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Peptide regulatory status tracker

Quick answer

This tracker records what FDA has actually published about 26 peptides: approval status, the section 503A and section 503B bulk drug substance categories tracked separately, advisory committee history, and any scheduled review. Removal from category 2 does not make a substance legal to compound — none of the substances here is on the 503A Bulks List, and the Pharmacy Compounding Advisory Committee is advisory, so FDA must still complete notice-and-comment rulemaking. Every row shows the date it was last verified against the FDA pages cited on it, and every changelog entry is dated by the event rather than by the edit.

By Peptides.NYC Editorial TeamPublished September 16, 2026
Newest recorded event: 2026-09-01Events on file from: 1990-12-28Rows last verified: 2026-09-16Download as JSON

How to read this table

Compounding law runs on two separate tracks and this table keeps them separate. Section 503A covers traditional pharmacy compounding for an identified patient with a prescription; section 503Bcovers registered outsourcing facilities, which compound at larger scale without patient-specific prescriptions. FDA maintains a distinct bulk drug substance nomination document for each, so one substance can hold two different positions at once — ipamorelin acetate is the standing example, cleared from the 503A list by the 2024 withdrawal and still category 2 for 503B. A single "FDA category" column would have to pick one and silently drop the other, so there are two. For what the statutes themselves say, read are peptides legal, which is the prose explainer this tracker sits beside.

The category vocabulary

Not nominated
The substance appears in none of the categories on that nomination document, as of the document's own date.
Nominated, then withdrawn
The nomination was withdrawn by the nominator, so FDA is no longer evaluating it. The substance came off the category it was in; it did not move onto the Bulks List.
Category 2
FDA has identified significant safety risks with this substance. Compounding from it is the position FDA warns about, not one it is exercising discretion over.
Proposed for exclusion
FDA considered the nomination and published a Federal Register notice proposing not to include the substance on the list, having found no clinical need.
Category 1
FDA does not intend to take action against compounding with this substance while it evaluates the nomination. That is enforcement discretion under an interim policy — it is not inclusion on the Bulks List.
Category 3
Nominated without adequate support: the nomination did not include enough information for FDA to evaluate it.

None of these is the 503A Bulks List. That list is the outcome of rulemaking, and no substance in this tracker is on it.

Every tracked substance (27 rows, 26 substances)

A row is a substance and a route of administration, which is why GHK-Cu appears twice: FDA's entries for injectable and non-injectable GHK-Cu say different things. Each status cell carries FDA's own qualifier and the date printed on the document it came from. The full FDA approval detail, the sources behind every field and the per-substance timeline are on each row's record page.

Regulatory status of each tracked peptide: FDA approval status, its category on FDA's section 503A and section 503B bulk drug substance nomination documents with the date each document carries, the most recent Pharmacy Compounding Advisory Committee outcome, any scheduled review, and the date the row was last verified against the cited pages.
SubstanceFDA approvalSection 503ASection 503BLatest PCAC outcomeNext scheduled reviewLast verifiedFull record
BPC-157Not FDA approved
Nominated, then withdrawn

as of 2026-04-22

Not nominated

as of 2025-03-21

Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.

Voted in favour

2026-07-23

Advisory only; FDA must still complete rulemaking.

None scheduled2026-09-16/status/bpc-157
KPVNot FDA approved
Nominated, then withdrawn

as of 2026-04-22

Not nominated

as of 2025-03-21

Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.

Voted in favour

2026-07-23

Advisory only; FDA must still complete rulemaking.

None scheduled2026-09-16/status/kpv
TB-500Not FDA approved
Nominated, then withdrawn

as of 2026-04-22

Not nominated

as of 2025-03-21

Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.

Voted in favour

2026-07-23

Advisory only; FDA must still complete rulemaking.

None scheduled2026-09-16/status/tb-500
MOTS-cNot FDA approved
Nominated, then withdrawn

as of 2026-04-22

Not nominated

as of 2025-03-21

Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.

Voted in favour

2026-07-23

Advisory only; FDA must still complete rulemaking.

None scheduled2026-09-16/status/mots-c
SemaxNot FDA approved
Nominated, then withdrawn

as of 2026-04-22

Not nominated

as of 2025-03-21

Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.

Voted in favour

2026-07-24

Advisory only; FDA must still complete rulemaking.

