13.7 Handling CSP and Manufacturer Product Returns

What if an IV or other CSP is returned from the nursing unit unopened and unused? The patient may have been discharged, transferred to another hospital, or died, or the physician may have changed the medication order. The decision as to whether to reuse any CSP or commercially available product is influenced by the nursing unit’s storage conditions, the hospital’s policies and procedures, and USP Chapter <797> directives. An unopened CSP can be returned for a short period of time to pharmacy storage, relabeled, and redispensed only when the pharmacist or technician is certain that it was stored by the nursing unit in compliance with instructions and remained sterile and chemically stable per USP <797>. Is there any doubt that it was refrigerated properly and protected from light as the instructions dictated? Is there evidence of compromises in package integrity? If so, the CSP must be discarded.

In the case of a proprietary vial-and-bag system that has not been “activated,” the vial-and-bag system may be returned to the pharmacy for reuse and relabeling.

Depending on the manufacturer’s recommendations, once the product has been removed from the exterior sterile packaging, there is a 14- to 30-day shelf life for future use. The manufacturer’s product package insert should be consulted for precise expiration dating. Activated doses returned to the pharmacy, however, must be discarded.

If a premade, frozen IVPB is stored for a short time at room temperature, the pharmacist must determine in accordance with manufacturer recommendations and hospital policies whether it can be relabeled and used soon after with a shorter expiration date. If the turnaround is quick enough that it can be used for another patient, then a new patient-specific label may be generated with an updated beyond-use date.