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Regulatory status tracker

PER COMPOUND14 COMPOUNDS TRACKED

For each compound below: the regulatory bucket it sits in today, whether a licensed compounding pharmacy may legally prepare it right now, and a dated history of every status change with the sources behind it. The regulatory timeline covers the same events as one chronology. This page is the per-compound view.

LAST VERIFIED
July 23, 2026
REVIEW CADENCE
Weekly, and within 24 hours of any FDA action.
Regulatory timeline →Legal status guide →Peptide directory →
At a glance
14 COMPOUNDS
FILTER14 OF 14 SHOWN
Sort by any column. "Compoundable today" means whether a licensed pharmacy may legally prepare the substance under section 503A right now, not whether it can be bought anywhere.
BPC-157WITHDRAWNNoFirst PCAC meeting, July 23-24, 2026
DihexaWITHDRAWNNoSecond PCAC meeting, expected before the end of February 2027
Emideltide (DSIP)WITHDRAWNNoFirst PCAC meeting, July 23-24, 2026
EpitalonWITHDRAWNNoFirst PCAC meeting, July 23-24, 2026
GHK-Cu (injectable)WITHDRAWNNoSecond PCAC meeting, expected before the end of February 2027
KPVWITHDRAWNNoFirst PCAC meeting, July 23-24, 2026
LL-37WITHDRAWNNoSecond PCAC meeting, expected before the end of February 2027
Melanotan IIWITHDRAWNNoSecond PCAC meeting, expected before the end of February 2027
MOTS-cWITHDRAWNNoFirst PCAC meeting, July 23-24, 2026
PEG-MGFWITHDRAWNNoSecond PCAC meeting, expected before the end of February 2027
SemaglutideAPPROVEDConditionalNone scheduled
SemaxWITHDRAWNNoFirst PCAC meeting, July 23-24, 2026
TB-500WITHDRAWNNoFirst PCAC meeting, July 23-24, 2026
TirzepatideAPPROVEDConditionalNone scheduled
Methodology

Status here means one thing only: where a substance sits in US federal compounding law. It says nothing about whether a peptide works, whether it is safe, or whether anyone should take it. Where we cite FDA's reasoning, we are reporting FDA's stated position, not endorsing it.

A compound is eligible for compounding as a bulk substance under section 503A of the Federal Food, Drug, and Cosmetic Act only if one of three things is true: it appears on the 503A Bulks List codified at 21 CFR 216.23, it is the subject of an applicable USP or NF monograph, or it is a component of an FDA-approved drug. Everything else on this page is context around those three tests.

The Category 1 and Category 2 designations are a separate, interim thing. They are FDA's working buckets for substances that have been nominated for the Bulks List and are still under review. Category movement is a signal about enforcement posture, not a grant of permission. Only notice-and-comment rulemaking adds a substance to the Bulks List, and that process typically runs 12 to 24 months after any advisory committee recommendation.

We set compoundable todayto "no" unless one of the three statutory tests is actually met. Where a substance is genuinely unresolved, we say so in the record rather than assigning a tidy label. Where an outcome is not yet public, the field stays empty: we do not estimate, and we do not repeat unsourced vote counts.

Every event carries at least one source URL, weighted toward fda.gov, federalregister.gov and ecfr.gov over secondary commentary. The tracker is reviewed weekly and within 24 hours of any FDA action. Found something wrong? Tell us and we will correct it and date the correction.

What each bucket means
APPROVED
FDA-approved drug

The substance is the active ingredient in an FDA-approved drug product. It has its own approval, labeling and supply history, and it is regulated on a completely separate track from the nominated bulk substances below. Compounding a copy of an approved drug is restricted under section 503A regardless of anything on this page.

BULKS LIST
On the 503A Bulks List

The substance appears on the list at 21 CFR 216.23, the formal list of bulk drug substances that may be used in compounding under section 503A. This is the only category on this page that reflects an actual FDA rule. Reaching it requires notice-and-comment rulemaking. No peptide tracked here is on this list.

CATEGORY 1
Category 1 (interim)

An interim designation for a nominated bulk substance under review where FDA has not identified a safety problem. FDA states it does not intend to take action against compounding that meets stated conditions while the review is pending. This is enforcement discretion, not authorization, and it can be withdrawn.

CATEGORY 2
Category 2 (interim)

An interim designation for a nominated bulk substance that FDA has determined may present significant safety risks. Category 2 substances fall outside enforcement discretion, so FDA has said it would consider action against a compounder using them.

WITHDRAWN
Nomination withdrawn

The original nomination was withdrawn by the nominator, so FDA removed the substance from the Category 2 list. The substance is not in Category 1 and is not on the 503A Bulks List. It sits outside the interim category system entirely. FDA has been explicit that this does not make the substance eligible for compounding.

NOT NOMINATED
Not nominated

The substance has not been nominated for the 503A Bulks List, so there is no interim designation and no pending FDA review of it as a compounding bulk substance.

Compound records
DATED AND SOURCED

BPC-157

WITHDRAWNBPC-157 profile →
ALSO KNOWN AS Body Protection Compound 157 · PL 14736
CURRENT STATUS

Removed from Category 2 in April 2026 after the nomination was withdrawn. Not in Category 1, not on the 503A Bulks List. Reviewed by PCAC on July 23-24, 2026 with no outcome published.

COMPOUNDABLE TODAY — NO

No. Eligibility to compound a bulk substance under section 503A requires that the substance appear on the 503A Bulks List at 21 CFR 216.23, be the subject of an applicable USP or NF monograph, or be a component of an FDA-approved drug. This substance meets none of the three. Leaving Category 2 removed an interim designation; it did not create a pathway.

ADVISORY COMMITTEE REVIEW

First PCAC meeting, July 23-24, 2026. FDA review staff recommended against adding the substance to the 503A Bulks List.

Outcome: not published as of July 23, 2026. We are not reporting a vote count for this substance because none has been made public.

STATUS HISTORY
July 23-24, 2026
→ WITHDRAWN

PCAC takes up BPC-157 for the 503A Bulks List

The Pharmacy Compounding Advisory Committee met at FDA's White Oak campus to consider whether seven peptides, including BPC-157, should be added to the section 503A Bulks List. BPC-157 was scheduled for day one of the meeting, July 23. FDA review staff briefing materials recommended against inclusion for all seven substances, concluding that none satisfy the criteria in 21 CFR 216.23(c) and citing inadequate substance characterization, inconsistent naming, missing quality data, insufficient or absent human clinical evidence, and immunogenicity concerns. The public comment window on docket FDA-2025-N-6895 closed July 22.

July 23, 2026 — as of 2026-07-23
→ WITHDRAWN

No vote outcome published

No vote tally for BPC-157 has been published by FDA or reported by established news coverage at the time of this review. We are not reporting, estimating or implying a result. Treat any vote count circulating before FDA or the meeting record publishes one as unverified. Even once a tally exists, a PCAC vote is a recommendation to FDA, not a decision, and it changes nothing about whether BPC-157 may be compounded.

