October 21, 2021

Drug Compounding Standards in the U.S.

When you first learn about compounded drugs, it’s wise to want to make sure these custom-formulated drugs are safe. Sure, your doctor and pharmacist can offer reassurance, but to feel confident in your decision to treat your medical condition with compounded drugs, it helps to know more about their general safety and efficiency. 

With this in mind, we have written this post about the U.S. Food and Drug Administration’s (FDA’s) standards regarding compounded drugs and some of the federal drug standards you might need to know.

The FDA and Compounded Drugs

The FDA has long stated that compounded medications are not eligible for approval. This is not because all compounded medications are unsafe. It’s because the FDA simply does not have the time or resources to review every single custom medication to ensure its safety and effectiveness. 

Even drugs that are FDA-approved can pose health risks. And the FDA has stated that, although they do not approve compounded drugs, they do recognize the importance of these medications to patients across the country. 

Recently, the FDA began to approve certain drugs that are often compounded, including bioidentical hormone replacement therapy. For patients undergoing hormone replacement therapy, this made it more likely that their health insurers would cover the treatments. Most insurers won’t cover medications that are not FDA-approved. 

U.S. Drug Standards You Want to Know 

Patients may be interested in a few important federal laws that deal with drug compounding standards, including two key sections of the 2013 Drug Quality and Security Act (DQSA). When the DQSA was enacted, it included important compounding changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act). 

Section 503A of the DQSA describes how compounded drugs are exempt from labeling directions for use, current good manufacturing practice (CGMP) requirements, and marketing rules. Patients can take comfort in knowing that drugs can only be compounded when the compounding pharmacist is presented with patient-specific prescription medications.

Section 503B was newly added to the FD&C Act and provides opportunities for compounding pharmacies to voluntarily be placed in a category of compounding pharmacies known as “outsourcing facilities.” Outsourcing facilities must adhere to the CGMP requirements, and the FDA inspects them.

Patients who are uncomfortable with 503A-compliant compounding pharmacies can instead obtain their custom medications from outsourcing facilities, or 503B-compliant compounding pharmacies. 

Contact a Reputable Drug Compounding Pharmacy

When you need a custom prescription medication, The Healthy Choice compounding pharmacy can help. We’ll carefully formulate your personalized medicine so you can finally get the treatment you need. If you have questions about drug compounding or your specific prescription, you can reach us by phone at 914-238-1700 or contact us online.