Beyond-use date (BUD) rules for sterile compounded drugs sit at the intersection of FDA enforcement authority and USP standards. Understanding who sets the rules, what the rules say, and how they are enforced is essential for any clinic or pharmacy that works with compounded sterile preparations.

This post provides a clear overview of the current regulatory framework, the key changes introduced by the 2023 USP <797> revision, and what clinics and pharmacies need to do to stay compliant.

BUD requirements for sterile compounded preparations come from two sources:

USP General Chapter <797>: The United States Pharmacopeia (USP) is a non-governmental standards-setting organization. Its General Chapter <797> establishes standards for sterile compounding, including BUD limits. USP standards are not federal law by themselves, but they are incorporated by reference into federal and state regulations, making them effectively mandatory.

FDA: The FDA has authority over compounding pharmacies under the Federal Food, Drug, and Cosmetic Act. The FDA uses USP <797> as a reference standard in its enforcement activities. When the FDA inspects a 503B outsourcing facility, it evaluates compliance with cGMP standards, which include USP <797> requirements.

State boards of pharmacy: State boards of pharmacy regulate 503A pharmacies and typically require compliance with USP <797> as a condition of licensure.

In practice, USP <797> sets the technical standards for BUD, and the FDA and state boards enforce compliance with those standards.

The most significant recent development in BUD rules is the 2023 revision to USP <797>, which took effect in November 2023. This revision made substantial changes to the BUD framework:

New Category System: The 2023 revision replaced the old low/medium/high risk framework with a new Category 1 / Category 2 system. This is a fundamental change in how BUDs are assigned.

Category 1 BUDs:

• 12 hours at controlled room temperature (20–25°C)
• 24 hours refrigerated (2–8°C)
• These are the default BUDs for preparations that do not meet Category 2 requirements

Category 2 BUDs (defaults, aqueous preparations):

• 45 days refrigerated
• 30 days at controlled room temperature
• Longer BUDs possible with supporting stability data

Sterility testing requirement for Category 2: To assign Category 2 BUDs, the pharmacy must perform sterility testing on each lot before release. This is a significant new requirement that many 503A pharmacies cannot meet.

Environmental monitoring: The 2023 revision strengthened requirements for environmental monitoring of compounding areas, including more frequent sampling and stricter action levels.

Personnel training: New requirements for documented personnel training and competency assessments.

Container-closure integrity testing: New requirements for demonstrating that the container-closure system maintains sterility over the assigned BUD.

The FDA enforces BUD rules primarily through inspections of 503B outsourcing facilities. During an inspection, FDA investigators will:

• Review the facility's BUD assignment procedures
• Verify that BUDs are supported by appropriate data (stability testing, sterility testing)
• Check that preparations are labeled with the correct BUD
• Review records to confirm preparations are not used past their BUD
• Assess whether the facility's quality system supports the BUDs it assigns

Common BUD-related findings in FDA inspections include:

• BUDs assigned without supporting stability data
• Sterility testing not performed on each lot (for Category 2 BUD claims)
• Preparations used past their BUD
• Inadequate documentation of BUD assignment rationale

For 503A pharmacies, BUD enforcement is primarily through state board of pharmacy inspections, which also reference USP <797>.

The FDA has been clear that extended BUDs — BUDs longer than the USP defaults — must be supported by appropriate stability data. In warning letters and guidance documents, the FDA has stated:

• Pharmacies cannot assign extended BUDs based on manufacturer's stability data for the raw API alone — the stability of the finished compounded preparation must be demonstrated
• Stability testing must use validated analytical methods appropriate for the specific preparation
• Stability data must be generated under the actual storage conditions for which the BUD is assigned
• The FDA will scrutinize extended BUD claims during inspections

This means that a pharmacy claiming a 90-day BUD for a compounded semaglutide preparation must have stability data specifically for that preparation, stored under the labeled conditions, demonstrating it meets quality specifications for 90 days.

Clinics are not compounding pharmacies, but they have responsibilities under the BUD framework:

Receive within BUD: Verify that preparations received from the pharmacy have sufficient BUD remaining for your intended use. A preparation that arrives with only a few days remaining on its BUD may not be usable.

Store as labeled: The BUD is only valid if the preparation is stored under the labeled conditions. Maintain temperature logs for your refrigerator and document any temperature excursions.

Use within BUD: Never administer a preparation past its BUD. Train all staff on this requirement.

Document: Maintain records of the BUD for every preparation received and administered. This documentation is essential for compliance and for responding to adverse events.

Report adverse events: If a patient experiences an adverse event that may be related to a compounded preparation, report it to the FDA's MedWatch program and to the compounding pharmacy.

The 2023 USP <797> revision has practical implications for how clinics source and manage compounded preparations:

Shorter BUDs from 503A pharmacies: Many 503A pharmacies cannot meet Category 2 requirements (sterility testing per lot, environmental monitoring, etc.). This means their preparations will have Category 1 BUDs — 24 hours refrigerated. This is not practical for most clinic supply arrangements.

503B facilities as the practical solution: 503B outsourcing facilities, which operate under cGMP standards, are better positioned to meet Category 2 requirements and assign longer BUDs. For clinics that need preparations with BUDs of 30–45 days or longer, sourcing from a 503B facility is often the only practical option.

Increased documentation burden: The 2023 revision's stricter requirements mean more documentation at every step of the supply chain. Clinics should be prepared for more detailed CoAs and quality documentation from their pharmacy partners.

1. United States Pharmacopeia. USP General Chapter <797> Pharmaceutical Compounding — Sterile Preparations. 2023 Revision.
2. U.S. Food and Drug Administration. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing. FDA, 2004.
3. U.S. Food and Drug Administration. Current Good Manufacturing Practice (CGMP) Regulations. 21 CFR Parts 210 and 211.
4. U.S. Food and Drug Administration. Warning Letters — Compounding. FDA database, accessed 2026.
5. U.S. Food and Drug Administration. Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act. FDA, updated 2024.
6. Allen LV Jr. Stability and Beyond-Use Dating of Compounded Preparations. International Journal of Pharmaceutical Compounding. 2019;23(4):272–278.

MedClinic Partners connects licensed clinics and 503A pharmacies with vetted 503B supply that meets current USP 797 and FDA standards. Questions about BUD compliance? Use the Get Connected form to reach our team.