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
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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