Comment from Alla Yusim

Docket No. FDA-2026-N-1116 — Proposed Rule Excluding Semaglutide, Tirzepatide, and Liraglutide from the 503B Bulks List Alla Yusim Brooklyn,New York I'm writing to oppose the FDA's proposed rule that would exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list. While I understand the FDA's role in ensuring drug safety, this proposed rule would eliminate a critical treatment pathway for patients who have no realistic alternative, and the agency's current analysis doesn't fully account for that. There are three main reason why this rule should be proposed: lack of insurance coverage for patient, patients whose needs can't be met by branded formulations, and patient safety concerns from unregulated online retailers. I urge you to take a hard look at who actually loses access if this rule goes through, and whether that outcome is consistent with the public health mission the FDA exists to serve. The core issue is that "FDA-approved alternatives exist" and "patients can access them" are two very different things. Many insurance plans don't cover the alternatives, or require patients to jump through prior authorization requirements that take long periods of time and frequently end in denial. For a lot of people, especially those without comprehensive employer coverage, compounded GLP-1s have been the only option that was actually within reach. Removing that option doesn't make the branded drugs more accessible. It just leaves those patients without treatment. This will have significant impact on the public's health. With the rise of GLP-1 use, many patients are becoming healthier and seeing real benefits. Taking this away will likely cause those positive results the public is experiencing to drastically decrease. There are also patients whose needs can't be met by the branded formulations. Some need doses or titration schedules that aren't available in the commercially manufactured versions. Some have allergies or sensitivities to ingredients in the branded products. These are real clinical situations that prescribers navigate regularly, and compounding exists precisely to serve them. I also want to raise a concern about what happens if this rule is finalized. People who need these medications aren't going to stop needing them. If they can't access compounded GLP-1s through legitimate, FDA-registered 503B facilities that operate under real safety standards, they will look elsewhere, including unregulated online pharmacies, foreign suppliers, and sources with no oversight at all. That outcome is worse for patient safety than the current system, not better. Keeping a regulated compounding pathway open is the safer choice. I recognize this is a complicated regulatory area and that the FDA has legitimate interests here. But I strongly urge the FDA to reconsider this proposed rule and to conduct a real access impact analysis before moving forward.