Frequently Asked Questions About Structured Product Labeling (SPL) Conversion Services
What is Structured Product Labeling (SPL)?
A drug last listed using paper forms must be listed electronically using SPL, which is an XML format. Electronic listings began in June 2009 for listing new drugs and revising existing listings; drug listings that hadn’t changed since they were last listed using paper forms previously did not need to be listed using SPL.
A drug listing is considered certified either by 1) being submitted at least once during the year, or 2) including its product code in a new type of SPL file, Blanket No Change Certification (BNCC).
How do I comply with FDA requirements for structured product labeling (SPL)?
private label distributors
US agents for the manufacturers
importers of the manufacturers, regulatory consultants, and drug sponsors acting on behalf of the manufacturers or distributors
What is a Manufacturer Listing?
a bulk ingredient (used for APIs (Active Product Ingredients)
drug for further processing (product needs additional work such as packaging and/or labeling by another manufacturer before being commercially distributed)
manufactured under contract (product is ready for commercial distribution by a private label distributor; note that:
a private label distributor in this context can be a drug manufacturer that distributes a drug manufactured for them under contract by a different drug manufacturer)
The manufacturer in this case is not necessarily the manufacturer of the drug, it can be the company that bought the drug either in bulk from the drug manufacturer and packaged and labeled it, or in packages from the packager of the drug and placed labels on the packages; the FDA includes manufacturing, packaging, and labeling in the overall manufacturing process for drugs.
What is Distributor Listing?
CFR Title 21 on-line, Electronic Code of Federal Regulations?
What information do you have on FDA’s Over-the-Counter Monograph User Fee Program?
The FDA charges manufacturers of Over-the-Counter drugs an annual fee. Please see FDA’s Over-the-Counter Monograph Drug User Fee Program (OMUFA) webpage for detailed information, but the contact points at FDA:
- For questions about the program, or regarding refunds and waiver requests, contact FDA by email to CDERCollections@fda.hhs.gov or call to 301-796-7900
- For questions about paying the fee or confirming the status of a payment, contact FDA by email to the User Fee Helpdesk at firstname.lastname@example.org or call to 301-796-7200.
Important Web Resources
How do you check the active/inactive status of a drug with the FDA?
Clicking on either Finished Products or Unfinished Products. Finished Products is for any Distributor Listing (product listing under marketing categories other than Bulk Ingredient, Drug For Further Processing, or Manufactured Under Contract). Unfinished Products is for any Manufacturer Listing under marketing categories Bulk Ingredient and Drug for Further Processing.
Selecting from pull-down list to Select Type. We recommend NDC Code if known.
Entering text in the "Enter at least three characters" window; we recommend entering the NDC code with either the first 2 parts or all 3 parts for specific product code, or only 1st part to see all product codes for the labeler
What is the URL for DailyMed – the NLM site for distributor listings?
What is the URL for the FDA Substance Registration System search page, which is used to find UNII and Preferred Substance Name?
What is the URL for FDA SPL Resources?
What is the URL for the FDA Online Label Repository - FDA site for distributor listings?
What is the URL for the Drug Establishments Current Registration Site – used to verify current registration, operations, and DUNS Number of Establishments?
What is the URL for Drug Nomenclature Monographs - Links to monographs that define FDA terms, some terms may not be allowed in SPL?
How can I check the status of OTC Rulemakings?
What is the URL to check active ingredient-active moiety relationship/basis of strength (click on the link, open the zip file, open the spreadsheet)?
What is the URL for Pragmatic Data Validator Lite (used to both validate and view SPL)?
How do I email the FDA SPL Group?
Who do I contact with regulatory questions and request setIds and version numbers?
The FDA Drug Registration and Listing System – email@example.com