Questions & Answers
Registration
Question: What does a practitioner/physician need to obtain before he/she can complete an application for a DEA registration?
Answer: Issuance of a DEA registration to prescribe controlled substances is predicated on successfully completing all of the requirements imposed by the state in which the practitioner will conduct business and obtaining a state license. If the practitioner fails to obtain the required state license or has the license revoked or rescinded, then the DEA cannot issue the requested registration. If an existing DEA registrant loses his/her state privileges, then the DEA must also rescind or revoke the federal authority to prescribe controlled substances.
Question: Are there any limits placed on a practitioner’s/physician’s registration?
Answer: The DEA Form 224 – New Application for Retail Pharmacy, Hospital/Clinic, Practitioner, Teaching Institution, or Mid–Level Practitioner has a space to list the Drug Schedules of controlled substances that the practitioner wishes to handle. The practitioner must be authorized by the state to handle those drugs for which he/she is applying for DEA authorization and accordingly will ONLY be authorized to handle those drugs that are checked on the application form.
Question: How often are DEA registrations renewed?
Answer: Practitioner registrations must be renewed every three years.
Question: Are separate registrations required for separate locations?
Answer: A separate registration is required for each principal place of business or professional practice where controlled substances are stored, administered, or dispensed by a person. If a practitioner will only be prescribing from another location(s) situated within the same state, then an additional registration is not necessary.
Question: What happens if a practitioner/physician relocates his/her business?
Answer: A practitioner who moves to a new physical location must request a modification of registration. A modification is handled in the same manner as a new application and must be approved by DEA. A modification of registration can be requested online at www.DEAdiversion.usdoj.gov or by writing to the local DEA Registration Program Specialist responsible for the area in which the new office is located. If the change of address involves a change in the state, the proper state issued license and, if applicable, state controlled substances registration must be obtained prior to the request to DEA for an address change. If the modification is approved, DEA will issue a new certificate of registration. The registrant should maintain the new certificate with the old certificate until expiration.
Question: What is the processing time for a new or renewal application?
Answer: New Applications (DEA Form 224) are processed within 4 to 6 weeks. Renewal Applications (DEA Form 224a) are processed within approximately 4 weeks.
Question: Has my application been processed?
Answer: You may call 1-800-882-9539 for the status of your application or you may call the DEA Field Office nearest you.
Question: Can you fax a new or renewal application/certificate?
Answer: Applications may be faxed under special circumstances, however, applications cannot be returned for processing via fax. Completed applications must be mailed with the appropriate fee and an original signature. Certificates are never faxed, however, we can send the requester a form letter that shows the Drug Enforcement Administration (DEA) number is current.
Question: What is the overnight address?
Answer: Note that DEA will not incur the cost of any delivery service, and due to security requirements, all parcels received by the DEA are scanned in an off-site location prior to delivery. This requirement will add an additional day to the time it takes to receive packages.
Drug Enforcement Administration
ATTN: Registration Unit, ODRR
8701 Morrissette Drive
Springfield, VA 22152
Question: Can you verify a DEA number?
Answer: NO. It is DEA policy that the credentialing of a physician may be accomplished by requesting a copy of the physician's current DEA registration certificate, which indicates the issue and expiration dates. This would satisfy the requirements for verification of a DEA registration. In addition, the DEA provides a list of active DEA registrants to the National Technical Information Service (NTIS), a component of the United States Department of Commerce. This list of active DEA registrants may be obtained from NTIS as a single purchase, or on a monthly or quarterly basis by calling 1-800-363-2068 or on the web at www.ntis.gov/product/dea.htm.
Question: When are renewal applications mailed out?
Answer: Renewal applications are mailed out 45 days prior to the expiration date to the last address listed in our files. The U.S. Postal Service will not forward a renewal application to a new address. Contact the DEA if you have changed your business or mailing address.
Question: How can I get a refund?