April 15, 2026
→ WITHDRAWN

BPC-157 removed from Category 2 after the nomination was withdrawn

FDA updated its nominated bulk substances list to remove BPC-157 from Category 2, effective within seven calendar days, because the party that originally nominated the substance withdrew the nomination. This is a procedural consequence of the withdrawal. It is not a move to Category 1, it is not addition to the 503A Bulks List at 21 CFR 216.23, and FDA has stated that removal from Category 2 does not by itself make a substance eligible for compounding under section 503A. BPC-157 therefore left the interim category system without gaining any compounding pathway.

April 15, 2026
→ WITHDRAWN

PCAC review of BPC-157 scheduled for July 23-24, 2026

The same day it removed the 12 peptides from Category 2, FDA published a Federal Register notice convening the Pharmacy Compounding Advisory Committee at public meetings on July 23-24, 2026 and before the end of February 2027 to consider these substances for the section 503A Bulks List. BPC-157 was assigned to the first meeting. The docket is FDA-2025-N-6895. PCAC is advisory: its recommendation does not change any rule, and adding a substance to the Bulks List would still require notice-and-comment rulemaking, which typically runs 12 to 24 months.

February 27, 2026
→ CATEGORY 2

HHS Secretary floats reclassification on a podcast

On episode 2461 of The Joe Rogan Experience, HHS Secretary Robert F. Kennedy Jr. said roughly 14 of the 19 Category 2 peptides would be considered for a move back to Category 1, and that he expected an announcement within weeks. These were remarks, not agency action. Nothing about the regulatory status of BPC-157 changed on this date, and a move to Category 1 would restore enforcement discretion rather than approve or authorize the substance.

September 2023
→ CATEGORY 2

BPC-157 placed in Category 2

FDA placed BPC-157 in Category 2 of its interim list of bulk drug substances nominated for use in compounding under section 503A. FDA's stated basis for the Category 2 peptides was a combination of immunogenicity risk, concerns about manufacturing impurities and substance characterization, and insufficient human clinical safety data. Category 2 substances sit outside FDA's enforcement discretion policy, so licensed compounding pharmacies could not use BPC-157 without exposure to FDA action.

TB-500

WITHDRAWNTB-500 profile →
ALSO KNOWN AS Thymosin beta-4 fragment
CURRENT STATUS

Removed from Category 2 in April 2026 after the nomination was withdrawn. Not in Category 1, not on the 503A Bulks List. Reviewed by PCAC on July 23-24, 2026 with no outcome published.

COMPOUNDABLE TODAY — NO

No. Eligibility to compound a bulk substance under section 503A requires that the substance appear on the 503A Bulks List at 21 CFR 216.23, be the subject of an applicable USP or NF monograph, or be a component of an FDA-approved drug. This substance meets none of the three. Leaving Category 2 removed an interim designation; it did not create a pathway.

ADVISORY COMMITTEE REVIEW

First PCAC meeting, July 23-24, 2026. FDA review staff recommended against adding the substance to the 503A Bulks List.

Outcome: not published as of July 23, 2026. We are not reporting a vote count for this substance because none has been made public.

STATUS HISTORY
July 23-24, 2026
→ WITHDRAWN

PCAC takes up TB-500 for the 503A Bulks List

The Pharmacy Compounding Advisory Committee met at FDA's White Oak campus to consider whether seven peptides, including TB-500, should be added to the section 503A Bulks List. TB-500 was scheduled for day one of the meeting, July 23. FDA review staff briefing materials recommended against inclusion for all seven substances, concluding that none satisfy the criteria in 21 CFR 216.23(c) and citing inadequate substance characterization, inconsistent naming, missing quality data, insufficient or absent human clinical evidence, and immunogenicity concerns. The public comment window on docket FDA-2025-N-6895 closed July 22.

July 23, 2026 — as of 2026-07-23
→ WITHDRAWN

No vote outcome published

No vote tally for TB-500 has been published by FDA or reported by established news coverage at the time of this review. We are not reporting, estimating or implying a result. Treat any vote count circulating before FDA or the meeting record publishes one as unverified. Even once a tally exists, a PCAC vote is a recommendation to FDA, not a decision, and it changes nothing about whether TB-500 may be compounded.

April 15, 2026
→ WITHDRAWN

TB-500 removed from Category 2 after the nomination was withdrawn

FDA updated its nominated bulk substances list to remove TB-500 from Category 2, effective within seven calendar days, because the party that originally nominated the substance withdrew the nomination. This is a procedural consequence of the withdrawal. It is not a move to Category 1, it is not addition to the 503A Bulks List at 21 CFR 216.23, and FDA has stated that removal from Category 2 does not by itself make a substance eligible for compounding under section 503A. TB-500 therefore left the interim category system without gaining any compounding pathway.

April 15, 2026
→ WITHDRAWN

PCAC review of TB-500 scheduled for July 23-24, 2026

The same day it removed the 12 peptides from Category 2, FDA published a Federal Register notice convening the Pharmacy Compounding Advisory Committee at public meetings on July 23-24, 2026 and before the end of February 2027 to consider these substances for the section 503A Bulks List. TB-500 was assigned to the first meeting. The docket is FDA-2025-N-6895. PCAC is advisory: its recommendation does not change any rule, and adding a substance to the Bulks List would still require notice-and-comment rulemaking, which typically runs 12 to 24 months.

February 27, 2026
→ CATEGORY 2

HHS Secretary floats reclassification on a podcast

On episode 2461 of The Joe Rogan Experience, HHS Secretary Robert F. Kennedy Jr. said roughly 14 of the 19 Category 2 peptides would be considered for a move back to Category 1, and that he expected an announcement within weeks. These were remarks, not agency action. Nothing about the regulatory status of TB-500 changed on this date, and a move to Category 1 would restore enforcement discretion rather than approve or authorize the substance.

September 2023
→ CATEGORY 2

TB-500 placed in Category 2

FDA placed TB-500 in Category 2 of its interim list of bulk drug substances nominated for use in compounding under section 503A. FDA's stated basis for the Category 2 peptides was a combination of immunogenicity risk, concerns about manufacturing impurities and substance characterization, and insufficient human clinical safety data. Category 2 substances sit outside FDA's enforcement discretion policy, so licensed compounding pharmacies could not use TB-500 without exposure to FDA action.

KPV

WITHDRAWNKPV profile →
ALSO KNOWN AS Lysine-proline-valine · alpha-MSH 11-13
CURRENT STATUS

Removed from Category 2 in April 2026 after the nomination was withdrawn. Not in Category 1, not on the 503A Bulks List. Reviewed by PCAC on July 23-24, 2026 with no outcome published.

COMPOUNDABLE TODAY — NO

No. Eligibility to compound a bulk substance under section 503A requires that the substance appear on the 503A Bulks List at 21 CFR 216.23, be the subject of an applicable USP or NF monograph, or be a component of an FDA-approved drug. This substance meets none of the three. Leaving Category 2 removed an interim designation; it did not create a pathway.

