Drug
Registration > Q&A's
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required state license or has the license revoked or rescinded,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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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 (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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