None scheduled2026-09-16/status/semax
EpitalonNot FDA approved
Nominated, then withdrawn

as of 2026-04-22

Not nominated

as of 2025-03-21

Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.

Voted in favour

2026-07-24

Advisory only; FDA must still complete rulemaking.

None scheduled2026-09-16/status/epitalon
Emideltide (DSIP)Not FDA approved
Nominated, then withdrawn

as of 2026-04-22

Not nominated

as of 2025-03-21

Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.

Voted against

2026-07-24

Advisory only; FDA must still complete rulemaking.

None scheduled2026-09-16/status/emideltide
Cathelicidin LL-37Not FDA approved
Nominated, then withdrawn

as of 2026-04-22

Not nominated

as of 2025-03-21

Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.

Not consideredNone scheduled2026-09-16/status/ll-37
DihexaNot FDA approved
Nominated, then withdrawn

as of 2026-04-22

Not nominated

as of 2025-03-21

Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.

Not consideredNone scheduled2026-09-16/status/dihexa
PEG-MGFNot FDA approved
Nominated, then withdrawn

as of 2026-04-22

Not nominated

as of 2025-03-21

Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.

Not consideredNone scheduled2026-09-16/status/peg-mgf
Melanotan IINot FDA approved
Nominated, then withdrawn

as of 2026-04-22

Not nominated

as of 2025-03-21

Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.

Not consideredNone scheduled2026-09-16/status/melanotan-ii
GHK-Cu (non-injectable routes)Not FDA approved
Category 1

as of 2026-05-14

FDA lists "GHK-Cu (except for injectable routes of administration)" in 503A category 1. In FDA's words: it "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 ... GHK-Cu (except for injectable routes of administration) will be added back to category 1." The non-injectable route is not named anywhere on FDA's bulk drug substances page — neither in its category 2 table nor in its withdrawn table, which lists only the injectable entry — so it was not part of the April 2026 category 2 removals. Orrick reports, as a secondary source, that GHK-Cu moved on the category 1 list rather than category 2. Read the withdrawn table's heading loosely: it calls its entries substances "previously in category 2 of the interim policies", yet FDA annotates ipamorelin acetate in that same table as still being in category 2 under the 503B interim policy. Category 1 is enforcement discretion under an interim policy, not inclusion on the 503A Bulks List, which holds six substances and no peptides.

Not nominated

as of 2025-03-21

Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.

Not considered

2027-02-28

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." FDA names GHK-Cu there without a route qualifier, unlike the route-qualified category 1 sentence immediately before it, so the document does not say whether the consultation covers both routes or only the non-injectable one. Nothing is inferred here either way.

2026-09-16/status/ghk-cu
GHK-Cu (injectable routes)Not FDA approved
Nominated, then withdrawn

as of 2026-04-22

FDA lists "GHK-Cu (for injectable routes of administration)" among the bulk drug substances nominated but withdrawn, in a table headed "This list of bulk drug substances previously in category 2 of the interim policies were withdrawn by the nominators." FDA's section 503A nomination document says something different in shape: that "the nominations for GHK-Cu were withdrawn by the nominators", and that the route-qualified entry "GHK-Cu (except for injectable routes of administration)" came off category 1 on April 22, 2026. What FDA dates to May 5, 2026 is a nominator's clarification that it had meant to withdraw only the injectable route and wished to retain its non-injectable nomination; of the listing itself FDA writes only that the entry "will be added back to category 1", and the document as updated May 14, 2026 does carry it there. Neither document states which category the injectable route itself occupied before the withdrawal, and this tracker does not resolve it; Orrick reports, as a secondary source, that FDA removed GHK-Cu from category 1 as a whole. Treat the withdrawn table's heading as loose: FDA annotates ipamorelin acetate in the same table as still being in category 2 under the 503B interim policy. What is not in dispute is that the injectable nomination was withdrawn, was not among those retained, and is on no positive list today: it is in neither 503A category 1 nor the 503A Bulks List at 21 CFR 216.23(a).

Not nominated

as of 2025-03-21

Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.

Not considered

2027-02-28

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." FDA names GHK-Cu there without a route qualifier, unlike the route-qualified category 1 sentence immediately before it, so the document does not say whether the consultation covers both routes or only the non-injectable one. Nothing is inferred here either way.

2026-09-16/status/ghk-cu
GHRP-2Not FDA approved
Category 3

as of 2026-05-14

FDA places GHRP-2 in 503A category 3, "Bulk Drug Substances Nominated Without Adequate Support".

