FDA Announces "Track and Trace" Delay Until November 1, 2015
Wednesday, July 1, 2015
The U.S Food and Drug Administration (FDA) announced a four month enforcement delay on dispenser requirements under the Drug Supply Chain Security Act (DSCSA), commonly referred to as "Track and Trace". Enforcement on the DSCSA requirements for dispensers are now set to begin on November 1, 2015.
The FDA announced that it "does not intend to take action against dispensers who, prior to November 1, 2015":
- accept ownership of product without receiving product tracing information, prior to or at the time of a transaction, or
- do not capture and maintain the product tracing information
This enforcement delay DOES NOT affect the following requirements for dispensers, which went into effect on January 1, 2015:
- Dispeners must only accept product from licensed manufacturers, wholesale distributors, or other pharmacies.
- Dispeners are to develop processes to inspect, quarantine, investigate and notify FDA and immediate trading partners of suspect product
In a joint letter submitted to FDA on June 22nd, the American Pharmacists Association, National Alliance of State Pharmacy Associations, and National Community Pharmacists Association requested a delay of enforcement of a July 1 product tracing deadline for dispensers to help avoid any potential disruptions in the pharmaceutical supply. Click here to read the joint letter.
The PSSNY Board of Directors has been working to identify solutions to offer to the membership to assist in compliance with the DSCSA. Stay tuned for more information on these solutions.
Guidance documents and a recorded webinar are available