FDA’s PCAC Votes in Favor of Six Peptides for Potential Inclusion on the 503A Bulks List: What Compounders Need to Know

On July 23-24, 2026, the U.S. Food and Drug Administration’s (FDA’s) Pharmacy Compounding Advisory Committee (PCAC) met to consider seven peptide-related bulk drug substances for potential inclusion on the 503A Bulks List. PCAC voted in favor of including the free-base and acetate forms of BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax, while voting against inclusion of Emideltide (DSIP). Vote outcomes were the same for the free-base and acetate forms of each substance. With peptide compounding at an important regulatory crossroads, it is worth unpacking what occurred during the July 2026 meeting, what the committee’s votes mean today, and what questions remain as FDA considers the next steps in the regulatory process.

503A, 503BAna AleksicAugust 17, 2026Peptides, Compounding, Compounding Bulk Drug Substances

Peptide Compounding Potency Challenges: Key Considerations for Pharmacies

Many compounders approach peptide compounding as a variation of small-molecule compounding they have performed for years. Then a batch that passed potency testing at release begins to decline (or mysteriously increase) during stability testing. In other cases, a formulation that performed well during development shows variable concentrations during routine production. Rather than searching for who is at fault, a more useful approach is to ask when the measurable intact drug began to change. This requires looking at the entire system to find the answers.

503A, 503BAna AleksicAugust 17, 2026Compounding, Peptides

FDA Peptides Meeting July 2026: What Happens After the PCAC Vote

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.

503A, 503BAmy SummersJuly 13, 2026Peptides, Compounding, Compounding Bulk Drug Substances

What Is a 503A Pharmacy? Key Facts & Regulations

503A pharmacies play an important role in personalized medicine by providing customized medications tailored to each patient’s needs. They prepare medications based on individual patient prescriptions for home use or administration in a healthcare setting. This guide covers the key definitions, regulations, and business considerations for 503As.

503AAna AleksicJanuary 26, 2026503A pharmacies

Personalized Hormone Therapy & The Menopause Care Gap

As 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.

503A, 503BAna AleksicDecember 9, 2025cHRT, Menopause, Compounding, Pharmacy Compounding, Telehealth

Compounding Pharmacy and Outsourcing Facility Cleanroom Design and Construction Principles

Cleanrooms must be purpose-built in order to achieve regulatory compliance and quality assurance. A retail pharmacy with plans to squeeze in a small area to prepare TPN or specialty IV compounds may find out the hard way that there was not enough space allotted to promote operational efficiencies. Similarly, a 503A pharmacy looking to convert to a 503B outsourcing facility may be in for a rude awakening to learn that cleanroom designs and space requirements are vastly different for each entity. However, the following principles hold true for most cleanroom layout design and cleanroom construction planning:

503A, 503BAmy SummersMarch 18, 2022CleanroomDesign, CleanroomConstruction

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