One of the great things about the FDA’s electronic Drug Registration and Listing System (eDRLS) is the automatic data validation process. When you submit a Structured Product Labeling (SPL) file to the FDA over the Electronic Submissions Gateway (ESG), the contents are automatically checked against the SPL schema and FDA business rules. If a file doesn’t meet all of the requirements, the system will kick back an error message and the file won’t be published to the NDC Directory or the NLM’s DailyMed site. This is a huge improvement over the old way of doing things before the eDRLS initiative, when the industry simply submitted unstructured content in PDF or even on paper. In this old system, the labeling and listing data was very difficult to search and check for accuracy, so errors were much more common.
Unfortunately, no automatic system performs perfectly in every situation. Sometimes manual intervention by a human operator is necessary. An SPL file can meet all automatic validation rules but still contain inaccurate data. Likewise, a submission may occasionally break a rule and generate an error, but actually be perfectly correct. That’s where the manual override comes in.
What is a Manual Override?
The FDA has the ability to see what submissions have been made through the ESG and whether or not they’ve been accepted by the system. If you have a submission that should be accepted by the agency but was automatically rejected, you can request an override, which allows a file that generated an error and was initially rejected to pass through into the FDA database.
A word of caution—the FDA doesn’t just give out a manual override just because someone asked for one. You’ll need to provide a satisfactory explanation of why the submission was rejected incorrectly.
Why Would a Manual Override Be Needed?
An override is given when the automatic validation rules set up to handle most situations are unable to meet the requirements of particular set of circumstances. The most common situation for an override is when an error is discovered in a published drug listing within a field that cannot be changed.
For example, you cannot change the brand name of a listed drug product. You would instead have to delist that product by updating the drug listing and including a marketing end date, then submit a new listing using a new NDC product code. But, if you discovered a typo in the published brand name of your drug product, you would need to correct that. Since the system won’t allow you to change the brand name without generating a new NDC, you would have to make the submission and wait for it to generate an error. You would then send an override request to the FDA to have the corrected version accepted and update the drug listing in the NDC Directory.
As always, it is important to remember that all submitted drug listing and labeling data must be accurate and up-to-date. So, if you discover an error in a published drug listing, you need to correct it as soon as possible.
How to Request a Manual Override
Manual override requests should be submitted via email to SPL@fda.hhs.gov. You’ll need your ESG submission acknowledgement message to locate some important elements of your request. See example below.
Your email request should include all of the following elements:
Specific Subject Line – Make your subject line clear and identify the SPL submission by CoreId. The CoreId is the file name of the submission called out in ESG submission acknowledgement message.
- Example: Manual Override Request for CoreId [insert your SPL CoreId here]
Brief explanation – Provide a succinct reason for why an override is appropriate.
- Example: My submission for [insert SPL submission type and drug product name, establishment name, etc.] failed validation due to the error listed below. This submission is being made as a correction to previously submitted data. Could you please perform a manual override and contact me if more information is needed? Thanks for your assistance.
CoreId – List your CoreId for the failed submission in the email body as well as in the subject. The CoreId is the file name that begins the ESG submission acknowledgement message.
Time of ESG Submission Receipt – Include the date and time from the ESG receipt.
Error – Include the error that caused your submission to be rejected. You can find this in the Validation Report after you download it. (Please note, your error may be different from the example below.)
- Example: If the NDC product/item code was previously submitted, then the product name must be same as in the most recent submission for this NDC product/item code.
Of course, you should also include all the normal elements of a professional email. Be sure to you have an email signature with your name, title, company, email and phone number.
You should receive a reply to your email letting you know the override has been processed, asking for more information or explaining why an override is not appropriate in this situation.
When it comes to the submissions you make to the FDA, data quality is paramount. That’s why FDA has these validation procedures in the first place. But we know that all the requirements surrounding electronic drug listing, especially the exceptions to the rules, can be daunting. If you have questions about manual overrides or other SPL submission topics, contact the team at Reed Tech. We’ll be happy to help.