Section 856IAC7-4-1. Requirement to keep records

   (a) Entities that engage in a take back program shall be required to keep a record of the following:

(1) Policies and procedures;

(2) Personnel involved with or who have access to returned medications;

(3) Dates when medications where [sic, were] collected by the party responsible for destruction; and

(4) Personnel responsible for destruction, transportation, and security.

This information may be maintained in conjunction or as part of the policies and procedures being utilized by the entity running the take back program.

  (b) A proper record validation process must include a documented signature and audit trail that includes review and/or witness by two (2) separate individuals, both of which are employed by the entity, one (1) of which must be a licensed individual and will ultimately be responsible for ensuring that drug storage devices are properly sealed, secured, and disposed of, either by means provided by the participating pharmacy or the contracted party. The intent of this process is to ensure safeguards against diversion, misuse, and/or improper disposal. Additional details on specific policies and procedures are provided in the article concerning access and security.

  (c) Model record keeping logs may be obtained from the board. While an entity is not required to use these forms, the board provides them as guidance for participating entities as models of an acceptable record keeping mechanism. (Indiana Board of Pharmacy; 856 IAC 7-4-1; filed Sep 18, 2012, 2:22 p.m.: 20121017-IR-856120414FRA)