Section 338.3635. Collection device; requirements.

A participating pharmacy or charitable clinic shall utilize a collection device to collect prescription drugs and other medications that are ineligible for distribution under the program for destruction and disposal that meets all of the following criteria:

(a)     Is designed to allow contents to be added to the device but not removed, except by authorized personnel for the purpose of destruction and disposal.

(b)    Is labeled pursuant to all applicable state and federal laws and regulations.

(c)     Is lined with a removable liner that is waterproof, tamper-evident, tear resistant, and capable of being sealed. The contents of the liner shall not be viewable from the outside and the size or capacity of the liner shall be clearly marked on the outside of the liner.

(d)    Is secured in a manner that will only allow authorized personnel to remove the contents of the container for the purpose of destruction and disposal.

(e)    Uses a design that is tamper resistant and is securely locked.

(f)    Is securely fastened to permanent structure within the designated pharmacy area so that it cannot be removed.

(g)    Is consistently monitored by security features and pharmacy personnel.

(h)    The following statements shall be prominently placed on the collection device and shall be posted as signage near the location of the collection device, “Controlled substances cannot be accepted for destruction and disposal, unless permitted under federal law.” and “Chemotherapeutic agents shall not be placed in this collection device.”

(i)    The collection device for the yellow jug old drugs program operated by the Great Lakes clean water organization is deemed to satisfy the requirements of this rule, provided the participating pharmacy or charitable clinic is a compliant participant in the yellow jugs old drugs program.

History: 2014 AACS.