FDA Updates Establishment Registration & Drug Listing Regulations

With the new year in swing, it’s worth reminding companies of their obligation with regard to Establishment Registrations and Drug Listings.  As such, they should be aware that the FDA published a final rule amending these regulations in August of last year.   These revisions update and clarify existing regulations and implement most of those that were proposed in 2006, and which were subsequently mandated by legislative changes to the FD&C Act, particularly those requiring electronic submissions.   The effective date for updated regulations was November 29, 2016 so companies should review the regulation to make sure that they are following the new requirements.

 For OTC products, it’s worth noting that the responsibilities of private label distributors (common in the industry) and the manufacturers that supply them have been more clearly defined. 

Some of the key changes/clarifications are as follows:

Definitions

  • Establishment registration number and Unique Facility Identifier (UFI) are two different numbers. The former is assigned by the FDA (upon a separate request) after an establishment is registered for the first time and is also referred to as the Facility Establishment Identifier (FEI).  The UFI is the DUNS number that is included with the initial registration.  
  • Content of labeling was added to describe what information needs to be included in that section of the drug listing submission.
  • Private label distribution, Relabeler and Repacker were added to the definitions as all of these functions have responsibilities that were previously unclear with regard to the registration and listing requirements.
  • Salvage/Salvager were added and define activities surrounding segregation of products that may have been subject to adverse storage or handling conditions but for which a firm wishes to return them to the market.

Establishment Registration

  • Establishment registration is required for all foreign and domestic manufacturers, repackers, relabelers and salvagers (unless otherwise exempt as provided for in the regulation).  
  • Private label distributors should not register any establishment (unless they also perform one of the functions above or are acting as an authorized agent on behalf of another establishment).  They must, however, apply for their own labeler code.  

Drug Listing

  • Registrants are responsible for listing each drug in commercial distribution, including those drug products that are marketed through a private label distributor (although private label distributors may elect to do their own listings if acting as an authorized agent on behalf of a registrant.)
  • Registrants must review their drug listing information each June and December and either update it accordingly or certify that no changes have occurred.  The regulation is not clear how this “no changes” certification is accomplished however, the FDA subsequently published on their website that this would be done simply by submitting an update to the Labeler Code file. It’s worth noting therefore that Private Label Distributors, as “owners” of those files, would need to submit their own “no changes” certification.
  • Drug listing submissions must now include a complete listing of inactive ingredients and their corresponding Unique Ingredient Identifier (UNII) - this was previously optional.  

NDCs

  • Changes that trigger a revision to the product code portion (i.e., middle segment) of the NDC were clarified.  Although the proposed rule had included a provision such that changes to inactive ingredients would necessitate a new product code, this was not adopted in the final rule.
  • The FDA clarified the restrictions for using NDC numbers on non-drug products (e.g., dietary supplements, medical foods).   Such representations render the product misbranded.  

There were 2 major changes proposed in 2006 that were NOT incorporated into the final rule:

  1. FDA did not assume responsibility for assigning the NDC to a product, but will continue to accept the product and packaging segments of the NDC that are proposed by the manufacturer in the drug listing submission. 
  2. OTC product labeling will not be required to declare the NDC numbers, although FDA will continue to request their inclusion.  

There is quite a bit more information in the regulations, particularly in the Comment section of the Federal Register notice. It’s worth reviewing that, as well as the regulations themselves, to gain an understanding of the new requirements.