Regulatory status tracker
Compounding status tracker: federal pathway by substance
For every substance below, this tracker states which federal compounding pathway applies under section 503A and, separately, under section 503B, with the date each FDA source was read. Nothing here decides whether your state permits office stock, or which state credential the facility filling your order has to hold — those are separate questions of state law, and the credential is not always issued by the board of pharmacy.
Most published tables in this market carry no date at all, or carry one that has stopped being true. Two of the FDA documents this page reads moved within the four months before the date above. Every row therefore states the date its source was read, and the maintenance commitment at the foot of the page is the point of the page as much as the table is.
On this page
- What this tracker records, and what it does not
- The four pathway classes
- Status table: federal pathway by substance
- Entries that carry a condition FDA states explicitly
- Why three substances occupy more than one row
- The dated record: what moved, and when
- Dates already on the calendar
- Updates to this page
- Questions prescribers ask about this table
- What this page cannot tell you
- How this page is maintained
- Sources
- Important notice
What this tracker records, and what it does not
Each row answers one narrow question: on the date shown, what did FDA's own documents say about the pathway available for that bulk drug substance — separately for a state-licensed 503A pharmacy and for a facility registered with FDA as an outsourcing facility under section 503B?
That framing is deliberate, because those two entity types are governed by different sections of the statute and reach different answers on the same substance more often than not. A 503A pharmacy is licensed by a state board. An outsourcing facility registers with FDA under section 503B. FDA has stated the point directly: compounding facilities, including pharmacies and outsourcing facilities, are not FDA-approved or FDA-licensed entities, and the statute establishes no such designation for either. Anyone offering you an "FDA-approved pharmacy" is describing something that does not exist.
What this page does not record: whether a preparation works, what it is used for, how it is dosed, what it costs, or whether your state permits you to hold it in your office. The first four are outside what a regulatory-status record may honestly contain. The last one is a genuine question with a genuine answer, and the answer lives on the state-by-state office-use guide, not here.
The four pathway classes
Every entry in the table falls into one of four classes. The distinction between them is not cosmetic — it decides how durable the entry is.
Component of an FDA-approved drug product
The substance is an ingredient of a drug product FDA has approved, which satisfies a prong of the statutory eligibility test on the face of the statute rather than by FDA's discretion. This is the most durable class on the page — but eligibility of the substance is not permission to make any product from it, because the essentially-a-copy restriction may still govern what may be compounded.
On one of FDA's bulk-substance category lists
FDA's interim policy sorts nominated substances into categories. For category 1 substances FDA has said it does not intend to take action against a compounder, provided the conditions in its guidance are met. That is a statement of enforcement intent that FDA may revise — it is not approval, not a determination that the substance belongs on the bulks list, and it must never be described as either. Category 2 and category 3 entries are the opposite: FDA has said it would consider taking action.
On FDA's drug shortage list
Shortage status opens one of only two gateways an outsourcing facility has to a bulk substance, and it switches off the essentially-a-copy restriction for a 503A pharmacy while the drug remains listed. It is also the least stable basis on this page: it is tracked per presentation, it moves without notice, and the statutory condition requires the drug to be listed at the time of compounding, distribution and dispensing — not merely on the day you read a webpage.
No lawful pathway stated
No prong of the statutory test is satisfied and no FDA list supplies a route. Three different situations produce this result: a nomination withdrawn by the party that made it, placement in a category FDA uses for substances it says present significant safety risks or that were nominated without adequate support, and a substance that is simply nowhere — not approved, not listed, not in any category.
Status table: federal pathway by substance
Read the 503A and 503B columns independently. They disagree frequently, and a favourable position in one column says nothing about the other. Where a substance is split by route of administration, each route has its own row, because a position that applies to one route does not travel to another.
