U.S. Department of JusticeDrug Enforcement Administration

DIVERSION REGISTRATION Wisconsin Association of Medical Staff Services

Fall 2011

DEA

Presented byRick Boyd

Section Chief, Registration and Program Support

SectionDEA, Office of Diversion Control

2

Topics• Who needs DEA registration• Background – population/history• Multiple locations/multiple DEA registrations• Locum Tenens• Fee exemption• Signature- New/renewals/changes• Free DEA# validation• DATA waived Practitioners• When/how to change address when moving• Timing of renewal/how retired

DIVERSION REGISTRATION

3

DIVERSION REGISTRATION

21 Code of Federal Regulations

REGISTRATION Section 1301.11 Persons required to register

(a)Every person who manufactures, distributes, dispenses, imports, or exports any controlled substance or who proposes to engage in the manufacture, distribution, dispensing (includes prescribing and administering) , importation or exportation of any controlled substance shall obtain a registration unless exempted by law or pursuant to Secs. 1301.22-1301.26. Only persons actually engaged in such activities are required to obtain a registration; related or affiliated persons who are not engaged in such activities are not required to be registered. (For example, a stockholder or parent corporation of a corporation manufacturing controlled substances is not required to obtain a registration.)

Office of Diversion ControlMission

Ensuring an adequate and uninterrupted supply

for legitimate medical and scientific purposes

To prevent, detect, and investigate the diversion of controlled substances from legitimate sources

while

4DRUG ENFORCEMENT ADMINISTRATION | DIVERSION CONTROL PROGRAM

DRUG ENFORCEMENT ADMINISTRATION | DIVERSION CONTROL PROGRAM

5

History of Drug Law Enforcement

Bureau of Narcotics and Dangerous DrugsParent Agency: Department of Justice

1968 - 1973

Bureau of Drug Abuse ControlFood and Drug Administration

Parent Agency: Department of Health, Education and Welfare

1966 - 1968

Bureau of NarcoticsParent Agency: Department of Treasury

1930 - 1968

Bureau of ProhibitionParent Agency: Department of Treasury

1927 - 1930

Bureau of Internal RevenueParent Agency: Department of Treasury

1915 - 1927

Drug Enforcement AdministrationParent Agency: Department of Justice

1973 - Present

DRUG ENFORCEMENT ADMINISTRATION | DIVERSION CONTROL PROGRAM

6

Controlled Substances ActControlled Substances ActControlled Substances ActControlled Substances Act

Comprehensive Drug Abuse Prevention and Control Act (1970)• Common Name: Controlled Substances Act of 1970 (CSA)

• Replaced more than 50 pieces of drug control legislation

• Established a single system of control for both narcotics and psychotropic drugs

• Established five schedules that classified controlled substances according to their properties

DRUG ENFORCEMENT ADMINISTRATION | DIVERSION CONTROL PROGRAM

7

DEA Registration:A Cornerstone of the CSA

• Every person or entity that handles controlled substances must be registered or be exempt by regulation from registration

• Must apply using the appropriate DEA form for the designated business activity and pay the required fee, unless fee exempt

• Must meet state licensure requirements in state(s) where business is conducted

• Must be in good standing and comply with DEA requirements

DRUG ENFORCEMENT ADMINISTRATION | DIVERSION CONTROL PROGRAM

8

Controlled Substances RegistrantsAs of Oct 2011

Retail Pharmacy

Hospital/Clinic

Practitioner

Teaching Institution

Mid-level Practitioner

Total Retail

67,470

15,823

1,121,749

339

196,491

1,401,872

Manufacturer

Distributor

Researcher

Analytical Lab

Importer

Exporter

Reverse Distributor

NTP

Total Wholesale 13,896

532

838

9,228

1,507

211

236

61

1,283

Retail Registrants Wholesale Registrants

Total Controlled Substances Registrants 1,415,769July 23, 2007

9

Topics• Who needs DEA registration• Background – population/history• Multiple locations/multiple DEA registrations• Locum Tenens• Fee exemption• Signature- New/renewals/changes• Free DEA# validation• DATA waived Practitioners• When/how to change address when moving• Timing of renewal/how retired

DIVERSION REGISTRATION

10

DIVERSION REGISTRATION

Multiple Locations/Multiple DEA registrationsTitle 21 United States Code (USC) Section 822. Persons Required to Register

-A separate registration shall be required at each principal place of business or professional practice where the applicant manufactures, distributes, or dispenses

controlled substances or list I chemicals

-DEA has historically provided an exception that a practitioner who is registered at one location, but also practices at other locations, is not required to register separately for

any other location at which controlled substances are only prescribed (21 CFR 1301.12(b)(3)) as long as it is in the same state.

- DEA registration is based on a State license, it cannot authorize controlled substance dispensing outside that State. Hence, the separate registration exception applies only to

locations within the same State in which practitioners have their DEA registrations.

