Comment from Miller KC

As a registered nurse, I support the FDA’s proposed decision to exclude semaglutide, tirzepatide, and liraglutide from the 503 bulks list to limit mass compounding of these drugs. FDA approval of drugs exists for many reasons - like to ensure quality ingredients are being used, best practices in manufacturing, and the safety of the final product, its packaging, and labeling. The mass compounding of GLP-1s after shortages of semaglutide and tirzepatide have side-stepped all of this and put consumers like my patients at risk. GLP-1s have been life-changing for so many, and these incredible drugs should always be taken under the care of medical professionals and only at the dosage prescribed. Online retailers selling mass compounding versions have made these medications easier for patients to get with less medical support. They are also offering these medications at unapproved dosages, with additional ingredients, and in some cases, versions that are still in clinical trials. This is incredibly dangerous to patients who often believe what they are getting is safe. While compounding is important during times of shortages or for specific medical accommodations like 503A compounding, the proliferation of these compounded weight-loss drugs also come with serious side effects like nausea, vomiting, diarrhea, gallbladder issues, and suicidality that have landed hundreds of people in the hospital. While I support increased access to these medications for patients who would benefit from them, that cannot come at the expense of safety. From a medical perspective, I will also advocate for my patients to have safe, FDA-approved medications and this proposed decision supports that. I hope the FDA moves forward with finalizing it.