The July 31st recommended deadline for 2024 CARES Act Drug Reporting is approaching fast. Here's what you need to know to stay compliant for 2024 and beyond:

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, 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.  

Make sure you are prepared to submit your drug reporting by the recommended July 31st time frame to avoid any compliance issues.  

FDA Guidance and Important Deadlines 

According to the FDA's final guidance titled 'Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act,' the reporting deadline for 2023 is July 31, 2024, with subsequent reports due by March 31 each year. All entities involved in manufacturing, preparing, distributing, compounding or processing for commercial distribution must comply with these requirements if they are not exempt under section 510 of the FD&C Act or 21 CFR part 207.  

Why Compliance is Crucial  

1. Legal Obligations: Adhering to drug reporting regulations is mandatory. Non-compliance can result in severe penalties, including fines and potential loss of licenses.  
2. Public Safety: Accurate reporting ensures controlled substances are properly tracked, minimizing the risk of misuse and abuse.  
3. Building Trust: Compliance fosters trust with patients, healthcare providers and regulatory bodies, reinforcing commitment to safety and integrity.  

Steps to Ensure Compliance  

With the July 31 deadline approaching, here are key steps to ensure your drug reporting is accurate and timely:  

1. Understand the Requirements: Familiarize yourself with the specific reporting requirements for your jurisdiction, including which substances need to be reported and the necessary data.  
2. Update Your Records: Make sure all records are current and accurately reflect your inventory, dispensing activities and any discrepancies.  
3. Submit Your Reports: Compile the required data and submit your reports through the appropriate channels by the deadline.  

Let Us Handle Your Drug Reporting  

We are here to help! We can perform your drug reporting for you.

Just fill out the Drug Reporting form here to get started.  

For more information or assistance with your drug reporting, please contact our compliance team at registration@applied-inc.com.