If you manufacture, repackage, relabel, or distribute pharmaceutical products, you must comply with FDA establishment registration and drug listing requirements under section 510 of the FD&C Act, section 351 of the PHS Act, and 21 CFR Part 207.
Navigating your establishment registration and drug listing obligations is essential to meeting FDA requirements. These registrations and listings give the FDA:
- A complete list of all manufacturers currently producing products for sale in the U.S.
- A comprehensive, up-to-date inventory of all drugs within the U.S. supply chain.
This information is critical for ensuring the safety, quality, and availability of your products.
As an establishment owner (registrant), you’re required to register your facilities and list all drugs in commercial distribution. You must also submit your registration by December 31 each year, and update your listings in June and December to include any drugs not previously listed.
Failing to comply is a prohibited act. Any drug manufactured in an unregistered establishment is considered misbranded and could face regulatory action and market disruptions.
How Intertek Can Help
Intertek’s regulatory experts can help you understand these requirements, prepare and submit your establishment registrations and drug listings in the correct SPL format, and manage your annual renewals and updates. With our support, you’ll ensure your submissions are accurate, complete, and filed on time, so you can protect your business and stay focused on your operations.
Keep your products on the market without compliance concerns, connect with Intertek to handle your establishment registration and drug listing requirements.
