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News & Regulatory
Source-cited coverage of the FDA rulings, regulatory shifts and research that change what you can access online. Editorially independent, every claim referenced.
On July 28, 2026, the FDA released 17 revised draft product-specific guidances that spell out how companies can develop generic versions of peptide drugs, including GLP-1 medicines such as semaglutide and tirzepatide. The guidances are proposals open for public comment through September 28, 2026, not approvals of any generic product.
Read more →On July 24, 2026, BBB National Programs' National Advertising Division said Willow Health Services, a telehealth company, permanently discontinued advertising claims for its compounded semaglutide products after a challenge by Novo Nordisk. Here is what the self-regulatory case decided, what claims were at issue, and what it signals for the compounded GLP-1 market.
Read more →Total MD Physicians Group, doing business as Total Men's Primary Care, and Dr. Mason Jones agreed to a consent judgment of up to $600,000 to resolve alleged Controlled Substances Act violations, including recordkeeping failures and electronically signing Schedule II prescriptions without a doctor-patient relationship. The claims are allegations only, with no determination of liability.
Read more →On July 23-24, 2026, the FDA's Pharmacy Compounding Advisory Committee voted to recommend six of seven peptides, including BPC-157 and TB-500, for the 503A compounding list, going against FDA scientists who urged rejection. Only emideltide (DSIP) was turned down. The recommendation is advisory and would still require a formal FDA rulemaking. Here are the tallies, the conflict-of-interest concerns, and what happens next.
Read more →On July 22, 2026, the FDA named Dexcom as the first participant in its TEMPO for Digital Health Devices Pilot, a voluntary program run with the CMS Innovation Center that has device makers collect and report real-world data tied to the CMS ACCESS Model for chronic care. Here is what the pilot covers, how it connects to Medicare coverage, and what is not yet settled.
Read more →CMS's proposed CY2027 Physician Fee Schedule rule, published July 16, 2026, would end Medicare payment for remote physiologic and remote therapeutic monitoring performed by outsourced, third party vendors, requiring that service instead come from a practice's own employed clinical staff. Comments are due September 14, 2026, and nothing has been finalized.
Read more →A federal judge sentenced Coeur d'Alene physician David Antonio Becerril to 40 months in prison and more than $1.25 million in restitution for signing Medicare orders through a telemedicine company for patients he never examined. Here is what the case shows about telehealth fraud, and how it differs from legitimate telehealth.
Read more →The FDA's Pharmacy Compounding Advisory Committee reviews BPC-157, TB-500, KPV, MOTS-c, DSIP, Semax and Epitalon on July 23-24, 2026. FDA's briefing documents recommend against all seven. Here is what the vote decides and what it means for patient access.
Read more →The 503A Bulks List controls which non-approved substances compounding pharmacies can legally prepare. Here is how it works, how 503A differs from 503B, and why it decides peptide access in the US.
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