ADVISORY COMMITTEE REVIEW

First PCAC meeting, July 23-24, 2026. FDA review staff recommended against adding the substance to the 503A Bulks List.

Outcome: not published as of July 23, 2026. We are not reporting a vote count for this substance because none has been made public.

STATUS HISTORY
July 23-24, 2026
→ WITHDRAWN

PCAC takes up KPV for the 503A Bulks List

The Pharmacy Compounding Advisory Committee met at FDA's White Oak campus to consider whether seven peptides, including KPV, should be added to the section 503A Bulks List. KPV was scheduled for day one of the meeting, July 23. FDA review staff briefing materials recommended against inclusion for all seven substances, concluding that none satisfy the criteria in 21 CFR 216.23(c) and citing inadequate substance characterization, inconsistent naming, missing quality data, insufficient or absent human clinical evidence, and immunogenicity concerns. The public comment window on docket FDA-2025-N-6895 closed July 22.

July 23, 2026 — as of 2026-07-23
→ WITHDRAWN

No vote outcome published

No vote tally for KPV has been published by FDA or reported by established news coverage at the time of this review. We are not reporting, estimating or implying a result. Treat any vote count circulating before FDA or the meeting record publishes one as unverified. Even once a tally exists, a PCAC vote is a recommendation to FDA, not a decision, and it changes nothing about whether KPV may be compounded.

April 15, 2026
→ WITHDRAWN

KPV removed from Category 2 after the nomination was withdrawn

FDA updated its nominated bulk substances list to remove KPV from Category 2, effective within seven calendar days, because the party that originally nominated the substance withdrew the nomination. This is a procedural consequence of the withdrawal. It is not a move to Category 1, it is not addition to the 503A Bulks List at 21 CFR 216.23, and FDA has stated that removal from Category 2 does not by itself make a substance eligible for compounding under section 503A. KPV therefore left the interim category system without gaining any compounding pathway.

April 15, 2026
→ WITHDRAWN

PCAC review of KPV scheduled for July 23-24, 2026

The same day it removed the 12 peptides from Category 2, FDA published a Federal Register notice convening the Pharmacy Compounding Advisory Committee at public meetings on July 23-24, 2026 and before the end of February 2027 to consider these substances for the section 503A Bulks List. KPV was assigned to the first meeting. The docket is FDA-2025-N-6895. PCAC is advisory: its recommendation does not change any rule, and adding a substance to the Bulks List would still require notice-and-comment rulemaking, which typically runs 12 to 24 months.

February 27, 2026
→ CATEGORY 2

HHS Secretary floats reclassification on a podcast

On episode 2461 of The Joe Rogan Experience, HHS Secretary Robert F. Kennedy Jr. said roughly 14 of the 19 Category 2 peptides would be considered for a move back to Category 1, and that he expected an announcement within weeks. These were remarks, not agency action. Nothing about the regulatory status of KPV changed on this date, and a move to Category 1 would restore enforcement discretion rather than approve or authorize the substance.

September 2023
→ CATEGORY 2

KPV placed in Category 2

FDA placed KPV in Category 2 of its interim list of bulk drug substances nominated for use in compounding under section 503A. FDA's stated basis for the Category 2 peptides was a combination of immunogenicity risk, concerns about manufacturing impurities and substance characterization, and insufficient human clinical safety data. Category 2 substances sit outside FDA's enforcement discretion policy, so licensed compounding pharmacies could not use KPV without exposure to FDA action.

MOTS-c

WITHDRAWNMOTS-c profile →
ALSO KNOWN AS Mitochondrial ORF of the 12S rRNA type-c
CURRENT STATUS

Removed from Category 2 in April 2026 after the nomination was withdrawn. Not in Category 1, not on the 503A Bulks List. Reviewed by PCAC on July 23-24, 2026 with no outcome published.

COMPOUNDABLE TODAY — NO

No. Eligibility to compound a bulk substance under section 503A requires that the substance appear on the 503A Bulks List at 21 CFR 216.23, be the subject of an applicable USP or NF monograph, or be a component of an FDA-approved drug. This substance meets none of the three. Leaving Category 2 removed an interim designation; it did not create a pathway.

ADVISORY COMMITTEE REVIEW

First PCAC meeting, July 23-24, 2026. FDA review staff recommended against adding the substance to the 503A Bulks List.

Outcome: not published as of July 23, 2026. We are not reporting a vote count for this substance because none has been made public.

STATUS HISTORY
July 23-24, 2026
→ WITHDRAWN

PCAC takes up MOTS-c for the 503A Bulks List

The Pharmacy Compounding Advisory Committee met at FDA's White Oak campus to consider whether seven peptides, including MOTS-c, should be added to the section 503A Bulks List. MOTS-c was scheduled for day one of the meeting, July 23. FDA review staff briefing materials recommended against inclusion for all seven substances, concluding that none satisfy the criteria in 21 CFR 216.23(c) and citing inadequate substance characterization, inconsistent naming, missing quality data, insufficient or absent human clinical evidence, and immunogenicity concerns. The public comment window on docket FDA-2025-N-6895 closed July 22.

July 23, 2026 — as of 2026-07-23
→ WITHDRAWN

No vote outcome published

No vote tally for MOTS-c has been published by FDA or reported by established news coverage at the time of this review. We are not reporting, estimating or implying a result. Treat any vote count circulating before FDA or the meeting record publishes one as unverified. Even once a tally exists, a PCAC vote is a recommendation to FDA, not a decision, and it changes nothing about whether MOTS-c may be compounded.

April 15, 2026
→ WITHDRAWN

MOTS-c removed from Category 2 after the nomination was withdrawn

FDA updated its nominated bulk substances list to remove MOTS-c from Category 2, effective within seven calendar days, because the party that originally nominated the substance withdrew the nomination. This is a procedural consequence of the withdrawal. It is not a move to Category 1, it is not addition to the 503A Bulks List at 21 CFR 216.23, and FDA has stated that removal from Category 2 does not by itself make a substance eligible for compounding under section 503A. MOTS-c therefore left the interim category system without gaining any compounding pathway.

April 15, 2026
→ WITHDRAWN

PCAC review of MOTS-c scheduled for July 23-24, 2026

The same day it removed the 12 peptides from Category 2, FDA published a Federal Register notice convening the Pharmacy Compounding Advisory Committee at public meetings on July 23-24, 2026 and before the end of February 2027 to consider these substances for the section 503A Bulks List. MOTS-c was assigned to the first meeting. The docket is FDA-2025-N-6895. PCAC is advisory: its recommendation does not change any rule, and adding a substance to the Bulks List would still require notice-and-comment rulemaking, which typically runs 12 to 24 months.

February 27, 2026
→ CATEGORY 2

HHS Secretary floats reclassification on a podcast

On episode 2461 of The Joe Rogan Experience, HHS Secretary Robert F. Kennedy Jr. said roughly 14 of the 19 Category 2 peptides would be considered for a move back to Category 1, and that he expected an announcement within weeks. These were remarks, not agency action. Nothing about the regulatory status of MOTS-c changed on this date, and a move to Category 1 would restore enforcement discretion rather than approve or authorize the substance.

