March 7, 2021

Compounding Pharmacy Regulations

One of the most common concerns people have when they learn about drug compounding is whether it is safe. It makes sense to wonder. However, formulating custom medications on a patient-by-patient basis is actually safer and more effective.

When regulated appropriately and formulated by a licensed compounding pharmacist, customized compound medications is a very safe option. Continue reading to learn more about how compounding pharmacy regulations are formed and how these regulations could impact you.

What Does The FDA Say About Drug Compounding?

The U.S. Food and Drug Administration (FDA) is responsible for overseeing certain foods and drugs that are available to consumers. The FDA does not currently approve of compounded medications as a whole. This is because they are formulated on a case-by-case basis, and there is no way for the FDA to review the endless prescriptions for compounded drugs across the country.

With that being said, the FDA does state that it recognizes the need and benefit of compounded medications, but it simply cannot approve them so broadly. Furthermore, the FDA has had to investigate many cases where patients were injured or became ill after taking compounded medications. 

One of the most widely publicized investigations involved the New England Compounding Center (NECC) in Boston, Massachusetts. The owner and several employees sent out drugs they knew had been compromised or were unsanitary. This gross misconduct caused a massive meningitis outbreak in 2012 that infected nearly 800 people and caused the deaths of 64.

Although the FDA continues to review drugs for safety and effectiveness, compounding pharmacy regulations are currently not in place by the FDA. Instead, each state has a state board of pharmacy that monitors the facilities for safety and ensures all appropriate regulations are followed. 

How Do These Regulations Affect You?

Now that you know that the vast majority of compounding pharmacies are regulated and safe, you may wonder how these regulations affect you. The answer is, in large part, they don’t. But what does affect you is the fact that your custom medication is more than likely not going to be FDA approved. 

This means that your health insurance provider may not be willing to cover the costs. In this case, you’ll need to be prepared to pay out of pocket for your compounded medications. The good news is that compounded medications will sometimes be much less costly than traditional drugs, depending on the type of medication. 

You can also discuss costs with your health insurance provider or your compounding pharmacist to learn more about what you should expect to pay for your prescription. 

Get in Touch with a Reputable Compounding Pharmacy

Compounded medications can be completely safe and are carefully regulated by the state boards of pharmacy. If you have additional questions about how drug compounding works, or if you need a custom medication, contact The Healthy Choice compounding pharmacy today. Call 914-238-1700 or complete the convenient contact form at the bottom of this page.