856 Ind. Admin. Code 7-7-5

Current through October 16, 2024

Section 856 IAC 7-7-5 - Maintenance, monitoring, and emptying

Authority: IC 25-26-23-2

Affected: IC 25-26-23

Sec. 5.

(a) The drug receptacle into which drugs are placed or returned must be maintained in such a way as to prevent unintended access, diversion, or harm to the personnel or patients/customers that might use or be in the vicinity of the receptacle.

(b) The storage device and drug receptacle should be monitored in accordance with the security provisions discussed in this article. The level of monitoring should correspond to the location and permanence of the device and should be focused on reasonably preventing diversion, inappropriate access, and harm to patients and/or customers. In no instance should the receptacle used to facilitate a take back program be located outside the facility or be left in an area incapable of being monitored via security cameras or live personnel.

(c) Emptying the device and receptacle shall be done in accordance with the provisions provided above and utilize a log or receipt schedule capable of being audited and maintained as a part of the program's record retention requirements.

(d) In the event that the device being used to accept returned medications is full or exceeds capacity, personnel involved in managing the take back program may remove the contents to the extent necessary to secure the returned medications until such time as personnel can arrange for destruction. Whatever contents are removed must be secured in an area separate from merchandise or prescriptions available for sale to customers or patients. Any additional storage area shall also only be accessible to the personnel named in this article and specified in the entity's policies and procedures. Additionally, if an entity maintains additional storage space, this process and space shall be addressed in their policies and procedures (for example, referenced as "Overflow Policy").

856 IAC 7-7-5

Indiana Board of Pharmacy; 856 IAC 7-7-5; filed Sep 18, 2012, 2:22 p.m.: 20121017-IR-856120414FRA

Readopted filed 11/21/2018, 8:35 a.m.: 20181219-IR-856180407RFA

Readopted filed 2/15/2024, 1:16 p.m.: 20240313-IR-856230795RFA