Summer Is Coming! Help your patients access the hottest weight loss medications with these semaglutide and tirzepatide resources for independent pharmacy owners, whether you compound or not.
You can’t turn on the TV, read a newspaper, or scroll social media without running into the words Ozempic, Mounjaro, Wegovy, or semaglutide and tirzepatide. These medications have taken the world by storm, and rightfully so. They have transformed patients’ lives by helping them achieve massive weight loss when other options have failed. It seems that there is a new article every day about some other great benefits of GLP-1s.
Yes, diet and exercise are important for all humans, but medical options are needed for patients who struggle with weight loss. Some patients might be getting commercially available products, while others either can’t afford them or cannot access them due to the supply shortage.
I gathered all the helpful resources so independent pharmacies everywhere can help patients get the medications they need to achieve their weight loss goals.
Here’s your comprehensive guide so your pharmacy can participate and support patients in getting semaglutide or tirzepatide.
Is It Legal To Compound Semaglutide and Tirzepatide?
Compounding laws and regulations are a patchwork of rules and guidelines created by the FDA, USP, and state boards of pharmacy. While states can create their own rules, according to FDA guidelines, semaglutide and tirzepatide can be compounded because they are on the FDA shortage list. Some states might have you check the list every day you compound with either of these APIs (i.e., Idaho), while others might only require you to check the list at least once a month. While the FDA says it’s ok, you need to check with your state for how you should ensure you comply with their preferences.
There have been a ton of rumors, myths, and straight-up misinformation spread about the legality of compounding these GLP-1s. No, just because your wholesaler has 5 boxes of Ozempic in stock does not mean it is not on the shortage list. A great source for legal opinions on what to do or not do in the compounding world is the Alliance for Pharmacy Compounding. Go to their website, and right on the main page, they have several great resources. If you aren’t a member, you should be.
Where Should You Buy Ingredients for Compounding?
One of the rules you need to follow is that you can only compound with APIs (active pharmaceutical ingredients) that
- are a component of an FDA-approved product
- has a USP monograph
- or on the FDA’s 503a bulk list
- you must have a COA
- API must be made in an FDA-registered facility
For semaglutide, this means that you can only compound with the base form, not any of the salts. This requirement isn’t much of an issue now. I helped our members find the base form back in January 2023. It is now readily available from many manufacturers and distributors.
My preferred places to source either semaglutide or tirzepatide include:
Compounded Forms of GLP-1s: Semaglutide and Tirzepatide
As a compounder, you have many options for compounding semaglutide and tirzepatide. There will be variations in dosing and efficacy across all these dosage forms. Compounding is about coming up with unique solutions that match your patient’s needs. There aren’t studies or a bunch of data on these unique formulations. Use the commercial dosing to help guide you along with your colleagues’ experiences. Our Pharmacy Badass University members can use the Community Chat or our live office hours to learn more about how to dose these various options.
- Sterile injectable with or without added ingredients
- Typically injected once a week, but for patients who get severe nausea, breaking that dose up into twice a week seems to work wonders.
- Non-sterile sublingual, nasal, films, or other forms
- Dosing can range from twice a day for nasal to daily or even 3 times a week for sublingual forms.
For many patients, lower dosages work well at reducing appetite and increasing fullness. There is no need to rush to higher doses. With higher doses, you’ll have a higher incidence of side effects. The most common side effects are nausea and constipation. I recommend that patients use Docusate when starting and get an Rx for Ondansetron as well.
Options for Non-Compounding Pharmacies
So… you don’t compound? No worries. I have you covered here as well. Non-compounding pharmacies still have many options to help their patients obtain GLP-1s.
Central Fill
Many states allow a local pharmacy to enter into a central fill agreement with another pharmacy. This system can allow you to offer your patients unique compounded products while still giving them amazing care yourself. If you are interested in learning more about central fill, I recommend Southend Pharmacy. You can learn more about their central fill services HERE.
503B Pharmacies
503b pharmacy advertisements are everywhere these days. While 503a compounding pharmacies (your typical small independent compounding pharmacy) can only dispense compounds that are patient-specific based on a prescription, 503b pharmacies have much more latitude. They can dispense to clinics and hospitals to provide stock supplies, or for office use, or to specific patients.
FDA Draft Guidance
The FDA has come out with draft guidance that will expand 503b’s scope of services even wider when it is approved. Many states allow 503bs to sell to 503as for dispensing. This allowance is logical. If there is a shortage of a prescription drug and 503bs can compound it but not sell to 503as, which is where the patients are, that wouldn’t make much sense. By allowing 503bs to wholesale to 503as, you can get hard to find medications to the patients who need them.
Even though 503b to 503a is logical, not all states allow it. In looking at many states’ laws, it seems most states don’t explicitly disallow it, while some do. It is important to know where your state stands. I recommend asking your state association, your board of pharmacy, or an in-state pharmacy lawyer for clarification. A word of advice: Ask for references in the actual law for the opinion someone gives you. I have spoken with some state board inspectors who say one thing, but the law says something completely different. So, know your law, and ask probing and clarifying questions to get a better answer.
Here are my recommended 503b pharmacies and their contacts. Use these contacts to get the best pricing. You will get better pricing through these contacts because I don’t make any money if you buy from them. Many 503bs use sales networks (which is totally fine), and the network gets to keep anything they sell a product for above the minimum price. That is why you will see the same vial of semaglutide go for $120, $140, or $155 a vial. If you buy through these contacts, you won’t pay for any mark-up that pads my wallet. I opted out of making any money to provide a lower price to pharmacy owners.
503b Pharmacies
- BPI:
- Can sell to a limited number of states
- Currently only semaglutide
- Lowest net cost for semaglutide
- john@highhealth.com or 310-779-4996
- Only 503b to have mixed temperature studies to ship product at room temp then store the product at refrigeration
- PQ Pharmacy
- Can sell to almost all states
- Semaglutide and Tirzepatide
- info@pqpharmacy.com or 352-477-8977
- Ships cold chain
- Has a variety of products
There are many other 503b pharmacies than these 2. Use one that will fit your needs.
Seeing your patients lose weight is awesome. I have seen some of my patients come off of insulin, blood pressure, and other medications. They have a visible bounce in their step, their knees don’t hurt as much, and they have more energy than they know what to do with!
Your pharmacy can help bring these amazing GLP-1 products to your patients. For just about everyone, there is a way to make it work. Even if you can’t dispense semaglutide or tirzepatide, you can still support your patients with supplements or food programs.
If you want a full training on how to legally and efficiently add peptide compounding to your pharmacy, check out our Peptide Compounding Mastery Workshop.
