Last updated July 16, 2026. This article reflects FDA information available as of this date.
Earlier this summer , we shared our first peptide update after the FDA announced that its Pharmacy Compounding Advisory Committee, known as PCAC, would meet on July 23 and 24, 2026.
The main point of that article still stands: an advisory committee meeting does not create broad access to peptides. It is one step in a longer regulatory process.
What has changed is the amount of information now available. FDA has released its briefing materials for the meeting, published its current position on the substances under review, updated the meeting schedule, and announced that another peptide-focused PCAC meeting will take place before the end of February 2027.
A Quick Reminder About the July PCAC Meeting
The meeting will address seven peptide families. FDA is considering the free base and acetate form of each family separately, creating 14 individual bulk drug substance questions.
On July 23, PCAC will discuss:
- BPC-157
- KPV
- TB-500
- MOTS-c
On July 24, PCAC will discuss:
- Emideltide, also referred to as DSIP
- Semax
- Epitalon
FDA’s agenda identifies the following uses for its review:
| Peptide family | Forms under review | Uses evaluated by FDA |
| BPC-157 | Free base and acetate | Ulcerative colitis |
| KPV | Free base and acetate | Wound healing and inflammatory conditions |
| TB-500 | Free base and acetate | Wound healing |
| MOTS-c | Free base and acetate | Obesity and osteoporosis |
| Emideltide, or DSIP | Free base and acetate | Opioid withdrawal, chronic insomnia, and narcolepsy |
| Semax | Free base and acetate | Cerebral ischemia, migraine, and trigeminal neuralgia |
| Epitalon | Free base and acetate | Insomnia |
These are the uses FDA selected for this regulatory review. They should not be read as statements about broad availability, suitability for an individual, or permission to use these substances for any particular purpose.
What Has Changed Since FDA’s April Announcement?
FDA has now published its position on all 14 substances
When the FDA first announced the meeting in April, the agency had not yet published the full briefing package or its proposed position for every substance.
The briefing materials now state that FDA proposes not to include any of the following on the 503A Bulks List:
- BPC-157 free base and BPC-157 acetate
- KPV free base and KPV acetate
- TB-500 free base and TB-500 acetate
- MOTS-c free base and MOTS-c acetate
- Emideltide free base and emideltide acetate
- Epitalon free base and Epitalon acetate
- Semax free base and Semax acetate
FDA has framed these as 14 separate questions. The committee will consider each free base and acetate form individually rather than making one decision about peptides as a whole.
FDA has confirmed that its current position is not final
PCAC provides scientific, technical, and medical advice to FDA. Its advice is nonbinding.
FDA’s introductory briefing document states that the agency does not intend to issue a final determination until it has considered input from the advisory committee process and finalized its reviews. The document also notes that the eventual determination could be affected by issues that are not discussed during the meeting.
This distinction matters. The briefing materials tell us where FDA currently stands, but they do not tell us the final outcome.
What Does 503A Bulks List Inclusion Mean?
Section 503A generally applies to eligible state-licensed pharmacies, federal facilities, and licensed physicians operating under the conditions established in federal law.
FDA explains that a bulk drug substance used through the 503A pathway generally must meet one of the following conditions:
- Comply with an applicable United States Pharmacopeia or National Formulary monograph
- Be a component of a drug product with federal marketing authorization when no applicable monograph exists
- Appear on the 503A Bulks List when the first two pathways do not apply
Additional requirements also apply, including documentation and sourcing requirements for the bulk drug substance.
Placement on the 503A Bulks List would therefore create one possible federal pathway for using a substance in 503A compounding. It would not create unrestricted access, authorize every finished formulation, or mean that every customer would be a candidate for a product containing that substance.
Likewise, being displayed in FDA’s withdrawn-nomination section does not place a substance on the 503A Bulks List.
Why 503A and 503B Should Not Be Blended Together
The July meeting is specifically about possible inclusion on the 503A Bulks List.
Section 503B applies to registered outsourcing facilities and uses a separate federal framework. Under 503B, a bulk drug substance generally must appear on the 503B Bulks List or be connected to a drug product appearing on FDA’s drug shortage list at the relevant time. Other requirements also apply.
Because the two sections use different standards and processes, the July 503A meeting should not be described as one universal decision affecting every compounding pathway in the same way.
This distinction is especially important when customers read broad statements such as “FDA is allowing peptides” or “FDA is banning peptides.” Neither statement accurately describes the scope of this meeting.
The Meeting Is Not the End of FDA’s Peptide Review
FDA has also announced that another PCAC meeting will be held before the end of February 2027.
That later meeting is expected to address:
- Cathelicidin, also known as LL-37
- GHK-Cu
- Dihexa acetate
- Melanotan II
- Pegylated mechano growth factor, also known as PEG-MGF
FDA has not yet posted the final date and time for that meeting. The agency states that additional details and a public comment docket will be published later.
The planned 2027 meeting is another reminder that FDA is reviewing peptide-related substances individually. The July meeting does not address every peptide or settle the regulatory status of the broader peptide category.
How to Follow the July PCAC Meeting
FDA updated the meeting schedule on July 14, 2026.
The current meeting times are:
- July 23, 2026: 8:00 a.m. to 6:20 p.m. Eastern Time
- July 24, 2026: 8:00 a.m. to 4:15 p.m. Eastern Time
The public can attend at FDA’s White Oak Campus or follow the meeting through an online platform. FDA plans to make the webcast information available through its meeting page. The meeting will also be captioned and recorded.
FDA’s public docket is FDA-2025-N-6895. The docket closes at 11:59 p.m. Eastern Time on July 22, 2026.
Comments received by July 9 were scheduled to be provided to the committee. Comments submitted after July 9 but before the docket closes will still be considered by FDA.
This content is provided for educational purposes and does not replace guidance from a licensed healthcare professional. Regulatory information may change as FDA completes its review.
