Understanding FDA Registration

If you're involved in the production or distribution of medical oxygen, you likely know that staying compliant with FDA regulations is crucial. One key requirement is the FDA registration and annual renewal for transfillers.

Who Needs to Register?

Any company involved in transfilling medical gases must register with the FDA.  According to the FDA, this means that any firm that transfers oxygen from one container to another, via gas to gas, liquid to gas, or liquid to liquid; is considered a drug manufacturer by the FDA and is required to register with the FDA every year between October 1st and December 31st of the year. (See 21 CFR 207.21(a)).

The Annual Renewal Process

FDA registration is not a one-time event. It requires annual renewal to ensure that companies continue to meet the necessary standards.

When you are getting ready to register or renew with the FDA, remember these tips:

1. Your transfilling site address must match the address on file with Dun and Bradstreet, so be sure to check your DUNS number.
2.  If you are filling different cylinder sizes since the last time you registered, your drug listing should be updated.
3. If you are no longer filling at a specific location, it is recommended that you remove the location from the FDA database.
4. Starting June 1, 2009, the FDA stopped accepting paper submissions for registration. Registration must now be done electronically.

Distinguishing FDA Registration from the CARES Act Drug Reporting Requirement

It's important to note that FDA registration for transfillers is separate from the CARES Act Drug Reporting requirement. While both are essential for regulatory compliance, they serve different purposes:

CARES Act Drug Reporting

What is CARES ACT Drug Reporting?

Under the CARES Act, enacted March 27, 2020, in response to the COVID-19 pandemic, transfillers and other drug manufacturers must annually report specific drug volume details to the FDA. This helps the FDA monitor drug manufacturing activities, preventing shortages and enhancing medical product oversight.

Why Oxygen Transfillers Must Report

As a transfiller of oxygen or a medical gas transfiller, you are considered a manufacturer of a product that is regulated as both a medical product and a drug. The CARES Act and FDA regulations mandate the maintenance of accurate, timely records and the submission of annual reports detailing drug-handling activities. This process is essential for ensuring regulatory compliance and the safety and proper use of medical oxygen.

Worried About Staying Compliant?

Don’t be! At Applied Home Healthcare Equipment, we understand the complexities of regulatory compliance. Our team can assist you in navigating the FDA registration renewal and drug reporting processes, ensuring that your business remains compliant, and your operations run smoothly.

For questions, contact our FDA Registration Team at registration@applied-inc.com, or to get an order started click the links below:

FDA Registration for Drug Establishments: https://applied-inc.com/fda

CARES Act Drug Reporting: https://applied-inc.com/drug-reporting