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Editorial: Three Default Beyond-use Dates in United States Pharmacopeia Chapters <795> and <797>
This week we will review the default beyond-use dates (BUDs) in United States Pharmacopeia (USP) Chapters <795> and <797>. It should be noted that these default dates are used in the absence of stability information that is applicable to a specific drug and preparation.
The three sets of default BUDs to be briefly discussed include those for:
- Nonsterile preparations
- Sterile preparations that are not sterility tested
- Sterile preparations in a facility with a program of sterility testing in place
Nonsterile Preparations
Chapter <795> presents "maximum BUDs recommended for (1) nonsterile compounded drug preparations that are packaged in tight, light-resistant containers and stored at controlled room temperature, unless otherwise indicated." The section proceeds to describe in tabular form the BUD by Type of Formulation.
- For Nonaqueous Formulations- The BUD is not later than the time remaining until the earliest expiration date of any API or 6 months, whichever is earlier.
- For Water-Containing Oral Formulations-The BUD is not later than 14 days when stored at controlled cold temperatures.
- For Water-Containing Topical/Dermal and Mucosal Liquid and Semisolid Formulations-The BUD is not later than 30 days.
Sterile Preparations that Are Not Sterility Tested
Chapter <797> states the following:
Low-Risk Level CSPs
For a low-risk level preparation, in the absence of passing a sterility test, the storage periods cannot exceed the following time periods: before administration, the CSPs are properly stored and are exposed for not more than 48 hours at controlled room temperature, for not more than 14 days at a cold temperature, and for 45 days in solid frozen state between -25� and -10�.
Medium-Risk Level CSPs
For a medium-risk preparation, in the absence of passing a sterility test, the storage periods cannot exceed the following time periods: before administration, the CSPs are properly stored and are exposed for not more than 30 hours at controlled room temperature, for not more than 9 days at a cold temperature and for 45 days in solid frozen state between -25� and -10�.
High-Risk Level CSPs
For a sterilized high-risk level preparation, in the absence of passing a sterility test, the storage periods cannot exceed the following time periods: before administration, the CSPs are properly stored and are exposed for not more than 24 hours at controlled room temperature, for not more than 3 days at a cold temperature, and for 45 days in solid frozen state between -25� and -10�.
[NOTE: Sterility tests for autoclaved CSPs are not required unless they are prepared in batches of more than 25 units.]
Sterile Preparations that Are Sterility Tested
In Chapter <797>, STORAGE AND BEYOND-USE DATING, Determining Beyond-Use Dates, we read:
BUDs for CSPs that lack justification from either appropriate literature sources or by direct testing evidence shall be assigned as described in Stability Criteria and Beyond-Use Dating under Pharmaceutical Compounding-Nonsterile Preparations <795>.
In Chapter <795>, STABILITY CRITERIA AND BEYOND-USE DATING, General Guidelines for Assigning Beyond-Use Dates, we read:
In the absence of stability information that is applicable to a specific drug and preparation, the following table presents maximum BUDs recommended for (1) nonsterile compounded drug preparations that are packaged in tight, light-resistant containers and stored at controlled room temperature, unless otherwise indicated; and for (2) sterile preparations for which a program of sterility testing is in place.
Note that the second set of preparations are sterile and involve a "program of sterility testing." If a program of sterility testing is in place and documented, then the BUDs provided in the <795> table can be used. Of those, the first two categories involve either nonaqueous formulations or water-containing oral formulations.
There has been confusion regarding this table and the use of the word "oral" that differentiates this category from the water-containing topical/dermal and mucosal liquid and semisolid formulations category. Practically, CSPs will generally be either nonaqueous or water-containing and the conservative BUD seems more appropriate.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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