May 26, 2024

Compounding Pharmacy and the FDA

Many people will be unaware of what drug compounding is or how it works until they have the need for a custom medication. But if you’ve found your way here, chances are you have or need a prescription for a compounded drug and are interested in learning more about what to expect. 

One of the most common topics surrounding drug compounding is how these drugs are regulated by the U.S. Food and Drug Administration (FDA). Below, we go into further detail about drug compounding pharmacies, pharmaceutical compounding, and what the FDA has to say about compounded medicines. 

Drug Compounding, Explained

The art of drug compounding involves the manipulation of standard medications to formulate drugs that meet the individual needs of a patient. At first glance, you may be confused as to why someone might need a compounded drug. 

There are many reasons a patient might need a personalized medicine. Maybe the standardized dose available at the local CVS is far too high or low for your needs. Or perhaps you find it difficult or impossible to swallow capsule medications and need your medicine formulated into a lozenge or liquid form. 

These are just a couple of examples of how drug compounding can benefit patients suffering from a multitude of medical conditions and symptoms. Your physician may suggest you visit a respected compounding pharmacy when traditional and standardized medications are unable to treat your condition.

The FDA’s Stance on Drug Compounding

Due to the fact that every compounded medication is created on a patient by patient basis, the U.S. Food and Drug Administration (FDA) is unable to check each and every drug for efficiency and safety. Since the FDA simply cannot examine all compounded drugs, they do not approve compounded medications.

With that being said, just because the FDA does not approve compounded drugs doesn’t mean they do not recognize the need for them. In fact, the FDA has clearly stated the benefits of compounded drugs are undeniable when formulated by highly trained compounding pharmacists. For this reason, it is important you get your custom medications from a reputable facility like The Healthy Choice compounding pharmacy. 

It should also be noted since the FDA does not regulate or approve compounded medications, you may find your health insurer does not provide coverage for your prescription compounded drug. 

Fortunately, every policy is different and even if your insurance company does not cover the costs of compounded drugs, you may need to be prepared to cover these costs out of pocket. Many compounded drugs are often less costly than traditional drugs, so don’t hesitate to reach out to your compounding pharmacy to discuss costs should it become a roadblock on your path to recovery. 

Contact The Healthy Choice Compounding Pharmacy

If you have additional questions about how drug compounding works, the FDA’s stance on compounded drugs, or if you have the need for a custom medication, reach out to The Healthy Choice compounding pharmacy. We can be reached by phone at 914-238-1700 or through the quick contact form provided below.