Regulatory Open Forum

My company is in the process of purchasing several topical drug products from another company and wants to over-label and re-serialize existing unreleased inventory using a separate 3rd party contract packaging organization. The idea has also been floated to manufacture new product using the old company labels after the sale is completed with the intention to then over-label this new product in the same manner. The idea of purposely manufacturing product with the intent to re-label it does not sit well with me for many reasons, but I would appreciate any thoughts or comments about this approach. Thanks.

Since its a purchase of products and given that transition takes time, over-labeling is not an issue. However, you should document the rationale (i.e. how many new batches and till how long will you do this....etc) and promptly end the over-labeling once your transition (upfront time to complete should be established) is completed.

My company is in the process of purchasing several topical drug products from another company and wants to over-label and re-serialize existing unreleased inventory using a separate 3rd party contract packaging organization. The idea has also been floated to manufacture new product using the old company labels after the sale is completed with the intention to then over-label this new product in the same manner. The idea of purposely manufacturing product with the intent to re-label it does not sit well with me for many reasons, but I would appreciate any thoughts or comments about this approach. Thanks.

Dear , 

Will you please give the reference article of GMP guidance for this , i do agree with your proposal but i couldn't find the reference paragraph in GMP guidance that supports . 

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Hakima Hoseh
Regulatory Affairs compliance S manager
Amman
Jordan

Original Message:
Sent: 24-Dec-2020 10:25
From: Anonymous Member
Subject: Re-labeling/over-labeling of finished drug product

This message was posted by a user wishing to remain anonymous

Since its a purchase of products and given that transition takes time, over-labeling is not an issue. However, you should document the rationale (i.e. how many new batches and till how long will you do this....etc) and promptly end the over-labeling once your transition (upfront time to complete should be established) is completed.

My company is in the process of purchasing several topical drug products from another company and wants to over-label and re-serialize existing unreleased inventory using a separate 3rd party contract packaging organization. The idea has also been floated to manufacture new product using the old company labels after the sale is completed with the intention to then over-label this new product in the same manner. The idea of purposely manufacturing product with the intent to re-label it does not sit well with me for many reasons, but I would appreciate any thoughts or comments about this approach. Thanks.

Since its a purchase of products and given that transition takes time, over-labeling is not an issue. However, you should document the rationale (i.e. how many new batches and till how long will you do this....etc) and promptly end the over-labeling once your transition (upfront time to complete should be established) is completed.

My company is in the process of purchasing several topical drug products from another company and wants to over-label and re-serialize existing unreleased inventory using a separate 3rd party contract packaging organization. The idea has also been floated to manufacture new product using the old company labels after the sale is completed with the intention to then over-label this new product in the same manner. The idea of purposely manufacturing product with the intent to re-label it does not sit well with me for many reasons, but I would appreciate any thoughts or comments about this approach. Thanks.

My company is in the process of purchasing several topical drug products from another company and wants to over-label and re-serialize existing unreleased inventory using a separate 3rd party contract packaging organization. The idea has also been floated to manufacture new product using the old company labels after the sale is completed with the intention to then over-label this new product in the same manner. The idea of purposely manufacturing product with the intent to re-label it does not sit well with me for many reasons, but I would appreciate any thoughts or comments about this approach. Thanks.

Hi Anon.

My first question on this is what is the basic reason for wanting to actually produce with the old (theoretically incorrect) labeling only to then over-label?  If this is a "cost saving" measure (the company management doesn't want to throw away any old labeling) then you need to consider whether or not the costs of producing the over-label plus the costs of transport plus the costs of the actual over-labeling activity for all of these units is still profitable.  More importantly, I am assuming that the company producing the product under the old labeling will either go out of business (potentially due to you buying the company) or will at minimum delist the items as part of their drug listing.  If there is any notation of this business on the old label, there is a potential for misbranding to be found during an inspection for the period of time after the sale up and until you relabel the product.  

