On July 23–24, 2026, FDA’s Pharmacy Compounding Advisory Committee (PCAC) will review seven peptides for potential inclusion on the 503A Bulks List. This discussion extends beyond headlines about “popular unproven chemicals.” It is a regulatory and drug safety matter with direct implications for compounders and patients nationwide. We examine which peptides will be reviewed, the regulatory steps that follow the PCAC meeting, and what the outcome could mean for patient access and the broader future of personalized medicine.
Read MoreAs FDA labeling evolves, telehealth scales, and demand for customized hormone therapy grows, pharmacies and outsourcing facilities face new expectations. The next era of menopause care will depend on infrastructure capable of supporting consistent, well-coordinated, personalized hormone therapy services at scale. Here’s what every 503A pharmacy, 503B outsourcing facility, and telehealth organization needs to anticipate next.
Read MoreProviding clinical trial services can yield a high return on investment. While CROs and CDMOs may be the first choice for conducting many clinical studies, some sponsors choose to partner with compounding pharmacies or outsourcing facilities. Pharmacies and outsourcing facilities that would like to provide clinical trial services should be aware of the different regulatory requirements and heightened quality assurance expectations. This article introduces compounders to the possibility of adding clinical trial services to their offerings.
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