steroid made by the Framingham, Massachusetts-based New England Compounding Center.

The legislation would draw a distinction between traditional compounding pharmacies, which make tailored drugs for individual patients, and those such as NECC which make large batches of commonly used products for physicians to keep for future use.

Under the proposed law, compounding pharmacies that make sterile products and ship them out of state without prescriptions would be known as “compounding manufacturers” and be regulated by the Food and Drug Administration. They would no longer be licensed as pharmacies, which are regulated by states.

The draft bill was developed by a bipartisan group of senators with input from the compounding industry’s chief lobbying organization, the powerful International Academy of Compounding Pharmacists (IACP), as well as regulators, hospitals and other stakeholders.

At a hearing of the Senate health committee last Thursday, all testified in favor of giving the FDA oversight over compounding pharmacies that make and ship sterile products across state lines. But they disagreed over who should regulate pharmacies that make and sell sterile drugs but do not ship them out of state.

“Some intrastate operations are as large and larger than interstate distributors,” Carmen Catizone, executive director of the National Association of Boards of Pharmacy testified. “Therefore the volume of products distributed, and the associated risk, can be equal to or greater than the interstate distribution of similar products.”

Exempting pharmacies which operate inside a single state from federal regulations could create a “safe haven” for entities and individuals who want to avoid such regulation, Catizone said.

IACP Chief Executive David Miller argued that pharmacies which operate within a state, even large sterile compounding pharmacies, should remain under the authority of state boards of pharmacy, a position with which the FDA agrees.

Massachusetts Democrat Elizabeth Warren pressed Miller for reassurances that the states have the resources needed to oversee in-state compounding pharmacies. She pointed to a recent report by Democratic representative Ed Markey of Massachusetts which found that states employ only 5 inspectors, on average, to inspect all pharmacies.

The report also found that only two states routinely track the number of compounding pharmacies and only 13 knew which pharmacies were providing sterile compounding services. Only five of those states had inspectors that were trained to identify problems with sterile compounding.

Miller said states are beginning to change.

“What we are seeing in Massachusetts and other states where the boards are taking this seriously and hiring the necessary individuals with the proper training to conduct those inspections, we’re uncovering things that should have been uncovered long ago.”

Under the proposed regulation, the FDA would have the power to access the records of compounding manufacturers but would not have access to records of traditional compounding pharmacies. Janet Woodcock, director of the FDA’s drugs division, told the committee that the agency should be able to access records of all compounding pharmacies to ensure they are not in fact compounding manufacturers.

That is something Catizone’s organization opposes.

“Authorizing the FDA access to pharmacy records could create jurisdictional conflicts with the states and impede the states from investigating or prosecuting a case,” he said. “What is needed in lieu of allowing such access is increased communication between the states and FDA.”

The bill would exempt compounding manufacturers from the strict regulatory oversight that governs traditional manufacturers. They would not, for example, be required to submit their products to the FDA for approval before selling them. Nor would they be required to negotiate the labeling of their drugs with the FDA.

Woodcock expressed concern that some pharmaceutical companies may try to pass themselves off as compounding manufacturers in order to evade the stricter regulations that go along with being a pharmaceutical company. To prevent that, she recommended that compounding manufacturers also be licensed as pharmacies.

That, Catizone argued, would just create confusion.

“If a compounding manufacturer is allowed to hold dual licensure and registration, it will be more difficult to separate the two enterprises and will provide a veil for unscrupulous entities to obfuscate their activities,” he said.

Iowa Democrat Tom Harkin, chairman of the Senate Committee on Health, Education, Labor and Pensions, which held the hearing, said he hopes the bill will be ready for a committee vote soon.

“Our staffs will work together again and resolve what little matters need to be resolved,” he said, “but I think we are very close to what we need to do.”

(Reporting by Toni Clarke in Washington; Editing by Phil Berlowitz)