Compounded GLP-1s: The Good, The Bad and The Necessary

By Hope Chang, PharmD and Kevin Masci, Pharm D

This edition covers:

• FDA rules during medication shortages
• Objective benefits and risks of using compounded medications??
• The role of virtual care in medication shortages and care navigation

“What’s the deal with these compounding pharmacies selling Ozempic?? And how are they legal? And more importantly, are they safe?”

These are the types of questions we’re getting from our consultants, clients, and of course our members.?

While compounded medications account for less than 3% of all U.S. prescriptions, the clamor for weight-loss drugs is putting this healthcare rarity in the spotlight, and compounding pharmacies are jumping into action. As a virtual care provider that neither prescribes nor distributes medications, we're here to provide an objective breakdown of compounded anti-obesity medications.

Unpacking the FDA Law

Patients typically use a compounding pharmacy when their provider prescribes a customized medication in a unique dose or form that’s not available from the manufacturer. Compounded medications are rare because the FDA restricts compounding pharmacies from making drugs that are “commercially available.”

But Ozempic? and Wegovy? are commercially available, so why are we seeing new compounds everywhere? Does that mean they’re illegal?

Fun fact: the FDA does not consider a medication “commercially available” if there is a shortage of that medication. As long as incretin mimetics — commonly referred to as GLP-1s, and how we’ll refer to them in this article — like Zepbound?, Wegovy?, and Ozempic? continue to appear on the official FDA drug shortage list, compounding pharmacies can continue to make these medications. So despite what some media outlets may make you believe, compounded GLP-1s are not necessarily “counterfeit” medications.

Ultimately this law exists to benefit patient care, as it provides an option for continuity of care when a patient’s prescribed medication is in shortage and they can’t get it filled at the pharmacy.?

Concerns of accessibility to GLP-1 medications (related to affordability and shortages) have left healthcare providers and patients to wonder if they should use compounding pharmacies. As with most questions in healthcare, the answer is “it depends,” and why it’s important to weigh the good, the bad, and what’s necessary for each individual.

Weighing the Benefits and Risks of GLP-1 Compounds?

For patients and providers alike, the risk of using compounded medications should be weighed against the risk of stopping or switching the diabetes or weight management medication. The following are key considerations to inform that decision.

The Good

Accessibility:?We mentioned earlier that compounded medications help with continuity of care, but they can also allow more patients to get started on a GLP-1. In fact, the makers of Wegovy? report that they have limited quantities of the lower dosages — typically prescribed when first starting the medication — as a way to control demand for the higher dosages.?

Affordability: The cash price for GLP-1s can be prohibitive for people who don’t have insurance coverage for them. Compounded GLP-1 prices (without insurance) vary depending on the pharmacy, but are typically sold at a significantly reduced price. Recently, Hims & Hers made headlines when they announced they were offering compounded semaglutide at an 85% discount off the list price of Wegovy? on a self-pay/no insurance basis.

The Bad

Lack of FDA approval: ?Although compounded drugs are intended to be chemical “copies” of available medications, they do not have the same safety, quality, and effectiveness assurances as medications approved by the FDA. The FDA oversees and regulates the manufacturing and distribution process, as well as ingredient quality. Quality requirements for compounded drugs differ depending on the setting where compounding occurs.

Regulation of compounding pharmacies varies by state: Those of us who have been in pharmacy and healthcare for some time remember the fungal meningitis outbreak that was traced back to a compounding pharmacy in Massachusetts. We bring this up not to scare people away from using compounding pharmacies, but to emphasize the need to?know your pharmacy. When selecting a compounding pharmacy, patients and providers should confirm that the compounding pharmacy is:

1. Accredited by a recognized body and licensed by (and in good standing with!) your state board of pharmacy;
2. Requires a prescription for medication; and
3. Has a licensed pharmacist on staff to answer your questions

Affordability (yes, here too): While price breaks on GLP-1s may seem like a welcomed relief, prioritizing price as the main factor in using compounded formulations does not account for safety and efficacy. Some compounded formulas may include unapproved add-ins or exclude key components to cut costs. These alternatives have not undergone the rigorous research required for FDA approval and may not be overseen in the same way the FDA oversees manufacturing and distribution of medication. This means they could present higher risks and potentially lead to serious adverse effects.

It's also worth noting that compounded GLP-1s may not be a more affordable option for all patients, because not all insurance plans cover compounded medications, and not all compounding pharmacies take insurance. So patients who have insurance coverage for GLP-1s may end up paying more for their medication if they have to get it through a compounding pharmacy.?

