MUST READ!! Very Important!! USP Answers Some Fequently Asked Questions

Compounding

1. Is USP considering revisions to <797> Pharmaceutical Compounding – Sterile Preparations?
   
   Yes, the Compounding Expert Committee began the revision process for General Chapter <797> in July 2010. Additionally, the Expert Committee formed an Expert Panel in April 2013. When the revisions are completed, the proposed changes will be posted in the Pharmacopeial Form (PF) for public comment. PF is published every two months and is a forum for stakeholders to submit their comments on the proposed changes. The PF comment period is 90 days.
    
2. 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. (See http://www.usp.org/usp-nf/official-text/revision-bulletins/pharmaceutical-compounding-nonsterile-preparations).
    
3. What are the considerations for assigning a BUD for a compounded sterile preparation?
   
   When assigning a BUD for a compounded sterile preparation, the compounder must consider both the sterility and stability of the preparation.
    
4. Is there a difference between testing stability with a strength (potency) or a stability-indicating method?
   
   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 BUD. (See article, “Strength and Stability Testing for Compounded Preparations.”)
    
5. Does General Chapter <797> require me to test according to <51> Antimicrobial Effectiveness Testing when compounding a multiple-dose container that contains a preservative?
   
   Currently, General Chapter <797> provides minimum practice and quality standards for compounding sterile preparations, but it does not contain specific requirements for compounding multiple-dose containers, such as the need for a preservative, nor requirements for testing, labeling, and container closures for compounded multiple-dose containers.  Future revisions of <797> may contain more specific standards for compounding multiple dose containers.
    
6. Why is General Chapter <51> Antimicrobial Effectiveness Testing mentioned in <797>?
   
   The reference to General Chapter <51> under the section Single-Dose and Multiple-Dose Containers in <797> is provided for informational purposes to refer to commercially manufactured sterile multiple-dose containers. The reference to <51> serves to indicate the source of the 28-day BUD after initially entering or opening (e.g., needle-punctured) a multiple-dose container, unless otherwise specified by the manufacturer.

quoted from here