FDA Limits Ongoing Dispenser Enforcement Discretion To First Responders

iStock_000022846474_smallerBack in October the FDA announced the extended use of enforcement discretion to temporarily set aside the data exchange provisions of the Drug Supply Chain Security Act (DSCSA) for dispensers until March 1, 2016 (see “FDA Extends Dispenser Delay in DSCSA Enforcement“).  That was itself an additional four month extension to the four month enforcement discretion they originally announced on June 30 (see “FDA Publishes New Guidance Delaying Dispenser 3T Requirements Until November 1, 2015“).  Many dispensers were hoping for another extension in these last few days of February.  It turns out, the enforcement discretion will be extended until further notice, but apparently mostly just for first responders.

This morning, the FDA posted new guidance called “Requirements for Transactions With First Responders Under Section 582 of the Federal Food, Drug, and Cosmetic Act–Compliance Policy; Guidance for Industry“.  In this document the FDA acknowledges that  “…transactions between dispensers and first responders may present challenges related to compliance with certain requirements in section 582 of the FD&C Act related to the exchange of product tracing information, conducting business only with authorized trading partners, and having verification systems in place.”

And so:

To minimize possible disruptions to the activities of first responders, FDA does not intend to take action against certain trading partners and first responders as described in the guidance. This compliance policy is in effect until further notice by FDA.

The guidance is in effect immediately and with no end date specified, but the FDA has also opened a docket to collect comments on this action.  To submit a comment, or to read those from others, go to http://www.regulations.gov and search for docket number FDA-2016-D-0631.

Unless the FDA posts a separate guidance today that extends the period of enforcement discretion over the DSCSA data exchange provisions for other dispensers, this appears to mean that all other dispensers not mentioned in today’s guidance must begin complying with those provisions tomorrow, March 1, 2016.  Watch the FDA website, or RxTrace for notice of any other extensions.