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How Up-To-Date are You with the Changes in DEA Regulations?

The DEA not only implements the rules and regulations for controlled substances, but also amends them from time to time. All DEA registrants have to stay tuned with the regulations and updates with full compliance.

Certain drugs are heavily regulated in USA due to their potential for misuse and abuse that can lead to grave consequences ranging from addiction to even death. Therefore, anyone who handles controlled substances – be it manufacturers, importers, exporters, distributors, pharmacists, physicians or other healthcare providers – need to first register with the Drug Enforcement Administration (DEA).

The DEA is a federal authority charged with the responsibility of regulating all aspects of handling the scheduled drugs under the Controlled Substances Act. It issues the DEA controlled substance licenses based on specific conditions and monitors compliance with the regulations on a continuous basis.



Changes in DEA Regulations


Not only are there myriad rules and regulations, but the DEA even amends them from time to time to control drug diversion and other illegal activities. For instance, a recent update requires all applications for DEA registrations, and renewal of those registrations, to be submitted online. This came into effect from 11th May, 2022 in a bid to mitigate issues created by paper applications. The aim is to simplify the process of submitting applications for new registrations and renewal for current registrations for registrants. Prior to this, the applications could be submitted either through a secure online portal or delivered to the DEA Headquarters.

Another important update in the recent past relates to the mandating of physical signatures on all prescriptions. The DEA has specified that paper prescriptions- including prescriptions created on paper, generated by computer, printed out or faxed by a practitioner - must be manually signed by the prescribing practitioner (who has to be licensed by the DEA).

Then again, having a current and active email address listed on the registration has become a must for all registrants as the DEA will be sending important information electronically. In fact, from June 2020, the authority has ceased sending renewal notifications by US Postal Service. Only electronic reminders for renewal are sent at 60, 45, 30, 15 and 5 days prior to the expiration date of the registration to the associated email address.

For queries and clarifications related to registration, registrants can call the DEA Registration Service Center at 1-800-882-9539 (8:30 am-5:50 pm ET) or email at dea.registration.help@dea.gov along with the DEA registration number.

Alternatively, both applicants and registrants can use the services of professional compliance services providers – like Titan Group. They are well-versed with the DEA regulations and amendments – be it controlled substance license registration, renewal, recordkeeping, ordering, disposal, audits and other criteria – and can provide full assistance to ensure that there is complete compliance at all times. The expert services cover everything from making changes to a DEA registration to training staff to face an unannounced audit or inspection to even minimizing the fallout of inadvertent non-compliance!
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