UPDATED: New DEA registration requirements as of January 1

DEA will end grace periods and adopt tougher policies to renew controlled substance registrations

DEA has released a notice that could have serious implications for pharmacists, prescribers, researchers, manufacturers, distributors, and others registered to dispense or otherwise access controlled substances.

According to the notice, as of January 1, 2017, DEA will only send out one renewal notification letter, by mail, approximately 65 days prior to the expiration date. The letter will be sent to the “mail to” address for each DEA registrant. Failure to renew prior to the expiration date will result in the original DEA registration not being reinstated. DEA’s notice also clarifies that, as of January 1, 2017, renewal applicants will need to apply for new DEA registration if attempting to renew after the expiration date or if DEA has not received paper renewal applications by the day of expiration. Consequently, prescriptions written and dispensed for controlled substances by registrants whose license has expired will be implicated.

While DEA does not require pharmacists to verify the registration status of prescribers, the upcoming DEA registration changes could put pharmacists in violation of state, federal, and payer regulations or policies. Prescriptions filled based on orders from providers whose registration has expired could be classified as false claims and may not be reimbursed by payers. The reports associated with these prescriptions could also be judged invalid by state prescription drug monitoring programs.

APhA and other stakeholders will send a letter to DEA expressing concerns that the registration changes may harm pharmacists, prescribers, and patients.

UPDATED December 21, 2016:

DEA wavers on registration renewal requirements
DEA will maintain grace periods and other policies regarding registration renewals

On December 20, DEA released a notice that clarifies DEA’s renewal process. The December 20 notice is a welcome change for pharmacists because DEA’s previous policy—which was quietly released in the fall of 2016 and was to be implemented January 1, 2017—was much more stringent and created significant concerns for pharmacists and other DEA registrants, as it removed a grace period to renew expired registration and modified notice procedures, among other changes to the renewal process. DEA’s new policy, which will be effective January 2017, clarifies that for registrants whose registrations are nearing expiration, DEA will send an electronic reminder to renew to the e-mail address associated with the DEA registration. The December 20 notice also clarifies that DEA will “retain its current policy and procedures with respect to renewal and reinstatement of registration.”

Several stakeholders expressed opposition to DEA regarding the fall 2016 policy change as it would have negative implications for registrants and paitents. Such advocacy efforts were likely factors DEA considered when deciding to redact its policy.  APhA will continue to monitor the issue, but applauds DEA’s decision to maintain its current policy.

Jenna Ventresca, JD, APhA Associate Director of Health Policy