This page tracks what US regulators have actually decided about specific peptides, with the source for each claim and the date it was true. It reports status. It does not rank compounds, and a compound appearing lower on this page is not a judgement about it.
The distinction that matters most on this page: an FDA advisory committee recommending a substance is not the FDA approving it, and is not the same as the FDA agreeing. Committee votes are advice. The status of every compound below is stated with that difference made explicit.
Reviewed by the FDA Pharmacy Compounding Advisory Committee
Two meetings are represented here, and they went different ways. Seven peptides were reviewed on July 23 and 24, 2026 for the section 503A bulk drug substances list, under docket FDA-2025-N-6895; the FDA’s own scientific review team recommended against all seven and the committee recommended six of them anyway. Thymosin alpha-1 was reviewed earlier, on December 4, 2024, and there the committee agreed with the FDA and voted 4 to 17 against inclusion. Each substance is voted separately in free base and acetate forms. On October 30, 2026 HHS published a draft enforcement-discretion policy (91 FR 68526) covering the six recommended peptides, each in one named salt form and named routes only, under strict conditions. It is not approval and adds nothing to the 503A list; each card states what it covers. The date on each card below is the date that compound’s status was decided, not the date of the most recent meeting.
Thymosin alpha-1 (thymalfasin)
As of December 4, 2024
Advisory committee did not recommend
On December 4, 2024 an FDA advisory committee voted 4 to 17, with no abstentions, against placing thymosin alpha-1 on the 503A bulk drug substances list, according to FDA's summary minutes. The tally was identical for the free base and the acetate. Several members voting no said there was no compelling evidence of clinical effectiveness and safety for the uses reviewed, which included hepatitis B, hepatitis C, HIV, COVID-19, sepsis, and use as an adjuvant to flu vaccines. It is not among the six peptides in the HHS draft enforcement-discretion policy published on October 30, 2026. Thymosin alpha-1 is not an FDA-approved drug in the United States; it is approved outside the United States and sold as Zadaxin, but the FDA has stated it cannot independently verify the claim, sourced to a company annual report, that it is approved across some thirty countries.
What this does and does not change
The Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Here the committee voted against inclusion, which leaves the 503A bulk drug substances list unchanged and means there is no pending rulemaking to follow. The nomination that prompted the review had already been withdrawn, and the FDA evaluated the substances at its own discretion. Thymosin alpha-1 is not an FDA-approved drug and no product containing it has ever been approved in the United States, and the FDA stated in its briefing document that a website advertising a compounded thymosin alpha-1 injection as FDA-approved was wrong to do so.
DSIP (delta sleep-inducing peptide, emideltide)
As of July 24, 2026
Advisory committee did not recommend
On July 24, 2026 an FDA advisory committee did not recommend emideltide (DSIP), in free base or acetate form, for the 503A bulk drug substances list, in line with FDA staff, who had proposed excluding it after evaluating it for opioid withdrawal, chronic insomnia and narcolepsy. It was the only one of the seven peptides at that meeting not recommended, and it is not among the six peptides in the HHS draft enforcement-discretion policy published on October 30, 2026. Emideltide is not an FDA-approved drug.
What this does and does not change
Two separate steps apply here, and neither is approval. First, the Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Its July 2026 recommendation is not binding, and FDA staff had proposed that none of the seven peptides be listed. Second, on October 30, 2026 the HHS Secretary published a draft enforcement-discretion policy (91 FR 68526) saying HHS does not intend to take enforcement action against 503A compounding of six of these peptides, in one named salt form and named routes, under strict conditions, until each is addressed in a final rule on the 503A bulk drug substances list. Enforcement discretion is a statement of what the government will not pursue, not a change in the law: no substance has been added to the 503A bulk drug substances list, which still names no peptide, and none of these compounds is an FDA-approved drug. Adding a substance to the list still requires notice-and-comment rulemaking: a proposed rule, a public comment period, then a final rule.
