FDA Extends Enforcement Discretion for Dispensers But Law Still in Effect

The FDA has just announced that it will extend DSCSA enforcement discretion for dispensers until March 1, 2016. This is primarily due to concerns that some smaller, independent dispensers need additional time to prepare, and indicates that the FDA is intent on ensuring that every US dispenser is fully equipped to comply with the law.

In today’s notification, the FDA reiterated that while they do not intend to take action against dispensers who are not currently receiving, capturing, and maintaining required compliance information, the law is still in effect and has been since July 1, 2015. Given that, all dispensers need to have a compliance plan and solution in place as soon as possible. State and other government officials are not bound by the FDA’s enforcement discretion and may conduct inspections at any time. In addition, should a drug integrity issue with patient consequences arise between now and March 1, 2016 the FDA would be obligated to investigate regardless of the enforcement discretion.

Lastly, dispensers who also loan, borrow, or resell product are subject to wholesale distributor requirements and timelines. Dispensers who move product downstream in these ways are not covered by the current enforcement discretion and should be prepared for inspections at any time.

If your pharmacy or hospital does not have a DSCSA lot level solution in place, the time to select one is now. TraceLink's experience in working with hundreds of pharmacy and hospital dispensers tells us that preparing for DSCSA compliance is more complex than most organizations expect. While it is possible to get up and running more quickly, the average dispenser needs six weeks to implement their solution between organizational planning, information gathering, and solution implementation.

Learn how TraceLink provides a single, cost-effective solution to seamlessly manage all of your DSCSA compliance needs, and find out about special programs for members of Novation, Yankee Alliance, and other GPO partners.