Big Buttons

• FDA doubles down: Tirzepatide is off shortage

  ...but that doesn't mean the issue is completely settled. read more →

• A couple of state updates

  Good news from Alabama, but a problem in Massachusetts read more →

• Defending GLP-1 compounding

  The latest letters APC's been sending to oppose efforts to restrict compounding read more →

• Thumbs-up for FDA crackdown

  APC was thrilled when the FDA announced it was taking action against illegal online businesses claiming to sell “research-grade” compounds. read more →

• A PANS/PANDAS explainer

  For your patients: Information about a couple of underdiagnosed pediatric mental health conditions read more →

• What, a year?

  In the final board chair column of the year, here are our top 7 accomplishments in 2024. read more →

• “Simply not a rational approach to regulating an industry”

  This week APC offered its final (and pointed) suggestions to the California Board of Pharmacy on their proposed significant – and we would say unjustified – changes to their compounding regulations. read more →

• Get a cease and desist letter from Verrica?

  APC has heard reports from several pharmacies that have received them — here's what to know. 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