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• CALL TO ACTION: Tell FDA to deny drugmakers’ request

  Drugmakers are urging FDA to prohibit compounded GLP-1s. FDA needs to hear from you and your patients NOW! read more →

• APC to FDA: Just say no to Lilly

  This week APC's lawyers sent a formal comment to the FDA about Eli Lilly’s request that tirzepatide be added to the Demonstrably Difficult to Compound list. read more →

• California BOP sends proposed compounding regs to comment period

  The California State Board of Pharmacy decided to move the modified proposed sterile compounding regulations forward to a 30-day comment period. read more →

• Checking in on the post-Chevron fallout

  What’s happened in the world of federal regulation since the end of Chevron? read more →

• Hi, Noom!

  Welcome to our newest Bronze-level Corporate Patron, Noom! read more →

• PFMs can get 2.5% credit card processing

  A new benefit for APC’s Pharmacy/Facility Members: They may be able to cut their credit card processing fees to just 2.5% – 2.8%. read more →

• Phoenix compounders, rise!

  The latest of APC’s new regional meetings — CompoundED UpDATE — is coming to the Phoenix area December 5. read more →

• APC election results: directors and bylaws

  See the results of APC's elections, including four new directors and several changes to our bylaws. read more →

More News

One of the most sensational drug classes in recent history is GLP-1s. Identifying a safe way to lose weight has always captivated the American public. GLP-1 drugs, including semaglutide and tirzepatide, are among the most successful treatments we’ve ever seen. However, this popularity and demand comes with risks.

Due to the popularity of these drugs, the commercial manufacturers have been unable to keep up with the demand. Compounding pharmacies have stepped in to fill the gap and help relieve the shortage, using permissions granted in guidance from the FDA. 

Unfortunately, there are also fake online ‘pop-up shops’ taking advantage of the shortage by pretending to be pharmacies and offering what they say are GLP-1 drugs. The problem of fake online pharmacies is so bad that a recent USC study found that as many as 40% of online “pharmacies” might be fake. 

So how can you make sure you receive quality, legitimate compounded prescriptions? Here are some tips.

Verify Pharmacy Licensing

Don’t confuse legitimate, state-licensed compounding pharmacies with those fake online shops peddling counterfeits. Fake and counterfeit drugs aren’t the same as compounded medications. “State-licensed” is the key — legitimate compounders are not only licensed by individual states, they’re closely monitored, regularly inspected, and must adhere to the strict standards of the U.S. Pharmacopeia.

There are two obvious red flags that the company is not a legitimate compounding pharmacy:

• When a company claims to sell prescription medications online without requiring a prescription. It’s not a licensed compounding pharmacy — and it’s breaking the law.
• If a store advertises a compounded drug by using a brand name (e.g., “Compounded Ozempic”), or says a compounded drug is FDA-approved. Those are illegal claims, and legitimate compounding pharmacies know better than to make them.

The Alliance for Pharmacy Compounding has developed a tool to help identify legitimate state-licensed pharmacies: APC: Is It Legit? Use this website to verify that the pharmacy your doctor has referred you to is appropriately licensed by their state board of pharmacy. 

Ask About Raw Material Sourcing

Once you have verified that the pharmacy is a legitimate, state-licensed compounding pharmacy, ask them questions about how they source the raw materials they use to compound. Under federal law, compounding pharmacies must source their active ingredients (we call it API) from FDA-registered wholesalers, who source API from the same kind of FDA-registered manufacturers that many pharmaceutical companies do. That API comes with a valid certificate of analysis and, often, third-party testing data. 

Here are some questions you can ask:

• Do you source your ingredients from FDA-registered wholesalers and manufacturers?
• Have you verified that the ingredients you use are not labeled for research and development?
• Does your wholesaler test the material to make sure it is what it says it is before selling it to compounding pharmacies?

Ask About Testing Done by the Pharmacy

Ask your compounding pharmacy how they make sure their compounded preparations contain what they’re supposed to contain — and don’t have anything in them that they shouldn’t. Here is one question you can ask:

• Do you test your compounds for sterility and potency before dispensing them to patients?

If the answers to any of the questions above are “No” or “I don’t know,” consider finding another compounding pharmacy. Also, report your findings to your doctor so they can be aware that a pharmacy they previously trusted may not be in the best interest of their patients.

Finally, make sure you talk to the pharmacist if you take a GLP-1 drug, compounded or not. These drugs come in various forms and strengths, and the doses usually change over the course of your treatment. It’s very important to know how to take them properly to make sure they work and to avoid accidentally harming yourself. Consult with your pharmacist and ask questions about any instructions that are unclear. 

By Matthew Johnson, President/CEO of Pharma Source Direct