PCAC Peptide Meeting and Next Steps

Key Takeaways

• On July 23–24, 2026, the Pharmacy Compounding Advisory Committee (PCAC) reviewed 7 peptides for potential inclusion on the FDA's 503A Bulks List.
• PCAC recommended 6 of the 7 - BPC-157, TB-500, KPV, MOTS-c, Semax, and Epitalon for Category 1 interim status; Emideltide (DSIP) was not recommended.
• PCAC's recommendation is advisory only. The FDA still must decide whether to move to formal notice-and-comment rulemaking or adopt an interim policy allowing compounding while rulemaking proceeds.
• Removal from Category 2 does not automatically mean addition to Category 1 or the Bulks List. These peptides remain in regulatory limbo until the FDA takes further action.
• Final approval could take months to years; a second PCAC meeting on 5 additional peptides (including Cathelicidin/LL-37, GHK-Cu, and Melanotan II) is expected in early 2027.

The words “Peptides” are on the tip of everyone’s tongues right now. On July 23 and 24, 2026, the Pharmacy Compounding Advisory Committee met to discuss a total of 7 peptides in order to advise the FDA regarding inclusion to the 503A Bulks List. This was step 3 in a 5 step process that the FDA takes when considering substances for inclusion to the list. The PCAC is a group of independent experts who provide scientific advise to the FDA for their evaluation process.

But what does all this mean?

While the 503A bulks list is the official regulatory list of substances that can be used by compounding pharmacies, the FDA has established an interim categorization system for substances under FDA review based on supporting data, clinical studies, and patient safety. 

Category 1 includes substances under FDA review for potential inclusion on the 503A Bulks List. These substances were nominated for evaluation with sufficient supporting information and have not been assigned to another category due to identified safety concerns. Once added to Category 1, the FDA does not intend to take enforcement action against 503A pharmacies using these substances for compounding patient medications, even while completing final approval processes. 

Category 2 includes substances for which FDA has identified potential significant safety risks. These substances are not covered by the Category 1 interim enforcement policy, and FDA may consider enforcement action against compounders using them.

Five peptides were removed from Category 2 in September 2024 and twelve peptides were removed in April 2026. But here’s where much of the confusion begins. Removal from Category 2 does not equal addition to Category 1- or the bulks list- and ability to compound. They remain outside the Category 1 interim policy and the official 503A Bulks List until FDA takes further action.

Based on PCAC’s recommendations, the FDA must now decide how to proceed. They could move forward to step 4, which is the notice-and-comment rulemaking, and this process can take several months or more. FDA also has the option to instate its interim policy, which would allow these six peptides to be placed in Category 1 while rulemaking proceeds and they await final ruling.

So Where Are We Now?

The PCAC, which is only an advisory committee to the FDA and not a final motion, recommended 6 of the 7 voted upon peptides to be considered for the Category 1 interim compounding list. The peptides that were recommended by the committee include BPC-157, TB-500, KPV, MOTS-c, Semax, and Epitalon. Emideltide (DSIP) was not recommended for inclusion. 

The entire process for FDA inclusion of a substance to the 503A bulks list follows:

1. Nomination and Initial Evaluation  

• Does the nomination contain sufficient information to permit a meaningful review

2. Scientific Review by FDA  

• FDA staff scientists evaluated the seven proposed peptides and recommended against adding them to the bulk compounding list

• FDA then presented the seven peptides to the PCAC for independent expert consultation, as part of the full evaluation process

3. PCAC consultation  

• The goal of this committee is to provide independent, expert advice on the substances in question

• These proposals are recommendations and not final actions

4. Notice-and-Comment Rulemaking

• FDA publishes a Notice of Proposed Rulemaking (NPRM) for both the substances it proposes to include in 503A bulks list as well as those it proposes NOT to include

• There is then a formal period of about 60 days for the public to submit comments either for or against the proposal

5. FDA Final Ruling

• FDA reviews submitted comments before issuing a final ruling. This can take many months to complete.

• This ruling determines if the substance gets added to the official 503A bulks list 

A second PCAC meeting is intended to occur at the beginning of 2027 to discuss 5 additional peptides for proposal to be added to the bulks list. These peptides include Cathelicidin (LL-37), GHK-Cu, Dihexa acetate, Melanotan II, and PEG-MGF. 

Where Does that Leave Us?

Still waiting…but actively waiting. DDL is currently investing heavily in formulation and testing so we can deliver products you can trust the moment they are approved. You can have confidence that our products are potent, stable, and pure- because we put the time, effort, and money into creating the best formulations for your patients.

Stay tuned. Reach out with questions. Our sales team would love to connect with you regarding your interests and needs. We will keep you updated on all the changes as they are happening. Ensure we have your email so you will get the most up to date information when we launch our peptide products.

Looking Ahead

PCAC recommended 6 peptides for Category 1. FDA now decides whether to start formal rulemaking or implement interim policy. Final approval could be months to years away. Designer Drugs Labs is preparing now!

Interested in learning more about Peptides or what's to come? Contact us, and we'll be happy to share more.