Question 1

What is Structured Product Labeling (SPL)?

Accepted Answer

In August of 2016, the FDA published the Final Rule for drug listings in the Federal Register. That rule became effective in 2017. In broad terms, the requirements of the Final Rule are not much different from the previous regulations, in that manufacturers need to keep their listings up to date, revising them by the June or December that follows any revision. While the previous regulations required that listings be updated as needed, the FDA strengthened that requirement by making two changes to the regulations:   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). Previously, if the last SPL listing was still accurate, nothing needed to be done.

Question 2

How do I comply with FDA requirements for structured product labeling (SPL)?

Accepted Answer

Per FDA requirements, the manufacturer is responsible for all drug listings, including listings done for private label distributors (PLDs) using the PLD’s National Drug Code (NDC) labeler. The actual listings may be done by 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 Placing the requirement on the manufacturers means that if a listing is not done it is the manufacturer that is responsible, even if it is a listing for a private label distributor.   See 21CFR207.41, (c)(1) and (c)(2), at this page; (c)(1) is for distributor listing, (c)(2) for manufacturer listing.

Question 3

What is a Manufacturer Listing?

Accepted Answer

Manufacturer listings are done where the product’s marketing category is:   a bulk ingredient (used for APIs [Active Pharmaceutical 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. The NDCs in the drug product information use the manufacturer’s labeler code.  See 21CFR207.41, (c)(2) for additional information.

Question 4

What is a Distributor Listing?

Accepted Answer

Distributor listings are done where the marketing category is any of the other marketing categories other than bulk ingredient, drug for further processing, or manufactured under contract (OTC Monograph Final/Not Final, any of the application type marketing categories such as NDA, or any one of the “unapproved” marketing categories such as unapproved medical gas).   The NDCs in drug product information use the distributor’s labeler code. If the manufacturer is the distributor, only the distributor’s listing is done.   Under certain circumstances, a product distributed by a domestic manufacturer that is produced by the manufacturer at a foreign site that it fully owns may have both listings for import reasons – the manufacturer’s listing for the domestic manufacturer’s foreign site and the distributor’s listing for the domestic manufacturer/distributor that distributes the product.   When a manufacturer fully manufactures and commercially distributes its products, the listings are normally handled by the manufacturer or someone with whom they contract. In our experience, the only exception is the drug sponsor who takes on that responsibility, but they need to make sure the manufacturer is aware of that. In all other cases the various parties (manufacturer, US agents, and distributors) need to know who is handling the listings. As indicated previously, there are manufacturer and distributor listings handled by a party other than the manufacturer. In other cases, the distributor listing are contractually assigned by the distributor to the manufacturer.   If a company is already tracking whatever listings it is handling, all is well and good. They are having a relatively easy time of making any updates or submissions this year. In practice, though, we are finding that many companies have not been doing that tracking.  See 21CFR207.41, (c)(1) for additional information.

Question 5

What information do you have on FDA’s Over-the-Counter Monograph User Fee Program?

Accepted Answer

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 userfees@fda.gov or call to 301-796-7200.

Question 6

How do you check the active/inactive status of a drug with the FDA?

Accepted Answer

To check the status of any drug listing other than those listed under marketing category Manufactured Under Contract, use the NDC Directory's searchable database at https://www.accessdata.fda.gov/scripts/cder/ndc/index.cfm, or the new NDC Express Mobile Application (download from either Apple's App Store or Google Play). Search by: 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 If the results show all the information for an NDC then the product is active, if only limited information than the product is inactive and should not be distributed.   If a listing is inactive, reactivate by re-submitting the last successful listing after, at a minimum, updating the document id and version number; other changes may be needed in order to meet current SPL validation rules. If you don't have the last listing you need to either download it from the DailyMed if it is there, or re-create it. To re-create it you need to contact the FDA’s Electronic Drug Registration and Listing System (EDRLS; edrls@fda.hhs.gov) group for the setId and version number used in the last listing.

Question 7

What is the URL for DailyMed – the NLM site for distributor listings?

Accepted Answer

http://dailymed.nlm.nih.gov/dailymed/about.cfm

Question 8

What is the URL for the FDA Substance Registration System search page, which is used to find UNII and Preferred Substance Name?"

Accepted Answer

http://fdasis.nlm.nih.gov/srs/srs.jsp

Question 9

What is the URL for FDA SPL Resources?

Accepted Answer

http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm

Question 10

What is the URL for the FDA Online Label Repository - FDA site for distributor listings?

Accepted Answer

http://labels.fda.gov

Question 11

What is the URL for the Drug Establishments Current Registration Site – used to verify current registration, operations, and DUNS Number of Establishments?"

Accepted Answer

http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm

Question 12

What is the URL for Drug Nomenclature Monographs  - Links to monographs that define FDA terms, some terms may not be allowed in SPL?"

Accepted Answer

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/DataStandardsManualmonographs/ucm071650.htm

Question 13

How can I check the status of OTC Rulemakings?

Accepted Answer

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/default.htm

Question 14

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)?"

Accepted Answer

http://www.fda.gov/Downloads/ForIndustry/DataStandards/StructuredProductLabeling/ucm362965.zip

Question 15

What is the URL for Pragmatic Data Validator Lite (used to both validate and view SPL)?

Accepted Answer

http://validator.pragmaticdata.com/validator-lite/

Question 16

How do I email the FDA SPL Group?

Accepted Answer

spl@fda.hhs.gov

Question 17

Who do I contact with regulatory questions and request setIds and version numbers?

Accepted Answer

The FDA Drug Registration and Listing System – edrls@fda.hhs.gov