| Substance | Pathway basis | What a 503A pharmacy may rely on | What a 503B outsourcing facility may rely on | As of | Primary source |
|---|---|---|---|---|---|
| Sermorelin acetate — injection (sterile) | Component of an FDA-approved drug product (applications 019863, 020443) | Substance eligible under the component-of-an-approved-drug prong. Both approved applications are discontinued and FDA's records carry a Federal Register determination that neither was withdrawn for safety or effectiveness reasons, so the essentially-a-copy restriction is largely inapplicable | Listed in FDA's 503B category document in category 1, carrying FDA's own component-of-an-approved-drug designation | 2025-03-21 | FDA 503B category list |
| Sermorelin acetate — sublingual spray (non-sterile) | Component of an FDA-approved drug product (applications 019863, 020443) | Same prong; eligibility attaches to the substance, not the route. No approved sermorelin product exists by any route today, so this route is not a copy of a marketed product | Listed in FDA's 503B category document in category 1 with the component-of-an-approved-drug designation | 2025-03-21 | FDA 503B category list |
| Gonadorelin (acetate / hydrochloride) | Component of an FDA-approved drug product (applications 019687, 018123) | Substance eligible under the component-of-an-approved-drug prong. Both approved products are discontinued | Listed in FDA's 503B category document in category 1 with the component-of-an-approved-drug designation | 2025-03-21 | FDA 503B category list |
| Oxytocin — sublingual spray (non-sterile) | Component of an FDA-approved drug product (application 018261) | Substance eligible under the prong. Route decides the copy question: approved oxytocin is injectable, and the one approved nasal product (application 012285) is discontinued, so this route is not essentially a copy of a marketed product. A compounded oxytocin injection would be | Listed in FDA's 503B category document in category 1 with the component-of-an-approved-drug designation | 2025-03-21 | FDA 503B category list |
| Oxytocin — oral tablet (non-sterile) | Component of an FDA-approved drug product (application 018261) | Substance eligible under the prong. No approved oral oxytocin product exists, so this route is not a copy of a marketed product. Shares nothing with the injectable route | Listed in FDA's 503B category document in category 1 with the component-of-an-approved-drug designation | 2025-03-21 | FDA 503B category list |
| Sildenafil citrate | Component of an FDA-approved drug product (application 020895) | Substance eligible under the prong, but the reference product is actively marketed, so the essentially-a-copy restriction governs. FDA's stated band is within 10% of a commercially available strength; the only route past it is a prescriber determining and documenting a significant difference for an identified individual patient | Listed in FDA's 503B category document in category 1 with the component-of-an-approved-drug designation | 2025-03-21 | FDA 503B category list |
| Tadalafil | Component of an FDA-approved drug product (application 021368) | Substance eligible under the prong, but the reference product is actively marketed, so the essentially-a-copy restriction governs, including where a compounded strength matches an approved strength exactly | Listed in FDA's 503B category document in category 1 with the component-of-an-approved-drug designation | 2025-03-21 | FDA 503B category list |
| Tesamorelin | Component of an FDA-approved drug product (application 022505) | Substance eligible under the prong, but the reference product is actively marketed, so the essentially-a-copy restriction governs absent a documented prescriber determination for an identified individual patient | Not on the 503B bulks list and not on the shortage list, so neither gateway to the bulk substance is open | 2026-08-28 | Drugs@FDA, application 022505 |
| Bremelanotide (PT-141) | Component of an FDA-approved drug product (application 210557) | Substance eligible under the prong, but the reference product is actively marketed, so the essentially-a-copy restriction governs absent a documented prescriber determination for an identified individual patient | Not on the 503B bulks list and not on the shortage list, so neither gateway to the bulk substance is open | 2026-08-28 | Drugs@FDA, application 210557 |
| Glutathione | On FDA's 503A and 503B category 1 lists — enforcement discretion, not approval | FDA has said it does not intend to act where the guidance conditions are met. Those conditions include the sourcing point FDA set out in its 2019 compounding alert (below) | Also in category 1 on the 503B side, on the same enforcement-discretion footing | 2026-05-14 | FDA 503A category list |
| Nicotinamide adenine dinucleotide (NAD+ / NADH) | On FDA's 503A and 503B category 1 lists — enforcement discretion, not approval | Enforcement discretion only. No approved US drug product contains it, so no prong-2 route exists | Listed on the 503B side under the beta-NAD name, on the same enforcement-discretion footing | 2026-05-14 | FDA 503A category list |
| Enclomiphene citrate | On FDA's 503A category 1 list — enforcement discretion, not approval | Enforcement discretion only. No approved US enclomiphene product exists, and FDA's placement of the substance in category 1 — the pathway for substances not otherwise eligible — cuts against the argument that it qualifies as a component of an approved drug | Not on any 503B list, so no route to the bulk substance | 2026-05-14 | FDA 503A category list |