September 2023
→ CATEGORY 2

MOTS-c placed in Category 2

FDA placed MOTS-c in Category 2 of its interim list of bulk drug substances nominated for use in compounding under section 503A. FDA's stated basis for the Category 2 peptides was a combination of immunogenicity risk, concerns about manufacturing impurities and substance characterization, and insufficient human clinical safety data. Category 2 substances sit outside FDA's enforcement discretion policy, so licensed compounding pharmacies could not use MOTS-c without exposure to FDA action.

Emideltide (DSIP)

WITHDRAWNEmideltide (DSIP) profile →
ALSO KNOWN AS Delta sleep-inducing peptide · DSIP
CURRENT STATUS

Removed from Category 2 in April 2026 after the nomination was withdrawn. Not in Category 1, not on the 503A Bulks List. Reviewed by PCAC on July 23-24, 2026 with no outcome published.

COMPOUNDABLE TODAY — NO

No. Eligibility to compound a bulk substance under section 503A requires that the substance appear on the 503A Bulks List at 21 CFR 216.23, be the subject of an applicable USP or NF monograph, or be a component of an FDA-approved drug. This substance meets none of the three. Leaving Category 2 removed an interim designation; it did not create a pathway.

ADVISORY COMMITTEE REVIEW

First PCAC meeting, July 23-24, 2026. FDA review staff recommended against adding the substance to the 503A Bulks List.

Outcome: not published as of July 23, 2026. We are not reporting a vote count for this substance because none has been made public.

STATUS HISTORY
July 23-24, 2026
→ WITHDRAWN

PCAC takes up Emideltide (DSIP) for the 503A Bulks List

The Pharmacy Compounding Advisory Committee met at FDA's White Oak campus to consider whether seven peptides, including Emideltide (DSIP), should be added to the section 503A Bulks List. Emideltide (DSIP) was scheduled for day two of the meeting, July 24. FDA review staff briefing materials recommended against inclusion for all seven substances, concluding that none satisfy the criteria in 21 CFR 216.23(c) and citing inadequate substance characterization, inconsistent naming, missing quality data, insufficient or absent human clinical evidence, and immunogenicity concerns. The public comment window on docket FDA-2025-N-6895 closed July 22.

July 23, 2026 — as of 2026-07-23
→ WITHDRAWN

No vote outcome published

No vote tally for Emideltide (DSIP) has been published by FDA or reported by established news coverage at the time of this review. We are not reporting, estimating or implying a result. Treat any vote count circulating before FDA or the meeting record publishes one as unverified. Even once a tally exists, a PCAC vote is a recommendation to FDA, not a decision, and it changes nothing about whether Emideltide (DSIP) may be compounded.

April 15, 2026
→ WITHDRAWN

Emideltide (DSIP) removed from Category 2 after the nomination was withdrawn

FDA updated its nominated bulk substances list to remove Emideltide (DSIP) from Category 2, effective within seven calendar days, because the party that originally nominated the substance withdrew the nomination. This is a procedural consequence of the withdrawal. It is not a move to Category 1, it is not addition to the 503A Bulks List at 21 CFR 216.23, and FDA has stated that removal from Category 2 does not by itself make a substance eligible for compounding under section 503A. Emideltide (DSIP) therefore left the interim category system without gaining any compounding pathway.

April 15, 2026
→ WITHDRAWN

PCAC review of Emideltide (DSIP) scheduled for July 23-24, 2026

The same day it removed the 12 peptides from Category 2, FDA published a Federal Register notice convening the Pharmacy Compounding Advisory Committee at public meetings on July 23-24, 2026 and before the end of February 2027 to consider these substances for the section 503A Bulks List. Emideltide (DSIP) was assigned to the first meeting. The docket is FDA-2025-N-6895. PCAC is advisory: its recommendation does not change any rule, and adding a substance to the Bulks List would still require notice-and-comment rulemaking, which typically runs 12 to 24 months.

February 27, 2026
→ CATEGORY 2

HHS Secretary floats reclassification on a podcast

On episode 2461 of The Joe Rogan Experience, HHS Secretary Robert F. Kennedy Jr. said roughly 14 of the 19 Category 2 peptides would be considered for a move back to Category 1, and that he expected an announcement within weeks. These were remarks, not agency action. Nothing about the regulatory status of Emideltide (DSIP) changed on this date, and a move to Category 1 would restore enforcement discretion rather than approve or authorize the substance.

September 2023
→ CATEGORY 2

Emideltide (DSIP) placed in Category 2

FDA placed Emideltide (DSIP) in Category 2 of its interim list of bulk drug substances nominated for use in compounding under section 503A. FDA's stated basis for the Category 2 peptides was a combination of immunogenicity risk, concerns about manufacturing impurities and substance characterization, and insufficient human clinical safety data. Category 2 substances sit outside FDA's enforcement discretion policy, so licensed compounding pharmacies could not use Emideltide (DSIP) without exposure to FDA action.

Semax

WITHDRAWNSemax profile →
ALSO KNOWN AS Met-Glu-His-Phe-Pro-Gly-Pro
CURRENT STATUS

Removed from Category 2 in April 2026 after the nomination was withdrawn. Not in Category 1, not on the 503A Bulks List. Reviewed by PCAC on July 23-24, 2026 with no outcome published.

COMPOUNDABLE TODAY — NO

No. Eligibility to compound a bulk substance under section 503A requires that the substance appear on the 503A Bulks List at 21 CFR 216.23, be the subject of an applicable USP or NF monograph, or be a component of an FDA-approved drug. This substance meets none of the three. Leaving Category 2 removed an interim designation; it did not create a pathway.

ADVISORY COMMITTEE REVIEW

First PCAC meeting, July 23-24, 2026. FDA review staff recommended against adding the substance to the 503A Bulks List.

Outcome: not published as of July 23, 2026. We are not reporting a vote count for this substance because none has been made public.

STATUS HISTORY
July 23-24, 2026
→ WITHDRAWN

PCAC takes up Semax for the 503A Bulks List

The Pharmacy Compounding Advisory Committee met at FDA's White Oak campus to consider whether seven peptides, including Semax, should be added to the section 503A Bulks List. Semax was scheduled for day two of the meeting, July 24. FDA review staff briefing materials recommended against inclusion for all seven substances, concluding that none satisfy the criteria in 21 CFR 216.23(c) and citing inadequate substance characterization, inconsistent naming, missing quality data, insufficient or absent human clinical evidence, and immunogenicity concerns. The public comment window on docket FDA-2025-N-6895 closed July 22.

July 23, 2026 — as of 2026-07-23
→ WITHDRAWN

No vote outcome published

No vote tally for Semax has been published by FDA or reported by established news coverage at the time of this review. We are not reporting, estimating or implying a result. Treat any vote count circulating before FDA or the meeting record publishes one as unverified. Even once a tally exists, a PCAC vote is a recommendation to FDA, not a decision, and it changes nothing about whether Semax may be compounded.