Answer: As per 21 CFR 1301.13(e),The application fees are not refundable. In the unusual circumstance that a duplicate application was made, submit a letter explaining the circumstances with a copy of the front and back of the canceled check. Mail to DEA, Attn: Registration Unit – ODRR, 8701 Morrissette Drive, Springfield, VA 22152
Question: Why is my expiration date not for the full three (3) years?
Answer: When an individual is first registered with the DEA, he/she may receive an initial registration period of a minimum of 28 months or a maximum of 39 months. For more information review Title 21, Code of Federal Regulations (CFR), Section 1301.13(d).
Question: Can I have my number changed to match my name?
Answer: YES. Send a letter requesting the change and enclose a copy of the legal document to support your name change. In addition, the second alpha character of your DEA number can be changed to match your new name upon request. Example:
Old Name/ DEA Number - Mary Jones, AJ2233445
Can be changed to : Mary Smith, AS2233445
Question: Do you have the telephone number for the field offices, State Licensing Boards, Food and Drug Administration (FDA), Chemicals, and National Technical Information Service (NTIS)?
Answer:
DEA Field Offices and State Licensing Boards.
DEA Chemicals – 202-307-4025
FDA - 301-480-1728
NTIS - 1-800-363-2068
Question: Is a separate registration required to provide Narcotic Treatment Services?
Answer: The Drug Enforcement Administration (DEA) and other federal agencies have received numerous inquiries requesting clarification of the three-day (72-hour) exception to the DEA’s separate registration requirement for maintenance or detoxification treatment. In addition, confusion continues to exist whether practitioners may prescribe, dispense, or administer Buprenex, a Schedule III controlled substance, for maintenance and detoxification treatment.
A practitioner who wants to use Schedule II narcotic drugs for maintenance and/or detoxification must obtain separate registration from DEA as a narcotic treatment program pursuant to the Narcotic Addict Treatment Act of 1974. This registration allows a practitioner to administer or dispense, but not prescribe, scheduled narcotic drugs that are approved by the United States Food and Drug Administration (FDA) for the treatment of narcotic addiction. Methadone and levo-alpha-acetyl-methadol (LAAM) are the only scheduled narcotics approved by FDA for use in maintenance and detoxification treatment. If a practitioner plans to use any other narcotic drug for addiction treatment, prior authorization must be obtained from FDA through an Investigational New Drug Application. Registration with DEA is contingent upon proper registration with the State Methadone Authority and the United States Department of Health and Human Services (HHS).
An exception to the registration requirement, known as the "three day rule" (Title 21, Code of Federal Regulations, Part 1306.07(b)), allows a practitioner who is not separately registered as a narcotic treatment program, to administer (but not prescribe) narcotic drugs to a patient for the purpose of relieving acute withdrawal symptoms while arranging for the patient’s referral for treatment, under the following conditions:
Not more than one day’s medication may be administered or given to a patient at one time;
This treatment may not be carried out for more than 72 hours and;
This 72-hour period cannot be renewed or extended.
The intent of 21 CFR 1306.07(b) is to provide practitioner flexibility in emergency situations where he or she may be confronted with a patient undergoing withdrawal. In such emergencies, it is impractical to require practitioners to obtain a separate registration. The 72-hour exception offers an opioid dependent individual relief from experiencing acute withdrawal symptoms, while the physician arranges placement in a maintenance/detoxification treatment program. This provision was established to augment, not to circumvent, the separate registration requirement. It should be noted that although Buprenex, a Schedule III controlled substance, is currently approved for the treatment of pain, it may not be prescribed or dispensed for use in narcotic addiction treatment, including the treatment of withdrawal symptoms as provided above under the three-day rule.
New legislation signed into law on October 17, 2000, known as the Children’s Health Act of 2000, includes Sections 3501-3502 of the Drug Addiction Treatment Act of 2000 (DATA). DATA amends 823(g) of the Controlled Substances Act by allowing practitioners to dispense or prescribe Schedule III, IV or V controlled substances specifically approved by the FDA for narcotic addiction treatment. These practitioners must notify the Secretary of HHS in writing of their intent to engage in this type of activity and must certify that they are qualified through appropriate measures such as state licensure, certification, training or experience in the area of addiction treatment. The practitioner will then be authorized to dispense and/or prescribe under the authority of his/her DEA practitioner registration. Upon receiving positive determination from HHS that the practitioner meets all the requirements for the exemption, DEA will assign a unique identification number to the practitioner’s DEA registration.