| GHK-Cu — non-injectable routes only | On FDA's 503A category 1 list for non-injectable routes only — enforcement discretion, not approval | Enforcement discretion, and only for the routes FDA names. The injectable route is a separate entry with a different answer. FDA has said it intends to consult its advisory committee before the end of February 2027 on possible inclusion on the 503A bulks list | Not on any 503B list, so no route to the bulk substance | 2026-05-14 | FDA 503A category list |
| Vasoactive intestinal peptide (VIP) | On FDA's 503A category 1 list — enforcement discretion, not approval | Enforcement discretion only. See the caveat above: this is the lowest-confidence entry on the page | Not on any 503B list, so no route to the bulk substance | 2026-05-14 | FDA 503A category list |
| Kisspeptin-10 | On FDA's active 503A category 2 list (added 2023-09-29) — FDA would consider taking action | No route. FDA places category 2 substances outside the policy that applies to category 1, and states it would consider taking action against a compounder using them | No 503B position located in the sources read for this entry | 2026-05-14 | FDA 503A category list |
| Ibutamoren mesylate (MK-677) | On FDA's category 2 lists under both sections — 503A since 2023-09-29, 503B since 2022-12-29 | No route. Category 2 under section 503A | No route. Category 2 under section 503B | 2026-04-22 | FDA category 2 and withdrawn-nomination page |
| Ipamorelin acetate | Nomination withdrawn on the 503A side; category 2 on the 503B side | No route. The nomination was withdrawn by the nominators, which removes the substance from evaluation entirely; it is not a component of an approved drug and has no bulks-list entry | No route. Category 2 under section 503B | 2026-04-22 | FDA category 2 and withdrawn-nomination page |
| Semaglutide | Shortage determined resolved 2025-02-21; separately a component of FDA-approved drug products (applications 209637, 215256) | Substance eligible under the component-of-an-approved-drug prong. The enforcement-discretion window has ENDED — stated to run to 2025-04-22, and FDA confirmed on 2025-04-28 that it had ended following the court's denial of a preliminary injunction on 2025-04-24. The essentially-a-copy restriction now governs | No route. Neither on the 503B bulks list nor on the shortage list. The 503B enforcement-discretion window ENDED 2025-05-22. FDA proposed on 2026-04-30 to exclude the substance from the 503B bulks list; comment period closed in 2026 on a date not re-verified here; no final determination located | 2026-04-01 policy page; shortage list re-checked 2026-08-28 | FDA GLP-1 policy page |
| Tirzepatide | Shortage determined resolved 2024-12-19; separately a component of FDA-approved drug products (applications 215866, 217806) | Substance eligible under the component-of-an-approved-drug prong. The enforcement-discretion window has ENDED — stated to run to 2025-02-18, and FDA confirmed on 2025-03-10 that it had ended following the court's denial of a preliminary injunction on 2025-03-05. The essentially-a-copy restriction now governs | No route. Neither on the 503B bulks list nor on the shortage list. The 503B enforcement-discretion window ENDED 2025-03-19. Covered by the same 2026-04-30 exclusion proposal; comment period closed in 2026 on a date not re-verified here; no final determination located | 2026-04-01 policy page; shortage list re-checked 2026-08-28 | FDA GLP-1 policy page |
| Liraglutide | On FDA's drug shortage list — status Current across several presentations, most recent record update 2026-08-27 | The essentially-a-copy restriction does not apply while the drug is on the shortage list: FDA states a drug is not considered commercially available when it is listed. This is a dated position, not a standing one | A route is open through the shortage gateway while the drug remains listed at the time of compounding, distribution and dispensing. FDA warns it may act if an outsourcing facility fills new orders after the drug leaves the list, or fills existing orders more than 60 days after. The separate 2026-04-30 proposal to exclude the substance from the 503B bulks list would not close this gateway while the shortage lasts | 2026-08-28 | openFDA shortage records |
| Retatrutide | No lawful pathway stated — not approved and not listed anywhere | No route. Not approved in the United States, so not a component of an approved drug; not on the 503A bulks list at 21 CFR 216.23; not in category 1, 2 or 3 | No route. Not on the 503B bulks list and not on the shortage list | 2025-09-09 | FDA warning letter 715883 |
| BPC-157 | No lawful pathway stated — nomination withdrawn by the nominators (previously category 2) | No route. A withdrawn nomination removes the substance from evaluation for the 503A bulks list; it is not a component of an approved drug and has no bulks-list entry, so no prong is satisfied | No route. No 503B bulks-list entry and not on the shortage list | 2026-04-22 | FDA category 2 and withdrawn-nomination page |
| GHK-Cu — injectable route | No lawful pathway stated — the nomination for the injectable route was withdrawn and was not restored when non-injectable routes returned to category 1 on 2026-05-05 | No route for this route of administration. The category 1 position recorded in the non-injectable entry does not reach it | No route. Not on any 503B list | 2026-04-22 | FDA category 2 and withdrawn-nomination page |
| GHRP-2 | No lawful pathway stated on the 503A side — category 3, nominated without adequate support | No route, for any route of administration. FDA states category 3 substances are not eligible for the policy that applies to category 1, and that it would consider taking action | Split by route: FDA places GHRP-2 for injectable and nasal administration in category 2, and other routes in category 1. The 503A position above is not split and does not follow the 503B carve-out | 2026-04-22 | FDA category 2 and withdrawn-nomination page |
