Groups push FDA for delay on Track and Trace regulations

ALEXANDRIA, Va.  — Pharmacy organizations, including, The American Pharmacists Association, National Alliance of State Pharmacy Associations and National Community Pharmacists Association, called on Food and Drug Administration officials to delay enforcement of a July 1 electronic product-tracing deadline for prescription drug dispensers, to “help avoid any potential disruptions in the pharmaceutical supply chain,” the groups noted in a joint letter to FDA.

“With the December, 2014 FDA enforcement discretion delaying enforcement of the product tracing requirements until May 1, 2015, this implementation timetable has been compressed,” the groups wrote in a June 22 letter to FDA deputy director, office of compliance, Dr. Ilisa Bernstein.

“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 letter said. “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. 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.”

To read the full letter, click here.