Category 2

as of 2026-04-22

FDA's entry is route-qualified: "Growth hormone releasing peptide-2 (GHRP-2) (for injectable and nasal routes of administration)", added to 503B category 2 on September 29, 2023. GHRP-2 for other routes sits in 503B category 1.

Not consideredNone scheduled2026-09-16/status/ghrp-2
GHRP-6Not FDA approved
Category 3

as of 2026-05-14

FDA places GHRP-6 in 503A category 3, "Bulk Drug Substances Nominated Without Adequate Support".

Category 2

as of 2026-04-22

Added to 503B category 2 on September 29, 2023.

Not consideredNone scheduled2026-09-16/status/ghrp-6
Ibutamoren mesylate (MK-677)Not FDA approved
Category 2

as of 2026-04-22

Added to 503A category 2 on September 29, 2023.

Category 2

as of 2026-04-22

Added to 503B category 2 on December 29, 2022.

Not consideredNone scheduled2026-09-16/status/ibutamoren
Ipamorelin acetateNot FDA approved
Nominated, then withdrawn

as of 2026-04-22

The withdrawal cleared ipamorelin acetate from the 503A list only: it appears in none of the three categories on FDA's section 503A nomination document, and it remains in category 2 for 503B outsourcing-facility compounding. Neither document dates the withdrawal, so no date is asserted here.

Category 2

as of 2026-04-22

Added to 503B category 2 on September 29, 2023. FDA notes on its own page that ipamorelin acetate "also appears in the table above because it is in category 2 under the 503B interim policy".

Not consideredNone scheduled2026-09-16/status/ipamorelin
Kisspeptin-10Not FDA approved
Category 2

as of 2026-04-22

Added to 503A category 2 on September 29, 2023.

Not nominated

as of 2025-03-21

Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.

Not consideredNone scheduled2026-09-16/status/kisspeptin-10
CJC-1295Not FDA approved
Nominated, then withdrawn

as of 2026-04-22

CJC-1295 came off 503A category 2 but was never added to category 1, so there is still no lawful 503A compounding pathway.

Not nominated

as of 2025-03-21

Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.

Not consideredNone scheduled2026-09-16/status/cjc-1295
AOD-9604Not FDA approved
Nominated, then withdrawn

as of 2026-04-22

Not nominated

as of 2025-03-21

Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.

Not consideredNone scheduled2026-09-16/status/aod-9604
SelankNot FDA approved
Nominated, then withdrawn

as of 2026-04-22

Not nominated

as of 2025-03-21

Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.

Not consideredNone scheduled2026-09-16/status/selank
SermorelinFDA approved
Not nominated

as of 2026-05-14

Appears in none of the three categories on FDA's section 503A nomination document as of that document's own date.

Category 1

as of 2025-03-21

FDA lists "Sermorelin Acetate" in 503B category 1 and marks it with the two asterisks it uses for category 1 substances that are components of FDA-approved drugs.

Not consideredNone scheduled2026-09-16/status/sermorelin
TesamorelinFDA approved
Not nominated

as of 2026-05-14

Appears in none of the three categories on FDA's section 503A nomination document as of that document's own date.

Not nominated

as of 2025-03-21

Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.

Not consideredNone scheduled2026-09-16/status/tesamorelin
SemaglutideFDA approved
Not nominated

as of 2026-05-14

Appears in none of the three categories on FDA's section 503A nomination document as of that document's own date.

Proposed for exclusion

as of 2026-05-01

FDA considered the nominations and proposes NOT to include semaglutide on the 503B Bulks List, finding no clinical need for outsourcing facilities to compound it from bulk substances. Comments closed June 30, 2026; a final determination had not been published as of the verification date.

Not consideredNone scheduled2026-09-16/status/semaglutide
TirzepatideFDA approved
Not nominated

as of 2026-05-14

Appears in none of the three categories on FDA's section 503A nomination document as of that document's own date.

Proposed for exclusion

as of 2026-05-01

FDA considered the nominations and proposes NOT to include tirzepatide on the 503B Bulks List, finding no clinical need for outsourcing facilities to compound it from bulk substances. Comments closed June 30, 2026; a final determination had not been published as of the verification date.

