Establishing BUDs (Beyond Use Dating)
Sterile Non-Hazardous Compounding <797>

Purpose/ Applicability: To provide a guideline as well as establish appropriate documentation for assigning appropriate BUDs for CSPs.

Scope: This applies when creating a master formulation / compounding record for a new product as well as when reviewing current BUDs for sterile products.

Definition(s):

CSP: Compounded Sterile Product

BUD: Beyond Use Date

USP: United States Pharmacopeia

Equipment: N/A

Procedure:

General Steps

1. In general, beyond use dates will be established by:
   1. Reviewing the most current USP Compounding Compendium
   2. Consulting the literature, available stability documentation or other publications
      1. IJPC, Compounding Today, compounding wholesalers
   3. Reviewing the nature of the drug and its degradation mechanisms
   4. The packaging container
   5. Expected storage conditions
   6. Duration of therapy
   7. Pharmacists personal knowledge and experience

2. In the absence of stability data regarding a formulation, the following table will be used to assign a beyond use date
   1. Then, the method of establishing the BUD (e.g. the reference) will be documented on the compounding record and the master formulation for each preparation
      
      

Table 1: Beyond-Use Dates for Compounded Sterile Preparations without Sterility Testing Program (2008)

Table 2: Beyond-Use Dates for Compounding Sterile Preparations without A Sterility Testing Program (2019)

Table 3: Beyond-Use Dates for Compounding Sterile Preparations With A Sterility Testing Program (2019)

Note: The above tables should be reviewed and the strictest BUD should be applied to the product.

References:  USP <797> 2008, USP <797> 2019