| GHRP-6 | No lawful pathway stated on the 503A side — category 3, nominated without adequate support | No route, for any route of administration | No route. Category 2 under section 503B outright, with no route carve-out | 2026-04-22 | FDA category 2 and withdrawn-nomination page |
| CJC-1295 | No lawful pathway stated — nomination withdrawn (previously category 2) | No route. Withdrawn from evaluation; not a component of an approved drug; no bulks-list entry | No route. No 503B bulks-list entry and not on the shortage list | 2026-04-22 | FDA category 2 and withdrawn-nomination page |
| Thymosin alpha-1 | No lawful pathway stated — 503A nomination withdrawn (previously category 2); category 3 on the 503B side | No route. Withdrawn from evaluation; no approved US drug product | No route. Category 3 under section 503B | 2026-04-22 | FDA category 2 and withdrawn-nomination page |
| Thymosin beta-4 fragment (LKKTETQ, TB-500) | No lawful pathway stated — nomination withdrawn (previously category 2) | No route. Withdrawn from evaluation; not a component of an approved drug; no bulks-list entry | No route. No 503B bulks-list entry and not on the shortage list | 2026-04-22 | FDA category 2 and withdrawn-nomination page |
| AOD-9604 | No lawful pathway stated — nomination withdrawn (previously category 2) | No route. Withdrawn from evaluation; not a component of an approved drug; no bulks-list entry | No route. No 503B bulks-list entry and not on the shortage list | 2026-04-22 | FDA category 2 and withdrawn-nomination page |
| MOTS-c | No lawful pathway stated — nomination withdrawn (previously category 2) | No route. FDA's stated rationale is route-agnostic, so no non-injectable carve-out is available | No route. No 503B bulks-list entry and not on the shortage list | 2026-04-22 | FDA category 2 and withdrawn-nomination page |
| KPV | No lawful pathway stated — nomination withdrawn (previously category 2) | No route. FDA's stated rationale is route-agnostic, so no oral carve-out is available | No route. No 503B bulks-list entry and not on the shortage list | 2026-04-22 | FDA category 2 and withdrawn-nomination page |
| Melanotan II | No lawful pathway stated — nomination withdrawn (previously category 2) | No route. FDA's recorded rationale names specific adverse events reported in the published literature (quoted below) | No route. No 503B bulks-list entry and not on the shortage list | 2026-04-22 | FDA category 2 and withdrawn-nomination page |
| Epitalon (epithalon) | No lawful pathway stated — nomination withdrawn (previously category 2) | No route. Withdrawn from evaluation; not a component of an approved drug; no bulks-list entry | No route. No 503B bulks-list entry and not on the shortage list | 2026-04-22 | FDA category 2 and withdrawn-nomination page |
| Selank acetate (TP-7) | No lawful pathway stated — nomination withdrawn (previously category 2) | No route. Withdrawn from evaluation; not a component of an approved drug; no bulks-list entry | No route. No 503B bulks-list entry and not on the shortage list | 2026-04-22 | FDA category 2 and withdrawn-nomination page |
| Semax (heptapeptide) | No lawful pathway stated — nomination withdrawn (previously category 2) | No route. Withdrawn from evaluation; not a component of an approved drug; no bulks-list entry | No route. No 503B bulks-list entry and not on the shortage list | 2026-04-22 | FDA category 2 and withdrawn-nomination page |
| Cathelicidin LL-37 | No lawful pathway stated — nomination withdrawn (previously category 2) | No route. One of only two withdrawn entries where FDA's recorded rationale names affirmative findings rather than absence of data (quoted below) | No route. No 503B bulks-list entry and not on the shortage list | 2026-04-22 | FDA category 2 and withdrawn-nomination page |
| Emideltide (delta sleep-inducing peptide, DSIP) | No lawful pathway stated — nomination withdrawn (previously category 2) | No route. Withdrawn from evaluation; not a component of an approved drug; no bulks-list entry. FDA's listed name is emideltide | No route. No 503B bulks-list entry and not on the shortage list | 2026-04-22 | FDA category 2 and withdrawn-nomination page |
| Dihexa acetate | No lawful pathway stated — nomination withdrawn (previously category 2) | No route. FDA's stated rationale is route-agnostic, so no carve-out is available | No route. No 503B bulks-list entry and not on the shortage list | 2026-04-22 | FDA category 2 and withdrawn-nomination page |
| PEG-MGF (pegylated mechano growth factor) | No lawful pathway stated — nomination withdrawn (previously category 2) | No route. FDA lists the pegylated form separately from the unpegylated form, on a different basis; the two are not interchangeable entries | No route. No 503B bulks-list entry and not on the shortage list | 2026-04-22 | FDA category 2 and withdrawn-nomination page |
| MGF (unpegylated mechano growth factor) | No lawful pathway stated — 503A category 3, nominated without adequate support | No route. Category 3 substances are not eligible for the policy that applies to category 1, and FDA states it would consider taking action | No route. No 503B bulks-list entry and not on the shortage list | 2026-05-14 | FDA 503A category list |
Entries that carry a condition FDA states explicitly
Six entries above are incomplete without the sentence FDA itself attached to them. Each is quoted here and nothing is added to it.
