What patients should know

In late 2023, the FDA placed 19 commonly used peptides on its Category 2 list, which significantly restricted compounding pharmacies from preparing them. The agency cited potential safety concerns, although many clinicians and compounding pharmacy organizations challenged the decision and argued that the restrictions were broader than the available evidence supported. Critics noted that, for many of the affected peptides, the FDA had not identified a specific safety event that clearly justified removing access.

On February 27, 2026, HHS Secretary Robert F. Kennedy Jr. announced that the FDA was moving toward restoring access to several peptides that had previously been restricted from compounding. His comments signaled a change in federal policy but did not, by themselves, reclassify or approve the peptides. The FDA later began the formal process of removing 12 peptide substances from Category 2 and referring selected peptides for further review by its Pharmacy Compounding Advisory Committee.

The next step will be a review by the FDA’s Pharmacy Compounding Advisory Committee at its July 23–24, 2026 meeting. The committee will consider whether any of these peptides should be recommended for inclusion on the list of substances that may be used in compounding.

Being removed from Category 2 does not automatically make a peptide available for compounding.

Even when compounding is allowed, these peptides are not considered FDA-approved drugs. They remain prescription therapies that should be used under the supervision of a qualified clinician, with appropriate dosing, careful patient selection, and ongoing monitoring.

Peptides are a hot topic, but not a great place to start

Peptides are being used for injury recovery, inflammation, sleep, metabolism, healthy aging, cognitive performance, and more.  However, it is important to address the basics first. If not backed with a healthy lifestyle that includes dialed in nutrition and moderate resistance training they can do more harm than good.  Sleep, nutrition, hormone balance, insulin resistance, inflammation, nutrient status, stress management, and strength training often have a much larger effect on long-term health than a peptide. Just like most things in life, to be successful you need to put the work in!

Peptide therapy should start with a medical question, not with a product. A treatment may sound promising online and still be poorly studied, incorrectly sourced, or inappropriate for a particular patient.

Clinical evaluation looks at the full picture, including:

• Your medical history, medications, and supplements
• Your symptoms, goals, and realistic treatment expectations
• Relevant physical examination and laboratory findings
• Contraindications, interactions, and known safety concerns
• The quality of the evidence for the proposed use
• A plan for follow-up, monitoring, and stopping treatment when appropriate

A closer look at a few peptides under review

These substances are often discussed online with much broader claims than the FDA is actually evaluating. Here is a practical overview of the current review.

BPC-157/ Pentadecapeptide: tissue repair, gut lining health, tendon/ligament recovery, localized inflammation.

KPV: anti-inflammatory; gut inflammation and immune regulation.

TB-500: muscle recovery, flexibility, connective-tissue repair.

GHK-Cu: skin remodeling, wound healing, hair-follicle support.

MOTS-c: mitochondrial function, metabolic regulation, cellular energy.

Semax: neuropeptide; cognitive performance, focus, neuroprotection.

“Research use only” products

Products sold online as “research use only” are not intended for human use. A polished website, a certificate of analysis, or an influencer testimonial does not guarantee that the vial contains the correct ingredient or dose. It also does not confirm sterility, purity, stability, or appropriate storage.

Potential risks include:

• Incorrect ingredient or concentration
• Microbial contamination or lack of sterility
• Peptide-related impurities or degradation
• Counterfeit or misleading labeling
• Improper shipping and temperature exposure
• Unreliable dosing instructions

When a compounded medication is clinically appropriate and legally available, it should be prescribed by a licensed clinician and dispensed by a properly licensed pharmacy using appropriate quality controls.

Peptides questions to consider

Where is the medication coming from? Your clinician should be able to identify the dispensing pharmacy and explain how the product is sourced.

What are the known and unknown risks? Limited human data means that some short-term and long-term risks may not yet be clear.

How will I be monitored? A legitimate plan should include follow-up, assessment of benefits and adverse effects.

The bottom line

Curious whether peptide therapy is appropriate for you?

Avalon Natural Medicine & Aesthetics provides individualized care focused on healthy aging, hormone balance, metabolic health, recovery, and long-term wellness.

Schedule a consultation with Dr. Alison Schulz to discuss your symptoms, goals, laboratory findings, and treatment options.

Sources and further reading

• FDA: July 23-24, 2026 Pharmacy Compounding Advisory Committee meeting
• FDA briefing document for the July 23-24, 2026 PCAC meeting
• FDA: Bulk Drug Substances Used in Compounding Under Section 503A
• FDA: Certain Bulk Drug Substances That May Present Significant Safety Risks
• FDA: FD&C Act Provisions That Apply to Human Drug Compounding

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