NCPA Commends FDA Enforcement Discretion on ‘Track & Trace' Requirement

June 30, 2015

National Community Pharmacists Association CEO B. Douglas Hoey, RPh, MBA issued the following statement in response to industry guidance published today by Food and Drug Administration.

PRESS RELEASE

ALEXANDRIA, Va. (June 30, 2015) — National Community Pharmacists Association (NCPA) CEO B. Douglas Hoey, RPh, MBA issued the following statement in response to industry guidance published today by

Food and Drug Administration (FDA) officials indicating that the agency would give pharmacies until November 1, 2015 — an additional four months – to comply with product tracing requirements scheduled to take effect tomorrow, July 1, 2015:

“Pharmacists appreciate and support the FDA’s decision announced today, which will help protect patients from disruptions in access to prescription drugs that may have otherwise and inadvertently occurred. Due to circumstances beyond their control, many pharmacies would have had difficulty complying with the July 1 statutory deadline. The FDA’s latitude should hopefully allow pharmacies to continue to work with their wholesaler partners in order to achieve compliance with new product tracing requirements intended to enhance the safety of the U.S. pharmaceutical system.

“We appreciate the partnership among organizations and companies representing pharmacists, pharmacies, wholesalers and other supply chain entities to educate FDA on industry dynamics and to continue moving forward with smooth implementation of this legislation. NCPA will continue to monitor this issue and support community pharmacists’ efforts to make the law a success.”