BUDs for Sterile Preparations and Stability in Compounding Pharmacies
By Rick Rhoades
Published in: IVT Jr Val Tech
Published on: February 23, 2021
Beyond Use Date (BUD) is very different from expiration date. USP Chapter 797 defines BUD as the date or time after which a compounded sterile preparation (CSP) may not be stored or transported and is calculated from the date or time of compounding. Expiration date is a manufacturer defined term based on very specific testing used for commercially available products. A CSP cannot be labeled with the term “expiration date” or any variance thereof. It must be labeled with a different phrase such as, “do not use after” or “use before” etc.
If you have not yet signed up for the StabilityHub newsletter, join hundreds of other stabilitarians to get the latest news, publications, job opportunities and more!
By submitting this form, you are consenting to receive emails from: StabilityHub, You can revoke your consent to receive emails at any time by using the SafeUnsubscribe® link, found at the bottom of every email. Emails are serviced by Constant Contact