Senate panel approves compounding bill

Senators from the Health, Education, Labor and Pensions (HELP) Committee have approved a compounding bill designed to help improve the safety of compounded human and animal drugs, following feedback received from stakeholders, including the American Society of Health-System Pharmacists (ASHP).

On May 15, Senators Tom Harkin (D-Iowa), Lamar Alexander (R-Tenn.), Pat Roberts (R-Kan.), and Al Franken (D-Minn.), all members of the HELP Committee, introduced the new legislation, S. 959, “Pharmaceutical Compounding Quality and Accountability Act,” which clarifies the oversight responsibilities of state and federal authorities for compounding pharmaceuticals. The Senate HELP Committee approved the bill on May 22, clearing it to advance to the full Senate for a vote.

Compounding manufacturers

The compounding bill clearly distinguishes between traditional compounding, which will continue to be regulated by state boards of pharmacy, and compounding manufacturers, to be regulated by FDA. The bill defines a compounding manufacturer as “an entity that compounds a sterile drug prior to or without receiving a prescription and introduces such drug into interstate commerce, with the exception that pharmacies within health systems will not be considered a compounding manufacturer and will remain regulated as traditional pharmacies.”

The legislation was developed in response to the national fungal meningitis outbreak last fall that resulted in more than 50 deaths and sickened more than 700 people who had received contaminated injections of methylprednisolone acetate produced at the New England Compounding Center (NECC), in Framingham, Mass. The failure to maintain sterility in the pharmacy led to a major threat to public safety.

Closing the gaps

“Following two hearings and many meetings with stakeholders, we developed a better understanding of the legal and regulatory gaps that allowed owners and managers of the New England Compounding Center to disregard basic procedures to ensure the products that they were manufacturing were sterile,” said Sen. Harkin during his opening statement on May 22.

Sen. Alexander said he believes the bill provides regulatory clarity for traditional compounding pharmacies, compounding manufacturers, and drug manufacturers.

“The bill raises the quality standard for compounded products, and provides clear lines of authority,” said Sen. Alexander of Tennessee, whose state experienced 152 cases of fungal infections and 15 deaths associated with the contaminated injections. “I do not [want] to sit through another hearing where FDA can point a finger at someone else, instead of taking responsibility for failure to regulate and enforce large-scale compounding or claim it did not have enough clear authority.”

ASHP helped the Senate HELP Committee to develop the legislation. Kasey K. Thompson, PharmD, MS, of ASHP, offered testimony that supported an exemption for health systems from the “compounding manufacturers’ designation.” In an ASHP news report, he explained that “the exemption is appropriate because in hospitals and health systems, medications, compounded or otherwise, are administered to patients with patient-specific medication orders.” He also noted that hospitals are not in the retail business of selling compounded products.

NCPA testifies 

A day after the Senate panel voted on the compounding bill, lawmakers of the U.S. House Energy and Commerce Subcommittee on Health also held a hearing to examine current regulations connected with drug compounding at the federal and state levels following the NECC tragedy.

In his testimony, Joseph H. Harmison, RPh, past president of the National Community Pharmacists Association (NCPA), emphasized the importance of oversight by state boards of pharmacy, the need for better communication between FDA and the state boards, and the definition of traditional compounding pharmacy.

“NCPA is committed to working with Congress on the issue of practices that exceed state-regulated compounding. We believe the committee is taking the proper steps to address this tragedy by focusing on investigations into what steps should have been taken and oversight to ensure that the appropriate regulatory bodies are exercising their full authority,” Harmison said. He is owner of DFW Prescriptions in Arlington, Texas.

NCPA recommendations

Among the recommendations for regulatory oversight provided by NCPA were the following:

Ÿ 1. All aspects of pharmacy should continue to be regulated by the state boards of pharmacy. FDA should work with the state boards when necessary.

Ÿ 2. Proper funding is needed for state boards of pharmacy to execute their regulatory responsibilities.

Ÿ 3. State boards of pharmacy should be encouraged to require compounding facilities to comply with USP 797 to ensure that production standards are maintained.

Ÿ4.  Traditional compounding should include pharmacists who prepare customized medications that are anticipated, based on historic prescribing patterns.

Ÿ5. FDA should share with state boards of pharmacy all inspection reports and requests for further actions.