Not consideredNone scheduled2026-09-16/status/tirzepatide
LiraglutideFDA approved
Not nominated

as of 2026-05-14

Appears in none of the three categories on FDA's section 503A nomination document as of that document's own date.

Proposed for exclusion

as of 2026-05-01

FDA considered the nominations and proposes NOT to include liraglutide on the 503B Bulks List, finding no clinical need for outsourcing facilities to compound it from bulk substances. Comments closed June 30, 2026; a final determination had not been published as of the verification date.

Not consideredNone scheduled2026-09-16/status/liraglutide
RetatrutideInvestigational
Not nominated

as of 2026-05-14

Appears in none of the three categories on FDA's section 503A nomination document as of that document's own date.

Not nominated

as of 2025-03-21

Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.

Not consideredNone scheduled2026-09-16/status/retatrutide

Next scheduled events

Only reviews FDA has itself put on the record appear here. A schedule reported by a law firm or in trade press is not published as a date, because the date is the whole claim. A date that has passed stays on the page, marked overdue, until an outcome is recorded against it.

By 2027-02-28 — GHK-Cu (non-injectable routes), GHK-Cu (injectable routes)

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." FDA names GHK-Cu there without a route qualifier, unlike the route-qualified category 1 sentence immediately before it, so the document does not say whether the consultation covers both routes or only the non-injectable one. Nothing is inferred here either way.

Source

Recent changes (65 entries)

Every recorded change across every row, newest first, dated by the underlying event rather than by the day we edited the file. Entries that correct an earlier one are marked as corrections and are the only ones that carry that label.

  1. Semaglutide

    The Fifth Circuit's revised opinion issued in Outsourcing Facilities Ass'n v. FDA, No. 25-10758, affirming the district court's judgment for FDA.

  2. Semaglutide

    The Fifth Circuit affirmed against the compounders in Outsourcing Facilities Ass'n v. FDA, No. 25-10758, an appeal over FDA's resolution of the semaglutide shortage.

  3. Tirzepatide

    In Outsourcing Facilities Ass'n v. FDA, No. 25-10758, the Fifth Circuit affirmed for the same reasons it had affirmed the district court's judgment in the companion Eli Lilly appeal over compounded tirzepatide.

  4. Emideltide (DSIP)

    PCAC discussed emideltide (DSIP) and voted against adding it to the 503A Bulks List.

  5. Epitalon

    PCAC discussed Epitalon and voted in favor of adding it to the 503A Bulks List; the recommendation is advisory and Epitalon has not been added to that list.

  6. Semax

    PCAC discussed Semax and voted in favor of adding it to the 503A Bulks List; the recommendation is advisory and Semax has not been added to that list.

  7. BPC-157

    PCAC discussed BPC-157 and voted in favor of adding it to the 503A Bulks List; the recommendation is advisory and BPC-157 has not been added to that list.

  8. KPV

    PCAC discussed KPV and voted in favor of adding it to the 503A Bulks List; the recommendation is advisory and KPV has not been added to that list.

  9. MOTS-c

    PCAC discussed MOTS-c and voted in favor of adding it to the 503A Bulks List; the recommendation is advisory and MOTS-c has not been added to that list.

  10. TB-500

    PCAC discussed TB-500 and voted in favor of adding it to the 503A Bulks List; the recommendation is advisory and TB-500 has not been added to that list.

  11. GHK-Cu (injectable routes)

    One of the nominators clarified that it had intended to withdraw only its nomination of the injectable route of administration, so FDA added back GHK-Cu except for injectable routes of administration; the injectable route was not restored to category 1.

  12. GHK-Cu (non-injectable routes)

    One nominator clarified that it had meant to withdraw only its nomination of the injectable route, so FDA said GHK-Cu except for injectable routes of administration would be added back to 503A category 1.

  13. Liraglutide

    FDA published a Federal Register notice proposing not to include liraglutide on the 503B Bulks List; the notice records a comment close date of June 30, 2026.

  14. Semaglutide

    FDA published a Federal Register notice proposing not to include semaglutide on the 503B Bulks List; the notice records a comment close date of June 30, 2026.

  15. Tirzepatide

    FDA published a Federal Register notice proposing not to include tirzepatide on the 503B Bulks List; the notice records a comment close date of June 30, 2026.

  16. Liraglutide

    FDA announced it was proposing to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need, and invited comments through June 29, 2026.

