According to the FDA’s site, as of today, Novo Nordisk has reported to the FDA that all doses of Ozempic and Wegovy are considered commercially available. So, what happens next? If you have followed the saga of compounded tirzepatide, the semaglutide story should unfold along a similar track and timeline.
FDA Review Period: The FDA will undergo a review process to confirm Novo Nordisk’s claim of ample supply, assessing whether these medications can be removed from the shortage list. Based on past precedent with tirzepatide, this review could last around 3-5 weeks.
Impact on Compounded Semaglutide: If the FDA confirms Novo Nordisk’s report and removes semaglutide from the master shortage list, 503B compounding pharmacies will no longer be permitted to mass-produce compounded semaglutide. These compounding facilities have filled a gap for patients in need by producing medications without the shortage-induced price tags, but the FDA’s decision could prompt an immediate cessation.
Possible Legal Challenges: In tirzepatide’s case, the Outsourcing Facilities Association (OFA), representing 503B pharmacies, filed a lawsuit within days of the FDA’s shortage list update. This led the FDA to pause enforcement against these pharmacies. A similar legal response could follow if compounded semaglutide production is halted.
What Could Happen Next?
The situation is still fluid. While we anticipate a similar path for semaglutide as we saw with tirzepatide, there’s always a possibility that the FDA may elect to keep semaglutide on the shortage list, particularly if they receive reports of ongoing supply issues. This could mean that compounded semaglutide remains accessible temporarily, offering a much-needed option for patients who can’t afford the branded versions.
If the process follows a similar timeline, expect a ruling on the master shortage list within the next 3-6 weeks. At that time, if the FDA removes semaglutide from the master shortage list, the clock on the 60 day off-ramp for 503B pharmacies begins ticking. Of course, all of this is baring legal action, which will most assuredly play a role.
If you’re facing accessibility or affordability issues with these medications, consider using the hashtag #ReportTheShortage to raise awareness. Patient voices can have an impact, particularly in critical health areas where demand often outstrips supply.
Exploring Other Options
For those who may soon lose access to compounded semaglutide, options are available to explore. Telehealth providers, like Ro, are excellent at handling prior authorizations and can often succeed where primary care providers lack the resources. Consider checking out Ro at ro.co/otp if you’re navigating insurance hurdles for branded GLP-1 medications.
In addition, some over-the-counter peptides have been useful for appetite suppression, though they’re no substitute for FDA-approved medications. For example, I’ve had success with a peptide product called “Can’t Wait,” which contains the peptide DNF10 that targets hunger hormones. For those interested, On The Pen has partnered with Integrated Peptides to offer a 10% discount — just use code OTP10 at checkout. However, always consult your medical provider before exploring alternatives to ensure they're safe and appropriate for you.
On the Ground at Obesity Week
On The Pen will also be bringing you live coverage from Obesity Week in San Antonio this weekend. This event, hosted by The Obesity Society, will feature presentations from industry leaders, including Novo Nordisk and Eli Lilly, and interviews with top doctors. Stay tuned as we share insights and developments live from the event. If you'd like to help defray some of our costs to attend, you may do so here!
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Stay updated with the latest from On The Pen, and as always, thank you for being part of the community. We’ll continue to provide real-time coverage and thorough analysis to support you in your health journey.
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