16 Chapter 16: Beyond Use Date and Stability of Compounded Preparations

When pharmaceutical preparations are compounded, we must determine how long the product is good for.

The Beyond-Use Date (BUD) is the date after which a non-sterile compounded preparation should no longer be used. Unlike expiry dates assigned to manufactured drug products, BUDs for non-sterile compounded preparations are determined based on different criteria due to the immediate-use or short-term storage nature of these preparations. Assigning a BUD requires extensive experience in non-sterile compounding, as well as a strong understanding of stability data and formulation properties.

If you have an existing Master Formulation Record with BUD, you simply need to calculate the date, using the day the compound is made as Day 1. If you have to create a Master Formulation record, you need to calculate the Beyond Use Date.

Considerations for Assigning a BUD

BUDs should be assigned conservatively, considering factors such as:

• The stability of the active pharmaceutical ingredient (API) and excipients
• Information provided by the manufacturer (if using a commercial product as an API)
• The compounding method and formulation type
• Potential degradation mechanisms
• Compatibility of ingredients
• Potential for microbial growth within the preparation
• The type of container used for storage
• Expected storage conditions (e.g., refrigeration or room temperature)
• The intended use and duration of therapy

Consult references and assign according to published monograph or formulation record (USP, Trissel’s, Remington’s, Sickkids).  The manufacturer’s expiry date of an API should not be used as the BUD for the final compounded preparation. Instead, appropriate references and stability data should be reviewed.  If not known, use the “default” dates for nonsterile preparations according to NAPRA.

Beyond-Use Date (BUD) Guidelines by Formulation Type From NAPRA

• Non-Aqueous Formulations – The BUD is the earlier of the remaining shelf life of the API or 6 months.
• Water-Containing Oral Formulations – The BUD is 14 days, with refrigeration required at controlled cold temperatures.
• Water-Containing Topical, Mucosal Liquid, and Semi-Solid Formulations – The BUD is 30 days.

*Recommended BUDs in absence of stability information

*BUD shall not be later than the expiration date of any component

Use a table from NAPRA Model standards for non sterile compounding…pg 23

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Additional Stability Considerations

• Ingredient Sensitivity – Drugs and chemicals prone to decomposition may require shorter BUDs.
• Microbial Growth Prevention – Where applicable, antimicrobial agents should be included to prevent bacterial, yeast, and mold contamination. However, these agents should not replace proper compounding practices.
• Storage Requirements – If antimicrobial preservatives are contraindicated, susceptible compounded products should be stored at controlled cold temperatures, and patients should be informed of proper storage practices.
• Monitoring for Instability – The compounded preparation should be examined at all stages for signs of instability or degradation, including changes in color, consistency, or odor.