Moving the HME Industry Forward

Legislative/Advocacy

Pharmacists Say Bill Enhances Drug Supply Security, But Threatens Patient Access

August 5, 2013

ALEXANDRIA, VA – Officials at the National Community Pharmacists Association (NCPA) expect Senate Bill S. 959 to be considered soon in the full Senate. NCPA advocates are particularly concerned that the bill would grant FDA unrestricted authority to establish a list of “do not compound” medications which, based on FDA interpretation, could impact patient access to compounded drugs.

B. Douglas Hoey, RPh, MBA, praised the bill’s ability to possibly enhance the security of the U.S. pharmaceutical supply chain by adopting national standards and policies, sometimes referred to as ‘track-and-trace,’ in place of a patchwork of conflicting state laws. These federal track-and-trace rules, however, must achieve a common-sense balance between the need for enhanced patient safety and minimizing unreasonable burdens on supply chain stakeholders.

“NCPA appreciates the sensitivity of Senate and House lawmakers to try and avoid potentially burdensome legislative requirements that may uniquely impact small business community pharmacies, compared to national corporations with large compliance departments,” says Hoey, CEO of the NCPA. “NCPA has worked tirelessly to balance supply chain safety without adding onerous requirements on small business pharmacies.”

Community pharmacies already struggle with growing regulatory mandates, yet the legislation would also require pharmacies to notify FDA, rather than their state Board of Pharmacy, when compounding medications already recognized by FDA as being in short supply.

The NCPA is disappointed that the Senate is avoiding regular order to “force through” the controversial provisions included in S. 959 without what the advocates say is adequate consideration, debate, or amendments. “NCPA staff spent countless hours working with Senators and Senate staff to educate them about these concerns,” says Hoey. “We are grateful that, as a result, the legislation is substantially improved; however, serious concerns remain with the legislation.” 

Hoey recommends that lawmakers split S. 959 into two separate bills, one dealing with supply chain safety and the other addressing the meningitis outbreak. Pharmaceutical stakeholders support the approach to enhancing supply chain integrity taken in S. 959. By contrast, significant questions remain regarding the compounding provisions included in S. 959.