Proper Storage of Refrigerated and Frozen Medications

(1) A pharmacy shall maintain policies and procedures to ensure proper refrigeration equipment is available, of adequate size, and utilized to maintain proper refrigeration and freezer temperatures. The policies and procedures shall include a protocol to respond to any out of range temperature, including an assessment of the integrity of the medication. (2) A pharmacy shall utilize a combination refrigerator/freezer or a standalone refrigerator or standalone freezer. Freezer units shall be frost-free with an automatic defrost cycle, unless otherwise approved by the Board. A pharmacy may not utilize an appliance that contains a freezer compartment within the refrigerator space, such as a dorm-style refrigerator. (3) A pharmacy shall measure and maintain refrigerator and freezer temperatures in accordance with Board guidance. (4) A pharmacy shall maintain temperature logs to clearly identify out of range temperatures and shall document actions taken in response to an out of range temperature. A pharmacy shall maintain records for at least one year. (5) A pharmacy may not store any food or beverage in a refrigerator or freezer used to store medications.