Glutathione — a sourcing condition, not just a category
FDA issued a compounding alert on 7 June 2019 after seven patients at one clinic reacted within minutes of receiving intravenous L-glutathione. FDA's laboratory examined the material and found samples "to contain excessive bacterial endotoxin with some results as high as five times the appropriate limit." The material was dietary-supplement grade. Category 1 placement does not answer the question this alert raises; the grade of the starting material does, and it is a reasonable thing to put in writing to any supplier.
Enclomiphene citrate — state the category and stop
The substance sits in category 1 on FDA's 14 May 2026 list, and no approved US enclomiphene product exists. It is the trans-isomer component of a mixed-isomer product that is approved — the approved label for application 016131 records that the product is a mixture of two geometric isomers containing between 30% and 50% of the cis-isomer. Whether that makes enclomiphene a component of an approved drug is a contested argument, not a settled FDA position, and FDA's own placement of it in category 1 cuts against the argument. No page on this site asserts the prong.
Melanotan II and cathelicidin LL-37 — FDA's own findings
On melanotan II, FDA records: "Published case reports discuss serious adverse events including melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome and priapism." On cathelicidin LL-37: "Nonclinical research findings suggest detrimental effects on male reproduction and that this drug can be protumorigenic in some tissues." These are the only two withdrawn entries where FDA names findings rather than an absence of information. Quote them; do not restate them in stronger or weaker words.
GHRP-2 and ibutamoren mesylate — the recorded rationale
On GHRP-2, FDA records that compounded drugs containing it for injectable and nasal administration "may pose risk for immunogenicity due to the potential for aggregation and peptide-related impurities," that the substance "contains an unnatural amino acid, which adds to the complexity of peptide characterization," and that FDA "is aware of reports of serious adverse advents in patients who received GHRP-2, including increased insulin requirement to maintain the blood glucose level, death of critically ill study subjects, infection and pancreatitis, though causality has not been established." On ibutamoren mesylate, the opening sentence of FDA's rationale is the operative one: "Ibutamoren mesylate poses significant safety risks due to the potential for congestive heart failure in certain patients."
The rule that governs how any of this may be described
One codified sentence disposes of an entire genre of marketing claim, and it applies even to substances that are on the list. 21 CFR 216.23(d):
Any person who represents that a compounded drug made with a bulk drug substance that appears on this list is FDA approved, or otherwise endorsed by FDA generally or for a particular indication, will cause the drug to be misbranded under section 502(a) and/or 502(bb) of the Federal Food, Drug, and Cosmetic Act.
Why three substances occupy more than one row
Sermorelin, oxytocin and GHK-Cu each appear more than once above, and collapsing any of them into a single row would produce a table that is technically sourced and practically misleading.
The GHK-Cu pair is the clearest case. FDA's 503A category list, updated 14 May 2026, carries this note verbatim:
GHK-Cu (except for injectable routes of administration) was removed from category 1 on April 22, 2026, because the nominations for GHK-Cu were withdrawn by the nominators. On May 5, 2026, one of those nominators clarified that it intended to withdraw only its nomination of the injectable route of administration with respect to GHK-Cu and would like to retain its nomination for GHK-Cu for non-injectable routes of administration. GHK-Cu (except for injectable routes of administration) will be reinstated in category 1. FDA has announced it intends to consult the Pharmacy Compounding Advisory Committee (PCAC) before the end of February 2027 regarding the potential inclusion of GHK-Cu on the 503A bulks list.
The parenthesis is the whole entry. FDA's own text names the excluded route, and the position it describes applies to everything except that route. A single merged row would put the more favourable half of that sentence directly above the form it excludes — which is how a true statement gets carried onto something it was never about. The same logic drives the sermorelin and oxytocin pairs: their routes sit under different compounding standards and, for oxytocin, reach opposite answers on the essentially-a-copy question.