11

DIVERSION REGISTRATION Locum Tenens

Practitioners may only administer, dispense, or prescribe a controlled substance in a state if they hold a DEA registration in that state, and are complying with all federal and state

laws and regulations. - Locum tenens have the following 3 options regarding their DEA registration when planning to legally handle controlled substances in multiple states: 1. Apply for a separate DEA registration in each state where they plan to administer, dispense, or prescribe controlled substances; 2. An alternative, if the practitioner will be working solely in a hospital/clinic setting, they may use the hospital’s DEA registration instead of registering independently with DEA if the hospital agrees and the situation warrants, as outlined in 21 C.F.R. §1301.22(c);3. Alternately, under 21 C.F.R. §1301.51, the practitioner may transfer their existing DEA registration from one state to another as needed by contacting ODR, or requesting the change on-line at www.DEADIVERSION.USDOJ.GOV. DEA will investigate these modifications of registration as if they were new applications. DEA will issue a new DEA certificate with the appropriate changes if DEA approves the modification.

12

Topics• Who needs DEA registration• Background – population/history• Multiple locations/multiple DEA registrations• Locum Tenens• Fee exemption• Signature- New/renewals/changes• Free DEA# validation• DATA waived Practitioners• When/how to change address when moving• Timing of renewal/how retired

DIVERSION REGISTRATION

13

Fee exemptionTitle 21 Code of Federal Regulations (CFR) § 1301.21:(a) The Administrator shall exempt from payment of an

application fee for registration or reregistration: (1) Any hospital or other institution which is operated by an

agency of the United States (including the U.S. Army, Navy, Marine Corps., Air Force, and Coast Guard), of any State, or any political subdivision or agency thereof.

(2) Any individual practitioner who is required to obtain an individual registration in order to carry out his or her duties as an official of an agency of the United States (including the U.S. Army, Navy, Marine Corps, Air Force, and Coast Guard), of any State, or any political subdivision or agency thereof

DIVERSION REGISTRATION

14

DIVERSION REGISTRATION Exempt (cont)

*The key phrase is “operated by an agency “- ownership is not a factor, the day to day operation must be done by an agency of the government.*The key phrase is “official of an agency “- this is a direct hire of the government entity- not a contractor or provider supplied thru 3rd party company* A political subdivision, it must have been specifically created by state legislative action and posses the following indicia of sovereignty: Power of eminent domainPower to sue and be suedPower to taxPolice power-The following do not qualify as fee exempt: - Non- Profit clinics/organizations - Volunteer Positions - 501(c) facilities/organizations - Faith based organizations - Federally Qualified Health Centers - Tax Exempt organizations

15

Signature- New/renewals/changesTitle 21 Code of Federal Regulations (CFR) § 1301.13Each application, attachment, or other document filed as part of an

application, shall be signed by the applicant, if an individual; by a partner of the applicant, if a partnership; or by an officer of the applicant, if a corporation, corporate division, association, trust or other entity. An applicant may authorize one or more individuals, who would not otherwise be authorized to do so, to sign applications for the applicant by filing with the Registration Unit of the Administration a power of attorney for each such individual.

WHY?

DIVERSION REGISTRATION

16

Topics• Who needs DEA registration• Background – population/history• Multiple locations/multiple DEA registrations• Locum Tenens• Fee exemption• Signature- New/renewals/changes• Free DEA# validation• DATA waived Practitioners• When/how to change address when moving• Timing of renewal/how retired

DIVERSION REGISTRATION

17

DEA registration validation“Registration Validation”

DEA Diversion Web Site at www.deadiversion.usdoj.gov

Log in using either your DEA registration or theirs- here is the information provided

DEA Registration Validation Result:

DEA Number: PF0203810

Name (Last, First): NORAMCO INC ,

Business Activity: ANALYTICAL LAB

Business Address 1: 500 SWEDES LANDING ROAD

Business Address 2:

Business Address 3:

City:

State: DE

Zip: 19801

Schedules: Schedule I, Schedule II Narcotic, Schedule III Narcotic, Schedule III Non Narcotic, Schedule IV, Schedule V

Expire Date:

18

DATA Waived Practitioners*The DATA amends the Controlled Substances Act [21 USC 823(g)] by waiving

the requirement for separate DEA registration as an NTP for practitioners who dispense or prescribe Schedules III-V narcotic controlled substances approved by FDA for use in the treatment of narcotic addiction.

*Practitioners must notify the Secretary of HHS in writing (SMA-167 or letter) of their intent to so practice -- The Substance Abuse & Mental Health Services Administration/Center for Substance Abuse Treatment (SAMHSA/CSAT)

*CSAT will provide the AG (DEA/ODR) with information from each practitioner’s written notification, and will be processed by designated personnel from ODR

*Practitioner’s who qualify for this waiver will be assigned a Unique Identification Number (UIN) by the DEA.

DIVERSION REGISTRATION

19

Change of addressThere are two addresses on a DEA registration

record- Business and “Mail To” address.Business address- must be the “principal place of

business…” (cant be POB)Change of Bus address should be done when

DEA registration is no longer needed at that location.

Any change to DEA record can be accomplished online : www.deadiversion.usdoj.gov

DIVERSION REGISTRATION

20

Renewal/Retirement*Renewal- Can only renew 60 days prior to expiration date-

not earlier *Retirement- DEA # available to renew for 30 days past expiration. NOT a “grace” period – business convenience

only- then irretrievably purged*3 written notifications to registrant to renew

-65 days prior to ED- reminder letter-55 days prior to ED- paper renewal if no online renewal

received-7 days AFTER ED- delinquent letter

DIVERSION REGISTRATION