- FDA, Pharmacy Compounding Advisory Committee meeting, July 23 to 24, 2026 (agenda and uses evaluated)
- FDA briefing document, introduction: FDA proposed that none of the seven be included
- Mintz, secondary legal reporting of the committee's recommendations (six recommended, emideltide not)
- Federal Register, HHS, Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, 91 FR 68526, October 30, 2026 (FR Doc. 2026-22192)
- HHS, draft policy text with Appendix A (peptides) and Appendix B (forms, routes, testing)
BPC-157
As of October 30, 2026
Advisory committee recommended
On July 23, 2026 an FDA advisory committee recommended BPC-157, in free base and acetate forms, for the 503A bulk drug substances list, against FDA staff, who had proposed excluding it after evaluating it for ulcerative colitis. On October 30, 2026 HHS published a draft policy (91 FR 68526) saying it does not intend to take enforcement action against compounding BPC-157 acetate for subcutaneous, intramuscular, oral or topical use, only when compounded by a state-licensed pharmacy, a federal facility or a licensed physician under section 503A, against a valid patient-specific prescription, as a single active ingredient (no blends), from an FDA-registered, CGMP-compliant manufacturer with a certificate of analysis, with serious adverse events reported to MedWatch; oral forms also need documented human bioavailability. The policy is a draft and interim, open for comment until November 13, 2026, and HHS may revisit it if a safety signal or quality problem arises. It is not FDA approval, does not add the peptide to the 503A bulk drug substances list, and does not cover 503B outsourcing facilities, research-use-only sellers or dietary supplements. BPC-157 is not an FDA-approved drug.
What this does and does not change
Two separate steps apply here, and neither is approval. First, the Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Its July 2026 recommendation is not binding, and FDA staff had proposed that none of the seven peptides be listed. Second, on October 30, 2026 the HHS Secretary published a draft enforcement-discretion policy (91 FR 68526) saying HHS does not intend to take enforcement action against 503A compounding of six of these peptides, in one named salt form and named routes, under strict conditions, until each is addressed in a final rule on the 503A bulk drug substances list. Enforcement discretion is a statement of what the government will not pursue, not a change in the law: no substance has been added to the 503A bulk drug substances list, which still names no peptide, and none of these compounds is an FDA-approved drug. Adding a substance to the list still requires notice-and-comment rulemaking: a proposed rule, a public comment period, then a final rule.
- Federal Register, HHS, Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, 91 FR 68526, October 30, 2026 (FR Doc. 2026-22192)
- HHS, draft policy text with Appendix A (peptides) and Appendix B (forms, routes, testing)
- FDA evaluation, BPC-157 (free base) and BPC-157 acetate, July 2026
- FDA, Pharmacy Compounding Advisory Committee meeting, July 23 to 24, 2026 (agenda and uses evaluated)
- FDA briefing document, introduction: FDA proposed that none of the seven be included
- Mintz, secondary legal reporting of the committee's recommendations (six recommended, emideltide not)
Epitalon (epithalon)
As of October 30, 2026
Advisory committee recommended
On July 24, 2026 an FDA advisory committee recommended epitalon, in free base and acetate forms, for the 503A bulk drug substances list, against FDA staff, who had proposed excluding it after evaluating it for insomnia. On October 30, 2026 HHS published a draft policy (91 FR 68526) saying it does not intend to take enforcement action against compounding epitalon acetate as a subcutaneous or intramuscular injection dispensed in intermittent courses, only when compounded by a state-licensed pharmacy, a federal facility or a licensed physician under section 503A, against a valid patient-specific prescription, as a single active ingredient (no blends), from an FDA-registered, CGMP-compliant manufacturer with a certificate of analysis, with serious adverse events reported to MedWatch. The policy is a draft and interim, open for comment until November 13, 2026, and HHS may revisit it if a safety signal or quality problem arises. It is not FDA approval, does not add the peptide to the 503A bulk drug substances list, and does not cover 503B outsourcing facilities, research-use-only sellers or dietary supplements. Epitalon is not an FDA-approved drug.
