“This legislation is a significant step forward in protecting the public from unsafe compounded products,” Sen. Tom Harkin (D-Iowa), one of the draft bill's sponsors, said in a statement. “By clarifying FDA authority over high-risk compounding practices, this bill will enhance protections for patients taking compounded drugs and help prevent crises like last year's tragic meningitis outbreak.”
Other sponsors include Sens. Lamar Alexander (R-Tenn.), Al Franken (D-Minn.) and Pat Roberts (R-Kan.).
The draft legislation would define compounders that mix sterile drugs without a prescription and sell those drugs across state lines as manufacturers, which would make them subject to regulation by the FDA.
So-called “compounding manufacturers” would have to register with the FDA, inform the agency about drugs they develop, investigate and report adverse events, and include a label that indicates the drugs have been compounded.
The draft legislation would exempt health systems that share sterile products among a system's hospitals, including in instances where systems have hospitals in more than one state.
States would continue to oversee traditional compounders that mix drugs for a specific patient.
The International Academy of Compounding Pharmacies said in an e-mailed statement that it was concerned about several elements of the draft bill, noting that “the term 'compounding manufacturer' and several of the definitions of that new category creates more confusion and further blurs the jurisdictional authority of regulators.”
“Most importantly, IACP is gravely concerned that compounding pharmacies located in hospitals and health systems have been exempted from many of the proposed changes,” the group said. “Such an exemption denies patients and their families the assurance, regardless of where they receive their medications, of the quality and safety that they deserve.”
There have been an increasing number of concerns about the quality and safety of compounded drugs in the supply chain.
Many hospitals have said they purchased drugs in short supply from compounders as drug shortages have worsened in recent years. The draft bill would continue to allow traditional compounders to mix FDA-approved drugs in short supply.
A spokeswoman for the American Hospital Association said in an e-mail that the draft bill “looks like it's a step in the right direction.”
The FDA has boosted surprise inspections of pharmacies expected to be operating large-scale, high-risk compounding businesses that cross state lines and has reported deficiencies at 31 compounders from inspections conducted this year.
“FDA appreciates the Senate HELP committee's bipartisan commitment to addressing this important public issue,” a FDA spokesman said in an e-mail. “We are currently reviewing the draft legislation and look forward to continuing to work closely with the committee to address existing limitations in the law.”
Follow Jaimy Lee on Twitter: @MHjlee
