NCPA Testifies at Congressional Hearing on Compounding Regulations

Published Online: Tuesday, July 16, 2013
Follow Pharmacy_Times:
PRESS RELEASE

ALEXANDRIA, Va. (July 16, 2013) – Today, National Community Pharmacists Association (NCPA) CEO B. Douglas Hoey, RPh, MBA, testified at the U.S. House of Representatives Energy and Commerce Subcommittee on Health’s hearing on “Reforming the Drug Compounding Regulatory Framework.”  His remarks focused on discussion draft legislation offered by U.S. Rep. Morgan Griffith (R-Va.) that seeks to address the concerns raised by the New England Compounding Center’s (NECC) fungal meningitis tragedy late last year. 

“NCPA supports the approach of Rep. Griffith’s discussion draft as it is not a broad expansion of FDA power over historically state-regulated pharmaceutical compounding but, to the contrary, strikes a proper balance of making certain that future tragedies are avoided while also preserving patients’ access to vital compounds,” said Hoey. “Representative Griffith’s discussion draft recognizes that pharmacist compounding is an integral part of the pharmacy profession and meets patients’ needs in a variety of care settings. When manufactured drugs aren't an option, independent community pharmacists prepare customized medications for patients in accordance with a prescriber’s prescription based on the patient's individual needs.”

The provisions in the discussion draft that NCPA supports include:
  • Preserving state Board of Pharmacy oversight over pharmacy compounding;
  • Maintaining anticipatory compounding and office use in instances where state law allows; and
  • Recognizing the need to strengthen the lines of communication between the state Boards of Pharmacy and the Food and Drug Administration (FDA).
NCPA also expressed concerns about three particular legislative proposals circulating that would:
  • Grant FDA unrestricted authority over a “do not compound” list, which could impact patient access to  compounded drugs such as hormone medications, thyroid preparations, promethazine gels, and medications to treat autism;
  • Require burdensome notification requirements from pharmacies to the FDA when compounding medications are in short supply, which could further exacerbate the impact of drug shortages while undercutting the oversight role of state Boards of Pharmacy; and
  • Exempt pharmacies within health systems from compounding standards, which sets up a dichotomy of care where patients are not assured they are receiving safe, customized medications regardless of where the patients obtain these compounded medications.
“Throughout Congress’ efforts to determine the best course of action for preventing another NECC tragedy from occurring, NCPA has been a constructive force to find the best solution,” said Hoey. “We believe patient access to compounded medications must be preserved and that Rep. Griffith’s proposal is the best approach going forward.”
Related Articles
The National Community Pharmacists Association announced today that 3 teams of pharmacy students have been named finalists in the 2015 Good Neighbor Pharmacy NCPA Pruitt-Schutte Student Business Plan Competition.
The $200 million fund created to compensate victims of the 2012 meningitis outbreak tied to tainted drugs is an extreme example of how expensive compounding errors can be.
For many pharmacy organizations, the Supreme Court King v. Burwell decision upholding the Affordable Care Act’s tax subsidies fended off potential confusion for patients concerning health insurance.
With prescription drug prices rising above reimbursement rates, many pharmacists are seeing patients struggle to access generic drugs.
Latest Issues
$auto_registration$