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Title: | Registration Issues |
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Body: | Practitioner Diversion
Awareness Conference
Registration
Paula Albert, Staff Coordinator
Liaison Section
The following presentation was accompanied by an oral presentation
on October 21 & 22, 2019, and does not purport to establish legal
standards that are not contained in statutes, regulations, or other
competent law. Statements contained in this presentation that are not
embodied in the law are not binding on DEA. Summaries of statutory
and regulatory provisions that are summarized in this presentation do
not purport to state the full extent of the statutory and regulatory
requirements of the cited statutes and regulations. I have no financial
relationships to disclose.
LEGAL DISCLAIMER
U.S. Drug Enforcement Administration
Diversion Control Division
This presentation is for educational purposes only. This presentation may not be
further copied or used, with the embedded images and videos, without an
independent analysis of the application of the Fair Use doctrine.
Fair Use
Under section 107 of the Copyright Act of 1976, allowance is made for "Fair Use"
for purposes such as criticism, comment, news reporting, teaching, scholarship,
education and research.
Fair Use is a use permitted by the copyright statute that might otherwise be
infringing. Any potentially copyrighted material used in this presentation has been
reviewed and found to be used in a manner consistent with Fair Use. A completed
Fair Use checklist is attached.
Fair Use Act Disclaimer
U.S. Drug Enforcement Administration
Diversion Control Division
Explain why the DEA issues registrations, the type of
registrations that the DEA issues, and how such registrations
fit into the closed system of distribution.
Explain how a practitioner obtains a DEA registration, and
what is required by the DEA as part of this process.
Explain the limits of a DEA registration, and the coincident
activities that a practitioner can perform.
Course Objectives
U.S. Drug Enforcement Administration
Diversion Control Division
Outline when a practitioner would need more than one DEA
registration.
Review some common problems practitioners have encountered
regarding their DEA registration and how they were resolved.
Explain some of the basic steps a practitioner can take to reduce the
chance of their DEA registration being used in the diversion of
controlled substances.
Course Objective
U.S. Drug Enforcement Administration
Diversion Control Division
Questions To Discuss
At the completion of this block of instruction you will be able to
answer the following questions:
1. What is the current number of DEA registrants?
2. As an individual practitioner, how many associates in my
practice can I authorize to use my registration number to
prescribe controlled substances?
U.S. Drug Enforcement Administration
Diversion Control Division
Questions To Discuss
3. Is a DEA practitioner registration always for a three year
period?
4. Is a DEA registration number publically available?
5. What should I do to prevent my DEA registration from being
used for diversion?
U.S. Drug Enforcement Administration
Diversion Control Division
U.S. Drug Enforcement Administration
Diversion Control Division
Registration Requirements
for Practitioners
First, let's begin by clarifying a few points.
The truth is that although a DEA registration is a Federal
registration it does NOT allow you to prescribe controlled
substances anywhere you wish to in the United States.
Registration Requirements
U.S. Drug Enforcement Administration
Diversion Control Division
If you change your last name you are NOT required to obtain a
new DEA registration number.
A DEA registration number is NOT privileged information, but is
available to the public.
Registration Requirements
U.S. Drug Enforcement Administration
Diversion Control Division
Closed System of Distribution
Cyclic
Investigations
Security
Requirements
Record
Keeping
Requirements
ARCOS
Established
Quotas
Registration
Established
Schedules
U.S. Drug Enforcement Administration
Diversion Control Division
The Registrant Community
U.S. Drug Enforcement Administration
Diversion Control Division
Total number of DEA registrants: 1,852,729
Total number of Practitioners: 1,331,285
Total number of Mid Level Practitioners: 415,722
Total number of Pharmacies: 71,108
Total number of Hospitals: 18,442
Website: www.DEAdiversion.usdoj.gov
Go to "Registration" (located at the top of the page)
Form used by the new applicant: DEA Form 224
How to Apply
U.S. Drug Enforcement Administration
Diversion Control Division
How to Apply
What if you encounter problems?
If you encounter problems, contact the DEA
Registration Service Center.
DEA.Registration.Help@usdoj.gov
Or
1-800-882-9539
Or . . .
U.S. Drug Enforcement Administration
Diversion Control Division
How to Apply
Contact the DEA Registration Specialist in your area. To find their
contact information go to the above website and look under "About
Us."
For example, using this method the Registration Specialist's contact
information for New Orleans, LA is Phone - (571) 362-4891 or 4890.
U.S. Drug Enforcement Administration
Diversion Control Division
The Registration Specialist for
your area can be located on the
Diversion Control Divisions
web-site.
You can search by zip code, city,
county, or state.
U.S. Drug Enforcement Administration
Diversion Control Division
How to Apply
How to Apply
U.S. Drug Enforcement Administration
Diversion Control Division
The DEA cannot consider an application unless you first have
state controlled substance authority, and each state is
different:
State Medical License
State controlled substance registration (if required)
Other state licensure (if required)
Certificates of advanced training (if required)
Practice Address vs
Mailing Address
During the application process you are asked for your Practice
Address, and you are asked for your Mail-to Address if these
two addresses are different.
