Authority: IC 12-23-1-6; IC 12-23-18

Affected: IC 12-23-18

Sec. 11. An OTP shall do the following:

1. (1) Ensure the security of its treatment medication supply.
2. (2) Account for all treatment medication in the facility.
3. (3) Meet the requirements of 440 IAC 10-3-2(b)(7).
4. (4) Meet the requirements of the federal Drug Enforcement Agency (DEA), including securing and retaining a valid DEA registration.
5. (5) Maintain a DEA acceptable security system that meets the requirements of 21 CFR §1301.71 through §1301.76 as applicable. The system shall be checked on a quarterly basis to ensure its continued safe operation.
6. (6) Physically separate the areas for the storage of, and administration of, treatment medication from other parts of the facility where patients are present.
7. (7) Implement written policies and procedures to ensure the positive identification of a patient before treatment medication is administered.

8. (8) Implement written policies and procedures regarding the recording of the following:

   1. (A) Patient medication intake.
   2. (B) A daily treatment medication inventory.

9. (9) The OTP shall develop and implement procedures for assuring the following:

   1. (A) The safety and security of the OTP and persons working at or visiting the OTP, including the provision of alarm protection and on-site security protection.
   2. (B) The clinic patients or others are not using the clinic to identify potential drug sale clients or for the transfer of medications from patient to patient.
   3. (C) Safety and security in the facility parking lot and grounds.

(Division of Mental Health and Addiction; 440 IAC 10-4-11; filed Dec 30, 2009, 2:00 p.m.: 20100127-IR- 440080412FRA; readopted filed May 10, 2016, 11:24 a.m.: 20160608-IR-440160134RFA; readopted filed Nov 9, 2022, 4:31 p.m.: 20221207-IR-440220292RFA)