Pharmacy Groups Ask FDA to Delay Enforcement of ‘Track & Trace' Requirement

June 24, 2015

Three leading pharmacy organizations have asked the FDA to help avoid any potential disruptions in the pharmaceutical supply chain by delaying enforcement of a July 1 product tracing deadline.

PRESS RELEASE

ALEXANDRIA, Va. (June 24, 2015) —

Three leading pharmacy organizations have asked the Food and Drug Administration (FDA) to help avoid any potential disruptions in the pharmaceutical supply chain by delaying enforcement of a July 1 product tracing deadline for dispensers. The American Pharmacists Association,

National Alliance of State Pharmacy Associations and National Community Pharmacists Association made the request 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. 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,” leaders of the three organizations wrote. “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.”

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to view a copy of the full letter.