The U.S. Food and Drug Administration (FDA) will hold a two-day advisory committee meeting on July 23 and 24 to evaluate several peptide-related bulk drug substances for possible inclusion on the 503A Bulks List, a key list that determines which bulk ingredients may be used in certain compounded medications.

The discussions will cover substances nominated for a range of conditions, from ulcerative colitis and wound healing to obesity, insomnia and opioid withdrawal.

On July 23, the committee will review BPC-157-related substances, including the free base and acetate forms, for use in ulcerative colitis.

It will also examine KPV-related substances for wound healing and inflammatory conditions, TB-500-related substances for wound healing and MOTs-C-related substances for obesity and osteoporosis.

The following day, the panel will consider Emideltide, also known as delta sleeping-inducing peptide (DSIP), for opioid withdrawal, chronic insomnia and narcolepsy.

It will also evaluate Semax for cerebral ischemia, migraine and trigeminal neuralgia, along with Epitalon for insomnia.

How The 503A Bulk List Works

Under Section 503A of the Federal Food, Drug, and Cosmetic Act, compounded drugs prepared by licensed pharmacists or physicians may qualify for exemptions from certain federal requirements, including premarket approval, labeling with adequate directions for use, and current good manufacturing practice requirements, provided specified conditions are met.

One of those conditions is that compounders use qualifying bulk drug substances.

FDA Uses Four Criteria To Evaluate Nominated Substances

The FDA said it evaluates nominated substances using criteria established in a 2019 final rule.

The review considers a substance’s physical and chemical characteristics, potential safety concerns in compounded drug products, available evidence supporting or refuting effectiveness, and its historical use in compounding, including treatment history and references in peer-reviewed medical literature.

However, as per the briefing documents, the agency highlighted a lack of evidence to evaluate the effectiveness of the seven peptides for the nominated uses.

The FDA noted a lack of clinical and nonclinical safety information, insufficiently characterized.

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