U.S. Department of Justice Drug Enforcement Administration DIVERSION REGISTRATION Wisconsin Association of Medical Staff Services Fall 2011 DEA Presented by Rick Boyd Section Chief, Registration and Program Support Section DEA, 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 21 Code of Federal Regulations REGISTRATION Section 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 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 Control Mission 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 4 DRUG ENFORCEMENT ADMINISTRATION | DIVERSION CONTROL PROGRAM

5 History of Drug Law Enforcement Bureau of Narcotics and Dangerous Drugs Parent Agency: Department of Justice Bureau of Drug Abuse Control Food and Drug Administration Parent Agency: Department of Health, Education and Welfare Bureau of Narcotics Parent Agency: Department of Treasury Bureau of Prohibition Parent Agency: Department of Treasury Bureau of Internal Revenue Parent Agency: Department of Treasury Drug Enforcement Administration Parent Agency: Department of Justice Present

DRUG ENFORCEMENT ADMINISTRATION | DIVERSION CONTROL PROGRAM 6 Controlled 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 Registrants As of Oct 2011  Retail Pharmacy  Hospital/Clinic  Practitioner  Teaching Institution  Mid-level Practitioner Total Retail 67,470 15,823 1,121, ,491 1,401,872  Manufacturer  Distributor  Researcher  Analytical Lab  Importer  Exporter  Reverse Distributor  NTP Total Wholesale 13, ,228 1, ,283 Retail RegistrantsWholesale Registrants Total Controlled Substances Registrants 1,415,769 July 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 registrations Title 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 (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. § (c); 3. Alternately, under 21 C.F.R. § , 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 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 exemption Title 21 Code of Federal Regulations (CFR) § : (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 3 rd 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 domain Power to sue and be sued Power to tax Police 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/changes Title 21 Code of Federal Regulations (CFR) § Each 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“Registration Validation” DEA Diversion Web Site at Log in using either your DEA registration or theirs- here is the information provided DEA Registration Validation Result: DEA Number: PF 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: 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 address There 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 : 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