April 15, 2026
→ WITHDRAWN

Semax removed from Category 2 after the nomination was withdrawn

FDA updated its nominated bulk substances list to remove Semax from Category 2, effective within seven calendar days, because the party that originally nominated the substance withdrew the nomination. This is a procedural consequence of the withdrawal. It is not a move to Category 1, it is not addition to the 503A Bulks List at 21 CFR 216.23, and FDA has stated that removal from Category 2 does not by itself make a substance eligible for compounding under section 503A. Semax therefore left the interim category system without gaining any compounding pathway.

April 15, 2026
→ WITHDRAWN

PCAC review of Semax scheduled for July 23-24, 2026

The same day it removed the 12 peptides from Category 2, FDA published a Federal Register notice convening the Pharmacy Compounding Advisory Committee at public meetings on July 23-24, 2026 and before the end of February 2027 to consider these substances for the section 503A Bulks List. Semax was assigned to the first meeting. The docket is FDA-2025-N-6895. PCAC is advisory: its recommendation does not change any rule, and adding a substance to the Bulks List would still require notice-and-comment rulemaking, which typically runs 12 to 24 months.

February 27, 2026
→ CATEGORY 2

HHS Secretary floats reclassification on a podcast

On episode 2461 of The Joe Rogan Experience, HHS Secretary Robert F. Kennedy Jr. said roughly 14 of the 19 Category 2 peptides would be considered for a move back to Category 1, and that he expected an announcement within weeks. These were remarks, not agency action. Nothing about the regulatory status of Semax changed on this date, and a move to Category 1 would restore enforcement discretion rather than approve or authorize the substance.

September 2023
→ CATEGORY 2

Semax placed in Category 2

FDA placed Semax in Category 2 of its interim list of bulk drug substances nominated for use in compounding under section 503A. FDA's stated basis for the Category 2 peptides was a combination of immunogenicity risk, concerns about manufacturing impurities and substance characterization, and insufficient human clinical safety data. Category 2 substances sit outside FDA's enforcement discretion policy, so licensed compounding pharmacies could not use Semax without exposure to FDA action.

Epitalon

WITHDRAWNEpitalon profile →
ALSO KNOWN AS Epithalon · Epithalamin · AEDG
CURRENT STATUS

Removed from Category 2 in April 2026 after the nomination was withdrawn. Not in Category 1, not on the 503A Bulks List. Reviewed by PCAC on July 23-24, 2026 with no outcome published.

COMPOUNDABLE TODAY — NO

No. Eligibility to compound a bulk substance under section 503A requires that the substance appear on the 503A Bulks List at 21 CFR 216.23, be the subject of an applicable USP or NF monograph, or be a component of an FDA-approved drug. This substance meets none of the three. Leaving Category 2 removed an interim designation; it did not create a pathway.

ADVISORY COMMITTEE REVIEW

First PCAC meeting, July 23-24, 2026. FDA review staff recommended against adding the substance to the 503A Bulks List.

Outcome: not published as of July 23, 2026. We are not reporting a vote count for this substance because none has been made public.

STATUS HISTORY
July 23-24, 2026
→ WITHDRAWN

PCAC takes up Epitalon for the 503A Bulks List

The Pharmacy Compounding Advisory Committee met at FDA's White Oak campus to consider whether seven peptides, including Epitalon, should be added to the section 503A Bulks List. Epitalon was scheduled for day two of the meeting, July 24. FDA review staff briefing materials recommended against inclusion for all seven substances, concluding that none satisfy the criteria in 21 CFR 216.23(c) and citing inadequate substance characterization, inconsistent naming, missing quality data, insufficient or absent human clinical evidence, and immunogenicity concerns. The public comment window on docket FDA-2025-N-6895 closed July 22.

July 23, 2026 — as of 2026-07-23
→ WITHDRAWN

No vote outcome published

No vote tally for Epitalon has been published by FDA or reported by established news coverage at the time of this review. We are not reporting, estimating or implying a result. Treat any vote count circulating before FDA or the meeting record publishes one as unverified. Even once a tally exists, a PCAC vote is a recommendation to FDA, not a decision, and it changes nothing about whether Epitalon may be compounded.

April 15, 2026
→ WITHDRAWN

Epitalon removed from Category 2 after the nomination was withdrawn

FDA updated its nominated bulk substances list to remove Epitalon from Category 2, effective within seven calendar days, because the party that originally nominated the substance withdrew the nomination. This is a procedural consequence of the withdrawal. It is not a move to Category 1, it is not addition to the 503A Bulks List at 21 CFR 216.23, and FDA has stated that removal from Category 2 does not by itself make a substance eligible for compounding under section 503A. Epitalon therefore left the interim category system without gaining any compounding pathway.

April 15, 2026
→ WITHDRAWN

PCAC review of Epitalon scheduled for July 23-24, 2026

The same day it removed the 12 peptides from Category 2, FDA published a Federal Register notice convening the Pharmacy Compounding Advisory Committee at public meetings on July 23-24, 2026 and before the end of February 2027 to consider these substances for the section 503A Bulks List. Epitalon was assigned to the first meeting. The docket is FDA-2025-N-6895. PCAC is advisory: its recommendation does not change any rule, and adding a substance to the Bulks List would still require notice-and-comment rulemaking, which typically runs 12 to 24 months.

February 27, 2026
→ CATEGORY 2

HHS Secretary floats reclassification on a podcast

On episode 2461 of The Joe Rogan Experience, HHS Secretary Robert F. Kennedy Jr. said roughly 14 of the 19 Category 2 peptides would be considered for a move back to Category 1, and that he expected an announcement within weeks. These were remarks, not agency action. Nothing about the regulatory status of Epitalon changed on this date, and a move to Category 1 would restore enforcement discretion rather than approve or authorize the substance.

September 2023
→ CATEGORY 2

Epitalon placed in Category 2

FDA placed Epitalon in Category 2 of its interim list of bulk drug substances nominated for use in compounding under section 503A. FDA's stated basis for the Category 2 peptides was a combination of immunogenicity risk, concerns about manufacturing impurities and substance characterization, and insufficient human clinical safety data. Category 2 substances sit outside FDA's enforcement discretion policy, so licensed compounding pharmacies could not use Epitalon without exposure to FDA action.

LL-37

WITHDRAWNLL-37 profile →
ALSO KNOWN AS Cathelicidin LL-37 · hCAP-18 fragment
CURRENT STATUS

Removed from Category 2 in April 2026 after the nomination was withdrawn. Not in Category 1, not on the 503A Bulks List. Assigned to the second PCAC meeting, expected before the end of February 2027.

COMPOUNDABLE TODAY — NO

No. Eligibility to compound a bulk substance under section 503A requires that the substance appear on the 503A Bulks List at 21 CFR 216.23, be the subject of an applicable USP or NF monograph, or be a component of an FDA-approved drug. This substance meets none of the three. Leaving Category 2 removed an interim designation; it did not create a pathway.

