FDA, state boards, and compounding pharmacists give the skinny on semaglutide
Hello, pharmily!
Many of you will REALLY not like today’s gritty pills, so let me start by being clear:
I’m not here to throw you under the bus if you are compounding semaglutide injections.
Rather, I’m here in support of well-meaning and hard-working compounding pharmacies which are a lifeline for millions of Americans and their pets. Most pharmacists are fierce guardians of patient safety and professional integrity. Some pharmacists will inevitably stray from their Oath, and the consequences can be dire and expensive. So we owe it to ourselves and our communities to stay true to our purpose, through all the challenges we face, regardless of the payoff or outside influence.
What’s the big deal about semaglutide?
It’s the 2020s posterchild blockbuster drug for weight loss having skyrocketed to trending in its post-marketing phase. The weight loss market has long been in search of the golden ticket; now they may have found it, and at the perfect time in history. Practically everyone’s lifestyle shifted in some way due to the COVID-19 pandemic. Through isolation many became more sedentary, though many also discovered healthier habits. Social media flourished under social distancing guidelines. It all adds up: organic, individual success stories with semaglutide have reached users across all platforms in the ultimate form of free marketing.
Ozempic, the most well-known brand name of semaglutide, is practically a household name these days. The results speak for themselves: one shot a week and you’ll lose the most weight you ever have. What’s not to like? It’s been picked up by social media algorithms and the traditional media alike, and demand has skyrocketed well beyond supply. It’s neither the first nor the only drug of its class - there are a handful of other GLP-1 receptor agonists which also produce weight loss via a common mechanism of action. But Ozempic is by far the most sought after. With a price tag in the neighborhood of a thousand dollars a month depending on dose, pharmacy benefits managers (PBMs) typically require the patient meet certain criteria before covering it. And even with insurance coverage, copays can still be well over a hundred dollars monthly, sometimes leaving the patient with a tough decision.
Is the weight loss worth the price tag?
Not for everyone. As a pharmacist I’ve seen too many patients choose to not fill their prescription due to cost when they would clearly benefit from the medication (any medication, not just semaglutide). Further, pharmacies are forced to shop from an ever-growing number of pharmaceutical wholesalers, at times even turning away prescriptions because there simply isn’t enough to go around. Naturally, business-minded folks have realized this gap, and have pursued some unconventional means of sourcing and marketing semaglutide products. Likely due to my search history throughout researching this topic, I’m currently being advertised on Facebook both compounded and manufactured semaglutide products via online providers, and seeing Instagram posts from medical spas, who somehow have semaglutide injections available for an attractive price, “no insurance needed!” It’s understandable that between the price and availability, patients and providers nationwide are in search of any avenue that leads to affordable semaglutide.
As of today the United States Food and Drug Administration (FDA) does list the manufactured semaglutide products Ozempic and Wegovy as “Currently in Shortage”. Through an FDA-regulated process, this status allows compounding pharmacies to work their magic and supply their communities with made-in-house alternatives to the manufactured product in short supply. However, compounding “essentially a copy” of a manufactured drug is only permitted under specific circumstances, and must not be a routine practice of compounding pharmacies in the absence of a manufacturing issue or a patient-specific clinical rationale. These criteria can be cumbersome to the well-meaning compounding pharmacist wishing to fulfill their community’s unmet need in the ways they know best. But we must not forget that many rules and regulations in compounding pharmacy have come about in the aftermath of harm to innocent people.
Whether or not you’ve worked in a pharmacy in the last 10 years, you probably know how compounding has been shaken up by the actions of a handful of greedy pharmacists who have cut corners, committed fraud, and harmed numerous patients. The most high-profile example in recent memory happened in 2012, when dozens of patients died and hundred of others suffered fungal meningitis infections after being given injections which were compounded at the New England Compounding Center under unsanitary conditions.
2018 FDA press release on the New England Compounding Center
Other compounders have caused financial harm by over-billing public insurance programs to the tune of thousands of dollars per prescription for very straightforward compounds, thereby wasting millions of public dollars. In response to such schemes, insurance billing is practically impossible at most compounding pharmacies, and the vast majority of patients must pay out of pocket for compounded prescriptions. When it comes to semaglutide though, the price for the compounded product might come as a pleasant surprise to someone who has been unsuccessful getting the manufactured product covered. Compounding pharmacies generally have access to bulk quantities of active pharmaceutical ingredients (APIs), so prices can vary significantly between manufactured and compounded products simply due to industry trends. Now you might be wondering, why wouldn’t every compounding pharmacy offer dirt-cheap alternatives to everything as the answer to all of our drug pricing problems?
Here’s the thing: not all semaglutide is created equally.
It goes back to the FDA’s prohibition of compounding “essentially a copy” of an FDA-approved manufactured product. This shouldn’t make you worry about compounding pharmacies, which are indeed held to very high standards themselves. However there are regulations for pharmaceutical manufacturing that simply cannot be met at the community pharmacy level. And with a nationwide craze over semaglutide, widespread sterile compounding of it would indeed present a small but increased public health risk, so the FDA’s stance is that it is in the public’s best interest to obtain the manufactured product whenever possible. Additionally, the semaglutide sodium salt is easily misused in place of the semaglutide base. The two are not therapeutically interchangeable, in fact the salt form has not been evaluated for safety or efficacy, so it might not work and/or it might harm you, or not. Hmm.
Here’s what the industry leaders are saying about compounding with semaglutide:
FDA’s statement on compounded semaglutide
North Carolina BOP statement on compounded semaglutide
Alliance for Pharmacy Compounding (APC) statement on compounded semaglutide
Check Ozempic availability per FDA and Wegovy availability per FDA.
Tip: Bookmark these pages and check them daily if you’re compounding with semaglutide.
Patients should trust their compounding pharmacies. In return, pharmacies should go to all lengths necessary to preserve that trust. It’s not impossible to compound semaglutide injections appropriately. But it’s also not difficult to do it incorrectly. And the right way to do it certainly shouldn’t be a secret. Anyone with questions about getting semaglutide compounded should have no trouble getting answers from a pharmacist at the nearest sterile compounding pharmacy (I’m all for supporting local as much as possible, but not every town has one). A certificate of analysis (CofA) comes with every bulk ingredient in compounding pharmacies; patients may ask their compounding pharmacist for a copy of the CofA for the active ingredient of their compound if they would like to know the source. Any lack of transparency should be cleared up with pharmacy management or reported to the state’s board of pharmacy immediately.
Gritty pill: It’s only a matter of time before we see a wave of law firm advertisements which go something like,
“If you or someone you know received compounded semaglutide injections during the Ozempic and Wegovy shortage, call our firm today for your free case valuation!!”
Cheers