While it is completely legal to do so provided you can present evidence that the formulation in the package matches that of the tested material that now can be extended, a couple of key thoughts come to mind on this point:
1. If the expiration date is to be extended to or beyond 3 years, there is no expiration date required at all per the regulations. So if you are extending to 3 years, it might be simpler to relabel rather than overlabel.
2. If the decision is to overlabel the product at this point, the rules are fairly straight-forward: make sure that the information is all correct; ensure that the overlabel only covers up what is absolutely necessary and nothing more; assure that the overlabel does not in any way obscure any required information on the packaging (thinking here of any information in the drug facts box, the domicile and contact information, the net contents, etc.); and if you can do all of that without problem, the label must be such that it is not reasonably possible to have the label obscured or in some way dissociated from the packaging that it is attached to.
3. Whatever you decide, I strongly suggest having a sample of the overlabeled packaging placed in any and all batch folders for the product so that there is contemporaneous evidence of how the overlabeled product was able to meet the requirements. Otherwise, it could become a "he said/FDA said" thing that you don't want to be in the middle of.
4. You also need to think about/consider how you might handle questions that arise in the field when someone looks at product potentially from the same lot number with different expiration dates (or someone who had a product and is purchasing replacement product potentially of the same lot) so you will want an answer to that question and you will want to be very consistent with that answer. Otherwise you could drive an individual to contact FDA which leads to lots of questions or contact a lawyer which could lead to a lot more questions.
Honestly, I have never been a fan of overlabeling old inventory. I have always recommended that the new expiration date be used prospectively on the very next lot produced out of the facility. This eliminates all of these issues and in my opinion the cleanest way to handle this. So my question here would be, "What is the reason for choosing to relabel an extended expiration date on product already manufactured versus simply using the new expiration period on the future production lots?" If the answer is simply that the company would like to be able to sell the product in their warehouse to the field for a longer period of time, I might wonder if there needs to be a different discussion (discontinuation; smaller production runs/batch sizes; etc.) than the expiration date.
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Victor Mencarelli
Global Director Regulatory Affairs
MelvilleNY
United States
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Original Message:
Sent: 31-Mar-2021 14:06
From: Anonymous Member
Subject: OTC product -over label
This message was posted by a user wishing to remain anonymous
"Relabeling and Over-labeling - Discouraged but acceptable
Over-labeling by placing a new label over an old label is discouraged by FDA but is acceptable as long as the new label and its use meet GMP requirements for attachment, legibility, reprocessing, and change control. (Over-labeling is also discouraged in some foreign countries.)"
https://www.fda.gov/medical-devices/device-labeling/quality-system-regulation-labeling-requirements
Original Message:
Sent: 31-Mar-2021 11:37
From: Aimei Wu
Subject: OTC product -over label
Thank you so much for your kindly reply. Would you please share the source of regulatory compliance? I was not able to find it. Really appreciate your help.
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Aimei Wu RAC
Manager, Product Safety and Regulatory Affairs
Southlake TX
United States
Original Message:
Sent: 31-Mar-2021 09:25
From: Anonymous Member
Subject: OTC product -over label
This message was posted by a user wishing to remain anonymous
Yes until the current inventory is depleted then you have to print new labels for the new lots!
Original Message:
Sent: 30-Mar-2021 23:21
From: Anonymous Member
Subject: OTC product -over label
This message was posted by a user wishing to remain anonymous
If the shelf life of a topical OTC product is extended for one more year with stability data support, can the expiration date be over-labelled? Thanks for your help!