  17. Semaglutide

    FDA announced it was proposing to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need, and invited comments through June 29, 2026.

  18. Tirzepatide

    FDA announced it was proposing to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need, and invited comments through June 29, 2026.

  19. AOD-9604

    FDA's bulk drug substances page, content current as of this date, listed AOD-9604 among the substances nominated but withdrawn rather than in category 2.

  20. BPC-157

    FDA's bulk drug substances page, content current as of this date, listed BPC-157 among the substances nominated but withdrawn rather than in category 2.

  21. Cathelicidin LL-37

    FDA's bulk drug substances page, content current as of this date, listed cathelicidin LL-37 among the substances nominated but withdrawn rather than in category 2.

  22. CJC-1295

    FDA's bulk drug substances page, content current as of this date, listed CJC-1295 among the substances nominated but withdrawn rather than in category 2.

  23. Dihexa

    FDA's bulk drug substances page, content current as of this date, listed dihexa acetate among the substances nominated but withdrawn rather than in category 2.

  24. Emideltide (DSIP)

    FDA's bulk drug substances page, content current as of this date, listed emideltide (DSIP) among the substances nominated but withdrawn rather than in category 2.

  25. Epitalon

    FDA's bulk drug substances page, content current as of this date, listed Epitalon among the substances nominated but withdrawn rather than in category 2.

  26. GHK-Cu (injectable routes)

    The nominations for GHK-Cu were withdrawn by the nominators, and FDA removed "GHK-Cu (except for injectable routes of administration)" from 503A category 1. FDA's bulk drug substances page lists "GHK-Cu (for injectable routes of administration)" among the substances nominated but withdrawn.

  27. GHK-Cu (non-injectable routes)

    The nominations for GHK-Cu were withdrawn by the nominators, and FDA removed "GHK-Cu (except for injectable routes of administration)" from 503A category 1. Orrick reports this as a category 1 action, separate from the 12 peptides removed from category 2 the same day.

  28. GHRP-2

    FDA's bulk drug substances page, content current as of this date, continued to list GHRP-2 for injectable and nasal routes of administration in category 2 under the 503B interim policy.

  29. GHRP-6

    FDA's bulk drug substances page, content current as of this date, continued to list GHRP-6 in category 2 under the 503B interim policy.

  30. Ibutamoren mesylate (MK-677)

    FDA's bulk drug substances page, content current as of this date, continued to list ibutamoren mesylate in category 2 under the 503A and 503B interim policy.

  31. Ipamorelin acetate

    FDA's bulk drug substances page, content current as of this date, listed ipamorelin acetate both among the nominations that were withdrawn and in category 2 under the 503B interim policy.

  32. Kisspeptin-10

    FDA's bulk drug substances page, content current as of this date, continued to list kisspeptin-10 in category 2 under the 503A interim policy.

  33. KPV

    FDA's bulk drug substances page, content current as of this date, listed KPV among the substances nominated but withdrawn rather than in category 2.

  34. Melanotan II

    FDA's bulk drug substances page, content current as of this date, listed melanotan II among the substances nominated but withdrawn rather than in category 2.

  35. MOTS-c

    FDA's bulk drug substances page, content current as of this date, listed MOTS-c among the substances nominated but withdrawn rather than in category 2.

  36. PEG-MGF

    FDA's bulk drug substances page, content current as of this date, listed mechano growth factor pegylated (PEG-MGF) among the substances nominated but withdrawn rather than in category 2.

  37. Selank

    FDA's bulk drug substances page, content current as of this date, listed selank acetate (TP-7) among the substances nominated but withdrawn rather than in category 2.

  38. Semax

    FDA's bulk drug substances page, content current as of this date, listed Semax (heptapeptide) among the substances nominated but withdrawn rather than in category 2.

  39. TB-500

    FDA's bulk drug substances page, content current as of this date, listed TB-500 (thymosin beta-4, fragment (LKKTETQ)) among the substances nominated but withdrawn rather than in category 2.

  40. BPC-157

    FDA published a Federal Register notice setting the July 23-24, 2026 PCAC meeting on substances nominated for the 503A Bulks List, BPC-157 among them, and opened a public docket for comment.

  41. Emideltide (DSIP)

    FDA published a Federal Register notice setting the July 23-24, 2026 PCAC meeting on substances nominated for the 503A Bulks List, emideltide (DSIP) among them, and opened a public docket for comment.

