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What is USP659?
The United States Pharmacopeia (USP) is an independent, not-for-profit organization that originated in 1820. The mandate of this organization is to develop standards for quality, purity, identity, and strength for medicines, food, and health. The standards are enforced by the U.S. Food and Drug Administration (FDA), and given the independent status of the USP, standard-setting activities are guided by impartial, empirical, and scientific evidence.
In December 2020, USP made significant changes to key areas, keeping the well-being of citizens in mind. These changes have started to impact the storage and distribution of products manufactured by life sciences and pharmaceutical companies.
If you’re wondering what changes were made and how they impact storage and distribution, here’s a quick introduction to what’s changed. In particular, one significant change is the shift in previously included definitions included in USP chapter 1079. These are now incorporated into USP chapter 659, and this move is remarkable as specific product temperature definitions are now considered laws as opposed to chapters above 1000, which were just guidelines.
What’s the significance of USP659?
The US FDA now has the power to move towards stricter enforcement for patient safety and ensure excursions are managed efficiently with the changes to the USP659 laws. Transferring the product temperature to US659 legally highlighted that all medications with temperature label claims must prove that temperature and climate control provide pure, efficient, and required potency of medications and vaccines.
Temperature conditions are essential to ensure all medications and vaccines’ efficacy, quality, and potency. A positive, proactive, and responsible attitude ensures that optimum room temperature within the given framework, along with the required settings, is maintained in laboratories, pharmacies, and hospitals.
What are some of the temperature definitions outlined by USP659?
USP659 outlines specific temperature conditions that ensure the efficacy and quality of medications and vaccines are maintained by optimum room temperature management. The temperature and storage definition specifically lays down temperature ranges for varied room types, including cold: not exceeding 8°C (46°F); cool: between 8°C and 15°C (46°F and 56°F); warm: between 30°C and 40°C (86°F and 104°F); and excessive heat: above 40°C (104°F).
Another new definition added to the December 2020 update is the Controlled Cold Temperature for temperatures between 2°C to 15°C. This new definition ensures that refrigerated products subjected to any excursions in temperature can be assessed quickly. Controlled Room Temperature is the temperature maintained thermostatically and encompasses the usual and customary working environment of 20°C to 25°C (68°F and 77°F). Also, excursions between 15°C and 30°C (59°F and 86°F) are experienced in pharmacies, hospitals, and warehouses during transportation are permitted.
Mean Kinetic Temperature (MTK) expresses the overall effect of temperature fluctuations during the storage or transit of perishable goods. MTK typically should not exceed 25°C. However, transient spikes up to 40°C are permitted as long as they don’t exceed 24 hours. The USP659 package and storage requirements are very precise for frozen products between -25°C to -10°C, refrigeration temperatures between 2°C to 8°C for pharmacies, with specifics on maintaining different conditions between 8°C to 15°C for cool, 30°C to 40°C for warm and excessive heat of >40°C.
What are some compliance measures for packing and storage?
USP also includes packaging definitions which are also referred to as container closure systems and are the sum of the packaging components and materials that together contain and offer protection to components such as medications, vaccines, or syrups during storage or shipping from the packaging system.
For further compliance, companies must adhere to the USP659 packaging and storage requirements by labeling every component. USP 659 allows manufacturers the choice of containers; however, dosing cups, spoons, and oral syringes must be marked in metric units corresponding to the dosing instructions. Storerooms should be designed and adapted to ensure good storage conditions are maintained within the acceptable temperature and humidity conditions. Pharmacopeia products should be off the floor, suitably spaced to permit cleaning and inspection, and away from heat, light, air, and moisture, which may damage the medicine.
Finally, to comply and successfully implement the USP659 mandate, regular training of staff and personnel is essential to eliminate inefficiencies. An automated documented system can be implemented as a tool for temperature or climate control while strategic planning, detailed protocols, responsible staff, and resources are required for maintenance and monitoring guidelines.
Solutions to help meet compliance
TempAid recently announced a first-of-its-kind thermal insulated shipping mailer that integrates PCM refrigerants into its construction, allowing specialty pharma and mail-order drug organizations to send individual doses of medications at a stable room temperature with an envelope form factor. The patent pending solution removes the need for EPS coolers, a corrugated box, and separate refrigerants by integrating a proprietary phase change material (PCM) into the lining of the envelope.
The solution is qualified for URAC requirements per USP 659. Each mailer is tested against the ISTA 7D & 7E Summer and Winter profiles (as well as Spring/Fall seasonal conditions) using lane data gathered from real-world conditions and tested with several different product payload boxes and instrumented with calibrated RTD temperature monitors.
If you have any questions about USP 659, our new CRT mailer, or how we apply this standard to package testing, contact our offices.
