The Pediatric Question
A sixteen-year-old patient who has been taking puberty blockers for three years and gender-affirming hormones for one is, depending on ...
The Compounding Loophole
The compounding pharmacy that produces bioidentical hormone preparations for a clinic in Arizona may dispense thousands of monthly subscriptions to ...
The Long Shadow of the WHI
On July 9, 2002, the principal investigators of the estrogen-progestin arm of the Women's Health Initiative announced that they were ...
The Low-T Economy
A man in his early forties, marginally overweight, sleeping poorly, exercising less than he used to, walks into a testosterone ...
The Generic That Isn’t
When the principal patents on semaglutide begin to expire over the next several years—the timing varies by jurisdiction, formulation, and ...
Research Use Only
The vial arrives in a padded envelope with a printed label disclaiming human consumption and an invoice describing the contents ...
The Wellness Pharmacopoeia
A man in his fifties walks into a wellness clinic in a Dallas suburb and is offered, in a single ...
The Cardiometabolic Sprawl
The phase 3 trial for semaglutide in chronic kidney disease was halted early in October 2023 because an interim analysis ...
A Two-Player Game
Two pharmaceutical companies, both headquartered in countries smaller than most American states, have built a competitive position in obesity and ...
The Bottleneck Is the Needle
A semaglutide molecule contains 31 amino acids assembled in a precise sequence with a fatty-acid side chain anchored at a ...
How To Strengthen Quality Control in Pharma Processes
Maintaining consistent product quality in pharmaceutical manufacturing is both a regulatory requirement and a patient safety imperative. For healthcare professionals ...
After the Shortage
When the FDA declared the semaglutide shortage resolved in February 2025 and the tirzepatide shortage resolved in October 2024, an ...
FDA Evaluation of Certain Bulk Drug Substances in Compounding: Clinical Interpretation
Clinicians increasingly encounter patients using or requesting peptide-based therapies sourced through compounding pharmacies. The U.S. Food and Drug Administration has identified a subset of bulk drug substances, including certain peptides, that may present significant safety risks when used in compounded formulations. The clinical question is whether these regulatory signals reflect meaningful patient-level risk and how they should influence prescribing behavior. This matters because compounded peptides often sit outside traditional approval pathways, creating uncertainty around quality, dosing consistency, and safety. Understanding...
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