1. “Medication Units” (Opioid Treatment Programs) Drug Enforcement Administration James “Jim” Arnold Chief, Policy Unit Office of Diversion Control D E A Headquarters November 2014 1

2. OD: Mission Statement The Office of Diversion Control’s Mission is to Prevent, Detect, and Investigate the Diversion of Pharmaceutical Controlled Substances and Listed Chemicals from Legitimate Channels The Office of Diversion Control’s Mission is to Prevent, Detect, and Investigate the Diversion of Pharmaceutical Controlled Substances and Listed Chemicals from Legitimate Channels While Ensuring an Adequate and Uninterrupted Supply of Pharmaceutical Controlled Substances to Meet Legitimate Medical, Commercial, and Scientific Needs. While Ensuring an Adequate and Uninterrupted Supply of Pharmaceutical Controlled Substances to Meet Legitimate Medical, Commercial, and Scientific Needs. 2

3. Authority Law Law Controlled Substance Act United States Code: Title 21 Food & Drugs (Sections 801-971) Regulations Code of Federal Regulations Title 21 Food & Drugs (Parts 1300-1321) Regulations Code of Federal Regulations Title 21 Food & Drugs (Parts 1300-1321) Policy Policy Written Memorandums, Letters Publications (Federal Register) 3

4. Title 42: 8.2 Definitions Medication unit means a facility established as part of, but geographically separate from, an opioid treatment program from which licensed private practitioners or community pharmacists dispense or administer an opioid agonist treatment medication or collect samples for drug testing or analysis. Medication unit means a facility established as part of, but geographically separate from, an opioid treatment program from which licensed private practitioners or community pharmacists dispense or administer an opioid agonist treatment medication or collect samples for drug testing or analysis. 4

5. Law: 21 USC 822 (a) (1) Persons Required to Register: Persons Required to Register: (1) Every person who manufactures or distributes any controlled substance or list I chemical, or who proposes to engage in the manufacture or distribution of any controlled substance or list I chemical, shall obtain annually a registration issued by the Attorney General in accordance with the rules and regulations promulgated by him (1) Every person who manufactures or distributes any controlled substance or list I chemical, or who proposes to engage in the manufacture or distribution of any controlled substance or list I chemical, shall obtain annually a registration issued by the Attorney General in accordance with the rules and regulations promulgated by him 5

6. Law: 21 USC 822 (a) (2) Persons Required to Register: Persons Required to Register: “Every person who dispenses, or who proposes to dispense, any controlled substance, shall obtain from the Attorney General a registration issued in accordance with the rules and regulations promulgated by him. “Every person who dispenses, or who proposes to dispense, any controlled substance, shall obtain from the Attorney General a registration issued in accordance with the rules and regulations promulgated by him. 6

7. Law: 21 USC 822 (e) Separate registration Separate registration 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. 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. 7

8. Law: 21 USC 827 (a)(1),(2) Inventories: Initial Inventory: Inventories: Initial Inventory: -When registrant first engages in manufacture/distribution/dispensing Biennial Inventory: -Every second year thereafter -Complete and Accurate Record of all Stocks on Hand -Every second year thereafter -Complete and Accurate Record of all Stocks on Hand 8

9. Law: 21 USC 827 (a)(3) “…every registrant … manufacturing, distributing, or dispensing a controlled substance…shall maintain, on a current basis, a complete and accurate record of each substance manufactured, received, sold, delivered, or otherwise disposed of …” “…every registrant … manufacturing, distributing, or dispensing a controlled substance…shall maintain, on a current basis, a complete and accurate record of each substance manufactured, received, sold, delivered, or otherwise disposed of …” 9

10. Law: 21 USC 827 (b) Availability of Records: -Contain Information and Be in a Form as Required by Regulation. Availability of Records: -Contain Information and Be in a Form as Required by Regulation. -Be in a Form That is Readily Retrievable. -Be Kept and Available for Two Years. 10

11. Federal Law & Regulation 11 Although medication units are exempt from NTP (OTP) licensing requirements by CSAT, under Federal law they must have a separate D E A (NTP) registration: 21 USC 822 (e). Although medication units are exempt from NTP (OTP) licensing requirements by CSAT, under Federal law they must have a separate D E A (NTP) registration: 21 USC 822 (e). Medication units are required to maintain separate inventories, records, reports, and security in accordance with D E A regulations. Medication units are required to maintain separate inventories, records, reports, and security in accordance with D E A regulations.

