Dodging the Quick Fixes: The Dangers of Unsanctioned Weight-Loss Medications

Many of you have reached out to me asking about the use of compounded GLP-1 medications.  

There has been a lot of debate in the field of Obesity Medicine about compounded medications.  As seems to be the case more often than not lately, the topic has divided people, resulting in a lot of vitriol, accusations, and misinformation coming from both sides.

The reason for the vitriol is often not clear.  

Many of the clinicians vehemently opposed to compounded medications derive income from big pharmaceutical companies.  Those relationships may or may not influence their decision to oppose them, but it should be noted that they commonly exist.  

Many of the clinicians loudly advocating for compounded medications are profiting from the distribution of these medications to their patients.  That relationship may or may not influence their decision to stand behind them, but it should also be noted.  (I should disclose that I was paid by Eli Lilly in the summer of 2022 for a one-time project to help edit and refine the slide deck built to educate providers about Zepbound.  I agreed to participate because I wanted to ensure that the data regarding the decreased efficacy of oral contraceptive pills was brought to providers’ attention.  It had not been when Mounjaro was released and I felt like this was wrong.  As I had suspected, before my engagement, this information was noted only on a reference slide, not to be discussed during the formal presentation.  Following this project, it was brought into the teaching slides.  Although I struggled with the decision to engage with pharma and stain my disclosures with pharma, I felt like it was the only way to get the topic brought to center stage.)  

As someone incredibly passionate about making obesity treatment affordable and accessible to everyone, I will tell you that I have spent more time than I care to admit looking into the possibility of using compounded medications to achieve this goal.  However, I have yet to turn this lever – and I’m about 99% sure I never will. 

I have several reasons for this, which I will share with you below – along with a condensed version of all of the notes I made while looking into the possibility.

Before diving in, please know that I have approached and continue to approach this topic with a very open mind.  

I’m not opposed to compounding in general.  I used compounded medications when I worked as an OB/GYN.  One of my kids spent his first year of life taking compounded Zantac (because the FDA-approved version repeatedly caused him to vomit the medication back up after administering it).  

I’m also not going to debate the legality of making or prescribing compounded medications.  Regardless of whether or not I agree with the process used to compound the medications (even the sketchy ones doing it without a lot of safety concerns), pharmacies doing this are not breaking the law.  They are using a valid loophole within the system to make it happen.  Clinicians writing prescriptions for compounded medications are also not breaking the law. 

The debate about whether or not to prescribe (or dispense) compounded medications to treat obesity rests upon issues of safety, liability, and ethics.

Also, I feel obligated to disclose that am a co-author on the Obesity Medicine Association’s recent position statement, published in the summer of 2024: Frequently Asked Questions to the 2023 Obesity Medicine Association Position Statement on Compounded Peptides: A Call for Action – ScienceDirect

I was not paid to help write this article, nor will I ever receive any royalties from it.  I wrote it because I wanted to help bring clarity to a messy conversation and help other clinicians who were trying to make sense amidst a lot of noise. 

If you haven’t read this position statement, I would encourage you to do so. Despite a lot of criticism from both sides of the aisle, my colleagues and I tried to write the position statement in a way that didn’t advocate for the use of these medications, nor did it condemn people for using these medications to treat their patients.  The goal was to provide clinicians with the information they need to make an educated decision.  We also provided a checklist of things to verify before potentially engaging in this practice – to protect both the patients from harm and the clinicians from unnecessary liability.  

QUALITY

What follows are my notes as I did the research – as well as notes about legislation specific to the state of Kansas – since that’s where I practice and am therefore beholden to the regulations and oversight by the boards compiled by Kansas. 

Because it’s a big industry and there are a lot of agencies and abbreviations involved, it’s difficult to explain without going into circular conversations.  I will do my best.  

All drugs are made up of an active molecule surrounded by fillers and other compounds that assist the drug in doing its thing.  For example, certain coatings protect the drug from absorption until it gets to the right place or help the drug survive the first-pass effect as it passes through the liver.  Stuff like that.

In this context, the active molecule is referred to as the “active pharmaceutical ingredient” – or API.  Big pharma develops, studies, and patents APIs.  When their patent runs out, other companies can access the API and make generic versions or compounded versions of the drug.   

When my son was taking generic Zantac, the API was the exact same as the API used in the brand name liquid Zantac and that used in the generic version.  The API was simply mixed with a different liquid medium that tasted better.  We had no way of knowing if the liquid medium was enough to protect the molecule from being degraded by stomach acid before making it into his bloodstream, but I was willing to take the risks (as none of it made it into his body when he vomited the medication back up)!  

