The CARES Act, enacted on March 27, 2020, expanded the FDA’s authority to monitor drug supply chains and reduce the risk of drug shortages in the U.S. market.
Under section 510(j)(3) of the FD&C Act, you’re required to report annually on the amount of each listed drug your establishment manufactured for commercial distribution.
The FDA’s NextGen Portal allows you or your authorized agent to submit this critical data in CSV format. Your reports give the FDA a complete picture of the drug supply chain, helping them make informed decisions and proactively address shortages.
Who Must Comply?
If you manufacture drug products for commercial distribution, these regulations apply to you. You’ll need to identify:
- When your drugs were manufactured
- Whether they were for commercial distribution
- The National Drug Code (NDC) for each drug
- The business operations performed (like manufacturing, repackaging, or relabeling)
- The type of drug and its packaging details
Properly structuring and submitting these reports is essential to staying compliant and supporting the FDA’s oversight of the drug supply chain.
How Intertek Can Help
Intertek can walk you through compiling the required data, structuring it correctly in CSV format, and submitting it through the FDA’s NextGen Portal. We’ll make sure your reports are accurate, complete, and filed on time, so you can stay compliant without the stress.
Don’t risk missing critical deadlines, contact us to see how Intertek can simplify your CARES Act drug amount reporting.
