Establishing BUDs
Non-Sterile Compounding <795>

Purpose/ Applicability:  To provide BUD (Beyond Use Date) guidelines for personnel who will participate in non-sterile compounding.

Scope: Applies to a nonsterile compounded preparation based on the stability and sterility of the compound.

Definitions:
BUD: Beyond Use Date
CNSP: Compounded nonsterile preparation

Equipment:

• N/A

Procedure:

USP Chapter 795 define BUD as the date or time after which a compounded nonsterile preparation (CNSP) should not be used. The BUD is determined from the date the CNSP is compounded (the day of compounding is Day 1). Stability information may come from documentation, literature or stability tests. In the absence of stability information, the maximum BUDs for CNSP packaged in tight, light resistant containers are:

Non-aqueous Formulations: no longer than 6 months or the earliest expiration date of any ingredient used, whichever is shorter, and stored at controlled room temperatures

Water Containing Oral Formulations: no longer than 14 days or the earliest expiration date of any ingredient used, whichever is shorter, and stored at controlled cold temperatures. This may include the following: emulsions, creams, gels, solutions, sprays, and suspensions. This also includes water being added as an ingredient or water is a component of any ingredient used. (For example: diphenhydramine syrup has water as a component)

Water Containing Topical/Dermal and Mucosal Liquid and Semisolid Formulations: no longer than 30 days or the earliest expiration date of any ingredient used, whichever is shorter, and stored at controlled room temperatures. This includes water being added as an ingredient or water is a component of any ingredient used.