Your Practice Address is your principal place of business or
professional practice pursuant to Title 21, C.F.R. 1301.12(a).
This is the address on your DEA certificate.
Your mail-to address is for correspondence.
U.S. Drug Enforcement Administration
Diversion Control Division
DEA Certificate
Access
The DEA is required to turn over the DEA registration, and other
information found on the DEA certificate, to the U.S. Department of
Commerce.
The Department of Commerce sells this information through the
National Technical Information Service (NTIS) to registrants such as
your neighborhood pharmacy.
U.S. Drug Enforcement Administration
Diversion Control Division
DEA Registration Limits
A DEA registration cannot allow you to do something that is otherwise
prohibited by state law.
For Example: If you are registered by the state in only schedules III-V
the DEA cannot authorize you to handle schedule II.
For Example: If state law says you cannot procure controlled
substances, the DEA cannot authorize you to do so.
U.S. Drug Enforcement Administration
Diversion Control Division
DEA Registration Limits
Final Rule: Clarification of Registration Requirements for Individual
Practitioners (December 1, 2006)
A practitioner can only administer, dispense, prescribe, procure, or store
controlled substances in a state if they first hold a DEA registration in that
state. The authority granted under this registration ends at that state's border.
A practitioner can only administer, dispense, procure, or store a controlled
substance at a location where he or she is registered with the DEA.
U.S. Drug Enforcement Administration
Diversion Control Division
DEA Registration Limits
U.S. Drug Enforcement Administration
Diversion Control Division
When more than one DEA registration number is needed:
If a practitioner plans to administer, dispense, procure or
store controlled substances at more than one location in a
state.
If a practitioner plans to administer, dispense, prescribe,
procure, or store controlled substances in more than one
state.
If the practitioner is registered with the DEA in one state
and is treating a patient in another state by telemedicine.
DEA Registration Limits
Unique exception: The Medical Bag. Administering or
dispensing a controlled substance inside a state where a
practitioner is registered, but at other than the practitioner's
DEA registered location.
Note: Random and as needed is - fact specific
U.S. Drug Enforcement Administration
Diversion Control Division
DEA Registration Limits
Coincident Activities allowed.
21 C.F.R. 1301.13(e)(1)(iv)
Practitioner: May conduct research and instructional activities
with those substances for which registration was granted,
except that a mid-level practitioner may conduct such research
only to the extent expressly authorized under state statute.
U.S. Drug Enforcement Administration
Diversion Control Division
Common Problems
Encountered
The applicant does not have appropriate state authority.
The registrant assumes their first registration will be for 36 months.
The applicant, or renewing registrant, fails to mark all appropriate
schedules.
The registrant fails to renew their registration in a timely manner.
U.S. Drug Enforcement Administration
Diversion Control Division
Common Problems
Encountered
Failure to maintain state licensure once achieved.
Failure to notify the DEA of an email address change.
Believing that the practitioner needs a separate DEA
registration for each location in the same state where they only
prescribe, (other than the one registration they already hold in
that state).
U.S. Drug Enforcement Administration
Diversion Control Division
Common Problems
Encountered
Renewals submitted simultaneously by both the practitioner and the
practitioner's office.
Applying or renewing using an expired credit card or using a check
from a closed account.
Relying upon an office manager to renew for the practitioner (but they
do not).
Applying for new DEA # due to a name change.
U.S. Drug Enforcement Administration
Diversion Control Division
Common Problems
Encountered
U.S. Drug Enforcement Administration
Diversion Control Division
Changing practice address:
In same state
To another state
In a national emergency
Common Problems
Encountered
Discontinuing Practice:
Permanently
DEA.Registration.Help@usdoj.gov
Drug Enforcement Administration
Attn: Registration Section DRR
P.O. Box 2639
Springfield, VA 22152-2639
U.S. Drug Enforcement Administration
Diversion Control Division
Hospitals and DEA
Registrations
Title 21 C.F.R. § 1301.22(c)(1-6)
An individual practitioner who is an agent or employee of a hospital
or other institution may, when acting in the normal course of business
or employment, administer, dispense, or prescribe controlled
substances under the registration of the hospital or other institution
which is registered in lieu of being registered him/herself, provided
that 6 conditions are met.
U.S. Drug Enforcement Administration
Diversion Control Division
Hospitals and DEA
Registrations
Using the number off-site:
When you can use it off-site
When you cannot use it off-site
U.S. Drug Enforcement Administration
Diversion Control Division
Group Practice Setting
Title 21 C.F.R. 1301.22(b)
(b) An individual practitioner who is an agent or employee of another
practitioner (other than a mid-level practitioner) registered to dispense
controlled substances may, when acting in the normal course of business or
employment, administer or dispense (other than by issuance of prescription)
controlled substances if and to the extent that such individual practitioner is
authorized or permitted to do so by the jurisdiction in which he or she
practices, under the registration of the employer or principal practitioner in
lieu of being registered him/herself.
