Alert: FDA Drug Listing Records Subject to Inactivation

Last month, the Food and Drug Administration (FDA) announced that it intends to inactivate drug listing records that are a) not certified as being active and up to date or b) associated with manufacturing establishments not currently registered with FDA.

FDA’s regulations require notification to the agency if commercial distribution of a listed drug is discontinued or any material changes are made to information previously submitted, including a change in manufacturing establishment. FDA says many listings are non-compliant because they a) have not been updated in more than a year, b) have not been certified as being up to date, or c) identify at least one manufacturing establishment not currently registered with FDA.

If drug listings are not updated, certified, or associated with a registered establishment, they will be marked “inactive.” This will result in the closure of drug records in FDA’s public drug listing databases; they will remain closed until corrections are made.

In its announcement, FDA noted Section 510 of the FD&C Act and 21 CFR 207 require registration of drug manufacturing establishments and “listing” of each drug manufactured for commercial distribution. The Act and regulations also require submission of updated drug listing information to FDA twice yearly (June and December) if any information has changed, including the discontinuation of commercial distribution or changes in the establishment(s) where the drug is manufactured.

Since August 2016, registrants have been required, at registration renewal, to certify that no changes occurred to listings that were not submitted or updated during the current calendar year. By December 31 of each calendar year, all registrants should review their files of listed human drugs to determine whether any information is no longer accurate and submit updated listing files or certification that there have been no changes.

Establishments and labeler code holders are also required to update contact information (name, telephone number, and email) within 30 calendar days of any changes.

New electronic drug listing submissions will not be accepted if they identify a manufacturing establishment that is not registered with FDA. However, previously submitted establishment and listing information may become outdated (e.g., lack of required annual certification, discontinued distribution, expired registration, change of manufacturing establishment). 21 CFR 207 requires each drug listing to reflect current manufacturing facilities and distribution.

Therefore, beginning Sept.14, 2019, and every January, FDA will begin to inactivate drug listings that are uncertified in the previous renewal period (Oct. 1 to Dec. 31). Further, every July FDA will begin to inactivate drug listings that are active and certified, but which contain at least one establishment that is not currently registered. This will apply to listings for both finished drug products, as well as for active pharmaceutical ingredients and other unfinished drugs.

These listings, including their NDCs, will be inactivated and subject to immediate removal from FDA’s NDC Directory. Notification of each NDC’s inactivation date will be included in FDA’s NSDE file. NDCs that are inactivated by FDA may be reactivated with an updated and compliant drug listing submission as soon as the next business day. Once activated, the listing will again be included in the NDC Directory and the reactivation date will be included in the NSDE file. If a drug remains in commercial distribution after it has been inactivated and removed from the NDC Directory, the drug may be deemed misbranded for failure to fulfill registration or listing obligations and may be subject to enforcement action.

For further information, read FDA’s announcement, with its background information and listing of resources available to assist with updating or certifying drug listings. The announcement includes a link to FDA’s NDC Directory, which identifies all active but uncertified or erroneous drug listings.