ADVISORY COMMITTEE REVIEW

Second PCAC meeting, expected before the end of February 2027. Not yet public. No briefing package for the second meeting has been released.

Outcome: not published as of July 23, 2026. We are not reporting a vote count for this substance because none has been made public.

STATUS HISTORY
Expected before the end of February 2027
→ WITHDRAWN

Second PCAC meeting to consider LL-37

LL-37 is assigned to the second Pharmacy Compounding Advisory Committee meeting, scheduled by the April 15, 2026 Federal Register notice to occur before the end of February 2027, alongside LL-37, GHK-Cu, dihexa, Melanotan II and PEG-MGF. No meeting date, briefing package or FDA review recommendation for this second meeting is public yet. Until then LL-37 remains outside both interim categories and off the 503A Bulks List.

April 15, 2026
→ WITHDRAWN

LL-37 removed from Category 2 after the nomination was withdrawn

FDA updated its nominated bulk substances list to remove LL-37 from Category 2, effective within seven calendar days, because the party that originally nominated the substance withdrew the nomination. This is a procedural consequence of the withdrawal. It is not a move to Category 1, it is not addition to the 503A Bulks List at 21 CFR 216.23, and FDA has stated that removal from Category 2 does not by itself make a substance eligible for compounding under section 503A. LL-37 therefore left the interim category system without gaining any compounding pathway.

April 15, 2026
→ WITHDRAWN

PCAC review of LL-37 scheduled for a meeting before the end of February 2027

The same day it removed the 12 peptides from Category 2, FDA published a Federal Register notice convening the Pharmacy Compounding Advisory Committee at public meetings on July 23-24, 2026 and before the end of February 2027 to consider these substances for the section 503A Bulks List. LL-37 was assigned to the second meeting. The docket is FDA-2025-N-6895. PCAC is advisory: its recommendation does not change any rule, and adding a substance to the Bulks List would still require notice-and-comment rulemaking, which typically runs 12 to 24 months.

February 27, 2026
→ CATEGORY 2

HHS Secretary floats reclassification on a podcast

On episode 2461 of The Joe Rogan Experience, HHS Secretary Robert F. Kennedy Jr. said roughly 14 of the 19 Category 2 peptides would be considered for a move back to Category 1, and that he expected an announcement within weeks. These were remarks, not agency action. Nothing about the regulatory status of LL-37 changed on this date, and a move to Category 1 would restore enforcement discretion rather than approve or authorize the substance.

September 2023
→ CATEGORY 2

LL-37 placed in Category 2

FDA placed LL-37 in Category 2 of its interim list of bulk drug substances nominated for use in compounding under section 503A. FDA's stated basis for the Category 2 peptides was a combination of immunogenicity risk, concerns about manufacturing impurities and substance characterization, and insufficient human clinical safety data. Category 2 substances sit outside FDA's enforcement discretion policy, so licensed compounding pharmacies could not use LL-37 without exposure to FDA action.

GHK-Cu (injectable)

WITHDRAWNGHK-Cu (injectable) profile →
ALSO KNOWN AS Copper tripeptide-1 · Glycyl-L-histidyl-L-lysine copper
CURRENT STATUS

Removed from Category 2 in April 2026 after the nomination was withdrawn. Not in Category 1, not on the 503A Bulks List. Assigned to the second PCAC meeting, expected before the end of February 2027.

COMPOUNDABLE TODAY — NO

No. Eligibility to compound a bulk substance under section 503A requires that the substance appear on the 503A Bulks List at 21 CFR 216.23, be the subject of an applicable USP or NF monograph, or be a component of an FDA-approved drug. This substance meets none of the three. Leaving Category 2 removed an interim designation; it did not create a pathway.

ADVISORY COMMITTEE REVIEW

Second PCAC meeting, expected before the end of February 2027. Not yet public. No briefing package for the second meeting has been released.

Outcome: not published as of July 23, 2026. We are not reporting a vote count for this substance because none has been made public.

STATUS HISTORY
Expected before the end of February 2027
→ WITHDRAWN

Second PCAC meeting to consider GHK-Cu (injectable)

GHK-Cu (injectable) is assigned to the second Pharmacy Compounding Advisory Committee meeting, scheduled by the April 15, 2026 Federal Register notice to occur before the end of February 2027, alongside LL-37, GHK-Cu, dihexa, Melanotan II and PEG-MGF. No meeting date, briefing package or FDA review recommendation for this second meeting is public yet. Until then GHK-Cu (injectable) remains outside both interim categories and off the 503A Bulks List.

April 15, 2026
→ WITHDRAWN

GHK-Cu (injectable) removed from Category 2 after the nomination was withdrawn

FDA updated its nominated bulk substances list to remove GHK-Cu (injectable) from Category 2, effective within seven calendar days, because the party that originally nominated the substance withdrew the nomination. This is a procedural consequence of the withdrawal. It is not a move to Category 1, it is not addition to the 503A Bulks List at 21 CFR 216.23, and FDA has stated that removal from Category 2 does not by itself make a substance eligible for compounding under section 503A. GHK-Cu (injectable) therefore left the interim category system without gaining any compounding pathway.

April 15, 2026
→ WITHDRAWN

PCAC review of GHK-Cu (injectable) scheduled for a meeting before the end of February 2027

The same day it removed the 12 peptides from Category 2, FDA published a Federal Register notice convening the Pharmacy Compounding Advisory Committee at public meetings on July 23-24, 2026 and before the end of February 2027 to consider these substances for the section 503A Bulks List. GHK-Cu (injectable) was assigned to the second meeting. The docket is FDA-2025-N-6895. PCAC is advisory: its recommendation does not change any rule, and adding a substance to the Bulks List would still require notice-and-comment rulemaking, which typically runs 12 to 24 months.

February 27, 2026
→ CATEGORY 2

HHS Secretary floats reclassification on a podcast

On episode 2461 of The Joe Rogan Experience, HHS Secretary Robert F. Kennedy Jr. said roughly 14 of the 19 Category 2 peptides would be considered for a move back to Category 1, and that he expected an announcement within weeks. These were remarks, not agency action. Nothing about the regulatory status of GHK-Cu (injectable) changed on this date, and a move to Category 1 would restore enforcement discretion rather than approve or authorize the substance.

September 2023
→ CATEGORY 2

GHK-Cu (injectable) placed in Category 2

FDA placed GHK-Cu (injectable) in Category 2 of its interim list of bulk drug substances nominated for use in compounding under section 503A. FDA's stated basis for the Category 2 peptides was a combination of immunogenicity risk, concerns about manufacturing impurities and substance characterization, and insufficient human clinical safety data. Category 2 substances sit outside FDA's enforcement discretion policy, so licensed compounding pharmacies could not use GHK-Cu (injectable) without exposure to FDA action.

Dihexa

WITHDRAWNDihexa profile →
ALSO KNOWN AS Dihexa acetate · N-hexanoic-Tyr-Ile-(6) aminohexanoic amide
CURRENT STATUS

Removed from Category 2 in April 2026 after the nomination was withdrawn. Not in Category 1, not on the 503A Bulks List. Assigned to the second PCAC meeting, expected before the end of February 2027.

