Maybe you’re already aware of a proposal from the U.S. Pharmacopeia that would restrict beyond-use...
Be careful: Missouri has its own BUDs
We’ve received reports from members that Missouri inspectors are citing pharmacies for using USP’s default beyond-use dates, particularly for sterile Category 2 preparations. In one recent inspection, a pharmacy assigned a 45-day refrigerated BUD based on USP <797>, but Missouri’s rules limit that product to 30 days.
Here’s the key point:
Missouri does not always adopt USP’s default BUDs. When nonsterile starting ingredients or certain sterile compounding scenarios are involved, the state relies on its own BUD limits, which are more restrictive than USP.
If you compound for patients in Missouri, review your BUD assignments and ensure they align with Missouri’s state-specific requirements, not just USP <797>.
We’re continuing to track states with more restrictive BUD frameworks, and we’ll share updates as we gather more information. If you’ve had an inspection finding related to BUDs in Missouri or another state, please let us know so we can include it in our monitoring.