by Sherri Thomas, DO
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As we’ve watched the treatment of obesity make incredible strides over the last few years with the advent of highly effective GLP-1 medications and now GLP-1/GIP medication and the likely soon to come triple G medication (GLP-1/GIP/glucagon), practitioners and patients have struggled with limited access. With overweight and obesity affecting ¾ of the U.S. adult population, the weight loss industry was already alive and well - sometimes with useful products backed by evidence, and other times with products that have no evidence and simply exploit the feelings of desperation that patients with overweight and obesity often feel because of the bias and stigma they experience because of their weight.
Considering this, it was not surprising in early 2023 that there would be those who would want to capitalize on these new medications when the shortages opened the window for compounding. Nor was it surprising that providers and patients who had been struggling to get access to these medications would eagerly seek out these more affordable products that claimed to be the exact same medication, only cheaper and more accessible. However, what was found to be happening, and unfortunately continues to happen, was not true compounding. Instead, in the fine print it was the salts of semaglutide, which has not been studied and has not been FDA approved. Not only this, but these products were/are also being made in non-FDA approved facilities. Which in short means that there is no third-party oversight as to identity, purity, and potency of the active pharmaceutical ingredient (API) which is then being compounded.
However, just because there are many nefarious players out there, does not mean that in the face of the ongoing shortage there are not appropriate ways to obtain properly compounded semaglutide for your patients. In the case of shortages, the FDA and federal law provide a very regulated pathway for the manufacturing of prescription drug base which can then be compounded by 503a and 503b compounding pharmacies. After months of research, I wanted to share with you what I have learned as I have educated myself on what appropriate compounding should look like and what we as clinicians should be thinking about as we consider which patients may be appropriate for compounded GLP-1 therapy.
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Regarding Compounding Pharmacy and Product:
                 Only FDA approved medications should be used. In the case of semaglutide and tirzepatide, the salts of these medications have NOT been FDA approved and should not be used.
                 Legitimate compounding pharmacies get their semaglutide and tirzepatide base (or active pharmaceutical ingredients – API) from FDA approved outsourcing facilities. At the time of this writing, there are 3 facilities approved to manufacture semaglutide and none approved to manufacture tirzepatide. They should be able to provide you with a certificate of authenticity. You can view the list here: https://dps.fda.gov/outsourcingfacilityÂ
                 Legitimate pharmacies do not dispense directly to patients without a compounding prescription from a licensed prescriber. PERIOD. Legitimate compounding pharmacies also do not prepare medications in bulk. They are prepared for specific patients once ordered by the prescriber.
                 The purpose of allowing compounding of non-generic medications in times of shortage is to keep patients who are already on these medications from experiencing a disruption of therapy. It is not to make the medication more affordable or accessible to those who would not have had it otherwise, and a legitimate compounding pharmacy should not advertise it to patients as such.
                 It is the clinician’s ethical duty to ensure that the compounding pharmacy they are using are licensed with their State Board of Pharmacy as well as an accredited 503a or 503b compounding pharmacy. In the case of injectable GLP-1s, they also need to be an accredited sterile compounding pharmacy.
                 It is worth noting that NE state law states that health professionals who dispense and charge for drugs and devices as part of their practice must have a pharmacy license. This includes compounded GLP-1s.
                 It is also worth checking with your malpractice insurance as there are many who now may not cover incidents related to the prescribing/dispensing of compounded GLP-1 medications.
Regarding Patient Selection:
                 Semaglutide and tirzepatide, whether used for the treatment of type 2 diabetes, overweight, obesity or in the case of semaglutide for secondary prevention of cardiovascular disease, are intended to be used indefinitely. They do not cure any of these chronic diseases and when the therapy stops, so does its effects. It is not known when the shortages will end, but if a patient did not have coverage for the GLP-1 before the shortage it is likely their therapy will be disrupted when the shortage ends and compounding is no longer legal.  Â
                 Patients receiving compounded GLP-1 therapy for weight should meet the same indications for therapy as those for FDA approved name brand therapy – ie. BMI>27 with weight related co-morbidity or BMI>30. It should also be prescribed as an adjunct to lifestyle and behavioral modification after a thorough obesity workup has been completed.
                 Patients considering the use of compounded GLP-1 medication should have documented informed consent acknowledging that it is not FDA approved as well as awareness of potential risk, benefits, and limitations of compounding. And if you’ve done your due diligence as listed in the pharmacy section, let them know that as well!
Hopefully you've come to the same conclusion that I have. Much like Nebraska, compounded GLP-1s are NOT for everyone!
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https://dhhs.ne.gov/licensure/Pages/Pharmacy-Facilities.aspx - Dispensing Practitioner
Fitch, A. Compounded peptides: An Obesity Medicine Association Position Statement, Obesity Pillars, Vol 6, 2023. 2667-3681.
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