USP Regulatory Blog Series, Part 1
Why are USP <659> Packaging and Storage Requirements Important?
USP <659> Changes are Fast Approaching
The United States Pharmacopeia (USP) is scheduled to make changes to key chapters that may affect life sciences companies such as manufacturers, wholesalers and pharmacists, along with all companies that handle, store and transport pharmaceuticals, including logistics service providers. The changes will be published in August 2020 and made effective by December 2020. In this Sensitech series, we will highlight important changes that will affect life sciences companies’ storage and distribution, and how to plan for those changes.
Difference Between Guidance and Law
Founded in 1820 in Washington, D.C., the USP is a nonprofit scientific organization that develops and disseminates public compendia quality standards for medicines and other articles. The USP product temperature definition was originally in USP <1079> and now resides in chapter, USP <659>. This is significant, because chapters numbered above 1,000 are considered guidance, whereas those numbered below 1,000 are considered law and are enforceable by the U.S. Food and Drug Association (FDA). Moving product temperature definitions to USP <659> has legally mandated that all products with temperature label claims must provide assurance that temperature is maintained.
Controlled Cold Definition Added
The USP has added a new temperature definition called Controlled Cold. Standard Refrigerated temperature is +2°C to +8°C. The added definition of Controlled Cold is +2°C to +15°C with temperature excursion time (above limits) no more than 24 hours and Mean Kinetic Temperature (MKT) not to exceed +8°C. No excursions are allowed below +2°C or above +15°C.
Standard Refrigerated Temperature vs. Controlled Cold
To further understand MKT, it is defined in (USP 35 Chapter <1150>, Pharmaceutical Stability) as: “…a single calculated temperature at which the total amount of degradation over a particular period is equal to the sum of the individual degradations that would occur at various temperatures.” For example, the MKT value is supposed to include the total amount of product degradation for a period of time that is equivalent to the incremental degradation that would occur in separate excursions. MKT is an additional tool that can be used to evaluate a temperature excursion.
This new Controlled Cold definition will allow refrigerated products that experience temperature excursions to be evaluated more quickly. The prior stricter +2°C to +8°C refrigerated definition required more shipments to be quarantined and evaluated. Companies can evaluate potential cost savings by reducing the number of shipments with excursions, thus reducing quality assurance time investigating excursions. TempTale® dataloggers can be programmed to the expanded +2°C to +15°C with 8°C MKT to potentially reduce the amount of time investigating excursions.
The two changes in USP <659> show that the FDA is continuing to move toward stricter enforcement to protect consumers, while at the same time defining ways to make the process of managing excursions more efficient.
Sensitech Regulatory Experts are Here to Help
Sensitech® Inc. tracks and maintains extensive information related to regulatory changes and can provide in-depth information to your company related to USP <659>. Sensitech also provides direct support on best practices for temperature controlled storage and transportation. With over 20 years of experience, Sensitech Professional Services conducts more than 100 engagements per year assisting life sciences customers improve their storage and distribution practices with actual data using proven methodologies.
If you would like more information on Sensitech’s thermal mapping studies, visit our Professional Services site or contact us.