Seven Key Cold Storage Recommendations from USP <1079>

Medication management across the health system can be complex. Drugs requiring refrigeration make workflow management and proper storage even more complicated. For this reason, USP Chapter <1079> provides guidance around maintaining the cold chain. Many health systems and pharmacies are looking to upgrade cold storage units due to increased pressure from storage guidelines and recommendations as well as the high risks related to the improper storage of refrigerated drugs. USP <1079> outlines seven key recommendations to ensure your pharmaceutical storage units are always storing drugs safely within the manufacturer’s recommended temperature range. Each recommendation will be covered in detail throughout this paper.

Risks of Improper Storage

Preparations which take several routes before reaching the patient are at higher risk of temperature excursions, exposure to humidity, light and oxygen.  Individuals must have systems in place to track and record storage conditions throughout the cold chain to ensure drug efficacy, patient safety, and protection from financial loss due to wasted refrigerated medications.

There is great risk associated with medication being compromised by exposure to temperatures beyond the safe temperature range determined by the manufacturer. “The loss of efficacy can result in many issues compromising the health of the patient. With some medications, the stakes are even higher. If epinephrine, for example, is exposed to repetitive heating and cooling, it can lose 64% of its efficacy. If a compromised dose of epinephrine is used to treat a patient suffering from a serious anaphylactic reaction, it may not work as intended, resulting in possible death (Katzki).”

Financial Burden

Another risk of storing medications out of the manufacturer’s recommended temperature range is financial loss. Drugs stored at out of range temperature for significant periods of time may become ineffective and must be disposed of. Some refrigerated drugs may be short dated and stored at ambient temperature significantly reducing the life of the drug. This increases the risk of the drug expiring before use leading to waste and amplified financial burden.

General Chapter <1079>

General Chapter <1079> provides guidance concerning storage, distribution, and shipping of Pharmacopeial preparations. This article focuses on the area of the chapter which describes essential procedures to maintain proper storage environments for temperature sensitive drugs to ensure a preparation’s integrity from prep to administration. There is a vast set of testing data recommended to ensure temperature-controlled storage environments maintain appropriate conditions for temperature sensitive drugs. Understanding and measuring temperature uniformity, stability, and recovery ensures drugs are stored according to manufacturer instructions.

USP <1079> reinforces that good practices are necessary for all temperature-controlled pharmaceuticals. The chapter explains the temperature ranges for drugs stored at the following requirements:

• Room Temperature Storage: 20 C – 25 C (Excursions permitted between 15 C and 30 C)
• Controlled Room Temperature: 20 C – 25 C
• Cool Storage: 8 C – 15 C
• Refrigerator Storage: 2 C – 8 C
• Freezer Storage: -25 C – 10 C

Other storage parameters such as, “store in a cool dry place or protect from light,” provide guidance on how to properly store various drugs which may be sensitive to humidity or light.

Following USP <1079> Storage Recommendations 

The chapter outlines seven key recommendations to ensure drugs are stored safely and within the correct temperature ranges. The use of medical-grade refrigerators, stability testing, uniformity testing, recovery testing, temperature monitoring, personnel training, and regular calibration will ensure drugs are stored within the recommended temperature ranges to prevent excess waste, patient harm, and financial burden. Each USP <1079> Good Drug Storage Practice is outlined inside the white paper below in further detail. Download the white paper now.

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