As the Senate Health, Education, Labor, and Pensions (HELP) Committee put the final touches on legislation that would give the FDA new powers to regulate pharmacy compounding, stakeholders issued mixed reviews on whether the bill does enough to ensure patient safety.
One major feature of the bill is to exempt hospital pharmacies from regulations that prohibit compounding batches of drugs without patient-specific prescriptions. Although the exemption was applauded by the American Society of Health-System Pharmacists (ASHP), others were not as sanguine.
The exemption is “a terrifying part of the legislation,” said Eric Kastango, RPh, MBA, the president and chief executive of Clinical IQ. The bill “will drive more compounding into
facilities that don’t have the expertise to ... comply with USP Chapter <797>. It’s only a matter of time before we have a catastrophic event in a hospital because of poor oversight.”
During a May 9, 2013, HELP committee hearing, Kasey Thompson, ASHP’s vice president of policy, planning and communications, offered a far more positive view. “Simply put, we believe the committee got it right with this proposed legislation,” he said. “It is critical to make the distinction between health systems—which are fully accountable for the comprehensive care of the patient—and a ‘compounding manufacturer’ that prepares and sells its products across state lines without a prescription or knowledge of the patient to a third party for administration.”
Mr. Thompson also suggested that the exemption should be extended to include ambulatory clinics and infusion centers under a health system’s control.
The Bill in Detail
The “compounding manufacturer” category that Mr. Thompson cited in his testimony is at the heart of the new legislation. Known as the “Pharmaceutical Compounding Quality and Accountability Act,” (S 959), it is one of several bills introduced following last year’s illnesses and deaths associated with the New England Compounding Center (NECC). The new bill would give the FDA authority to oversee compounding manufacturers as a new category that would include companies that prepare sterile products without, or far in advance of, patient-specific requests from prescribers and then ship the products across state lines. Currently, state pharmacy boards oversee such facilities, in addition to smaller and hospital-based compounding entities.
Hospital and health-system pharmacies, regardless of their size, would be exempt from being considered to be compounding manufacturers, even if they do ship products to their affiliates in other states. In contrast, entities (other than a hospital or health system) that pool sterile products, or that repackage sterile, single-use, preservative-free vials, would be categorized as compounding manufacturers and thus fall under the regulatory eye of the FDA. And such manufacturers could not be licensed as pharmacies in any state.
Among other requirements of the legislation, compounding manufacturers must register with the FDA and be inspected according to a risk-based schedule; prepare products under a state-licensed pharmacist’s oversight and in compliance with current good manufacturing practices; file reports with the FDA every six months; and report adverse events within 15 days and do follow-up investigations and label their products as being compounded and not for resale. These companies also would pay an annual $15,000 “establishment fee” to help defray the costs of FDA inspections and regulation. (Companies with no more than $1 million in annual gross sales would pay $5,000.)
The new legislation “is a significant step forward in protecting the public from unsafe compounded products,” said HELP committee chairman Sen. Tom Harkin (D-IA). “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,” Mr. Harkin said during the committee hearing. Other bill sponsors include ranking committee member Lamar Alexander (R-TN) along with committee members Al Franken (D-MN), Barbara Mikulsi (D-MN), Pat Roberts (R-KS), and Elizabeth Warren (D-MA).
IACP Not a Fan
The International Academy of Compounding Pharmacists (IACP) strongly disagreed that health-system pharmacies should be exempt from rules preventing batch preparation. “We would note that health systems were the primary client of NECC and they purchased these injections in large quantities without a patient script and without a doctor’s order,” said David G. Miller, IACP’s executive vice president and chief executive. “All legislation or regulation pertaining to compounding should cover all pharmacy practices, whether they are freestanding or located within a hospital or health care facility.” The exemption is “especially questionable in light of the volume and types of compounding done in hospital pharmacies, a substantial amount of which includes sterile compounded preparations,” he said in written testimony.
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