Frequently Asked Questions: Compounding
- Can the table of “Beyond-Use Date (BUD) by Type of Formulation” under the section General Guidelines for Assigning Beyond-Use Dates in <795> Pharmaceutical Compounding – Nonsterile Preparations be applied to sterile preparations?
- How can I access USP compounding-related (e.g. <797>) or supporting general chapters (e.g. <71>)?
- Is there a difference between testing stability with a strength (potency) or a stability-indicating method?
Can the table of “Beyond-Use Date (BUD) by Type of Formulation” under the section General Guidelines for Assigning Beyond-Use Dates in <795> Pharmaceutical Compounding – Nonsterile Preparations be applied to sterile preparations?
No, General Chapter <795> is specific for nonsterile preparations. Footnote (a) under the table indicates that the table represents the maximum Beyond-Use Date (BUD) for compounded nonsterile preparations in the absence of stability information. A Revision Bulletin for <795> was posted on November 22, 2013 (official January 1, 2014) to further clarify this distinction.
You can access all compounding-related and supporting general chapters through the USP Compounding Compendium. The USP Compounding Compendium contains the 5 essential compounding chapters, over 40 supporting general chapters, and more than 170 compounded preparation monographs. You can purchase the USP Compounding Compendium online at the USP store or by contacting USP Customer Service. You may also purchase copies of individual chapters by contacting USP Customer Service.
Yes, a strength (potency over time) test determines the amount of active ingredient in a preparation, however, it may not be able to separate the inactive ingredient from its degradation products and impurities for quantitation depending on the analytical methods used for the test. A stability-indicating method will be able to quantitate the active ingredient and its degradation products or related impurities in the preparation by separating the inactive ingredient from its degradation products and impurities, and to show a change in the concentration of the active ingredient with increasing storage time. A stability-indicating method is used to determine stability of a drug and used to establish the Beyond-Use Date. (See article, “Strength and Stability Testing for Compounded Preparations.”)