There are two types of compounding pharmacies:  503A and 503B

503A compounding pharmacies make medications for individual patients.  They are what most of us think of when we think of brick-and-mortar compounding pharmacies. There are quite a few in our area. 503A compounding pharmacies play a vital role when commercially available drugs do not meet the needs of an individual patient; when a medication contains a filler or coating that someone is allergic to, when an alternative delivery method is indicated, or when a non-standard dose is required.  

503A compounding pharmacies are overseen by the State Boards of Pharmacy of each individual state.  Just as we answer to the Kansas State Board of Healing Arts (doctors) or the Kansas Board of Nursing (nurse practitioners), pharmacies and pharmacists in Kansas answer to the Kansas Board of Pharmacy.  Bear with me – this will become important here in a sec.  

The purpose of 503B compounding pharmacies is to sell and directly distribute ready and reliable sterile medication to healthcare facilities. These pharmacies are held to a higher set of regulatory standards than in-hospital pharmacies, and their facilities are required to be registered with the FDA and maintain compliance with current good manufacturing practices (cGMP). 503B pharmacies are classified as compounding pharmacies that prepare medications at a large-scale, mass-production level, helping to reduce the per-unit cost of medications.  A lot of the sterile medications given in hospitals actually come from 503B compounding pharmacies.  

503B pharmacies are overseen by the FDA (they are FDA-registered).  503B pharmacies cannot sell to individuals (“fill prescriptions”) and can only sell their products directly to anyone with a license who wants to resell them. Until recently, their primary customer was hospitals needing drugs on the shortage list – narcotics, antibiotics, etc.

Both 503A and 503B pharmacies buy active pharmaceutical ingredients (APIs) and use the APIs to assemble the drug. 

The pharmaceutical-grade APIs for semaglutide and tirzepatide are still under patent by Novo Nordisk and Eli Lilly.  That means any pharmacy making these drugs is using an API that is coming from somewhere else.  The question is, where are they getting it?

Clever chemists can take a drug, study the API, and work backward to figure out how to make it (think Walter White making methamphetamine in Breaking Bad).  It’s not terribly difficult, nor is it technically illegal.  The API doesn’t undergo any regulatory scrutiny, and it may or may not be accurate.  The API creator can then sell their API to a distributor who then sells it to a compounding pharmacy – either a 503A or 503B pharmacy – they are both buyers.  

503B pharmacies have to use the API to make drugs in bulk and sell them to “healthcare facilities”.  Remember, they can’t sell to patients directly.  503A pharmacies can buy the API, mix up the drug, and sell it directly to consumers.  Or, if they don’t want to go to the trouble, they can buy it from a 503B pharmacy and resell it. 

Just like small 503A pharmacies, other “healthcare organizations” can buy in bulk from 503B pharmacies and resell the medication themselves.  This is how med spas can “sell” medication.

Again, none of this is illegal.  It may not always be safe – which is a different story.  Each of the industries involved in the process is overseen by various regulatory agencies – and they each have their limitations.  This creates a lot of space for sketchy shortcuts:

Let’s start at the very beginning – with getting the API:

Getting the API from the lab to the pharmacy:  Regulatory agencies such as the FDA, European Medicines Agency, and Health Canada impose stringent API sourcing, manufacturing, and quality assurance guidelines. They have criteria they use for API oversight called Good Manufacturing Practices (cGMP), which are critical for maintaining product integrity and safety.  If an API is created by a chemist in one of these countries (at this point, it could be by Walter White or Novo Nordisk) and registered with the appropriate agency, in theory, the product they distribute is tested and verified by one of these agencies.  

API Suppliers: API suppliers are responsible for testing APIs for purity and quality before passing them along to pharmacies. 

Professional Compounding Centers of America (PCCC) is probably the biggest, most well-known API supplier in the US.  They supply pharmacies with over 900 products.  They don’t list semaglutide or tirzepatide on their list of products.

Pharmacies don’t have to buy from PCCC.  There are other suppliers willing to sell to them. They can also buy from repackagers, who buy the bulk API and puts it into smaller containers before selling it.  Navigating the intricacies of global regulatory and quality assurance requirements for each supplier is complicated, so many pharmacies use an API sourcing partner to vet their suppliers. 

The FDA is responsible for oversight of suppliers, including inspecting API manufacturers, repackagers, and relabelers.  As you might expect, the FDA regularly issues warning letters to API manufacturers and repackagers, citing significant violations of current good manufacturing practice (CGMP) requirements.  If you want to dig in, here are some of them:  

When an API is made in a country that doesn’t have the oversight of the FDA, European Medicines Agency, or Health Canada, it’s wholly up to the API supplier to ensure the safety and quality of the product.  

These complicated regulations allow for a lot of loosey-goosey when it comes to claiming oversight.  Most companies that sell compounded medications (whether they make them or not) claim that the product is coming from an FDA-regulated facility.

