US Senate Committee on Health, Education, Labor, & Pensions

Harkin, Alexander, Roberts, Franken Introduce Legislation to Clarify Oversight Responsibilities for Pharmaceutical Compounding, Ensure Safety for Consumers

Wednesday, May 15, 2013

‘Pharmaceutical Compounding Quality and Accountability Act’ Preserves States’ Primary Role in Traditional Pharmacy Regulation; Clarifies FDA Authority Over Those Making Sterile Products Without Prescriptions and Shipping Across State Borders

Harkin and Alexander Announce That HELP Committee Will Convene for an Executive Session on Wednesday, May 22, to Consider New Legislation—Along With A Proposal to Strengthen and Improve the Drug Distribution Supply Chain

WASHINGTON, D.C.—Chairman of the Senate Health, Education, Labor and Pensions Committee U.S. Senator Tom Harkin (D-Iowa) and Ranking Member Lamar Alexander (R-Tenn.), with Senators Pat Roberts (R-Kan.) and Al Franken (D-Minn.) and other members of the HELP Committee, today introduced legislation—S. 959, the Pharmaceutical Compounding Quality and Accountability Act—that would improve the safety of compounded human and animal drugs by making clear the compounding oversight responsibilities of state and federal authorities. Chairman Harkin and Ranking Member Alexander also announced that the Committee will convene for an executive session next Wednesday, May 22nd, 2013 to consider the compounding bill, along with newly-introduced legislation to strengthen and improve the drug distribution supply chain.

In April, Harkin, Alexander, Roberts, and Franken released draft legislation relating to pharmaceutical compounding and requested that stakeholders provide feedback on the policy merits, potential unintended consequences, and opportunities to improve the legislative language. Additionally, the HELP Committee held a legislative hearing in early May to listen to more in-depth testimonies from experts and stakeholders to improve the draft bill.  An updated one-pager, section-by-section and the Pharmaceutical Compounding Quality and Accountability Act can be viewed on the HELP Committee website.

The Pharmaceutical Compounding Quality and Accountability Act makes a clear distinction between traditional compounding—which will continue to be regulated primarily by state pharmacy boards—and compounding manufacturers that make sterile products without, or in advance of, a prescription and sell those products across state lines. The compounding manufacturers would be regulated by the U.S. Food and Drug Administration (FDA). It clarifies a national, uniform set of rules for compounding manufacturers while preserving the states’ primary role in traditional pharmacy regulation.

“We cannot wait for the next public health crisis—as we saw with the New England Compounding Company disaster that led to more than 50 deaths and caused serious illness in 700 more—to act to improve the safety of compounded drugs,” Chairman Harkin said. “The Pharmaceutical Compounding Quality and Accountability Act will help protect the public from unsafe compounded products and clarify FDA authority over high-risk compounding practices. I am proud of the bipartisan effort that members of this Committee have put forth in drafting this bill, and I am appreciative of the helpful and constructive feedback received from stakeholders throughout this process. I look forward to considering this bill in an executive session of the Committee next week.”

Ranking Member Alexander said: “My primary goal with this legislation is to erase the confusion over who regulates pharmacies and manufacturing facilities, and make it clear exactly who oversees each business. Putting one agency on the flagpole for each of these businesses will mean greater safety for American families, so they don’t have to question whether the drugs they take are safe.”

“I am proud of the work we have done to craft a solution that protects patients, while preserving the practice of traditional pharmacy compounding,” Roberts said. “After reviewing stakeholder comments, we made a concerted effort to address their concerns in this legislation. This bipartisan bill is balanced, clear and will leave no questions about the regulatory oversight of compounded drugs. I urge my colleagues to support it.”

"We've seen far too many deaths in Minnesota, and nationwide, because some pharmacies in this country have acted more like drug manufacturers – without following rigorous safety rules that drug manufacturers must follow,” said Sen. Franken. “This bipartisan legislation will keep Minnesotans safe by ensuring that drug manufacturers have appropriate oversight, and that responsible pharmacies don't see any unnecessary restrictions."

In addition to distinguishing between pharmacies and manufacturers, and clarifying proper oversight of each, the legislation sets forth requirements on compounding manufacturers. Compounding manufacturers must register with the FDA and tell the agency what products they have made; make products under a pharmacist’s oversight and in compliance with good manufacturing practices; and investigate and report when things go wrong.

The bill allows FDA to identify categories of drugs that currently cannot be safely compounded; preserves and enhances current protections regarding the ingredients from which drugs are compounded; and preserves the line between compounding manufacturers and traditional manufacturers by placing prohibitions on wholesale distribution of compounded products.

The legislation also encourages communication among states and increases communication between states and the FDA. FDA will designate a point of contact for a State Board of Pharmacy to notify the agency if it appears that a state-licensed business should be registered as a compounding pharmacy. The FDA must notify the state within 15 days if it determines that business is a compounding manufacturer.

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