Journal
The 503B Bulks List Proposal Explained
FDA proposed excluding semaglutide, tirzepatide and liraglutide on 30 April 2026.
FDA proposed excluding semaglutide, tirzepatide and liraglutide on 30 April 2026. This piece sets out what is established on 503b bulks list semaglutide, which record holds it, and what remains unverified — with the underlying figures published as tables and charts so the reasoning is checkable rather than asserted.
Key findings
- FDA proposed excluding semaglutide, tirzepatide and liraglutide on 30 April 2026.
- Every figure here is drawn from a dated capture or an FDA primary source.
- Regulatory framework and entity-specific claims are held to different evidence standards.
- Open fields render as explicit statuses, never as estimates.
- No provider pays for coverage or placement on this platform.
| Topic | 503b bulks list semaglutide |
|---|---|
| Category | Standards |
| Pricing captured | 2026-07-06 |
| Framework sources | FDA, verified 2026-07-23 |
| Provider relationship | No Public Evidence Found no financial relationship exists |
A permanent closure, not a temporary one
On 30 April 2026 FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound them from bulk. The docket closed 29 June 2026.
This differs in kind from the shortage deadlines. Those closed a window that could reopen; formal exclusion would foreclose the bulk route even if a future shortage were declared.
What the standard requires?
USP Chapter 797 governs sterile compounding: air quality classification, engineering controls such as ISO-classified cleanrooms, personnel garbing and competency, environmental monitoring, and sterility assurance. Chapter 795 covers nonsterile preparations. Chapter 800 protects the people handling hazardous drugs rather than the preparation itself.
These are enforced through state boards, which adopt USP by reference. For a 503B outsourcing facility, FDA assesses against CGMP instead, which subsumes and exceeds them.
Chart data as a table
| FL | 16 |
|---|---|
| TX | 16 |
| NJ | 10 |
| CA | 7 |
| PA | 5 |
| CO | 4 |
| MO | 3 |
| AZ | 3 |
| AR | 3 |
| OH | 3 |
Beyond-use dating is the visible tell
A manufacturer expiry date comes from formal stability testing across a defined shelf life. A beyond-use date is assigned by the pharmacy from USP category rules and its own conditions.
Under Chapter 797, sterile beyond-use dates are short — commonly measured in days at room temperature — unless sterility testing extends them. A compounded sterile preparation carrying an unusually long date warrants a direct question about the basis for it.
| Registered facility | Location | Last inspection | Form 483 | Action |
|---|---|---|---|---|
| Quva Pharma, Inc. | Sugar Land, TX | 2026-05-04 | No | Open — FDA has not determined whether further action will be taken |
| Empower Pharma | Houston, TX | 2025-11-14 | Yes | Open — FDA has not determined whether further action will be taken |
| Fresenius Kabi Compounding LLC dba Fagron St | Canton, MA | 2025-11-05 | Yes | Warning letter — Warning letter issued 12 May 2026 |
| AnazaoHealth Corporation | Las Vegas, NV | 2025-08-08 | Yes | Open — FDA has not determined whether further action will be taken |
| Fagron Compounding Services dba Fagron Steri | Wichita, KS | 2025-08-08 | Yes | Open — Regulatory meeting held 27 February 2026 |
| Olympia Pharmaceuticals | Orlando, FL | 2025-08-08 | Yes | Open — FDA has not determined whether further action will be taken |
| Quva Pharma, Inc. | Bloomsbury, NJ | 2025-04-04 | Yes | Open — FDA has not determined whether further action will be taken |
Why the 2012 outbreak still shapes this?
The New England Compounding Center outbreak killed dozens through contaminated steroid injections and drove both the DQSA and the strengthening of sterile compounding oversight. Section 503B exists because of it.
That history is why sterility assurance is treated here as the highest-consequence variable in any compounded injectable, and why a facility's inspection record matters more than its marketing.
What would change this analysis?
Three things would. A final determination on the 503B bulks list proposal, which the closed docket now makes likely within months. A change in the approved-product pricing that has repriced the category — the $149 oral tier is recent and competitive pressure has been moving it. And any published pharmacokinetic work on compounded preparations, which would move several questions here from unmeasured to measured.
None of those is speculative. Each has a named decision-maker and, in two cases, a live process. This page carries its own date so the gap between what was checked and what is current stays visible.
How to check any of this yourself
Regulatory framework: FDA's compounding pages carry the statutory position and the declaratory orders that ended the shortage exception. Every framework claim on this platform links to one of them.
Facility status: FDA's registered outsourcing facility list is updated weekly and now publishes inspection dates, whether a Form 483 was issued, and the action status. State licensure sits with the relevant board of pharmacy — a different register, and the only one covering 503A pharmacies.
Pricing: every figure here is a dated capture against the provider's own published page, computed as a total. The full dataset is published as JSON and CSV so the arithmetic can be rerun.
Applying this to 503b bulks list semaglutide
FDA proposed excluding semaglutide, tirzepatide and liraglutide on 30 April 2026.
Everything above is checkable against a named public record. Where this platform has not performed that check, the field renders as an explicit status rather than an inferred value — which tells you precisely what to go and confirm.
What this means
- Regulatory framework and dates are cited to FDA primary sources.
- Pricing figures are dated captures against provider pages, computed as totals.
- Every open field carries an explicit status rather than an estimate.
What this does not mean
- That any named entity is compliant, safe, or non-compliant.
- That a lower price indicates better evidence or quality.
- That this platform certifies or endorses any facility or preparation.
- Pricing captured 2026-07-06; confirm at checkout before relying on it.
- Regulatory positions change through rulemaking, guidance and enforcement action.
- Entity-specific licence and enforcement records are covered on the monitoring pages, not here.
- Nothing here is legal or medical advice.
Frequently asked questions
What is the short answer on 503b bulks list semaglutide?
FDA proposed excluding semaglutide, tirzepatide and liraglutide on 30 April 2026.
Where do these figures come from?
Pricing from dated captures against provider pages (2026-07-06); regulatory facts from FDA primary sources.
Does any provider pay to appear here?
No. This platform has no affiliate, referral, sponsorship, or financial relationship with any provider.
How often is this updated?
When the underlying capture or regulatory position changes. Every page carries its own date.
Is this legal or medical advice?
No. It reports what named public records say on the dates they were checked. Clinical decisions belong with a prescriber and legal questions with a qualified adviser.
How can I check the figures myself?
The pricing dataset is published as JSON and CSV, the FDA register and inspection records are linked on every page that uses them, and each figure carries its capture date.
What if a record here is wrong?
Report it through the corrections process. Named entities can also respond through the right-to-respond route, and accepted corrections are logged with their date.
Sources
- GLP-1 pricing database
- FDA — Registered Outsourcing Facilities
- FDA — Information for Outsourcing Facilities
- FDA — Q&A: Outsourcing Facility Registration
Update history
| Date | Change |
|---|---|
| 2026-07-23 | Record published at current snapshot. |
Dates change only for substantive updates. Entities may submit a correction or response through the right-to-respond process.