Although it may be true that they are purchasing the API from registered wholesalers who are getting the API from FDA-registered manufacturers, it doesn’t mean the product itself has undergone testing by the FDA or is FDA-approved.  

It’s similar to saying a patient is getting a procedure done by a board-certified doctor in a board-certified facility (even if the treatment is completely experimental).  The fancy term “board certification” can falsely reassure people (who don’t understand the differences).

This is why there is further oversight before the drugs move from the behind-the-scenes businesses to the patients.  

Let’s talk about the pharmacies.

State agencies oversee the pharmacies.  

In April 2024, the State Board of Pharmacy for Kansas released a statement prohibiting the use of semaglutide salts, the use of any nonpharmaceutical grade API, or one not produced by an FDA-registered establishment.  

This means pharmacies located in Kansas (503A and 503B pharmacies) are prohibited from making compounded GLP1s unless they are using pharmaceutical-grade APIs (which are not available for them to purchase until the patents expire).  

I spoke with someone at the Kansas Board of Pharmacy asking how pharmacies in Kansas were still able to sell  compounded GLP-1 medications and they responded that there were loopholes: 

  • Med spas are not pharmacies, and thus, they are out of the jurisdiction of the Board of Pharmacy.  They are considered “prescriber offices” and therefore are governed by the Board of Healing Arts (if run by doctors) or the Board of Nursing (if run by nurse practitioners).  
  • The Kansas Board of Pharmacy cannot legally prohibit 503A pharmacies from buying the product from a 503B pharmacy located outside of Kansas and reselling their product.  

Since compounding pharmacies are independently run and operated, the quality varies tremendously.  PCAB accreditation is the highest designation a compounding pharmacy can get – which signifies they have jumped through the strictest of hoops.  The only two PCAB-accredited compounding pharmacies that sell directly to patients (not associated with infusion therapy) in Kansas are Stark Pharmacy and O’Brien Pharmacy.  

  • Lisa Anderson,B.SC. PHARM, FACA,CCN, the owner of O’Brien Pharmacy, said she refuses to resell compounded GLP-1s.  She said there’s no way to get legal API and she doesn’t want to put her pharmacy or her license at risk.  
  • Ernie Rupp, one of the managing partners of Stark Pharmacy said it took them over a year of research to find a supplier that they felt comfortable using.  They import it from a 503B pharmacy and get a certificate of analysis for every batch. I reached out to the 503B pharmacy with questions, as their last FDA inspection noted some concerns about quality and purity, and did not hear back. When I was more serious about offering patients at Heartland Weight Loss an option for compounded medications, this was the only avenue I seriously considered (more on why I ultimately decided against it below).
  • Stark Edler, a compounding pharmacy that I used extensively when I practiced women’s health, said they won’t resell compounded GLP-1s as they won’t risk their licenses.
  • Midwest Compounders told me they are making it themselves in their sterile lab.  The pharmacist I spoke with said they get their API directly from Biopeptek (a company that makes their own API), mix it up in their lab in bulk, and send 10-20 vials to a third-party lab for testing (ensuring stability, potency, etc.) before selling vials from that batch directly to patients.  I have no idea how they are getting around the Board of Pharmacy regulations prohibiting this practice, but it seems to be working for them.  I can’t find anything about the quality of the API they are using either.  I don’t know if that’s a good thing or a bad thing, however, it’s enough to prevent me from sending patients that way.

If you are interested in seeing the (very long) list of the US 50Bb pharmacies and what I’ve learned about each one, reach out to me directly and I will share it with you.  It’s a big document with a bunch of links in it to a bunch of FDA reports and it’s a bit overwhelming.  Most of them don’t sell GLP1s at all. 

LEGAL IMPLICATIONS

Novo Nordisk and Eli Lilly have filed lawsuits against companies selling compounded versions of their drugs, semaglutide and tirzepatide.  Although the suits are nuanced and have not been decided yet, the fact that they have been filed is concerning.  

In August of 2024, Eli Lilly sent cease and desist letters to a large number of clinicians, telehealth companies, and med spas across the US warning them to cease the “manufacture, promotion, and/or sale” of compounded versions of tirzepatide — the active ingredient in Mounjaro and Zepbound.  Although the threat may be unfounded, some companies decided to stop the practice, knowing they would not be able to withstand a legal battle against such a well-funded corporation.  

In September of 2024, Eli Lilly reached out to individual patients who had received prescriptions for compounded versions of their drugs, asking them to release a copy of their medical records to the pharma giant.  At this point, we have no idea what type of case Lilly is building, but personally, I don’t want to be on the wrong side of it!

I’ve also heard horror stories from colleagues of mine in Obesity Medicine who found out the hard way that their malpractice policy didn’t cover bad outcomes arising from the prescribing and/or dispensing of non-FDA-approved medications.  Ouch.