What this does and does not change
Two separate steps apply here, and neither is approval. First, the Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Its July 2026 recommendation is not binding, and FDA staff had proposed that none of the seven peptides be listed. Second, on October 30, 2026 the HHS Secretary published a draft enforcement-discretion policy (91 FR 68526) saying HHS does not intend to take enforcement action against 503A compounding of six of these peptides, in one named salt form and named routes, under strict conditions, until each is addressed in a final rule on the 503A bulk drug substances list. Enforcement discretion is a statement of what the government will not pursue, not a change in the law: no substance has been added to the 503A bulk drug substances list, which still names no peptide, and none of these compounds is an FDA-approved drug. Adding a substance to the list still requires notice-and-comment rulemaking: a proposed rule, a public comment period, then a final rule.
- Federal Register, HHS, Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, 91 FR 68526, October 30, 2026 (FR Doc. 2026-22192)
- HHS, draft policy text with Appendix A (peptides) and Appendix B (forms, routes, testing)
- FDA evaluation, Epitalon (free base) and Epitalon acetate, July 2026
- FDA, Pharmacy Compounding Advisory Committee meeting, July 23 to 24, 2026 (agenda and uses evaluated)
- FDA briefing document, introduction: FDA proposed that none of the seven be included
- Mintz, secondary legal reporting of the committee's recommendations (six recommended, emideltide not)
KPV (Lys-Pro-Val)
As of October 30, 2026
Advisory committee recommended
On July 23, 2026 an FDA advisory committee recommended KPV, in free base and acetate forms, for the 503A bulk drug substances list, against FDA staff, who had proposed excluding it after evaluating it for wound healing and inflammatory conditions. On October 30, 2026 HHS published a draft policy (91 FR 68526) saying it does not intend to take enforcement action against compounding KPV acetate in topical and oral forms, only when compounded by a state-licensed pharmacy, a federal facility or a licensed physician under section 503A, against a valid patient-specific prescription, as a single active ingredient (no blends), from an FDA-registered, CGMP-compliant manufacturer with a certificate of analysis, with serious adverse events reported to MedWatch; oral forms also need documented human bioavailability. The policy is a draft and interim, open for comment until November 13, 2026, and HHS may revisit it if a safety signal or quality problem arises. It is not FDA approval, does not add the peptide to the 503A bulk drug substances list, and does not cover 503B outsourcing facilities, research-use-only sellers or dietary supplements. KPV is not an FDA-approved drug.
What this does and does not change
Two separate steps apply here, and neither is approval. First, the Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Its July 2026 recommendation is not binding, and FDA staff had proposed that none of the seven peptides be listed. Second, on October 30, 2026 the HHS Secretary published a draft enforcement-discretion policy (91 FR 68526) saying HHS does not intend to take enforcement action against 503A compounding of six of these peptides, in one named salt form and named routes, under strict conditions, until each is addressed in a final rule on the 503A bulk drug substances list. Enforcement discretion is a statement of what the government will not pursue, not a change in the law: no substance has been added to the 503A bulk drug substances list, which still names no peptide, and none of these compounds is an FDA-approved drug. Adding a substance to the list still requires notice-and-comment rulemaking: a proposed rule, a public comment period, then a final rule.
- Federal Register, HHS, Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, 91 FR 68526, October 30, 2026 (FR Doc. 2026-22192)
- HHS, draft policy text with Appendix A (peptides) and Appendix B (forms, routes, testing)
- FDA evaluation, KPV (free base) and KPV acetate, July 2026
- FDA, Pharmacy Compounding Advisory Committee meeting, July 23 to 24, 2026 (agenda and uses evaluated)
- FDA briefing document, introduction: FDA proposed that none of the seven be included
- Mintz, secondary legal reporting of the committee's recommendations (six recommended, emideltide not)
MOTS-c
As of October 30, 2026
Advisory committee recommended
On July 23, 2026 an FDA advisory committee recommended MOTS-c, in free base and acetate forms, for the 503A bulk drug substances list, against FDA staff, who had proposed excluding it after evaluating it for obesity and osteoporosis. On October 30, 2026 HHS published a draft policy (91 FR 68526) saying it does not intend to take enforcement action against compounding MOTS-c acetate as a subcutaneous or intramuscular injection, only when compounded by a state-licensed pharmacy, a federal facility or a licensed physician under section 503A, against a valid patient-specific prescription, as a single active ingredient (no blends), from an FDA-registered, CGMP-compliant manufacturer with a certificate of analysis, with serious adverse events reported to MedWatch. The policy is a draft and interim, open for comment until November 13, 2026, and HHS may revisit it if a safety signal or quality problem arises. It is not FDA approval, does not add the peptide to the 503A bulk drug substances list, and does not cover 503B outsourcing facilities, research-use-only sellers or dietary supplements. MOTS-c is not an FDA-approved drug.