  42. Epitalon

    FDA published a Federal Register notice setting the July 23-24, 2026 PCAC meeting on substances nominated for the 503A Bulks List, Epitalon among them, and opened a public docket for comment.

  43. KPV

    FDA published a Federal Register notice setting the July 23-24, 2026 PCAC meeting on substances nominated for the 503A Bulks List, KPV among them, and opened a public docket for comment.

  44. MOTS-c

    FDA published a Federal Register notice setting the July 23-24, 2026 PCAC meeting on substances nominated for the 503A Bulks List, MOTS-c among them, and opened a public docket for comment.

  45. Semax

    FDA published a Federal Register notice setting the July 23-24, 2026 PCAC meeting on substances nominated for the 503A Bulks List, Semax among them, and opened a public docket for comment.

  46. TB-500

    FDA published a Federal Register notice setting the July 23-24, 2026 PCAC meeting on substances nominated for the 503A Bulks List, TB-500 among them, and opened a public docket for comment.

  47. BPC-157

    FDA gave notice that after seven days it would remove 12 peptide bulk drug substances from category 2 of its section 503A list, because the nominators had withdrawn the nominations. The page as revised April 22, 2026 lists which substances now sit in the withdrawn group.

  48. Cathelicidin LL-37

    FDA gave notice that after seven days it would remove 12 peptide bulk drug substances from category 2 of its section 503A list, because the nominators had withdrawn the nominations. The page as revised April 22, 2026 lists which substances now sit in the withdrawn group.

  49. Dihexa

    FDA gave notice that after seven days it would remove 12 peptide bulk drug substances from category 2 of its section 503A list, because the nominators had withdrawn the nominations. The page as revised April 22, 2026 lists which substances now sit in the withdrawn group.

  50. Emideltide (DSIP)

    FDA gave notice that after seven days it would remove 12 peptide bulk drug substances from category 2 of its section 503A list, because the nominators had withdrawn the nominations. The page as revised April 22, 2026 lists which substances now sit in the withdrawn group.

  51. Epitalon

    FDA gave notice that after seven days it would remove 12 peptide bulk drug substances from category 2 of its section 503A list, because the nominators had withdrawn the nominations. The page as revised April 22, 2026 lists which substances now sit in the withdrawn group.

  52. KPV

    FDA gave notice that after seven days it would remove 12 peptide bulk drug substances from category 2 of its section 503A list, because the nominators had withdrawn the nominations. The page as revised April 22, 2026 lists which substances now sit in the withdrawn group.

  53. Melanotan II

    FDA gave notice that after seven days it would remove 12 peptide bulk drug substances from category 2 of its section 503A list, because the nominators had withdrawn the nominations. The page as revised April 22, 2026 lists which substances now sit in the withdrawn group.

  54. MOTS-c

    FDA gave notice that after seven days it would remove 12 peptide bulk drug substances from category 2 of its section 503A list, because the nominators had withdrawn the nominations. The page as revised April 22, 2026 lists which substances now sit in the withdrawn group.

  55. PEG-MGF

    FDA gave notice that after seven days it would remove 12 peptide bulk drug substances from category 2 of its section 503A list, because the nominators had withdrawn the nominations. The page as revised April 22, 2026 lists which substances now sit in the withdrawn group.

  56. Semax

    FDA gave notice that after seven days it would remove 12 peptide bulk drug substances from category 2 of its section 503A list, because the nominators had withdrawn the nominations. The page as revised April 22, 2026 lists which substances now sit in the withdrawn group.

  57. TB-500

    FDA gave notice that after seven days it would remove 12 peptide bulk drug substances from category 2 of its section 503A list, because the nominators had withdrawn the nominations. The page as revised April 22, 2026 lists which substances now sit in the withdrawn group.

  58. Retatrutide

    FDA issued a warning letter to Gram Peptides stating that the "Retatrutide" and "Tirzepatide" products it offered for sale are unapproved new drugs under section 505(a) of the FD&C Act.

  59. Sermorelin

    FDA's categorized 503B nomination list, updated this date, placed sermorelin acetate in category 1 and flagged it as a component of an FDA-approved drug.

  60. Tirzepatide

    FDA approved MOUNJARO (tirzepatide injection) under NDA 215866.

  61. Tesamorelin

    The EGRIFTA application was deemed to be a biologics license application.

