Articles tagged “FDA”
11 articles
PCAC July 2026 Results: What the FDA Advisory Committee Decided on 7 Peptides
The FDA's Pharmacy Compounding Advisory Committee met July 23-24, 2026 to evaluate 7 peptide compounds for 503A inclusion. Here's what they decided and what it means for patients, clinics, and the compounding industry.
Compounding Pharmacy Red Flags: How to Spot a Bad Actor
Not all compounding pharmacies are created equal. With the FDA issuing warning letters and the PCAC meeting approaching, here's how to identify legitimate pharmacies — and avoid dangerous ones.
What Happens If the FDA Reverses Course on Peptides
The PCAC could vote no. The next administration could reverse the current one's position. Here's what a regulatory reversal would actually mean for patients, clinics, and the compounding industry.
How to Submit a Public Comment to the FDA Before July 9 (Step-by-Step)
The FDA's public comment period for the July 2026 PCAC meeting closes July 9. Here's exactly how to submit a comment on docket FDA-2025-N-6895 — and what to say if you're a patient, clinician, or researcher.
What Category 2 Removal Actually Means (And What It Doesn't)
The FDA removed 12 peptides from Category 2 in April 2026. Many people think this means they're legal to compound. It doesn't. Here's the critical legal nuance that most sources are getting wrong.
MOTS-c: The Mitochondrial Peptide That Might Change Metabolic Medicine
MOTS-c is a mitochondria-derived peptide that regulates metabolism, improves insulin sensitivity, and may protect against age-related metabolic decline. It's also heading to the FDA's PCAC meeting in July 2026. Here's what the science says.
Semax: The Russian Nootropic Peptide Now Under FDA Review
Semax has been used clinically in Russia for decades to treat stroke and cognitive impairment. Now it's one of seven peptides heading to the FDA's PCAC meeting in July 2026. Here's what the research says, what the regulatory path looks like, and what it means for US access.
The History of Peptide Regulation: From the 2023 Ban to the 2026 Reversal
How 19 peptides went from legally compoundable to banned to partially restored in three years — a timeline of the most turbulent period in peptide regulatory history.
The July 2026 PCAC Meeting: What's at Stake for BPC-157, TB-500, Semax, and More
On July 23–24, 2026, the FDA's Pharmacy Compounding Advisory Committee will decide whether seven peptides — including BPC-157 and TB-500 — get formally authorized for compounding. Here's what the process looks like, what outcomes are possible, and what it means for patients and clinicians.
FDA Removes 12 Peptides from Category 2: What It Actually Means
On April 15, 2026, the FDA announced that 12 peptides — including BPC-157, TB-500, Semax, and Epitalon — will exit the Category 2 restricted list on April 22. Here's a clear breakdown of what changed, what didn't, and what happens next.
The 2026 FDA Peptide Reclassification: What Changed and What It Means
In February 2026, 14 peptides were reclassified from Category 2 to Category 1. Here's what that means for patients, clinics, and the peptide market.