Every product on the market in the U.S. containing an active drug ingredient is required to be electronically drug listed with the FDA and assigned a National Drug Code (NDC). During this process, drug labelers submit complete electronic copies of the Content of Labeling (narrative), images of the Principal Display Panel (package label) and dozens of data values in the drug listing information (metadata) section. All of this is coded into the HL7 SPL document authoring standard prior to submission. After passing an automated technical validation by FDA, drug listings appear in the NDC Directory and in other publications, such as the National Library of Medicine’s DailyMed site, where regulators, healthcare providers and patients may look to find up-to-date, accurate drug information by product name, ingredient or NDC.
In capturing all this information, labelers must make sure the final SPL-XML file contains the full, latest version of the approved Content of Labeling and correct values in every data field. While that might seem like a straightforward task, there are many opportunities for errors to creep in.
FDA Warning Letter for Drug Listing Inaccuracy
Just this month, FDA issued a warning letter to an OTC drug labeler for failing to provide complete and accurate information in the metadata sections of two drug listing files. In this case, the drug listings contained complete ingredient information in the narrative labeling, but an active ingredient was left out of the drug listing data tables in the metadata section for both products.
Mistakes like this can easily happen. One ingredient in a list of dozens can be overlooked. A line of code in the SPL-XML file can be accidentally altered or deleted. Data values can be confused for similar controlled terms, units of measurement incorrectly assigned or decimals put in the wrong place.
But seemingly small mistakes can have big consequences. FDA’s letter reinforces the message delivered many times by the agency in the past, that failure to provide complete and accurate drug listing information constitutes misbranding and means the product cannot be legally sold—“your firm’s failure to fulfill its listing obligations misbrands the product…introduction into interstate commerce of a misbranded product is a prohibited act.”
While it would be nice to think that “failure to fulfill listing obligations” is always the result of willfully ignoring regulations or carelessness during the listing process, even careful regulatory professionals can overlook data inaccuracies. And remember, a drug listing file passing technical validation when submitted does not mean that all the data it contains is accurate and complete, it only means that the formatting of the data that is there meets the FDA’s technical requirements.
Check and Recheck for Accuracy
The story above emphasizes the importance of having robust proofreading and data quality processes in place when building SPL drug listing files. Data and copy should pass through machine and human checks. Drug listings should be reviewed thoroughly before publication and regularly afterwards to ensure that the information available regarding your drug product to FDA and to the public is always complete, accurate and up-to-date. Of course, any errors or out-of-date information you do find, no matter how small, should immediately be corrected.
If you are concerned about the accuracy of your drug listing submissions, contact the Reed Tech Life Sciences Team. We have been helping drug product labelers and manufacturers to build and submit SPL drug listing and labeling files since FDA first adopted SPL in 2005. We will be happy to help you understand FDA’s electronic drug listing requirements and what steps you can take to ensure accuracy in your SPL submissions.