In addition to a reminder of the Drug Establishment Registration Renewal period (1 October – 31 December) EAS would like to remind you of significant changes being implemented for OTC monograph drug product listings. The changes were announced by FDA last year and reminders were included in EAS’ Drug and Device Corner during 2024.
The FDA’s drug establishment registration and drug product listing regulations provide much needed insight for the agency. Failing to list drug products renders these drugs misbranded. Information provided by registrants in facility registrations and drug product listing submissions are used by the agency primarily for:
- Drug shortage mitigation efforts
- Inspection planning
- Drug importation review and supply chain oversight
- Recall oversight
- Injury monitoring
In FY2024, the FDA inactivated 19,899 drug listings due to either lack of certification as an active listing, or an associated establishment that was no longer registered with the agency as a drug facility. 141 deficiency letters were issued to firms for inaccurate or incomplete registration or listing data.
Any changes to the information in a drug establishment registration (ie – establishment name, address, contact details) are required to be submitted to the agency within 30 days of such change. This ensures the FDA can reach a facility when necessary.
The FDA recommends that establishments include all appropriate business operations in their registration SPL file, meaning all stages of manufacturing. These details will need to match business processes identified in NDC listing files which include the establishment. The FDA expects NDC SPL files to include the entire supply chain (API manufacturer, manufacturer, any contract facilities used – testing, label, pack). Additionally, the agency uses these details for inspection planning purposes, assessing user fees, and for drug volume reporting. An important note to keep in mind, an inaccurate establishment registration will affect all listings in which the facility is identified rendering the listed drugs misbranded.
Foreign facilities should be updating their registration files with current importer information as needed.
A much-overlooked FDA submission is the labeler code file. Many firms neglect to update contact information after the initial labeler code request submission. Per regulation, changes to the data in a labeler code should be updated with the agency within 30 calendar days. The contact information in a firm’s labeler code is used by the agency when there is an issue with an NDC listing. This contact information is also used for agency communications regarding data requests, clarifications, and new agency initiatives.
When changes in a firm’s name are submitted for a labeler code, do remember this name change will need to be submitted for each NDC listing that includes the impacted labeler code.
NDC SPL files should be updated as changes occur, however they are required to be updated at minimum the June or December following such change. A refresher on changes that require assignment of a new NDC product code:
- A change in drug’s established name or proprietary name, if any
- A change in active ingredient or strength
- A change in dosage form
- A change in drug status
- A change in drug’s intended use
- Any changes to the drug’s distinguishing characteristics
Now to the significant change for OTC monograph drug listings for this renewal period. Per the CARES Act the FDA has overhauled the OTC monograph system. As a result, the previously identified marketing categories of “OTC monograph final” and “OTC monograph not final” with the associated CFR reference are no longer valid. OTC monograph drug product listing SPL files should be identifying “OTC monograph drug” with the appropriate monograph published on the FDA’s OTC MONOGRAPHS @ FDA website.
Old outdated system:
New correct system:
During the annual renewal/certification period, a no change certification will not be available for SPL files still referencing the outdated monograph categories. All NDC listings will need to be updated to align with the correct OTC monograph.
With heightened enforcement and the automated system inactivating outdated NDC SPL files, addressing this need sooner rather than later will avoid an urgent issue at the end of the year. Do note, an SPL file inactivated by the FDA does NOT fulfill a registrant’s requirement to submit a marketing complete SPL file for that NDC.
The one take away we hope you will gather, is that all SPL files submitted to FDA (establishment registration, NDC listing, labeler code) should be reviewed often and reflect current accurate information.
If you need assistance with your NDC listing updates, please reach out to EAS for support.
Posted in FDA and USDA Regulatory Update.