Those applying for DEA registration and existing registrants have to keep abreast of the changes in the regulations to ensure that they do not run afoul even unintentionally on any occasion.
The U.S. law clearly mandates that every physician, nurse, veterinarian or pharmacist that prescribes, administers or dispenses controlled substances should have a controlled substance license registration issued by the federal Drug Enforcement Administration (DEA).
Any person can apply for the DEA license using the DEA Form 224. Manufacturers, distributors, researchers, importers and exporters should use DEA Form 225. Complete instructions accompany the forms. These forms are available on the DEA website and could also be obtained by contacting the DEA field office or headquarters.
However, since May last year, the DEA regulations have been amended to require all applications for both DEA new registration and renewal to be submitted online only. Indeed, from 11th May, 2022, the DEA has stopped accepting hard copies of the forms and made online submission mandatory for all applicants.
Two years prior to this change, in June 2020, the DEA had also discontinued the practice of sending renewal of registration notifications by post. Since then, the federal agency is sending electronic reminders 60, 45, 30, 15 and 5 days prior to the expiration date of the registration to the associated email address.
In fact, it is also mandatory for registrants to have a current and active email address listed on their registration in order to receive this and other important information from the DEA.
Any person can apply for the DEA license using the DEA Form 224. Manufacturers, distributors, researchers, importers and exporters should use DEA Form 225. Complete instructions accompany the forms. These forms are available on the DEA website and could also be obtained by contacting the DEA field office or headquarters.
However, since May last year, the DEA regulations have been amended to require all applications for both DEA new registration and renewal to be submitted online only. Indeed, from 11th May, 2022, the DEA has stopped accepting hard copies of the forms and made online submission mandatory for all applicants.
Two years prior to this change, in June 2020, the DEA had also discontinued the practice of sending renewal of registration notifications by post. Since then, the federal agency is sending electronic reminders 60, 45, 30, 15 and 5 days prior to the expiration date of the registration to the associated email address.
In fact, it is also mandatory for registrants to have a current and active email address listed on their registration in order to receive this and other important information from the DEA.
Other DEA Rule Changes
As of 30th October, 2021, the DEA implemented the mandatory use of a single sheet DEA 222 order form (used for ordering Schedule II controlled substances) and discontinued the practice of triplicate order forms. These are no longer available or usable and all DEA registrants were required to relinquish any unused triplicate order forms to the DEA Registration Section.
Another DEA regulations requires that computer-generated prescriptions for controlled substances in any schedule that are printed out or faxed by the practitioner must be signed manually. While pharmacies can still dispense oral or not-manually-signed prescriptions for Schedule III, IV and V drugs in emergency situations, the rules are more restrictive for Schedule II substances due to the higher potential for abuse and/or dependence.
The Last Word
It can get extremely taxing for a DEA registrant to take care of the regular business while keeping track of the DEA requirements, not to mention the constant changes in rules. Here, a professional compliance service provider – like Titan Group can prove to be very handy.
The compliance experts can take care of everything from obtaining the DEA controlled substance licenses to ensuring that the practice always stays in complete compliance with the DEA. This will include all the nitty-gritties like staying abreast with the DEA announcements and other changes apart from training the staff to handle audits and investigations by the DEA. Indeed, this is one prudent investment that will pay off in terms of business security and public confidence!
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