The dated record: what moved, and when
Every date below comes from an FDA document or a court record named in the sources block. Where an event closed a window, the closing date is stated rather than characterised. Three of the 2026 entries are routinely reported as though they were one story; what actually happened to peptides in 2026 separates them and states what did not change.
| Date | What happened |
|---|---|
| 2024-12-19 | FDA re-evaluates and issues a new decision determining the tirzepatide injection shortage resolved. Enforcement discretion stated to run to 2025-02-18 for 503A and 2025-03-19 for 503B |
| 2025-02-21 | FDA determines the semaglutide injection shortage resolved. Discretion stated to run to 2025-04-22 for 503A and 2025-05-22 for 503B |
| 2025-03-05 | District court denies the preliminary-injunction motion in the tirzepatide litigation, 4:24-cv-00953 (N.D. Tex.) |
| 2025-03-10 | FDA states the 503A tirzepatide enforcement-discretion period has ended |
| 2025-04-24 | District court denies the preliminary-injunction motion in the semaglutide litigation, 4:25-cv-00174 (N.D. Tex.) |
| 2025-04-28 | FDA states the 503A semaglutide enforcement-discretion period has ended |
| 2025-05-22 | The 503B semaglutide enforcement-discretion period closes |
| 2025-09-05 | FDA launches an import alert for GLP-1 active ingredients: sources not on the list are "subject to detention without physical examination" |
| 2025-09-09 | FDA issues warning letter 715883, which treats a compounded retatrutide product as an unapproved new drug because it fails bulk-substance eligibility under both sections |
| 2026-02-06 | FDA states it intends to take action against non-FDA-approved GLP-1 drugs |
| 2026-04-01 | FDA's running compounder policy page is updated, carrying the essentially-a-copy worked example and the position on four or fewer prescriptions in a calendar month |
| 2026-04-22 | The nominations for GHK-Cu are withdrawn by the nominators and the substance leaves category 1. FDA's category 2 and withdrawn-nomination page is current as of this date |
| 2026-04-30 | FDA proposes to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list; the comment-period closing date is reported inconsistently in secondary sources and is not asserted here |
| 2026-05-05 | One nominator clarifies it intended to withdraw only the injectable route for GHK-Cu; non-injectable routes are to be reinstated in category 1 |
| 2026-05-14 | FDA's 503A category list is updated. This is the version every 503A entry above is read from |
| 2026-06-08 | FDA issues warning letter 728274 to a telehealth company on promotional grounds alone, with no unapproved-drug count |
| 2026-06-15 | FDA's guidance page for telehealth companies promoting compounded drugs is updated |
| 2026-06-17 | FDA issues warning letter 729447 to a peptide seller; gonadorelin is among the products named. The letter concerns direct-to-consumer selling, not whether a licensed compounder may use the substance |
| 2026 (date not re-verified) | The comment period on the 30 April proposal closes. No final determination has been located |
| 2026-08-27 | The Fifth Circuit affirms the district court in the tirzepatide litigation, No. 25-10600, in an unpublished per curiam opinion |
| 2026-08-28 | FDA's live shortage database re-checked for this page: liraglutide records show status Current; semaglutide has no injection shortage record; tirzepatide has no shortage record |
Dates already on the calendar
Three items have a date attached and have not happened yet. Each is a reason this page carries a review commitment rather than a publication date.
| Date | What is scheduled |
|---|---|
| 2026-10-19 | The mandate in the tirzepatide appeal, No. 25-10600, is scheduled to issue. Until it does, the decision is not final and the correct description is "affirmed, mandate pending" |
| Before the end of February 2027 | FDA has stated it intends to consult the Pharmacy Compounding Advisory Committee regarding the potential inclusion of GHK-Cu on the 503A bulks list |
| Undated, pending | Three items with no scheduled date: the semaglutide appeal, No. 25-10758, argued 2026-03-30 with no decision located as of this review; the final determination on the 30 April 2026 exclusion proposal; and the demonstrable-difficulties rulemaking, docket FDA-2023-N-0061, proposed 2024-03-20 with no final rule, which would move several entries at once |
On that last item, one correction is worth making plainly because the lists are frequently cited as though they are in force. They are not. The docket contains one document — a proposed rule. The proposed regulation is not codified, and nothing appears on either demonstrable-difficulties list today. No entry above is affected by them.
Updates to this page
Changes are appended here with the date they were made. A date at the top of this page is never advanced without a corresponding entry below and a re-read of the source.
- 2026-08-28 — initial publication. All entries read from FDA's 503A category list dated 14 May 2026, FDA's 503B category list dated 21 March 2025, FDA's category 2 and withdrawn-nomination page current 22 April 2026, FDA's GLP-1 policy page entry dated 1 April 2026, and a live pull of FDA's drug shortage records on this date. Separately tracked, on the state office-use pages rather than in this table: Arizona's office-use rule amendments take effect 2026-09-05, and anything written about Arizona office use without a date qualifier is about to be wrong.
Questions prescribers ask about this table
Does a favourable entry mean a compounded preparation is FDA-approved?
