Mixing track-and-trace, compounding: Would bill unfairly burden pharmacies?

Big data finds another application and another supporter. Sort of.

The full Senate will shortly take up a new track-and-trace bill (S. 959), which would establish a national system for tracking the pedigree and movement of most pharmaceuticals, from point of manufacture and distribution to the dispensing pharmacy and the patient at the end of the supply chain. The goal: to replace the hodge-podge of different state laws with a single, nationwide track-and-trace system capable of capturing the daily flood of drug production, distribution, dispensing and utilization data and channeling it into an accessible tool by which stakeholders and regulators could secure the pharmaceutical supply chain.

All well and good, says the National Community Pharmacists Association, the biggest lobbying group for independent pharmacy. But the NCPA is unhappy with a provision of S. 959 that would significantly beef up federal oversight of pharmacy-based drug compounding in the wake of a deadly outbreak of fungal meningitis last year whose source was traced to the New England Compounding Center.

In a statement July 25, NCPA CEO Doug Hoey praised Congress’ new effort to secure the drug supply network. But Hoey also expressed “serious concerns” with the legislation. The bill, he said, “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.

“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,” Hoey added. Hoey suggests that lawmakers split the proposed bill in two, separating the track-and-trace legislation from a new, more carefully considered effort to address the meningitis outbreak and compounding safety.

Are NCPA’s reservations justified? Do the additional FDA reporting requirements for drug compounding represent a new burden on pharmacies and a new hurdle for patient access to needed medicines? Click on the comment link to share your thoughts.

Login or Register to post a comment.