COMPOUNDABLE TODAY — NO

No. Eligibility to compound a bulk substance under section 503A requires that the substance appear on the 503A Bulks List at 21 CFR 216.23, be the subject of an applicable USP or NF monograph, or be a component of an FDA-approved drug. This substance meets none of the three. Leaving Category 2 removed an interim designation; it did not create a pathway.

ADVISORY COMMITTEE REVIEW

Second PCAC meeting, expected before the end of February 2027. Not yet public. No briefing package for the second meeting has been released.

Outcome: not published as of July 23, 2026. We are not reporting a vote count for this substance because none has been made public.

STATUS HISTORY
Expected before the end of February 2027
→ WITHDRAWN

Second PCAC meeting to consider Dihexa

Dihexa is assigned to the second Pharmacy Compounding Advisory Committee meeting, scheduled by the April 15, 2026 Federal Register notice to occur before the end of February 2027, alongside LL-37, GHK-Cu, dihexa, Melanotan II and PEG-MGF. No meeting date, briefing package or FDA review recommendation for this second meeting is public yet. Until then Dihexa remains outside both interim categories and off the 503A Bulks List.

April 15, 2026
→ WITHDRAWN

Dihexa removed from Category 2 after the nomination was withdrawn

FDA updated its nominated bulk substances list to remove Dihexa from Category 2, effective within seven calendar days, because the party that originally nominated the substance withdrew the nomination. This is a procedural consequence of the withdrawal. It is not a move to Category 1, it is not addition to the 503A Bulks List at 21 CFR 216.23, and FDA has stated that removal from Category 2 does not by itself make a substance eligible for compounding under section 503A. Dihexa therefore left the interim category system without gaining any compounding pathway.

April 15, 2026
→ WITHDRAWN

PCAC review of Dihexa scheduled for a meeting before the end of February 2027

The same day it removed the 12 peptides from Category 2, FDA published a Federal Register notice convening the Pharmacy Compounding Advisory Committee at public meetings on July 23-24, 2026 and before the end of February 2027 to consider these substances for the section 503A Bulks List. Dihexa was assigned to the second meeting. The docket is FDA-2025-N-6895. PCAC is advisory: its recommendation does not change any rule, and adding a substance to the Bulks List would still require notice-and-comment rulemaking, which typically runs 12 to 24 months.

February 27, 2026
→ CATEGORY 2

HHS Secretary floats reclassification on a podcast

On episode 2461 of The Joe Rogan Experience, HHS Secretary Robert F. Kennedy Jr. said roughly 14 of the 19 Category 2 peptides would be considered for a move back to Category 1, and that he expected an announcement within weeks. These were remarks, not agency action. Nothing about the regulatory status of Dihexa changed on this date, and a move to Category 1 would restore enforcement discretion rather than approve or authorize the substance.

September 2023
→ CATEGORY 2

Dihexa placed in Category 2

FDA placed Dihexa in Category 2 of its interim list of bulk drug substances nominated for use in compounding under section 503A. FDA's stated basis for the Category 2 peptides was a combination of immunogenicity risk, concerns about manufacturing impurities and substance characterization, and insufficient human clinical safety data. Category 2 substances sit outside FDA's enforcement discretion policy, so licensed compounding pharmacies could not use Dihexa without exposure to FDA action.

Melanotan II

WITHDRAWNMelanotan II profile →
ALSO KNOWN AS MT-II · MT2
CURRENT STATUS

Removed from Category 2 in April 2026 after the nomination was withdrawn. Not in Category 1, not on the 503A Bulks List. Assigned to the second PCAC meeting, expected before the end of February 2027.

COMPOUNDABLE TODAY — NO

No. Eligibility to compound a bulk substance under section 503A requires that the substance appear on the 503A Bulks List at 21 CFR 216.23, be the subject of an applicable USP or NF monograph, or be a component of an FDA-approved drug. This substance meets none of the three. Leaving Category 2 removed an interim designation; it did not create a pathway.

ADVISORY COMMITTEE REVIEW

Second PCAC meeting, expected before the end of February 2027. Not yet public. No briefing package for the second meeting has been released.

Outcome: not published as of July 23, 2026. We are not reporting a vote count for this substance because none has been made public.

STATUS HISTORY
Expected before the end of February 2027
→ WITHDRAWN

Second PCAC meeting to consider Melanotan II

Melanotan II is assigned to the second Pharmacy Compounding Advisory Committee meeting, scheduled by the April 15, 2026 Federal Register notice to occur before the end of February 2027, alongside LL-37, GHK-Cu, dihexa, Melanotan II and PEG-MGF. No meeting date, briefing package or FDA review recommendation for this second meeting is public yet. Until then Melanotan II remains outside both interim categories and off the 503A Bulks List.

April 15, 2026
→ WITHDRAWN

Melanotan II removed from Category 2 after the nomination was withdrawn

FDA updated its nominated bulk substances list to remove Melanotan II from Category 2, effective within seven calendar days, because the party that originally nominated the substance withdrew the nomination. This is a procedural consequence of the withdrawal. It is not a move to Category 1, it is not addition to the 503A Bulks List at 21 CFR 216.23, and FDA has stated that removal from Category 2 does not by itself make a substance eligible for compounding under section 503A. Melanotan II therefore left the interim category system without gaining any compounding pathway.

April 15, 2026
→ WITHDRAWN

PCAC review of Melanotan II scheduled for a meeting before the end of February 2027

The same day it removed the 12 peptides from Category 2, FDA published a Federal Register notice convening the Pharmacy Compounding Advisory Committee at public meetings on July 23-24, 2026 and before the end of February 2027 to consider these substances for the section 503A Bulks List. Melanotan II was assigned to the second meeting. The docket is FDA-2025-N-6895. PCAC is advisory: its recommendation does not change any rule, and adding a substance to the Bulks List would still require notice-and-comment rulemaking, which typically runs 12 to 24 months.

February 27, 2026
→ CATEGORY 2

HHS Secretary floats reclassification on a podcast

On episode 2461 of The Joe Rogan Experience, HHS Secretary Robert F. Kennedy Jr. said roughly 14 of the 19 Category 2 peptides would be considered for a move back to Category 1, and that he expected an announcement within weeks. These were remarks, not agency action. Nothing about the regulatory status of Melanotan II changed on this date, and a move to Category 1 would restore enforcement discretion rather than approve or authorize the substance.

September 2023
→ CATEGORY 2

Melanotan II placed in Category 2

FDA placed Melanotan II in Category 2 of its interim list of bulk drug substances nominated for use in compounding under section 503A. FDA's stated basis for the Category 2 peptides was a combination of immunogenicity risk, concerns about manufacturing impurities and substance characterization, and insufficient human clinical safety data. Category 2 substances sit outside FDA's enforcement discretion policy, so licensed compounding pharmacies could not use Melanotan II without exposure to FDA action.