No, and representing one as approved is itself a violation. There is no such thing as an FDA-approved compounded drug. 21 CFR 216.23(d) states that representing a compounded drug made with a listed bulk substance as FDA approved, or otherwise endorsed by FDA, "will cause the drug to be misbranded under section 502(a) and/or 502(bb)" of the Act. That applies even to substances that are on the list. What a favourable entry above records is narrower and duller: that a pathway to the bulk substance exists under a named section of the statute, on the date shown.
What does it mean when FDA says a nomination was "withdrawn"?
It means the party that nominated the substance stopped pursuing it, so FDA is no longer evaluating it for the 503A bulks list. This is read backwards constantly. Leaving a safety-risk category by withdrawal is not a clearance — FDA did not evaluate the substance, clear it, or permit anything, and the substance now satisfies no prong of the eligibility test. FDA's guidance also states the agency does not intend to place substances nominated on or after 7 January 2025 into these categories, so the route back in is itself closed. A withdrawn nomination removes a pathway rather than opening one.
Why do the 503A and 503B columns disagree so often?
Because they are answering different statutory questions about different kinds of entity. A 503A pharmacy is licensed by a state board and compounds against a patient-specific prescription; its bulk substance must satisfy one of the statutory prongs. A facility registered with FDA as an outsourcing facility under section 503B has only two gateways to a bulk substance: the substance appears on the 503B bulks list, or the drug product is on FDA's shortage list at the time of compounding, distribution and dispensing. Those are genuinely different tests, so a substance can have a route under one section and none under the other. Reading one column and assuming the other is the single most common error in this material.
What happened to the shortage-based route for semaglutide and tirzepatide?
It closed, on dates FDA published. FDA determined the tirzepatide injection shortage resolved on 2024-12-19 and the semaglutide injection shortage resolved on 2025-02-21. The associated enforcement-discretion windows then ran out: for tirzepatide, 503A ended on 2025-03-10 by FDA's own statement and 503B on 2025-03-19; for semaglutide, 503A ended on 2025-04-28 and 503B on 2025-05-22. FDA's current position is that neither substance appears on the 503B bulks list or on FDA's drug shortage list. Both remain components of FDA-approved drug products, so a 503A pharmacy retains substance-level eligibility — now constrained by the essentially-a-copy restriction rather than relieved of it.
Why is liraglutide answered differently from the other two?
Because it is on the shortage list and they are not, and that single fact flips both halves of the answer. A live pull of FDA's shortage records on 2026-08-28 returned status Current across several presentations, with the most recent record update dated 2026-08-27. While a drug is listed, FDA states it is not considered commercially available, so the essentially-a-copy limitation does not apply to it — and the shortage gateway to the bulk substance is open to an outsourcing facility. Two cautions come with that. Shortage status is tracked per presentation and moves without notice, so the answer must always carry a date. And the shortage gateway and the bulks-list gateway are independent: FDA's April 2026 proposal to exclude the substance from the 503B bulks list would not close the shortage route while the shortage lasts.
What does category 1 actually get a compounder?
A statement of enforcement intent, and nothing more. FDA's formulation is that it does not intend to take action against a compounder for compounding drugs using bulk drug substances listed in category 1, provided the conditions described in the guidance document are met. Three things follow. It is conditional, so the guidance conditions have to be met and read. It is revisable, because a statement of what an agency intends to do is not a rule and FDA revised this interim policy in January 2025. And it is not a determination that the substance belongs on the 503A bulks list — that list is a regulation at 21 CFR 216.23 and can only be changed by rulemaking.
Does a federal pathway mean my practice may keep the preparation in the office?
No. This page answers a federal question about what a compounder may use, and office-use permission is a separate question answered by your state board of pharmacy under state rules. The two come apart in both directions: a substance with a clean federal pathway can sit behind a state rule that prohibits holding compounded stock for administration without a patient-specific prescription, and a state rule permitting office use is frequently conditioned on compliance with applicable federal law, which requires a patient-specific prescription in the first place. Read the state-by-state office-use guide for that layer.
Why does a warning letter naming a substance not always change its entry?
Because two different enforcement theories are in play and they answer different questions. One line of letters targets sellers marketing substances directly to consumers, on an unapproved-new-drug theory; those letters say something about the seller's conduct, not about whether a licensed compounder may use the substance. A second and newer line targets compounding pharmacies and telehealth platforms, on eligibility and on false or misleading promotion. Gonadorelin is the clearest example on this page: it is named in a June 2026 letter to a direct-to-consumer seller while its compounding entry above rests on it being a component of an approved drug product. Both facts are true and they are not in tension.
If a substance is not in this table, what does that mean?
That we have not published a verdict on it, and nothing else. A substance is absent from this table for one of two reasons: nobody has completed the primary-source research for it, or the source material does not contain enough to place it in any class. The second case applies to two catalogue blends whose composition is stated as a ratio with no named components — there is no substance to assess, so there is no entry, and silence is the correct output rather than a row saying the status is unclear. Absence from this table is never evidence of a favourable position.