  62. Semaglutide

    FDA approved OZEMPIC (semaglutide injection) under NDA 209637.

  63. Tesamorelin

    FDA approved EGRIFTA (tesamorelin acetate) under application 022505.

  64. Liraglutide

    FDA approved VICTOZA (liraglutide injection) under NDA 022341.

  65. Sermorelin

    FDA approved GEREF (sermorelin acetate) under NDA 019863.

Frequently asked questions

Does removal from category 2 make a peptide legal to compound?

No. Coming off category 2 means FDA is no longer evaluating that nomination — in the April 2026 changes, because the nominators withdrew it. It does not add the substance to the 503A Bulks List, and none of the substances in this tracker is on that list. The Pharmacy Compounding Advisory Committee votes taken on 2026-07-23 and 2026-07-24 are recommendations; FDA must still complete notice-and-comment rulemaking before anything is added.

What is the difference between section 503A and section 503B?

Section 503A covers traditional pharmacy compounding for an identified patient with a prescription. Section 503B covers outsourcing facilities, which compound at larger scale without patient-specific prescriptions and register with FDA. Each has its own bulk drug substance list and its own nomination document, so one substance can sit in different categories on the two lists: ipamorelin acetate was cleared from the 503A list by the 2024 withdrawal and is still category 2 for 503B. That is why this tracker shows two columns and never collapses them into a single "FDA category".

Why are there no vote tallies on this page?

Because FDA has published no minutes or transcript for the 2026-07-23 and 2026-07-24 Pharmacy Compounding Advisory Committee meeting. The vote counts circulating in press coverage are second-hand, and a tally is exactly the kind of fact that should come from the record itself. The data model has a field for one; it is filled only when a primary record exists, so this page says "voted in favour" and "voted against" and stops there.

What does a PCAC recommendation actually do?

It advises FDA. The committee votes on whether a bulk drug substance should be included on the 503A Bulks List, and FDA then decides through notice-and-comment rulemaking whether to include it. Until that rulemaking is complete the substance is not on the list, whatever the committee recommended, and compounding from it has no new lawful basis.

Why does GHK-Cu appear twice in the table?

Because FDA's own entries are qualified by route of administration and they say different things. GHK-Cu except for injectable routes of administration was removed from 503A category 1 on 2026-04-22 after the nominations were withdrawn, and FDA said it would be added back once a nominator clarified on 2026-05-05 that it had meant to withdraw only the injectable route. GHK-Cu for injectable routes of administration sits among the nominations that were withdrawn and was not added back. A single row would state something FDA did not.

How current is this tracker, and how would I know?

Every row prints the date its cited FDA pages were last re-fetched, in the table's last-verified column, and every changelog entry is dated by the event rather than by the edit. A build-time check fails the site when any row's verification date is more than 120 days old. Nothing is restamped on deploy, so a date that looks stale is stale.

Can I download or reuse this data?

Yes. The records that build this page are published as JSON at peptides.nyc/status.json, carrying the dataset name, license and last-modified date. Reuse it with attribution to Peptides.NYC and a link back to this page, and please keep the source links attached to the claims they support — the sourcing is the part that makes the data worth anything.

Sources and method

Every asserted field on this page carries at least one source on a primary host — fda.gov, federalregister.gov, a federal court, clinicaltrials.gov, or the anti-doping bodies for the WADA listing. Law-firm alerts and trade press are marked as secondary, render as "reported by", and never carry a field on their own. Nothing here is written from memory: every URL cited was fetched, and the sentence it supports was read off the fetched document.

Some things are deliberately missing. There are no vote tallies, because FDA has published no minutes or transcript of the July 2026 meeting. There are no state-law, scheduling or enforcement claims, because the ones circulating could not be confirmed against a primary record — an unverifiable claim is left out rather than published with a hedge. WADA status appears only where an anti-doping body states it in terms, and it links to the live Prohibited List, which is revised annually.

Rows are re-verified against the FDA pages they cite, and the date of that check is printed on each row. A build-time check fails the site if any row's verification date is more than 120 days old, so the stamp cannot quietly go stale. Corrections to this page are logged in the changelog above and on our corrections page. How we source and review everything else is in the editorial policy.

The machine-readable version of this record lives at /status.json. Found something that does not match the document it cites? Tell us on the contact page and we will fix it and log the correction.

