TRACK-&-TRACE LAW UPDATE

The FDA has decided not to create an exemption to the Drug Supply Chain Security Act (aka the track-and-trace law) for 340B contract pharmacy arrangements.  The exemption, which was requested by 340B Health and other associations, would have required wholesalers to send product tracing information to the contract pharmacy instead of the covered entity.  In response to the request, the FDA issued two consecutive four-month enforcement delays before notifying us on March 1 that the agency had decided not to establish an exemption.

For more information, visit www.340bhealth.org