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Policy Statement

Policy Statement 2011-01: Proper Storage of Refrigerated and Frozen Medications

Date: 03/08/2011
Organization: Board of Registration in Pharmacy
Referenced Sources: M.G.L. c. 112, §§ 24 – 42A
247 CMR

The Massachusetts Board of Registration Pharmacy (Board) establishes this policy to ensure the proper storage of refrigerated and frozen medications in Board licensed pharmacies. 

The duties of a Pharmacist Manager of Record include the “maintenance of necessary pharmaceutical equipment” to conduct pharmacy practice in accordance with current United States Pharmacopeia (USP) standards and the establishment, implementation and monitoring of policies and procedures in the pharmacy that maintain the professional practice standards in the dispensing of pharmaceuticals, which includes proper storage of refrigerated and frozen medications in the pharmacy.

Following review of pharmacy refrigeration systems, the Board has determined that Board licensed pharmacies must meet ALL the below listed conditions to ensure proper storage of refrigerated and frozen medications.

Accordingly, each Board licensed pharmacy must:

  1. Develop policies and procedures to ensure proper refrigeration equipment is available and of adequate size to maintain medication stability and safety;
  2. Utilize either:
    • (a) combination refrigerator/freezer with compartments that are self-defrosting or frost-free with an automatic defrost cycle (preferred); or
    • (b) a stand alone refrigerator or freezer with compartments that are self-defrosting or frost-free with an automatic defrost cycle (preferred);
  3. Ensure proper refrigeration temperatures at 36º to 46ºF (2º to 8ºC) and freezer temperatures at 14º to -13ºF (-25º to -10ºC) are maintained at all times;
  4.  Proper refrigeration and freezer temperatures of each unit must be monitored at least daily using a check-in-range temperature log or certified thermometer equipped with an audible out of range alarm for both refrigerator and freezer compartments. Each log shall be labeled identifying the corresponding refrigerator or freezer unit that it represents, and  must contain retrospective temperature readings that are readily retrievable upon request;
  5. Develop an action policy and plan of correction to respond to any out of range individual temperature readings or excursions to ensure the integrity of stored medications;
    1. If a temperature excursion occurs, all affected inventory must be temporarily removed from active inventory and not dispensed until an evaluation of product integrity is completed
    2. All inventory that appears to be visibly altered or damaged (i.e. visible particulate, refrigerated product that has been frozen), must be not be dispensed and removed from active inventory for return via an authorized vendor
    3. Manufacturers of refrigerated/frozen products must be contacted to confirm safety and efficacy of products after exposure to inadequate storage conditions
    4. Product(s) which cannot be confirmed safe and effective by the manufacturer must otherwise be proven safe and effective by other means before dispensing
    5. Document confirmation or evidence of safety and effectiveness of products prior to returning to active inventory
    6. If confirmation of product integrity cannot be obtained, or product(s) have been deemed unsafe or ineffective, they must not be dispensed and shall be properly disposed of and returned via authorized vendor; documentation of such shall be retained and readily retrievable
    7. In the event that an unsafe or ineffective product was administered or dispensed to a patient, the patient and patient’s provider shall be notified and evidence of such notification and plan of correction shall be documented, maintained, and readily retrievable
  6. Develop and monitor a policy that NO food or beverage products are permitted to be stored in the refrigerators or freezers; and
  7. Educate pharmacists and other pharmacy personnel regarding the importance of proper storage of refrigerated and frozen medications. Review current refrigeration standards established by Centers of Disease Control and Prevention, USP, and the Massachusetts Department of Public Health, Division of Epidemiology and Immunization.
  8. Review the Compliance Inspection tool, specifically section H “Refrigeration”:

Adopted: March 08, 2011
Revised: April 6, 2017


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