References (27 documents)

Every document cited by any row, deduplicated. Secondary sources are marked; they report an action rather than record it, and no status on this page rests on one alone. Each entry carries the date we fetched it, because FDA revises several of these pages in place.

  1. 21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides) . Office of the Federal Register. Retrieved 2026-09-16.
  2. List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the FD&C Act, Doc. 2026-08552, published May 1, 2026; comments closed June 30, 2026 . Office of the Federal Register. Retrieved 2026-09-16.
  3. Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 91 FR (Doc. 2026-07361), April 16, 2026 . Office of the Federal Register. Retrieved 2026-09-16.
  4. USADA, BPC-157: What Athletes Should Know About the Prohibited Experimental Peptide . U.S. Anti-Doping Agency. Retrieved 2026-09-16.
  5. Outsourcing Facilities Ass'n v. FDA, No. 25-10758 (5th Cir. Aug. 27, 2026; opinion revised Sept. 1, 2026) . U.S. Court of Appeals for the Fifth Circuit. Retrieved 2026-09-16.
  6. Drugs@FDA, application 022505 (EGRIFTA, tesamorelin acetate) . U.S. Food and Drug Administration. Retrieved 2026-09-16.
  7. Drugs@FDA, NDA 019863 (GEREF, sermorelin acetate) . U.S. Food and Drug Administration. Retrieved 2026-09-16.
  8. Drugs@FDA, NDA 022341 (VICTOZA, liraglutide injection) . U.S. Food and Drug Administration. Retrieved 2026-09-16.
  9. Drugs@FDA, NDA 209637 (OZEMPIC, semaglutide injection) . U.S. Food and Drug Administration. Retrieved 2026-09-16.
  10. Drugs@FDA, NDA 215866 (MOUNJARO, tirzepatide injection) . U.S. Food and Drug Administration. Retrieved 2026-09-16.
  11. FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: BPC-157-related bulk drug substances . U.S. Food and Drug Administration. Retrieved 2026-09-16.
  12. FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: Emideltide-related bulk drug substances . U.S. Food and Drug Administration. Retrieved 2026-09-16.
  13. FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: Epitalon-related bulk drug substances . U.S. Food and Drug Administration. Retrieved 2026-09-16.
  14. FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: KPV-related bulk drug substances . U.S. Food and Drug Administration. Retrieved 2026-09-16.
  15. FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: MOTS-c-related bulk drug substances . U.S. Food and Drug Administration. Retrieved 2026-09-16.
  16. FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: Semax-related bulk drug substances . U.S. Food and Drug Administration. Retrieved 2026-09-16.
  17. FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: TB-500-related bulk drug substances . U.S. Food and Drug Administration. Retrieved 2026-09-16.
  18. FDA warning letter to Gram Peptides (MARCS-CMS 721806), March 31, 2026: "Retatrutide" and "Tirzepatide" products are unapproved new drugs under section 505(a) . U.S. Food and Drug Administration. Retrieved 2026-09-16.
  19. FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026 . U.S. Food and Drug Administration. Retrieved 2026-09-16.
  20. FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025 . U.S. Food and Drug Administration. Retrieved 2026-09-16.
  21. FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act . U.S. Food and Drug Administration. Retrieved 2026-09-16.
  22. FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus "bulk drug substances nominated but withdrawn"), content current as of April 22, 2026 . U.S. Food and Drug Administration. Retrieved 2026-09-16.
  23. FDA, FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List, April 30, 2026 . U.S. Food and Drug Administration. Retrieved 2026-09-16.
  24. FDA, July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee . U.S. Food and Drug Administration. Retrieved 2026-09-16.
  25. ClinicalTrials.gov, NCT06662383: "A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Retatrutide Compared to Tirzepatide in Adults Who Have Obesity" (Eli Lilly and Company; active, not recruiting) . U.S. National Library of Medicine. Retrieved 2026-09-16.
  26. NCPA, FDA advisory committee nominates six peptides for pharmacies to compound, July 31, 2026 . National Community Pharmacists Association. Secondary source. Retrieved 2026-09-16.
  27. Orrick, FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings to Consider Adding Peptides to 503A Bulk Drug Substances List, April 2026 . Orrick, Herrington & Sutcliffe LLP. Secondary source. Retrieved 2026-09-16.

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Editorial team. We cite published research; we are not licensed clinicians and content is not medically reviewed.

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