PEG-MGF

WITHDRAWNPEG-MGF profile →
ALSO KNOWN AS Pegylated mechano growth factor · PEG IGF-1Ec
CURRENT STATUS

Removed from Category 2 in April 2026 after the nomination was withdrawn. Not in Category 1, not on the 503A Bulks List. Assigned to the second PCAC meeting, expected before the end of February 2027.

COMPOUNDABLE TODAY — NO

No. Eligibility to compound a bulk substance under section 503A requires that the substance appear on the 503A Bulks List at 21 CFR 216.23, be the subject of an applicable USP or NF monograph, or be a component of an FDA-approved drug. This substance meets none of the three. Leaving Category 2 removed an interim designation; it did not create a pathway.

ADVISORY COMMITTEE REVIEW

Second PCAC meeting, expected before the end of February 2027. Not yet public. No briefing package for the second meeting has been released.

Outcome: not published as of July 23, 2026. We are not reporting a vote count for this substance because none has been made public.

STATUS HISTORY
Expected before the end of February 2027
→ WITHDRAWN

Second PCAC meeting to consider PEG-MGF

PEG-MGF is assigned to the second Pharmacy Compounding Advisory Committee meeting, scheduled by the April 15, 2026 Federal Register notice to occur before the end of February 2027, alongside LL-37, GHK-Cu, dihexa, Melanotan II and PEG-MGF. No meeting date, briefing package or FDA review recommendation for this second meeting is public yet. Until then PEG-MGF remains outside both interim categories and off the 503A Bulks List.

April 15, 2026
→ WITHDRAWN

PEG-MGF removed from Category 2 after the nomination was withdrawn

FDA updated its nominated bulk substances list to remove PEG-MGF from Category 2, effective within seven calendar days, because the party that originally nominated the substance withdrew the nomination. This is a procedural consequence of the withdrawal. It is not a move to Category 1, it is not addition to the 503A Bulks List at 21 CFR 216.23, and FDA has stated that removal from Category 2 does not by itself make a substance eligible for compounding under section 503A. PEG-MGF therefore left the interim category system without gaining any compounding pathway.

April 15, 2026
→ WITHDRAWN

PCAC review of PEG-MGF scheduled for a meeting before the end of February 2027

The same day it removed the 12 peptides from Category 2, FDA published a Federal Register notice convening the Pharmacy Compounding Advisory Committee at public meetings on July 23-24, 2026 and before the end of February 2027 to consider these substances for the section 503A Bulks List. PEG-MGF was assigned to the second meeting. The docket is FDA-2025-N-6895. PCAC is advisory: its recommendation does not change any rule, and adding a substance to the Bulks List would still require notice-and-comment rulemaking, which typically runs 12 to 24 months.

February 27, 2026
→ CATEGORY 2

HHS Secretary floats reclassification on a podcast

On episode 2461 of The Joe Rogan Experience, HHS Secretary Robert F. Kennedy Jr. said roughly 14 of the 19 Category 2 peptides would be considered for a move back to Category 1, and that he expected an announcement within weeks. These were remarks, not agency action. Nothing about the regulatory status of PEG-MGF changed on this date, and a move to Category 1 would restore enforcement discretion rather than approve or authorize the substance.

September 2023
→ CATEGORY 2

PEG-MGF placed in Category 2

FDA placed PEG-MGF in Category 2 of its interim list of bulk drug substances nominated for use in compounding under section 503A. FDA's stated basis for the Category 2 peptides was a combination of immunogenicity risk, concerns about manufacturing impurities and substance characterization, and insufficient human clinical safety data. Category 2 substances sit outside FDA's enforcement discretion policy, so licensed compounding pharmacies could not use PEG-MGF without exposure to FDA action.

Semaglutide

APPROVEDSemaglutide profile →
ALSO KNOWN AS Ozempic · Wegovy · Rybelsus
CURRENT STATUS

Active ingredient in FDA-approved drug products. Not part of the Category 1 / Category 2 nomination system. Compounding under the shortage provisions ended in 2025 when FDA declared the shortage resolved.

COMPOUNDABLE TODAY — CONDITIONAL

Semaglutide is a component of FDA-approved drugs, which is one of the three statutory routes to eligibility under section 503A. But section 503A separately restricts compounding drug products that are essentially copies of a commercially available approved drug. The shortage-based basis that supported large-scale compounding ended when FDA declared the shortage resolved in February 2025, with a compounding wind-down deadline of April 22, 2025 for 503A pharmacies and May 22, 2025 for 503B outsourcing facilities. Individualized compounding based on a documented clinical need for a specific patient is a narrow and fact-specific question for a licensed pharmacist and prescriber, not something this page can answer.

STATUS HISTORY
April 22, 2025
→ APPROVED

503A pharmacy deadline to stop compounding semaglutide

State-licensed 503A compounding pharmacies had to cease compounding semaglutide by this date. Outsourcing facilities operating under section 503B had until May 22, 2025.

February 21, 2025
→ APPROVED

FDA declares the semaglutide shortage resolved

FDA determined that the semaglutide shortage was resolved, removing the statutory basis under section 503A and 503B that had allowed compounders to prepare semaglutide products during a shortage. FDA set a transition period rather than requiring an immediate stop.

Tirzepatide

APPROVEDTirzepatide profile →
ALSO KNOWN AS Mounjaro · Zepbound
CURRENT STATUS

Active ingredient in FDA-approved drug products. Not part of the Category 1 / Category 2 nomination system. Shortage-based compounding ended in 2025 after a contested shortage-resolution decision.

COMPOUNDABLE TODAY — CONDITIONAL

As with semaglutide, tirzepatide is a component of FDA-approved drugs, but section 503A restricts compounding essentially-copy products of a commercially available approved drug, and the shortage basis has ended. FDA's enforcement discretion for 503A pharmacies ended February 18, 2025 and for 503B outsourcing facilities March 19, 2025.

STATUS HISTORY
February 19 and March 19, 2025
→ APPROVED

Compounding transition deadlines take effect

FDA's enforcement discretion for compounding tirzepatide ended February 18, 2025 for state-licensed 503A pharmacies and March 19, 2025 for 503B outsourcing facilities. Note that these dates differ from the semaglutide deadlines of April 22 and May 22, 2025; the two drugs are frequently and incorrectly given the same timeline.

December 19, 2024
→ APPROVED

FDA reaffirms the tirzepatide shortage is resolved

After reconsidering, FDA reaffirmed that the tirzepatide shortage was resolved and set a transition period for compounders rather than an immediate cutoff.

October 2024
→ APPROVED

FDA first declares the tirzepatide shortage resolved

FDA removed tirzepatide from the drug shortage list. The determination was challenged in litigation brought by the Outsourcing Facilities Association and FDA agreed to revisit it, so this initial decision did not stand on its own.

Primary sources

Most coverage of the 2026 peptide story collapsed three different legal constructs into one headline. This page keeps them apart, per compound, with dates and sources, and says plainly where the record does not yet resolve.

— THE EDITORS