What this does and does not change
Two separate steps apply here, and neither is approval. First, the Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Its July 2026 recommendation is not binding, and FDA staff had proposed that none of the seven peptides be listed. Second, on October 30, 2026 the HHS Secretary published a draft enforcement-discretion policy (91 FR 68526) saying HHS does not intend to take enforcement action against 503A compounding of six of these peptides, in one named salt form and named routes, under strict conditions, until each is addressed in a final rule on the 503A bulk drug substances list. Enforcement discretion is a statement of what the government will not pursue, not a change in the law: no substance has been added to the 503A bulk drug substances list, which still names no peptide, and none of these compounds is an FDA-approved drug. Adding a substance to the list still requires notice-and-comment rulemaking: a proposed rule, a public comment period, then a final rule.
- Federal Register, HHS, Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, 91 FR 68526, October 30, 2026 (FR Doc. 2026-22192)
- HHS, draft policy text with Appendix A (peptides) and Appendix B (forms, routes, testing)
- FDA evaluation, MOTS-c (free base) and MOTS-c acetate, July 2026
- FDA, Pharmacy Compounding Advisory Committee meeting, July 23 to 24, 2026 (agenda and uses evaluated)
- FDA briefing document, introduction: FDA proposed that none of the seven be included
- Mintz, secondary legal reporting of the committee's recommendations (six recommended, emideltide not)
Semax
As of October 30, 2026
Advisory committee recommended
On July 24, 2026 an FDA advisory committee recommended Semax, in free base and acetate forms, for the 503A bulk drug substances list, against FDA staff, who had proposed excluding it after evaluating it for cerebral ischemia, migraine and trigeminal neuralgia. On October 30, 2026 HHS published a draft policy (91 FR 68526) saying it does not intend to take enforcement action against compounding Semax free base for intranasal use only, only when compounded by a state-licensed pharmacy, a federal facility or a licensed physician under section 503A, against a valid patient-specific prescription, as a single active ingredient (no blends), from an FDA-registered, CGMP-compliant manufacturer with a certificate of analysis, with serious adverse events reported to MedWatch. The acetate form and injectable forms are not covered. The policy is a draft and interim, open for comment until November 13, 2026, and HHS may revisit it if a safety signal or quality problem arises. It is not FDA approval, does not add the peptide to the 503A bulk drug substances list, and does not cover 503B outsourcing facilities, research-use-only sellers or dietary supplements. Semax is not an FDA-approved drug.
What this does and does not change
Two separate steps apply here, and neither is approval. First, the Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Its July 2026 recommendation is not binding, and FDA staff had proposed that none of the seven peptides be listed. Second, on October 30, 2026 the HHS Secretary published a draft enforcement-discretion policy (91 FR 68526) saying HHS does not intend to take enforcement action against 503A compounding of six of these peptides, in one named salt form and named routes, under strict conditions, until each is addressed in a final rule on the 503A bulk drug substances list. Enforcement discretion is a statement of what the government will not pursue, not a change in the law: no substance has been added to the 503A bulk drug substances list, which still names no peptide, and none of these compounds is an FDA-approved drug. Adding a substance to the list still requires notice-and-comment rulemaking: a proposed rule, a public comment period, then a final rule.
