FDA Peptide Compounding Status Tracker (Updated September 30, 2026)

TL;DR

On April 15, 2026, FDA announced it would remove 12 peptides, including BPC-157, TB-500 and KPV, from Category 2 (“do not compound”) of the interim 503A bulks list. Removal from Category 2 does not place a substance in Category 1 or on the 503A Bulks List. [Frier Levitt, Apr 2026; McDermott Will & Schulte, Jul 27, 2026]

On July 23–24, 2026, FDA’s Pharmacy Compounding Advisory Committee (PCAC) voted to recommend six of them (BPC-157, KPV, TB-500, MOTS-c, Semax and Epitalon) and voted against Emideltide (DSIP). FDA’s review team had recommended against all seven. [McDermott Will & Schulte, Jul 27, 2026; Frier Levitt, Sep 17, 2026]

PCAC votes are advisory. As of September 17, 2026, FDA had taken no further action, and none of the seven can be lawfully compounded under 503A until FDA completes notice-and-comment rulemaking or Congress amends the law. [Holland & Knight, Aug 4, 2026; Frier Levitt, Sep 17, 2026]

The 12 peptides removed from Category 2 (April 15, 2026)

1. BPC-157
2. KPV
3. Thymosin beta-4 fragment (TB-500)
4. MOTS-c
5. Semax (heptapeptide)
6. Epitalon
7. Emideltide (DSIP)
8. Cathelicidin LL-37
9. Dihexa acetate
10. GHK-Cu (injectable routes)
11. PEG-MGF (pegylated mechano growth factor)
12. Melanotan II

Timeline

1. April 15, 2026: 12 peptides removed from Category 2

   FDA announced its intent to remove 12 bulk drug substances from Category 2 (“do not compound”) of the interim 503A bulks list and scheduled a PCAC meeting for July 23–24. Removal from Category 2 does not place a substance in Category 1 or on the 503A Bulks List. [Frier Levitt, Apr 2026; McDermott Will & Schulte, Jul 27, 2026]

2. July 23–24, 2026: PCAC votes on seven peptides

   The committee recommended BPC-157, KPV, TB-500 and MOTS-c (July 23) and Semax and Epitalon (July 24) for the 503A Bulks List, and voted against Emideltide (DSIP). In every case the FDA review team recommended against inclusion, citing insufficient safety, efficacy and characterization information. [McDermott Will & Schulte, Jul 27, 2026; Frier Levitt, Sep 17, 2026]

3. September 17, 2026: No further FDA action

   FDA had taken no further action. The PCAC recommendations are advisory, and formal rulemaking is required before any of the recommended substances can be added to the 503A Bulks List. [Frier Levitt, Sep 17, 2026]

4. Before end of February 2027: Second PCAC consultation

   FDA said the remaining five (Cathelicidin LL-37, Dihexa acetate, GHK-Cu for injectable routes, PEG-MGF and Melanotan II) are slated for a separate PCAC consultation before the end of February 2027. [Frier Levitt, Apr 2026; McDermott Will & Schulte, Jul 27, 2026]

July 23–24, 2026 PCAC votes (yes–no–abstain)

In every case the FDA review team recommended against inclusion, citing insufficient safety, efficacy and characterization information. [McDermott Will & Schulte, Jul 27, 2026; Frier Levitt, Sep 17, 2026]

Status by peptide

Approved-drug rows restate each profile’s verified regulatory data and are shown for context; they are not among the 12 Category 2 removals or the seven PCAC votes.

What this means

• PCAC recommendations are advisory. FDA is not obligated to follow them. [Holland & Knight, Aug 4, 2026; Frier Levitt, Sep 17, 2026]
• Adding a substance to the 503A Bulks List requires notice-and-comment rulemaking, or an act of Congress amending the FDCA. [Holland & Knight, Aug 4, 2026]
• Rulemaking could conclude in 2027 or run for several years. [McDermott Will & Schulte, Jul 27, 2026]
• FDA may consider interim enforcement discretion for the recommended peptides while rulemaking proceeds. No such policy has been announced. [McDermott Will & Schulte, Jul 27, 2026; Frier Levitt, Apr 2026; Frier Levitt, Sep 17, 2026]

What this does not mean

• A favorable PCAC vote is not FDA approval, and it does not by itself change any peptide’s legal status. [Frier Levitt, Sep 17, 2026; Holland & Knight, Aug 4, 2026]
• Removal from Category 2 is not placement in Category 1 or on the 503A Bulks List, and does not make a substance eligible for 503A compounding. [Frier Levitt, Apr 2026; McDermott Will & Schulte, Jul 27, 2026]
• As of the most recent source (September 17, 2026), the six recommended peptides still could not be lawfully compounded under 503A. [Holland & Knight, Aug 4, 2026; Frier Levitt, Sep 17, 2026]
• A “Research Use Only” (RUO) label is not a legal pathway for human use. None of the seven peptides PCAC reviewed is on the 503A Bulks List or in an FDA-approved drug. [Holland & Knight, Aug 4, 2026]

This page tracks regulatory status only. It does not describe any peptide as safe or effective; for what the published research reports, and in which study subjects, see each linked profile.