What this page cannot tell you
The honest boundaries, stated rather than buried, because a status table that hides its edges is worse than one that has none.
It cannot tell you whether a preparation is appropriate for a patient, what it does, or how it is used — a regulatory-status record has no field for any of that and this one does not either. It cannot tell you what your state permits, which is the question that most often decides whether an order can be filled the way you want it filled. It cannot tell you that a favourable federal entry will still be favourable next month: three entries here are re-verified on a fortnightly cycle precisely because they move. And where FDA's own two lists disagree in age — the 503A list current to May 2026, the 503B list dated March 2025 — this page reports both dates rather than smoothing them into one answer.
How this page is maintained
The date at the top is the date a person last read the sources named below, not the date the file was edited. Advancing it without a re-read is banned here and detectable.
The commitment is a re-verification within 72 hours of any FDA, PCAC or Federal Register event affecting an entry above. Under that, a standing floor applies: the three entries sourced to the GLP-1 policy page and the live shortage database are re-checked every fourteen days; the two GHK-Cu route entries and the vasoactive intestinal peptide entry every thirty days; everything else every ninety days. Four standing triggers sit on the calendar — the pending semaglutide appeal, the mandate in the tirzepatide appeal, the final determination on the April 2026 exclusion proposal, and the advisory committee consultation on GHK-Cu. Every change lands as a dated line in the updates section above, never as a silent edit.
If you are reading this well after the date at the top, treat it as a map of how to check rather than the current state, and open the sources. That is the standard worth holding any supplier to as well: the citation, the version date, and the document itself.
Sources
Every source below was reachable when this page was reviewed on 28 August 2026. Statutory and regulatory text first, then FDA's lists and policy, then the specific documents behind individual entries.
Statute and regulation
- 21 CFR 216.23 — bulk drug substances that can be used to compound under section 503A
- 21 CFR 216.24 — drug products withdrawn or removed for safety or effectiveness reasons
- Federal Register, 20 March 2024 — proposed rule on drug products presenting demonstrable difficulties for compounding, docket FDA-2023-N-0061
FDA lists and policy
- Bulk drug substances used in compounding under section 503A of the FD&C Act — content current 14 May 2026
- 503A category list, PDF — updated 14 May 2026
- Bulk drug substances used in compounding under section 503B of the FD&C Act — content current 7 January 2025
- 503B bulk drug substances list — content current 21 August 2023
- 503B category list, PDF — updated 21 March 2025
- Certain bulk drug substances for use in compounding may present significant safety risks — carries the nominated-but-withdrawn table; content current 22 April 2026
- Interim policy on compounding using bulk drug substances under section 503A, final guidance — 7 January 2025
- Compounding when drugs are on FDA's drug shortages list — content current 8 August 2025
- Telehealth companies: what to know when promoting compounded drugs — content current 15 June 2026
GLP-1 substances
- FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize — running update page; entry dated 1 April 2026
- FDA's concerns with unapproved GLP-1 drugs used for weight loss
- FDA proposes to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list — 30 April 2026
- FDA intends to take action against non-FDA-approved GLP-1 drugs — 6 February 2026
- FDA launches "green list" to protect Americans from illegally imported GLP-1 drug ingredients — 5 September 2025
- openFDA drug shortage records for liraglutide — live endpoint, pulled 28 August 2026
Approved-application records and entry-specific documents
- Drugs@FDA, application 019863 — carries FDA's Federal Register determination note
- Drugs@FDA, application 022505
- Drugs@FDA, application 210557
- FDA-approved label, application 016131 — 2017 revision
- FDA compounding alert on the dietary ingredient glutathione — 7 June 2019
Enforcement and litigation
- FDA warning letter 715883 — 9 September 2025
- FDA warning letter 729447 — 17 June 2026
- FDA warning letter 728274 — 8 June 2026
- FDA warning letter 695156 — 10 December 2024
- Fifth Circuit, No. 25-10600, opinion filed 27 August 2026 — unpublished, per curiam
Important notice
This page is educational information about the federal regulatory record for bulk drug substances used in compounding. It is not legal advice, not medical advice, and not advice about any particular preparation. Verify with your own counsel and your state board of pharmacy before acting on anything here.
USPeptideRx is not a pharmacy and does not compound, manufacture or dispense any drug. Nothing on this page describes any drug's safety or effectiveness, and nothing here states that any substance may or may not be used in your practice.
Every entry above states what a named FDA document said on the date shown beside it. FDA's documents move — two of the sources this page reads moved within the four months before it was published. If the date at the top of this page is not recent, open the sources and read them yourself.