- Federal Register, HHS, Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, 91 FR 68526, October 30, 2026 (FR Doc. 2026-22192)
- HHS, draft policy text with Appendix A (peptides) and Appendix B (forms, routes, testing)
- FDA evaluation, Semax (free base) and Semax acetate, July 2026
- FDA, Pharmacy Compounding Advisory Committee meeting, July 23 to 24, 2026 (agenda and uses evaluated)
- FDA briefing document, introduction: FDA proposed that none of the seven be included
- Mintz, secondary legal reporting of the committee's recommendations (six recommended, emideltide not)
TB-500 (thymosin beta-4 fragment)
As of October 30, 2026
Advisory committee recommended
On July 23, 2026 an FDA advisory committee recommended TB-500, in free base and acetate forms, for the 503A bulk drug substances list, against FDA staff, who had proposed excluding it after evaluating it for wound healing. On October 30, 2026 HHS published a draft policy (91 FR 68526) saying it does not intend to take enforcement action against compounding TB-500 acetate as a subcutaneous or intramuscular injection, only when compounded by a state-licensed pharmacy, a federal facility or a licensed physician under section 503A, against a valid patient-specific prescription, as a single active ingredient (no blends), from an FDA-registered, CGMP-compliant manufacturer with a certificate of analysis, with serious adverse events reported to MedWatch. The policy is a draft and interim, open for comment until November 13, 2026, and HHS may revisit it if a safety signal or quality problem arises. It is not FDA approval, does not add the peptide to the 503A bulk drug substances list, and does not cover 503B outsourcing facilities, research-use-only sellers or dietary supplements. TB-500 is not an FDA-approved drug.
What this does and does not change
Two separate steps apply here, and neither is approval. First, the Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Its July 2026 recommendation is not binding, and FDA staff had proposed that none of the seven peptides be listed. Second, on October 30, 2026 the HHS Secretary published a draft enforcement-discretion policy (91 FR 68526) saying HHS does not intend to take enforcement action against 503A compounding of six of these peptides, in one named salt form and named routes, under strict conditions, until each is addressed in a final rule on the 503A bulk drug substances list. Enforcement discretion is a statement of what the government will not pursue, not a change in the law: no substance has been added to the 503A bulk drug substances list, which still names no peptide, and none of these compounds is an FDA-approved drug. Adding a substance to the list still requires notice-and-comment rulemaking: a proposed rule, a public comment period, then a final rule.
- Federal Register, HHS, Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, 91 FR 68526, October 30, 2026 (FR Doc. 2026-22192)
- HHS, draft policy text with Appendix A (peptides) and Appendix B (forms, routes, testing)
- FDA evaluation, TB-500 (free base) and TB-500 acetate, July 2026
- FDA, Pharmacy Compounding Advisory Committee meeting, July 23 to 24, 2026 (agenda and uses evaluated)
- FDA briefing document, introduction: FDA proposed that none of the seven be included
- Mintz, secondary legal reporting of the committee's recommendations (six recommended, emideltide not)
Scheduled for review
These are listed separately because “scheduled for review” is a materially weaker statement than “reviewed”. No vote has been taken on any of them and no status has changed.
Cathelicidin LL-37
As of July 24, 2026
Scheduled for advisory review
Cathelicidin LL-37 is scheduled for review by the FDA Pharmacy Compounding Advisory Committee at a meeting to be held before the end of February 2027. No committee vote has been taken, it is not covered by the HHS draft enforcement-discretion policy of October 30, 2026, and no regulatory status has changed.
What this does and does not change
Two separate steps apply here, and neither is approval. First, the Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Its July 2026 recommendation is not binding, and FDA staff had proposed that none of the seven peptides be listed. Second, on October 30, 2026 the HHS Secretary published a draft enforcement-discretion policy (91 FR 68526) saying HHS does not intend to take enforcement action against 503A compounding of six of these peptides, in one named salt form and named routes, under strict conditions, until each is addressed in a final rule on the 503A bulk drug substances list. Enforcement discretion is a statement of what the government will not pursue, not a change in the law: no substance has been added to the 503A bulk drug substances list, which still names no peptide, and none of these compounds is an FDA-approved drug. Adding a substance to the list still requires notice-and-comment rulemaking: a proposed rule, a public comment period, then a final rule.
Dihexa acetate
As of July 24, 2026
Scheduled for advisory review
Dihexa acetate is scheduled for review by the FDA Pharmacy Compounding Advisory Committee at a meeting to be held before the end of February 2027. No committee vote has been taken, it is not covered by the HHS draft enforcement-discretion policy of October 30, 2026, and no regulatory status has changed.
