Take action now to assure that your facility information, drug listing information, and manufacturing sites are correct and that no changes have been made to any of these items or others that are listed in the FR notice due to publish on Wednesday (pre-publication notice here).
The Notice indicates registrant’s responsibilities as follows:
Each registrant must list all drugs it manufactures for commercial distribution within 3 days of initial registration (21 CFR 207.45). Establishment registration must be renewed annually between October 1 and December 31 (21 CFR 207.29). Each registrant must in June and December each year: (1) update its drug listing information to provide FDA with information about any drugs introduced for U.S. commercial distribution not previously listed, (2) report the discontinuation of any listed drug, and (3) report any material changes in drug listing information submitted previously (including any updates in the manufacturing establishments) (§ 207.57). If there are no changes to listing information to report in June or December, then the registrant must certify that there have been no changes to the listing information previously submitted, during the October 1 and December 31 registration renewal and listing certification period (§ 207.57).
What are the consequences for not keeping information up to date? According to the FR Notice:
“to address the above registration and listing problems, FDA is encouraging firms that are required to register drug establishments and list human drugs under Part 207 to review their currently listed human drugs and determine whether any information in their drug listings, including drug establishments identified, is no longer accurate. Any active drug listing submissions that are inaccurate should be updated as soon as possible.
Thirty days after publication of this notice, and every January thereafter, FDA will begin to inactivate human drug listings that remain uncertified from the previous renewal period of October 1 to December 31. In addition, every July thereafter, 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 in accordance with FDA’s requirements.
If the Agency inactivates the products, even if there is a mistake, the products will no longer be considered to be listed and thus could be considered misbranded for failure to fulfill registration or listing obligations. In addition, if delisted, there could be significant issues associated with reimbursement as the products are removed from the NDC directories.
Don’t wait to assure your information is correct, because the consequences could be very troublesome and impactful for your firm.