U.S. Drug Enforcement Administration
Diversion Control Division
Group Practice Setting
What this lets you do
What this does not let you do
U.S. Drug Enforcement Administration
Diversion Control Division
Fee Exempt Registrations (Not Military)
21 C.F.R. 1301.21
Conditions under which it is granted
Limits of this registration
Conversion to a fee paid registration
U.S. Drug Enforcement Administration
Diversion Control Division
DEA Registration (Military)
21 C.F.R 1301.23
Conditions under which it can be used.
Conditions under which it cannot be used.
When you leave the military.
U.S. Drug Enforcement Administration
Diversion Control Division
Steps to Reduce Diversion
U.S. Drug Enforcement Administration
Diversion Control Division
Steps you can take to reduce the chance of your registration being used
in the diversion of controlled substances.
Check your PMP for use:
False prescriptions
Sloppy use by pharmacies
Misuse by office staff
Steps to Reduce Diversion
U.S. Drug Enforcement Administration
Diversion Control Division
Monitor the use of your practice's credit card and
checking account.
Have all controlled substances you purchase be
checked in upon delivery by two employees.
Steps to Reduce Diversion
If you dispense controlled substances, including samples,
conduct random audits to ensure they are not getting
diverted.
Do not create an atmosphere of self-use in your practice by
your staff.
U.S. Drug Enforcement Administration
Diversion Control Division
Steps to Reduce Diversion
Do not print your full DEA registration number on your prescription.
Instead add the last few digits yourself.
Limit the amount you prescribe and the refills you authorize, if this is
not already required by your state.
U.S. Drug Enforcement Administration
Diversion Control Division
Steps to Reduce Diversion
Stick with certain controlled substances, and strengths thus calling to
attention any deviation from this pattern.
When issuing paper prescriptions, list both the # being prescribed and
write out the amount.
Cooperate with your local pharmacists.
Do not leave your prescription pad unattended, and lock it up if not in
use.
U.S. Drug Enforcement Administration
Diversion Control Division
Steps to Reduce Diversion
SCAM!!!
Criminals posing as DEA employees are targeting practitioners using
an extortion scam. They use a disguised telephone number that
appears on a practitioners' caller ID as the "DEA's 800 registration
support number". The criminals then demand money and threaten to
suspend a practitioner's DEA registration if they do not comply. You
were sent an email about this on April 2, 2018.
DEA Registration Helpline at 1-800-882-9539
U.S. Drug Enforcement Administration
Diversion Control Division
Qualified Practitioners and
Other Qualified Practitioners
The Unique Identification Number, often called the X number, is not a
DEA registration. It is certification that the prescriber has met all the
necessary requirements to use FDA approved Schedules III-V
narcotics for the treatment of opioid use disorder.
Unlike the DEA registration number, only one Unique Identification
Number is issued.
U.S. Drug Enforcement Administration
Diversion Control Division
Qualified Practitioners and
Other Qualified Practitioners
When prescribing FDA approved Schedules III-V narcotics
for the treatment of opioid use disorder the prescriber must
place both their DEA registration number and their Unique
Identification Number on the prescription.
U.S. Drug Enforcement Administration
Diversion Control Division
Course Review
We reviewed why the DEA issues registrations, how to apply,
and how registrations fit into the closed system of distribution.
We identified and discussed what a DEA registration does, and
does not let you do.
We reviewed some common problems practitioners have
encountered regarding their DEA registration, and how these
are resolved.
We listed some of the steps a practitioner can take to reduce the
chance that their DEA registration will be used to divert
controlled substances.
U.S. Drug Enforcement Administration
Diversion Control Division
Post Question
1. What is the current number of DEA registrants?
A. Under 250,000
B. 780, 000
C. 1, 100,000
D. Over 1,800,000
U.S. Drug Enforcement Administration
Diversion Control Division
Post Question
2. As an individual practitioner, how many associates in my
practice can I authorize to use my registration number to
prescribe controlled substances.
A. None
B. One
C. Up to three
D. Up to five
U.S. Drug Enforcement Administration
Diversion Control Division
Post Question
3. Is a DEA practitioner registration always for a three year
period?
A. Yes
B. No
U.S. Drug Enforcement Administration
Diversion Control Division
Post Question
4. Is a DEA registration number publically available?
A. Yes
B. No
U.S. Drug Enforcement Administration
Diversion Control Division
Post Question
5. What should I do to prevent my DEA registration from being
used for diversion?
A. Lock up my prescription pads.
B. Limit my prescribing to the amount I believe is currently
medically necessary.
C. Check my state's prescription monitoring program.
D. All of the above.
U.S. Drug Enforcement Administration
Diversion Control Division
Thank you for your time
and attention !
U.S. Drug Enforcement Administration
Diversion Control Division
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