DEA Practitioner's Manual: Detailed Guidelines on Certificate of Registration and Other Requirements
Who Needs to Register?
If you're a practitioner involved in administering, prescribing, or dispensing controlled substances classified in Schedules II through V, registration with the Drug Enforcement Administration (DEA) is mandatory. Additionally, a state license is a prerequisite for DEA registration.
Registration Process
To initiate registration, complete DEA Form 224. For renewals, use Form 224a. Both the application and renewal fees are outlined on the respective forms. Importantly, as of April 11, 2022, only online submissions are accepted for both initial registration and renewals.
Multiple Locations Requirement
Practitioners must obtain separate DEA registrations for each principal place of business, defined as a single geographical location where controlled substances are dispensed.
New Opioid Treatment Regulations
Recent amendments require "qualified practitioners" to fulfill specific conditions for treating patients with Opioid Use Disorder (OUD). Qualified practitioners must attest to having fulfilled certain training requirements concerning the treatment and management of patients with OUD or other Substance Use Disorders (SUDs).
Record-Keeping for Training
Although there is no obligation to provide training records to the DEA at the time of registration or renewal, it's advised to maintain these for potential future verification.
Training Resources
The DEA doesn't provide or endorse training modules. For training resources, practitioners may refer to SAMHSA’s website.
Address Specifications
The DEA requires the business address to be provided during the application or renewal process. This address is listed on the Certificate of Registration (DEA Form 223), which must be kept readily accessible at the registered location. Note that if the principal place of business is also a residence, it will be treated as a controlled premise subject to DEA inspection.
Mailing Address
A separate mailing address should be provided for receiving DEA correspondence. This address won’t appear on the Certificate of Registration unless it's identical to the business address.
Initial Inventory
Upon receiving the Certificate of Registration, practitioners are required to take an initial physical inventory of all controlled substances in possession.
Certificate of Registration (DEA Form 223)
A practitioner must maintain the Certificate of Registration at the registered location, making it readily available for official inspection, as stipulated by 21 CFR 1301.35(c). If a duplicate is needed, various channels are available:
- Download from the DEA website
- Contact DEA Headquarters at 1-800-882-9539
- E-mail a request to Registration.Help@dea.gov
- Reach out to the local DEA Registration Specialist
The certificate is valid for 36 months, but the initial registration period may range from 28 to 39 months, as explained in 21 CFR 1301.13(d).
Multiple Location Requirements
A separate DEA registration is mandatory for each principal place of business where controlled substances are administered, stored, or dispensed (21 U.S.C. 822(e)(1); 21 CFR 1301.12(a)). Exceptions exist: for instance, if a practitioner is registered at one location in a state, additional registration is not required for other locations within that state where only prescribing occurs (21 CFR 1301.12(b)(3)). For veterinarians, the Veterinary Medicine Mobility Act of 2014 created another exception (21 U.S.C. 822(e)(2)).
Registration Exemption for Agents and Employees
Per 21 CFR 1301.22(b), individual practitioners employed by another DEA-registered practitioner may administer or dispense controlled substances under the employer's registration if permitted by the state. This exemption doesn't extend to prescribing.
Use of a Hospital’s DEA Registration
Under specific conditions, individual practitioners can use the DEA registration number of their employing hospital or institution (21 CFR 1301.22(c)). These conditions include authorization by the jurisdiction, verification by the institution, and a specific internal code number assigned to the practitioner by the institution.
Renewal of Registration
Registrants must renew their DEA registration every three years using Form 224a, per 21 CFR 1301.13(e)(1)(iv). Renewals must be done online and no more than 60 days prior to expiration, as specified in 21 CFR 1301.13(b). Renewal reminders are sent electronically, and it’s vital to maintain an accurate and active email address.
Registration Reinstatement Policy
DEA allows reinstatement of an expired registration for one month. After that, a new application is needed. Handling controlled substances without a valid registration is prohibited (21 CFR 1301.11(a)).
Use of DEA Registration Number
Although the DEA strongly discourages the use of a DEA registration number for anything other than its intended purpose (transactions involving controlled substances), there are no specific regulations that prohibit parties from using it for identification purposes.
Termination of Registration
A practitioner's DEA registration will automatically terminate under the following circumstances, as specified in 21 CFR 1301.52(a):
- Death of the practitioner.
- The business ceases legal existence.
- Discontinuation of business or professional practice.
- Voluntary surrender of DEA registration.
For voluntary surrender, DEA Form 104 or any written intent to surrender must be received by the DEA. If a practitioner discontinues their business or practice, prompt notification to the DEA is required. It's also recommended to contact the local DEA Special Agent in Charge for directions on controlled substances disposal.
Denial, Suspension, or Revocation of Registration
DEA has the authority under 21 U.S.C. 824(a) to suspend or revoke a registration if a practitioner:
- Falsifies the application materially.
- Gets convicted of a felony related to controlled substances or list I chemicals.
- Loses state licensing or authorization related to controlled substances.
- Engages in acts making DEA registration inconsistent with public interest.
- Is excluded from a Medicare or state health care program.
Before taking any action, DEA serves an order to show cause. In cases of imminent danger to public health, immediate suspension can be invoked per 21 U.S.C. 824(d).
Denial of Registration in Public Interest
DEA may also deny a registration if it's against the public interest. Factors considered for this, as outlined in 21 U.S.C. 823(f), include:
- Recommendations from state licensing or disciplinary bodies.
- The applicant’s experience with controlled substances.
- Federal or state convictions related to controlled substances.
- Compliance with related laws.
- Other conduct posing threats to public health and safety.
This provides a structured approach for regulatory actions concerning DEA registration.
By understanding and adhering to these regulations, practitioners can maintain compliance with the DEA and ensure a lawful practice.
For more information, consult DEA's Registration Section at 1-800-882-9539 or DEA.Registration.Help@dea.gov.
This information comes from the 2023 DEA Practitioner’s Manual.