Authority: IC 25-26-13-4

Affected: IC 25-26

Sec. 3. The parties performing or contracting for central fill or processing, or both, services shall maintain a policy and procedures manual and documentation that implementation is occurring in a manner that shall be made available to the board for review, upon request, and that includes, but it is not limited to, the following:

1. (1) A description of how the parties will comply with federal and state laws and regulations.

2. (2) The maintenance of the following:

   1. (A) Appropriate records to identify the responsible pharmacist or pharmacists in the dispensing and counseling processes.
   2. (B) A mechanism for tracking the prescription or drug order during each step in the processing or dispensing, or both, process.

   3. (C) A mechanism to identify all pharmacies or licensed persons, or both, involved in:

      1. (i) processing;
      2. (ii) filling and dispensing; or
      3. (iii) providing cognitive services.

3. (3) The provision of adequate security to:

   1. (A) protect the product integrity; and
   2. (B) prevent the illegal use or disclosure of protected health information.
4. (4) The maintenance of a continuous quality improvement program for central fill or processing, or both, services.

(Indiana Board of Pharmacy; 856 IAC 1-37-3; filed Oct 14, 2005, 1:00 p.m.: 29 IR 816; readopted filed Nov 22, 2011, 12:16 p.m.: 20111221-IR-856110370RFA; filed Jun 19, 2013, 10:06 a.m.: 20130717-IR-856120619FRA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR- 856230795RFA)