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“DEA Reverses Decision to Change Registration Policy”

DEA Chronicles By Larry P. Cote

We recently reported that the Drug Enforcement Administration (DEA) was changing its longstanding policy of allowing for a grace period for registrants who file an untimely application for renewal. This notice was posted on the homepage of DEA’s Office of Diversion Control’s website.

A Revised Announcement Regarding Renewal Applications is now posted on DEA’s website indicating that, except for one minor change, DEA is retaining its current policy and procedures regarding registration renewals. The announcement now reads:

Starting January 2017, DEA will no longer send its second renewal notification by mail. Instead, an electronic reminder to renew will be sent to the email address associated with the DEA registration.

At this time, DEA will otherwise retain its current policy and procedures with respect to renewal and reinstatement of registration. This policy is as follows:

  • If a renewal application is submitted in a timely manner prior to expiration, the registrant may continue operations, authorized by the registration, beyond the expiration date until final action is taken on the application.
  • DEA allows the reinstatement of an expired registration for one calendar month after the expiration date. If the registration is not renewed within that calendar month, an application for a new DEA registration will be required.
  • Regardless of whether a registration is reinstated within the calendar month after expiration, federal law prohibits the handling of controlled substances or List 1 chemicals for any period of time under an expired registration.

While a DEA registration number will not automatically be retired if a renewal application is not timely submitted, DEA warns that the registration is not valid during the grace period until it is reinstated by the agency. What remains to be seen is whether the filing of a renewal application during the one-month grace period automatically reinstates the registration number or whether DEA must adjudicate the renewal application before the number becomes valid. On a related note, what happens to a DEA registration number if the registrant files a renewal application during the grace period and DEA fails to adjudicate the application before the end of the month?  Is the number still valid?

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