Health safety experts have raised concerns after a US Food and Drug Administration (FDA) advisory committee supported adding six of seven peptide substances to a list that would allow wider compounding in pharmacies.
The FDA’s Pharmacy Compounding Advisory Committee (PCAC) met in July and voted in favour of most of the peptides reviewed, despite FDA staff recommending that all seven should be rejected due to insufficient safety data.
The decision has alarmed medication safety specialists, who say the evidence base for many of the substances remains limited, especially in humans.
Concerns over limited human safety data
Rita Jew, president of the Institute for Safe Medication Practices (ISMP), said there is still a major gap in understanding how the peptides behave in the human body.
She warned that expanding access before key questions on dosing, delivery methods, and side effects are answered could increase risks to patients.
“There is a substantial gap in the evidence for peptide safety and efficacy,” she said. “In some cases, they have only been studied in animals.”
She added that without human pharmacokinetic and clinical trial data, it is difficult to establish safe dosing or predict adverse effects.
What the committee decided
The panel reviewed seven peptide substances over a two-day meeting in July:
- Six peptides were recommended for inclusion on the 503A bulk drug substances list
- One peptide, emideltide, was rejected
- FDA reviewers had recommended against listing all seven substances
Among the approved substances were peptides being studied for conditions such as insomnia, migraines, and neurological disorders.
However, the committee’s recommendations were not unanimous and differed from FDA staff advice.
Safety risks and quality concerns
Experts also raised concerns about product quality, contamination, and inconsistent naming of peptide substances.
Dr Jew said analysis of grey market peptide products has found wide variation in purity, with some samples contaminated with heavy metals.
She also warned that inconsistent naming and formulation differences could lead to confusion between similar compounds.
“Without clear-cut physical and chemical characteristics, we don’t have an actual identity,” she said. “It’s basically apples and oranges.”
Other concerns included:
- Lack of sterility controls in some compounding settings
- Risk of incorrect dosing due to self-injection
- Limited ability to track adverse reactions
- Differences in state-level pharmacy regulation
Concerns over wider public exposure
If the peptides are added to the bulk substances list, they could be compounded into injectable, topical, or nasal products by licensed pharmacies under state regulation.
Experts warned that this could significantly expand access before safety profiles are fully understood.
John Hertig of the Collaborative for Evidence-Based Medicines said safety oversight would vary widely between US states, leading to inconsistent levels of protection.
Hard-to-track side effects and long-term risks
Specialists also warned that monitoring harm could be difficult because compounded drugs do not have standard tracking systems like approved medicines.
There is also no requirement for adverse event reporting in many compounding settings, and reporting systems that do exist are voluntary.
Dr Jew said this could delay recognition of serious side effects, including potential long-term risks such as cancer-related signals or immune reactions.
She added that incorrect dosing based on animal data rather than human studies could increase risk, citing historical examples of harm when adult dosing is applied to other patient groups without proper testing.
Next steps
The FDA said the committee’s recommendations are not binding. It has received more than 2,000 public comments and will review them before deciding whether to propose a rule.
Any final decision will determine whether the peptides can be more widely used in compounding pharmacies across the United States.
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