Leading pharmacy groups ask FDA to delay product requirements

Three pharmacy organizations have asked the U.S. Food and Drug Administration (FDA) to delay enforcement of the "track & race" requirement.

The American Pharmacists Association, National Alliance of State Pharmacy Associations and National Community Pharmacists Association sent a joint letter to the FDA asking it to help avoid any possible disruptions in the pharmaceutical supply chain by delaying enforcement of a July 1 product-tracing deadline for dispensers.

“With the December 2014 FDA enforcement discretion delaying enforcement of the product tracing requirements until May 1, 2015, this implementation timetable has been compressed,” NCPA CEO Douglas Hoey, APhA Executive Vice President and CEO Thomas E. Menighan and NASPA Executive Vice President and CEO Rebecca P. Snead said in the letter. “Our organizations remain concerned that despite the extensive efforts by pharmacy and wholesale distributor associations to educate dispensers, some trading partners will encounter challenges beyond their control, with the possible outcome of disruptions in the supply chain.”

The leaders of the three organizations asked the FDA to forestall the potential disruptions to prevent product shortages and to allow patients access.

“In order to forestall potential disruptions in the pharmaceutical supply chain, the undersigned organizations respectfully request that FDA utilize its enforcement discretion to delay the July 1 product tracing deadline for dispensers,” they wrote. “Our members fully intend to continue intense, concerted efforts toward full compliance, but by exercising its enforcement authority, FDA would allow progress to continue while minimizing the risk of product shortages or disrupting patient access to prescription drugs.”