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FDA News: Drug Listing Records Inactivated, Export Listing Module Changes

Wednesday, September 11, 2019
Sandler, Travis & Rosenberg Trade Report

For more information on FDA-related trade issues, please contact FDA Practice Leader Shelly Garg at (305) 894-1043.

Drug Listing Records to be Inactivated

The Food and Drug Administration has announced its intention to begin inactivating drug listing records that are not certified as being active and up-to-date or are associated with a manufacturing establishment that is not currently registered.

FDA regulations require foreign and domestic drug establishment registrants to notify the agency if commercial distribution of a listed drug is discontinued. Firms must also update drug listings if any material changes are made to information previously submitted, including a change in manufacturing establishment.

However, the FDA has found that listings for many drug products have not been updated in over a year, have not been certified as being up-to-date, or identify at least one manufacturing establishment that is not currently registered. Many of the drugs that are the subject of these listings appear to no longer be in commercial distribution.

As a result, beginning Sept. 13 and every January thereafter, the FDA will begin to inactivate human drug listings that remain uncertified from the previous renewal period of Oct. 1 to Dec. 31. In addition, every July thereafter the FDA will begin to inactivate human drug listings that remain active and certified after the June listing update but still contain at least one establishment that is not currently registered. This action will include listings for finished drug products as well as active pharmaceutical ingredients and other unfinished drugs. If a drug remains in commercial distribution after it has been inactivated and removed from the National Drug Code Directory it may be deemed misbranded and persons marketing the drug in the U.S. or offering it for import into the U.S. may be subject to enforcement.

Export Listing Module Changes

The FDA has announced the following with respect to its Export Listing Module, an electronic portal for receiving and processing requests from FDA-regulated establishments that seek to be included on all export lists for FDA-regulated food products.

- The European Union dairy export list and all export lists maintained for Chile and China have been fully transitioned to the ELM.

- U.S. establishments currently included on the EU collagen, gelatin, or seafood export lists should submit applications in the ELM if they wish to remain on these lists.

- Effective immediately, any U.S. establishment that wishes to be included on any FDA-maintained export list for food products should apply in the ELM. Establishments that do not update and resubmit their ELM applications every two years will be removed from the lists.

For certain exported food products, some foreign food safety authorities require the FDA to provide publicly available lists of exporters eligible to ship products to that country. The FDA has established and currently maintains export lists in response to importing country requirements for dairy, infant formula, collagen, gelatin, and seafood products. Foreign authorities that require these lists use FDA-provided information to identify and publish their own lists of approved firms.

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