On October 8, 2002, the FDA approved two high-dose schedule III formulations of sublingual buprenorphine drug products (Suboxone® and Subutex®) for use in narcotic addiction treatment.
Question: I am a practitioner who has received a waiver to treat opioid dependent patients pursuant to the Drug Addiction Treatment Act of 2000 (DATA). Since receiving my waiver, I have moved my primary practice location. Who do I notify of this address change and how?
Answer: Each DATA Waived Physician (DWP) is responsible for notifying the Department of Health and Human Services’ Substance Abuse and Mental Health Services Administration (SAMHSA) and DEA of a change in his/her primary practice address.
A "Change of Address" request to SAMHSA should be made through the Center for Substance Abuse Treatment (CSAT) by calling 1-866-BUP-CSAT (1-866-287-2728), or via internet. To avoid errors and save time, DWPs may use a new online form to submit changes to their contact information. DWPs may click on Update Physician Contact Information and use the State Medical License Number and DEA Registration Number currently on file to locate and change the necessary address information.
Additional information regarding HHS policies and regulations concerning the DATA and DWPs may be found on the following SAMHSA/CSAT website at http://buprenorphine.samhsa.gov.
Additionally, a modification of registration is required by DEA when a practitioner moves to a new physical location. Modifications are handled in the same manner as applications and must be approved by DEA. A modification of registration can be requested online at www.DEAdiversion.usdoj.gov or in writing to the local DEA Registration Program Specialist responsible for the area in which the practice is located. If the change of address involves a change in the state, the proper state issued license and, if applicable, state controlled substances registrations must be obtained prior to the approval of modification of the federal registration. If the modification is approved, DEA will issue a new certificate of registration. The registrant should maintain the new certificate with the old certificate until expiration.
Question: How does a schedule I researcher apply for a DEA registration?
Answer: A schedule I research applicant should submit a DEA Form 225 with the required registration fee and must include the following information:
Investigator:
- Name, address, DEA registration number (if any)
- Institutional or company affiliation
- Qualifications, including curriculum vitae (CV) with a list of publications
Research Project:
- Title of project
- Statement of the purpose
- Name of controlled substances (CS) involved, amount (with justification) of each needed and source.
- Research protocol (detailed description of procedures), including number and species of research subjects, dosage to be administered, route and method of administration, and duration of project.
- Location where research will be conducted.
- Statement of security provisions for storing and dispensing the CS(s) in order to prevent diversion.
- If investigator plans to manufacture or import the CS(s), statement of quantity to be manufactured or imported and sources of chemicals to be used or substance to be imported.
Authority (if applicable):
- Institutional approval
- Approval of a Human Research Committee for human studies.
- Indication of an approved active Notice of Claimed Investigational Exemption for a New Drug (IND) (number).
- Indication of an approved funded grant (number), if any.
The applicant should mail the items to this address:
U.S. Department of Justice
Drug Enforcement Administration
Attn: Registration Section ODR
P.O. Box 2639
Springfield, VA 22152-2639
See Title 21 Code of Federal Regulation Section 1310.18 for additional Instructions
Question: Does DEA use the Social Security Administration Death Master file (DMF) to identify those registrants that have been reported as deceased?
Answer: DEA matches the DMF weekly against the DEA registrant database and those matching records are removed from the active database.
Question: A DEA registration is no longer required due to retirement, death or out of business, how do I have it retired?
Answer: Please send an email with your request and explanation to DEA.Registration.Help@usdoj.gov.
You may also mail your request to:
Drug Enforcement Administration
Attn: Registration Section ODR
P.O. Box 2639
Springfield, VA 22152-2639
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