Frequently Asked Questions

Is BPC-157 legal to compound in 2026?

Not as of September 17, 2026. FDA removed BPC-157 from Category 2 on April 15, 2026, and PCAC voted 8–6–1 on July 23, 2026 to recommend it for the 503A Bulks List. The vote is advisory: until FDA completes notice-and-comment rulemaking (or Congress amends the law), BPC-157 is not on the 503A Bulks List and cannot be lawfully compounded under 503A. [Frier Levitt, Apr 2026; McDermott Will & Schulte, Jul 27, 2026; Holland & Knight, Aug 4, 2026; Frier Levitt, Sep 17, 2026]

What did the FDA advisory committee vote on BPC-157?

On July 23, 2026, PCAC voted 8 yes, 6 no and 1 abstention to recommend BPC-157 (free base and acetate) for the 503A Bulks List. The FDA review team had recommended against inclusion, citing insufficient safety, efficacy and characterization information. [McDermott Will & Schulte, Jul 27, 2026]

What is 503A Category 1 vs Category 2?

On FDA’s interim 503A bulks list, Category 1 meant FDA had received sufficient information and had not identified significant safety concerns; FDA has said it does not intend to take enforcement action against pharmacies that compound with Category 1 substances and otherwise meet the conditions of section 503A. Category 2 meant FDA had identified significant safety concerns, so those substances could not be compounded without risk of FDA enforcement. Removal from Category 2 does not place a substance in Category 1. [McDermott Will & Schulte, Jul 27, 2026; Frier Levitt, Apr 2026]

When will FDA decide?

There is no announced date. As of September 17, 2026, FDA had taken no further action. Adding the recommended peptides requires notice-and-comment rulemaking, which could conclude in 2027 or take several years. FDA may consider interim enforcement discretion, but none has been announced. [Frier Levitt, Sep 17, 2026; McDermott Will & Schulte, Jul 27, 2026; Holland & Knight, Aug 4, 2026]

Which peptides are still under review?

Five peptides removed from Category 2 have not yet gone before PCAC: Cathelicidin LL-37, Dihexa acetate, GHK-Cu (injectable routes), PEG-MGF and Melanotan II. FDA said they are slated for a separate PCAC consultation before the end of February 2027. The six peptides PCAC recommended in July 2026 still await FDA rulemaking. [Frier Levitt, Apr 2026; McDermott Will & Schulte, Jul 27, 2026; Frier Levitt, Sep 17, 2026]

Was DSIP approved?

No. Emideltide (DSIP) is not an FDA-approved drug, and on July 24, 2026 PCAC voted 6 yes, 7 no and 1 abstention, so it was not recommended for the 503A Bulks List. As of September 17, 2026, FDA had taken no further action. [McDermott Will & Schulte, Jul 27, 2026; Holland & Knight, Aug 4, 2026; Frier Levitt, Sep 17, 2026]

Does a PCAC recommendation mean FDA approval?

No. PCAC is an advisory committee. Its recommendation is not FDA approval and does not by itself change a substance’s legal status. FDA is not obligated to follow it. [Frier Levitt, Sep 17, 2026; Holland & Knight, Aug 4, 2026; FDA, Pharmacy Compounding Advisory Committee]

Sources

1. FDA to Remove 12 Popular Peptides from the Category 2 “Do Not Compound” List. Frier Levitt, April 16, 2026.
2. Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. McDermott Will & Schulte, July 27, 2026.
3. FDA Advisory Committee Endorses Compounding of Certain Peptides. Holland & Knight, August 4, 2026.
4. FDA Advisory Committee Recommends Six Peptides for 503A Compounding: What Businesses Need to Know. Frier Levitt, September 17, 2026.
5. Pharmacy Compounding Advisory Committee. U.S. Food and Drug Administration.

Changelog

Last verified: September 30, 2026

• September 30, 2026: Tracker published. All entries verified against the sources listed below.

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