Addressing the fungal meningitis outbreak, APhA sent a letter dated November 1 to the U.S. Senate Committee on Health, Education, Labor, & Pensions (HELP Committee) regarding appropriate regulations of pharmacy compounding.
“Despite news stories that continue to blame ‘compounding,’ the tragedy that continues to unfold from the apparent large scale unauthorized and unlicensed manufacturing in Massachusetts was not the result of poor compounding,” the Association wrote in response to an October 26 set of questions for stakeholders from the HELP Committee. “Rather, the manufacture and distribution of large quantities of sterile products to non-patient recipients for resale or administration in multiple states is just that—manufacturing. The pharmacists of America are prepared to support legislators and regulators in our collective desire to promote enhanced public health and safety.”
The Association’s 14-page letter described 2008 policies established through its House of Delegates process that address the differences between compounding and manufacturing. The majority of the letter consisted of responses to a series of questions posed by the HELP Committee.
In response to a HELP Committee question on “what state or federal laws or regulations could have and should have been used to prevent the New England Compounding Center tragedy from happening,” APhA wrote, “While not all the facts have been established, based on our understanding of the situation, both the Massachusetts Board of Pharmacy and FDA had the respective regulatory authority to act on compliance concerns and previous warning letters. From all reports the New England Compounding Center (NECC) was in violation of a myriad of existing laws and regulations. These violations are the apparent cause of the cascade of issues that resulted from distribution of products created by NECC.”
Continued APhA, “As evident in reports in this case, it appears that the company crossed the line from traditional compounding pharmacy (regulated by boards of pharmacy) into manufacturing (regulated by FDA) but clear and existing regulations were not invoked and enforcement options may not have been pursued.”
The Association supported increased resources for state boards of pharmacy and FDA to enforce existing laws. “While it does not diminish the magnitude of the transgressions by NECC in this case, we are concerned that the lack of resources related to staff, inspectors and inspector education/training for either FDA or the Board of Pharmacy authority to act on such concerns and perform follow-up inspections contributed to lack of enforcement and patient safety issues,” the letter added. “Due to budgetary constraints, we see many state boards without the resources to conduct even cursory inspections of pharmacies, let alone having the expertise to inspect specialized facilities that prepare sterile products.”
“APhA is committed to our longstanding work with state boards of pharmacy, FDA, Congress, our colleague pharmacy organizations, physicians, and other stakeholders in ensuring good compounding practices and standards are enforced to ensure patient safety and patient access to appropriately compounding products,” APhA wrote. “We support the Committee’s efforts to address compounding oversight and regulatory authority and would appreciate the opportunity to be a resource for the Committee as compounding discussions evolve.”
The HELP Committee has scheduled a hearing, Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak, for November 15 at 10:00 am. Represented will be CDC, FDA, and the Massachusetts Department of Public Health on Panel I; the New England Compounding Center on Panel II; and International Academy of Compounding Pharmacists and American Society of Health-System Pharmacists on Panel III.