What this does and does not change
Two separate steps apply here, and neither is approval. First, the Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Its July 2026 recommendation is not binding, and FDA staff had proposed that none of the seven peptides be listed. Second, on October 30, 2026 the HHS Secretary published a draft enforcement-discretion policy (91 FR 68526) saying HHS does not intend to take enforcement action against 503A compounding of six of these peptides, in one named salt form and named routes, under strict conditions, until each is addressed in a final rule on the 503A bulk drug substances list. Enforcement discretion is a statement of what the government will not pursue, not a change in the law: no substance has been added to the 503A bulk drug substances list, which still names no peptide, and none of these compounds is an FDA-approved drug. Adding a substance to the list still requires notice-and-comment rulemaking: a proposed rule, a public comment period, then a final rule.
GHK-Cu
As of July 24, 2026
Scheduled for advisory review
GHK-Cu is scheduled for review by the FDA Pharmacy Compounding Advisory Committee at a meeting to be held before the end of February 2027. No committee vote has been taken, it is not covered by the HHS draft enforcement-discretion policy of October 30, 2026, and no regulatory status has changed.
What this does and does not change
Two separate steps apply here, and neither is approval. First, the Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Its July 2026 recommendation is not binding, and FDA staff had proposed that none of the seven peptides be listed. Second, on October 30, 2026 the HHS Secretary published a draft enforcement-discretion policy (91 FR 68526) saying HHS does not intend to take enforcement action against 503A compounding of six of these peptides, in one named salt form and named routes, under strict conditions, until each is addressed in a final rule on the 503A bulk drug substances list. Enforcement discretion is a statement of what the government will not pursue, not a change in the law: no substance has been added to the 503A bulk drug substances list, which still names no peptide, and none of these compounds is an FDA-approved drug. Adding a substance to the list still requires notice-and-comment rulemaking: a proposed rule, a public comment period, then a final rule.
Melanotan II
As of July 24, 2026
Scheduled for advisory review
Melanotan II is scheduled for review by the FDA Pharmacy Compounding Advisory Committee at a meeting to be held before the end of February 2027. No committee vote has been taken, it is not covered by the HHS draft enforcement-discretion policy of October 30, 2026, and no regulatory status has changed.
What this does and does not change
Two separate steps apply here, and neither is approval. First, the Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Its July 2026 recommendation is not binding, and FDA staff had proposed that none of the seven peptides be listed. Second, on October 30, 2026 the HHS Secretary published a draft enforcement-discretion policy (91 FR 68526) saying HHS does not intend to take enforcement action against 503A compounding of six of these peptides, in one named salt form and named routes, under strict conditions, until each is addressed in a final rule on the 503A bulk drug substances list. Enforcement discretion is a statement of what the government will not pursue, not a change in the law: no substance has been added to the 503A bulk drug substances list, which still names no peptide, and none of these compounds is an FDA-approved drug. Adding a substance to the list still requires notice-and-comment rulemaking: a proposed rule, a public comment period, then a final rule.
PEG-MGF
As of July 24, 2026
Scheduled for advisory review
PEG-MGF is scheduled for review by the FDA Pharmacy Compounding Advisory Committee at a meeting to be held before the end of February 2027. No committee vote has been taken, it is not covered by the HHS draft enforcement-discretion policy of October 30, 2026, and no regulatory status has changed.
What this does and does not change
Two separate steps apply here, and neither is approval. First, the Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Its July 2026 recommendation is not binding, and FDA staff had proposed that none of the seven peptides be listed. Second, on October 30, 2026 the HHS Secretary published a draft enforcement-discretion policy (91 FR 68526) saying HHS does not intend to take enforcement action against 503A compounding of six of these peptides, in one named salt form and named routes, under strict conditions, until each is addressed in a final rule on the 503A bulk drug substances list. Enforcement discretion is a statement of what the government will not pursue, not a change in the law: no substance has been added to the 503A bulk drug substances list, which still names no peptide, and none of these compounds is an FDA-approved drug. Adding a substance to the list still requires notice-and-comment rulemaking: a proposed rule, a public comment period, then a final rule.
