Follow-up on New Final Rule for Drug Listing and Establishment Registration

After slogging through the 200+ pages of the Final Rule, here is a partial list of some of the comments I found interesting or that explain some of the changes or comments along with a summary of the FDA response from the Final Rule (here).

Comment 9 – Clarification of importers requirement to identify every entity it delivers product to will be narrowed in scope to the “importer” should include a U.S. owner, consignee, or recipient at the time of the drug’s entry into the United States and should not include additional subsequent owners, consignees, or recipients of the drug.

Comment 15 – Asks for clarification on when new labeling must be submitted and what is considered not a material change in accordance with the regulations.  FDA responds that material change includes any labeling change other than changes in the format of labeling, changes of an editorial nature, inclusion of a bar code, or initial inclusion of an NDC. In this context, changes of an editorial nature would not include any changes that add or revise meaning. Thus, the new definition of “material change” adopted as part of this Final Rule is broader than the previous definition and is not limited to “significant” changes. The definition includes– with very few exceptions–any change in previously reported drug listing information.

Comment 16 – Relates to private label distributors (PLD) and, in that regard, FDA has further defined a private label distributor as a person that distributes a product under their own name but does not manufacture, repackage, relabel or salvage the drug product.  Someone else does that for them.  The PLD is, however, responsible for obtaining their own drug labeler code for use on their products whether they or someone else drug lists the products.

Comment 32 – Discusses a proposal to “reserve” an NDC number in advance of approval or distribution.  “Accordingly, this final rule includes a new § 207.33(d)(3) that allows a person to voluntarily reserve a proposed NDC for a period of 2 years prior to its inclusion in a drug listing submission for the first time. Note that an NDC reserved under § 207.33(d)(3) would need to include most importantly a labeler code and a product code. At the discretion of the person submitting the reservation request, a single package code could be included, or not, with one or more package codes included later in NDC(s) submitted with complete drug listing information.”  FDA will also entertain requests to extend the reservation beyond 2 years. Alternatively, “to the procedure established under § 207.33(d)(3), a registrant wishing to reserve an NDC also has the option of submitting complete listing information for a drug that is under development and specifying a future “start marketing date” in the listing submission. That listing submission could then be updated, as needed, when the actual marketing date arrives.”

Comment 35 – FDA discusses the inevitability of running out of 5-digit labeler codes and thus at some point in time will be assigning 6-digit labeler codes. Thus, the Final Rule states that an NDC code will be 10 or 11 digits.

Comment 43 – In response to this comment about the use of multiple labeler codes, FDA explains that it will permit firms to retain multiple labeler codes after mergers or acquisition so the firms that merge will not have to change to a single labeler code and thus will not run the risk of exhausting NDC codes. FDA notes, however, that it would prefer (but not require) firms to use a single labeler code.

Comment 51 – Assignment of a new NDC number will not be required for inactive ingredient changes as previously required and proposed.

Comment 52 – Changes in labeling of the product may not require a change in NDC number but we suggest you read this comment closely and in conjunction with other sections of the Fnal Rule before reaching any decision on whether an NDC number change might be required based on a label change.

Well, that’s it for today.  We will tackle some additional comments and FDA response at a later date.  Remember that we are only highlighting certain FDA response and that it will be important for each firm to fully review the Final Rule and adjust its practices in conformance with it.