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Drug Registration > Q&A's

Questions & Answers


REGISTRATION


Question – What does a practitioner/physician need to obtain before they can complete an application for 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 If the practitioner fails to obtain the required state license or has the license revoked or rescinded, then the DEA cannot issue the requested registration.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 looses their state privileges, then the DEA must also rescind or revoke their 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 for listing of the Drug Schedules of controlled substances that the practitioner wishes to be allowed 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 this additional location located within the same state, then an additional registration is not necessary.

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Question – What happens if a practitioner/physician relocates their business?

Answer – A practitioner who moves to a new location must request a modification of registration. It is the practitioner’s responsibility to notify the DEA about a change of address before the effective date of the move. The notice of change of address should be made in writing to the local DEA office. An Address Change Request is available on the Internet at www.DEAdiversion.usdoj.gov. The form must be manually signed and faxed or mailed to the local DEA office. The request must include a copy of the practitioner’s current state medical/professional license for the new address along with a copy of the practitioner’s corrected state controlled substance registration if applicable.


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 me a new or renewal application/certificate?

Answer:  Applications may be faxed under special circumstances, however, applications can not 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.

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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
2401 Jefferson Davis Highway
Alexandria, VA  22301


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 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, monthly or quarterly by calling 1-800-363-2068 or for more information, see them 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 applications to a new address. Contact the DEA if you have changed your business address.


Question:  How can I get a refund?

Answer:  Submit a letter explaining the circumstances with a copy of the front and back of the canceled check. Mail to DEA, Registration Unit – ODRR, Washington, D.C. 20537


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

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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 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 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.

Although DATA allows the dispensing and prescribing of approved Schedules III, IV and V controlled substances for narcotic addiction treatment, it is important to emphasize at the present time there are no buprenorphine products approved for narcotic addiction treatment. Buprenorphine products are currently under development for use in the treatment of narcotic addiction; however, they have not been approved for marketing.

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QuestionI 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 (HHS/SAMHSA) and DEA of a change in their primary practice address.

A "Change of Address" request to SAMHSA should be made through their Center for Substance Abuse Treatment (CSAT) by calling 1-866-BUP-CSAT (1-866-287-2728), or via e-mail at info@buprenorphine.samhsa.gov.

Additional information regarding HHS policies and regulations concerning the DATA and DATA Waived Physicians may be found on the following SAMHSA/CSAT website at http://buprenorphine.samhsa.gov.

A "Change of Address" request to DEA must be submitted in writing to the Office of Diversion Control’s Registration and Program Support Section at DEA Headquarters via facsimile at (202) 353-1125, ATTN: DATA Specialist.

This written request must include the DATA Waived Physician’s name and DEA Registration Number, current address, new address and telephone number, and social security number or tax I.D.

Alternatively, DATA Waived Physicians may use DEA’s fillable PDF document entitled, "Change of Address" Request Form at www.DEAdiversion.usdoj.gov/drugreg/change_requests/addchange.pdf

This document may be completed on screen, printed to your local printer, signed and then faxed to (202) 353-1125, ATTN: DATA Specialist.

A copy should be kept for your records.

PLEASE NOTE: 
When an address change involves moving to another state, please include a copy of your new State Medical License and, if applicable, your new State Controlled Substances License with your "Change of Address" request.

 


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