ETHICS:

Even if I could trace the APIs down to the source and ensure that everyone touching the medications was adhering to best practices and all regulatory bodies were performing their checks and balances, the only way to ensure that my patients got those specific versions of the drug would be to dispense the drugs directly from my office.  

Although that could easily put hundreds of thousands of dollars in my pocket (and make patients happy), the idea of profiting directly from the sale and distribution of medications doesn’t sit well with me. I have no issues telling patients they must pay a reasonable rate for my services.  After all, performing those services is what I’m trained to do – and I have to cover the overhead required to perform those services (malpractice, support staff, rent, etc.)  But recommending one treatment over another, knowing that decision puts money in my pocket, seems like a huge conflict of interest. Pharma isn’t allowed to give us gifts anymore – not even simple ballpoint pens.  Why?  Because the data showed that incentives drove decisions in favor of the company that provided the gifts – even when the physicians weren’t conscious of it.   The idea of getting “kickbacks” just doesn’t sit well with the Hippocratic oath I took when I became a physician.  

LOGISTICS:

Until recently, compounding pharmacies were not in the practice of compounding drugs that were still under patent (that had not released their API).  The loophole that allows this right now has to do with the drugs being on the FDA shortage list – a loophole that was put in place for hospitals needing these drugs for acute emergencies.  

Someday these drugs are going to come off the FDA-shortage list. Right now, the holdup in production has to do with the factories making the pens – and both Eli Lilly and Novo Nordisk are working hard to solve that problem.  Eli Lilly just released two doses of Zepbound in vials, which has almost completely alleviated the drug shortage problem.  Once the drugs come off the shortage list, compounding pharmacies will have very little justification to continue selling (or reselling) these drugs without risking significant liability.  They may be able to skirt the issue of similarity by claiming patients need one-off doses or that they have compounded an entirely new product altogether (mixing one of the drugs with another drug, such as B12), but that is some really murky legal water to be swimming in.  I for one, won’t go there.  

SUMMARY: 

If you want to send your patients to a compounding pharmacy for compounded GLP-1 medications and are comfortable assuming liability for outcomes that may arise as a result of that medical decision-making, the Obesity Medicine Association has created a checklist of things to consider.  I would encourage you to go through it line by line and check the boxes before engaging (or continuing to engage) in the practice.  

  • Is the “active pharmaceutical ingredient” (API), dosage, and the specific mode of delivery (e.g., oral, injectable, sublingual), currently on the FDA drug shortage list?
  • Is the source of the compounded peptide a 503A compounding pharmacy or a 503B outsourcing facility? Knowing the type of pharmacy allows clinicians better insight regarding sourcing, safety, and regulatory compliance. For example, 503A pharmacies require a prescription and produce individually tailored formulations, while 503B outsourcing facilities can produce and distribute drugs with or without a prescription and distribute large batches of drugs that are on the FDA drug shortage list or that appear on the 503B Bulk Drug Substance list.
  • What is the name and affiliation of the licensed pharmacist who will be compounding the API?
  • Are both the compounding pharmacist and compounding pharmacy licensed to dispense or ship pharmaceuticals respective to the state of patient residence? *
  • Is the pharmacy accredited by the Pharmacy Compounding Accreditation Board?
  • Is the manufacturing facility providing the API to the compounding pharmacy registered with the FDA (with the potential to undergo FDA inspections) and does the facility undergo periodic third-party verification of API safety and purity?
  • Does the prescribing clinician have a copy of the “Certificate of Analysis”?
  • Does the compounding pharmacy periodically send a batch of received API for third-party testing, to ensure an independent assessment of sterility, potency, stability and lack of endotoxins and impurities?
  • Does the prescribing clinician have documentation that the patient underwent an informed consent process, and signed an informed consent document, agreeing to be treated with compounded therapeutics?
  • If the compounding pharmacy claims that their compounded peptide is a “generic” formulation of a branded pharmaceutical, then did the compounding pharmacist provide the prescribing clinician verification of bioequivalence studies, published in reputable medical journals, and approval by the Food and Drug Administration?
  • If a clinician or a compounding pharmacist is involved in the prescribing, creation, and administration of a compounded peptide that is not on the FDA drug shortage list, then did the clinician and/or compounding pharmacist notify their respective malpractice carriers to determine the extent claims would be covered, in the event a patient had an adverse health outcome to a non-FDA-approved therapeutic intervention?
  • Did the clinician and patient consider alternative options for access to anti-obesity peptide medications, such as through pharmaceutical-sponsored programs, employer-sponsored health plans, other private/government health insurance plans, and/or other organizations?

This entire practice may seem harmless at first glance (and making patients happy by giving them a low-cost option to get these medications may feel great), but the risks can be substantial. 

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