“Medication Units” (Opioid Treatment Programs)

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

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 fromLegitimateChannels • WhileEnsuring an Adequate and UninterruptedSupply of Pharmaceutical Controlled Substances to MeetLegitimateMedical, Commercial, and ScientificNeeds.

3. Authority • 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) • Policy Written Memorandums, Letters Publications (Federal Register)

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

5. Law: 21 USC 822 (a) (1) • 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

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

7. Law: 21 USC 822 (e) • Separate registration • A separate registration shall be required at each principal place of business or professional practice where the applicant manufactures, distributes, or dispensescontrolled substances or list I chemicals.

8. Law: 21 USC 827 (a)(1),(2) • 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

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 accuraterecord of each substance manufactured, received, sold, delivered, or otherwise disposed of …”

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

11. Federal Law & Regulation Although medication units are exempt from NTP (OTP) licensing requirements by CSAT, under Federal law they must have a separateD 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.

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).

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.

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

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

16. Safes, Steel Cabinets, or Vaults 21 CFR 1301.72 (a), (b) Alarm Systems 21 CFR 1301.72 (a) 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) 21 CFR 1301.74 (l) Security

17. 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. D E A Discretion

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

19. Publications & Manuals

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

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