Hi David.
I have always been of the belief that so long as the product is on the market and within expiration the requirements to track and submit reports or keep the records would be a regulatory requirement. Think about it logically. If I as a manufacturer decide to discontinue a product 1 week before my annual is due to be created/submitted I would have essentially distributed that product all year and the product which was distributed would likely either (1) not completed its way through the supply chain and/or (2) the most recent lot of product would not have expired (absent a very short shelf life of the product) so what you seem to be asking is whether or not a discontinuation decision by the company can eliminate an otherwise enforceable regulation requirement. I would say you still need to keep up the reports until there is no further reason for them. For example, your distribution report will likely be able to be stopped before the safety reports and your annual report might be able to be stopped earlier than your distribution report because the input data for these will no longer be created (e.g., no batch production means no rejections or approval of batches; no further inventory means no further distribution, etc.) but I think you need to continue to report as long as there is potentially something to further report.
------------------------------
Victor Mencarelli
Global Director Regulatory Affairs
MelvilleNY
United States
------------------------------
Original Message:
Sent: 19-Oct-2021 12:04
From: David Lucking
Subject: Regulatory Requirements for Product on the Discontinued List
Dear Colleagues,
If a drug products has been placed on the discontinued list for a short period of time is it still necessary to submit, annual reports, safety reports and lot distribution reports while the product is on the discontinued list?
Thank you.
------------------------------
David Lucking
Coral Gables FL
United States
------------------------------