12. Federal Law Medication units are another method of expanding narcotic treatment. D E A regulations require that currently approved and available controlled substance medications (e.g. Methadone, Buprenorphine, BCP’s) be dispensed directly to the patient by a practitioner registered with D E A as a “narcotic treatment program.” Prescribing remains prohibited under an NTP Registration: 21 CFR 1306.07 (a). D E A regulations require that currently approved and available controlled substance medications (e.g. Methadone, Buprenorphine, BCP’s) be dispensed directly to the patient by a practitioner registered with D E A as a “narcotic treatment program.” Prescribing remains prohibited under an NTP Registration: 21 CFR 1306.07 (a). 12

13. Law: 21 USC 822 (f) The Attorney General is authorized to inspect the establishment of a registrant or applicant for registration in accordance with the rules and regulations promulgated by him. The Attorney General is authorized to inspect the establishment of a registrant or applicant for registration in accordance with the rules and regulations promulgated by him. 13

14. Record Requirements (1 of 2) Inventories Inventories  21 CFR 1304.11 D E A 222 Order Forms D E A 222 Order Forms  21 CFR 1305 Dispensing Records Dispensing Records  21 CFR 1304.24 Reports of Theft or Loss Reports of Theft or Loss  21 CFR 1301.74(c) – D E A Form 106 Drug Destruction Records Drug Destruction Records  21 CFR 1304.21(e) – D E A Form-41 14

15. Record Requirements (2 of 2) Name of substance Name of substance Strength of substance Strength of substance Dosage form Dosage form Date dispensed Date dispensed Dispenser’s initials Dispenser’s initials Adequate identification of patient Adequate identification of patient Amount consumed (patient) Amount consumed (patient) Amount & dosage form taken home by patient Amount & dosage form taken home by patient 15

16. Security Safes, Steel Cabinets, or Vaults Safes, Steel Cabinets, or Vaults § 21 CFR 1301.72 (a), (b) Alarm Systems Alarm Systems § 21 CFR 1301.72 (a) Accessibility of Controlled Substances Accessibility of Controlled Substances § 21 CFR 1301.72 (d) § 21 CFR 1301.74 (h) § 21 CFR 1301.74 (i) § 21 CFR 1301.74 (j) D E A Discretion (Security) D E A Discretion (Security) § 21 CFR 1301.74 (l) 16

17. D E A Discretion D E A may exercise discretion regarding the degree of security required in narcotic treatment programs based on such factors as the location of a program, the number of patients enrolled in a program and the number of physicians, staff members and security guards. Similarly, such factors will be taken into consideration when evaluating existing security or requiring new security at a narcotic treatment program. 17

18. Office of Diversion Control http://www.DEAdiversion.usdoj.gov/ 18

19. Publications & Manuals 19

20. Any Questions Concerning D E A’s Presentation Today Can Be Sent to D E A at ODL@DEA.usdoj.gov 20

21. 21 Contact Information: Drug Enforcement Administration Drug Enforcement Administration 8701 Morrissette Drive 8701 Morrissette Drive Springfield, Virginia 22317 Springfield, Virginia 22317 Attn: James Arnold, Chief/Policy/ODLP Attn: James Arnold, Chief/Policy/ODLP 202-353-1414 (Office) 202-353-1414 (Office) 202-353-1263 (Fax) 202-353-1263 (Fax) James.A.Arnold@usdoj.gov James.A.Arnold@usdoj.govJames.A.Arnold@usdoj.gov