The Necessary

Continuity of care: A benefit of using compounded GLP-1s is continuity of care when there is a shortage of the manufactured medication and a person is already on the medication. This is especially true when we consider the titration schedule and side effects associated with starting GLP-1s, and the weight regain that can happen when the medications are stopped. Suddenly losing access to GLP-1s can significantly hinder a patient’s progress and health goals.??

Medication delivery may look different: Unlike Wegovy?, Ozempic?, and Zepbound?, which come in easy-to-use pen injectors, compounded versions will not be in the same delivery tool as a manufactured version; those tools, like an injection pen, are typically patented by the manufacturer. There are also novel formulations only available from compounding pharmacies, such as sublingual semaglutide and tirzepatide tablets that may be placed under the tongue. This technically isn’t illegal and could be very enticing for someone with a needle phobia. Still, keep in mind that the sublingual formulation has not been extensively studied nor approved by the FDA.?

Why Are We Talking About This at Omada?

As a company who neither prescribes nor fulfills medications, you might wonder why we care about compounded GLP-1s. What we’ve found is that virtual care solutions play a crucial role in supporting patients looking to continue their GLP-1 medications, even in times of?supply challenges. GLP-1 companion programs provide between-visit support to the patient and their provider and offer a line of communication for patient inquiries.

"I am doing very well with my diabetes program. In fact, I am down 55lbs and A1C is down from 8.9 to 6.6. I just finished my first month of Tirzepatide (Mounjaro?). Had to switch due to lack of availability of Ozempic?. Purchased a treadmill that is being delivered Wednesday and will keep on getting more healthy. This program has essentially been a life saver for me." - Omada Member Testimonial

At Omada, we have resources and clinical specialists that educate members on their options if they cannot fill their GLP-1 medications. For members who aren’t interested in using compounded medications, some options include:

• Reaching out to other pharmacies to see if they have their medication in stock — many patients don’t know that pharmacists can transfer prescriptions to each other without contacting their provider.
• Talking to their provider about switching to another dose for the short-term, as sometimes only particular medication dosages are in a shortage.
• Talking to their provider about other medication options for diabetes treatment and weight management.

Virtual care providers like Omada help patients monitor their response (such as weight loss or side effects) to prescribed medications and our care teams empower patients to have conversations with their providers, allowing for?a collaborative approach to their health. Such support can help the patient's treatment journey be smoother and well informed, even during times of medication shortages.

Prescriptions Start in the Medical Home?

If you came here looking for a yes or no answer to whether you should use compounded semaglutide or tirzepatide — we wish it were that simple. Compounding pharmacies make a convincing pitch; still, choosing to use a compounded GLP-1 is a big decision that needs careful thought.

It's important for a patient and their doctor to talk about the pros and cons together, thinking about the patient's health history and medical needs, insurance coverage, and other issues. In the end, the choice they make should carefully consider what's best for the patient's health and what makes the most sense based on where they are along their weight loss journey.

References

1. FDA. (2022, June 29). Compounding and the FDA: Questions & Answers. U.S. Food and Drug Administration. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers ?
2. FDA. (2023, March 24). Drug Compounding and Drug Shortages. U.S. Food and Drug Administration. https://www.fda.gov/drugs/human-drug-compounding/drug-compounding-and-drug-shortages
3. FDA. (2024, May 16). Bulk drug substances used in compounding. U.S. Food and Drug Administration. https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding?
4. Harmon, M. (2024, May 28). Hims & Hers Weight Loss Shots: What you need to know about the $199 compounded drug. Forbes Health. https://www.forbes.com/health/weight-loss/hims-hers-weight-loss-shots/?
5. Koppelman, S., Cera, M., Termine, M., Impoco, J., & Nick? Gibbons. (2024, June 27). Hims & Hers selling GLP-1 injection that’s not FDA approved, from Shady Supplier - and won’t make you talk to a doctor to get it . HUNTERBROOK. https://hntrbrk.com/hims/?
6. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Replacement Therapy, Jackson, L. M., Parker, R. M., & Mattison, D. R. (Eds.). (2020). The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. National Academies Press (US).? DOI: 10.17226/25791
7. Souza, S., & Maxouris, C. (2024, March 6). Former Compounding Pharmacy owner linked to deadly 2012 fungal meningitis outbreak pleads no contest to involuntary manslaughter. CNN. https://www.cnn.com/2024/03/05/us/barry-cadden-fungal-meningitis-outbreak-plea-involuntary-manslaughter/index.html?