Section 856IAC1-37-3. Policy and procedures manual

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

(2) The maintenance of the following:

(A) Appropriate records to identify the responsible pharmacist or pharmacists in the dispensing and counseling processes.

(B) A mechanism for tracking the prescription or drug order during each step in the processing or dispensing, or both, process.

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

(i) processing;

(ii) filling and dispensing; or

(iii) providing cognitive services.

(3) The provision of adequate security to:

(A) protect the product integrity; and

(B) prevent the illegal use or disclosure of protected health information.

(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)