March 7, 2021

503a vs. 503b Compounding Pharmacies

As an average consumer, the classification of your pharmacy wouldn’t normally be of any importance to you. But as someone getting customized medications from a compounding pharmacy, understanding how your pharmacy is classified and why can go a long way in educating yourself about your personalized medicine and where it came from. 

Continue reading to learn more about the two types of compounding pharmacies regulated by the U.S. Food and Drug Administration (FDA): 503a compounding pharmacies and 503b compounding pharmacies. 

What Is a 503a Compounding Pharmacy?

503a compounding pharmacies include your traditional compounding pharmacies. These facilities must compound medications under a patient’s individual prescription. These compounding pharmacies are required to comply with FDA guidelines. 

503a compounding pharmacies also cannot dispense medications for office use. They can only dispense medications for home use, which dramatically limits their product line for consumers. 

The FDA limits the batch size of compounded medications 503a compounding pharmacies. This often ends up resulting in an increased production cost, which is then passed on to the consumer. 503a compounding pharmacies are not required by law to register with the FDA.

What Is a 503b Compounding Pharmacy?

The differences between 503a and 503b compounding pharmacies are clear. Although 503a compounding pharmacies cannot produce large batches of compounded medications, 503b compounding pharmacies can. 

503b compounding pharmacies are also not restricted to producing compounding medication for patient specific prescriptions the same way 503a compounding pharmacies are. 503b compounding pharmacies can not only produce patient specific medicines, but large batches of compounded medications are not patient specific, which are then sold to healthcare facilities as being for “office use only.”

By selling the compounded medications to healthcare facilities in large batches, it drives the production cost down, allowing the consumer to purchase the drug for far less. 

Although 503b compounding pharmacies are not required to formulate patient-specific drugs, they are held to the highest standard. It should also be noted 503b compounding pharmacies are required to register with the FDA in addition to the U.S. Drug Enforcement Agency (DEA) and each state board of pharmacy. 

These are just a few of the more notable differences between traditional 503a and 503b compounding pharmacies. The FDA has put these guidelines in place for protecting consumers and to ensure the compounding pharmacy industry is being regulated. Although compounded drugs are not approved for use by the FDA, the agency still works to maintain safety and integrity, as compounded medications serve a valuable purpose to patients across the country. 

Contact a Reputable Compounding Pharmacy in New York

If you have additional questions about how compounding pharmacies work or how you can go about obtaining a customized prescription drug, contact The Healthy Choice compounding pharmacy to learn more. Call 914-238-1700 or complete the quick contact form included below to discuss your individual needs.