The A beyond use date is the date, or the hour and date, after which a compounded medication must not be used. The compounding pharmacy assigns it under United States Pharmacopeia standards, calculated from the date or time of compounding. The term applies to compounded preparations, including the sterile injectable semaglutide and tirzepatide vials that BrightSide patients receive.
How does a beyond use date apply to compounded GLP-1 treatment?
A compounded semaglutide or tirzepatide vial is a sterile preparation, so the pharmacy that makes it assigns a beyond use date. Two limits then apply. The first is the beyond use date itself, which covers how long the vial can be stored. The second starts when the vial is first punctured. United States Pharmacopeia chapter 797 says a multiple-dose compounded preparation must not be used for longer than its assigned beyond use date or 28 days after first puncture, whichever is shorter. FDA gives patients the same number. It recommends discarding a multiple-dose vial 28 days after the first use, even if medication remains and even if the compounder's instructions give a longer period. BrightSide's compounded tirzepatide ships cold from the pharmacy and goes in the refrigerator when it arrives.
What does a beyond use date mean at the pharmacy?
At the pharmacy, the beyond use date is capped by United States Pharmacopeia chapter 797. The chapter sorts compounded sterile preparations into three categories, and the limit depends on the category, the storage temperature and whether the batch passed a sterility test. The shortest limits are for preparations released without a sterility test. An aseptically processed Category 2 preparation in that group is limited to 4 days in a refrigerator when it starts from a nonsterile ingredient, or 10 days when every starting ingredient is sterile. Sterility testing opens longer dates. An aseptically processed Category 2 preparation that passes sterility testing can be dated up to 45 days in a refrigerator or 30 days at controlled room temperature. Category 3 goes further, to 90 days refrigerated, for pharmacies that meet added quality requirements. A pharmacy can assign a shorter date than the limit, and it has to when stability or sterility calls for one. Dates are not additive. Our pharmacy network page covers how we choose the pharmacies we work with.
How does Washington set beyond use dates?
Washington adopts the United States Pharmacopeia standard by rule. WAC 246-945-100 requires every licensee of the Pharmacy Quality Assurance Commission that compounds sterile products to comply, at a minimum, with USP General Chapter 797 in the version official as of November 1, 2023. That chapter sets the beyond use date limits described above, so a Washington pharmacy assigns its dates inside those limits. The commission's 2026 self-inspection worksheet for sterile compounding reproduces the chapter's limit tables and asks each pharmacy whether its dates are set as required. Nordic Pharmacy in Poulsbo, Washington fills BrightSide's Washington and Oregon prescriptions, and our Washington page names it alongside treatments such as compounded tirzepatide for Washington. Questions about the date on a vial from BrightSide go to hello@jointhebrightside.com, and a person answers.
| Preparation | Sterility test | Controlled room temperature | Refrigerator |
|---|---|---|---|
| Category 1 | Not required | 12 hours | 24 hours |
| Category 2, one or more nonsterile starting ingredients | Not performed | 1 day | 4 days |
| Category 2, sterile starting ingredients only | Not performed | 4 days | 10 days |
| Category 2 | Performed and passed | 30 days | 45 days |
| Category 3 | Performed and passed | 60 days | 90 days |
Common questions
Is a beyond use date the same thing as an expiration date?
No. A beyond use date belongs to a compounded preparation and is calculated from the time of compounding. An expiration date belongs to a manufactured drug. USP's own example pairs a manufactured multiple-dose vial that has a one-year expiration date with a compounded preparation that has a 60-day beyond use date.
Can you use a compounded vial for more than 28 days after the first dose?
No. FDA recommends discarding a multiple-dose vial 28 days after the first use, even when medication is left in it, because the risk of contamination increases after 28 days. That holds even if the compounder's instructions say the medication can be used for longer.
Related terms
- Compounded medication: the kind of drug a beyond use date applies to.
- 503A compounding pharmacy: the pharmacy that assigns the date.
- Certificate of analysis (COA): the batch report for the ingredient that goes into the vial.
Sources
- USP, General Chapter 797 frequently asked questions, updated December 11, 2023: https://pages.usp.org/rs/711-SXF-172/images/USP_HQS_797_FAQs_December2023_V6__002.pdf?version=0
- Washington Pharmacy Quality Assurance Commission, 2026 USP 797 sterile compounding self-inspection addendum, DOH 690-296, January 2026: https://doh.wa.gov/sites/default/files/2024-02/690-296-USP797SterileCompoundingAddendum.pdf
- FDA, FDA's concerns with unapproved GLP-1 drugs used for weight loss, content current as of October 1, 2026: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
- Washington Administrative Code 246-945-100, Compounding minimum standards: https://app.leg.wa.gov/wac/default.aspx?cite=246-945-100
Compounded medications are not FDA approved. They are prescribed by a licensed clinician and filled by a licensed 503A pharmacy.