Generally I hate the idea of over-labeling for multiple reasons, not the least of which is the fact that you effectively concede the fact that the product is incorrectly labeled in your facility to begin with and therefore you have in essence admitted to a failure of your GMP label review system.  If you are intentionally doing this knowing that the label is incorrect when you run the production of the product, I would think that would be willful misconduct.  I think if you document, as noted by another respondent earlier in the replies to your original post, as a deviation, you might be in a better place but there really does need to be a strong rationale, in my opinion, before I would sign off on this deviation from the typical labeling requirements.

My company is in the process of purchasing several topical drug products from another company and wants to over-label and re-serialize existing unreleased inventory using a separate 3rd party contract packaging organization. The idea has also been floated to manufacture new product using the old company labels after the sale is completed with the intention to then over-label this new product in the same manner. The idea of purposely manufacturing product with the intent to re-label it does not sit well with me for many reasons, but I would appreciate any thoughts or comments about this approach. Thanks.

Hi Anon.

My first question on this is what is the basic reason for wanting to actually produce with the old (theoretically incorrect) labeling only to then over-label?  If this is a "cost saving" measure (the company management doesn't want to throw away any old labeling) then you need to consider whether or not the costs of producing the over-label plus the costs of transport plus the costs of the actual over-labeling activity for all of these units is still profitable.  More importantly, I am assuming that the company producing the product under the old labeling will either go out of business (potentially due to you buying the company) or will at minimum delist the items as part of their drug listing.  If there is any notation of this business on the old label, there is a potential for misbranding to be found during an inspection for the period of time after the sale up and until you relabel the product.  

Generally I hate the idea of over-labeling for multiple reasons, not the least of which is the fact that you effectively concede the fact that the product is incorrectly labeled in your facility to begin with and therefore you have in essence admitted to a failure of your GMP label review system.  If you are intentionally doing this knowing that the label is incorrect when you run the production of the product, I would think that would be willful misconduct.  I think if you document, as noted by another respondent earlier in the replies to your original post, as a deviation, you might be in a better place but there really does need to be a strong rationale, in my opinion, before I would sign off on this deviation from the typical labeling requirements.

My company is in the process of purchasing several topical drug products from another company and wants to over-label and re-serialize existing unreleased inventory using a separate 3rd party contract packaging organization. The idea has also been floated to manufacture new product using the old company labels after the sale is completed with the intention to then over-label this new product in the same manner. The idea of purposely manufacturing product with the intent to re-label it does not sit well with me for many reasons, but I would appreciate any thoughts or comments about this approach. Thanks.

Sorry, I hate to say this, Mr. V is absolutely incorrect! There are so many acquisitions going on in the last 5 or 10 years, re-labeling of the existing inventory from the old company is not an issue from the compliance stand point. The only grey area that was addressed by the anonymous above (i.e. documenting rationale) is regarding re-labeling the products that are produced fresh!

Hi Anon.

My first question on this is what is the basic reason for wanting to actually produce with the old (theoretically incorrect) labeling only to then over-label?  If this is a "cost saving" measure (the company management doesn't want to throw away any old labeling) then you need to consider whether or not the costs of producing the over-label plus the costs of transport plus the costs of the actual over-labeling activity for all of these units is still profitable.  More importantly, I am assuming that the company producing the product under the old labeling will either go out of business (potentially due to you buying the company) or will at minimum delist the items as part of their drug listing.  If there is any notation of this business on the old label, there is a potential for misbranding to be found during an inspection for the period of time after the sale up and until you relabel the product.  

Generally I hate the idea of over-labeling for multiple reasons, not the least of which is the fact that you effectively concede the fact that the product is incorrectly labeled in your facility to begin with and therefore you have in essence admitted to a failure of your GMP label review system.  If you are intentionally doing this knowing that the label is incorrect when you run the production of the product, I would think that would be willful misconduct.  I think if you document, as noted by another respondent earlier in the replies to your original post, as a deviation, you might be in a better place but there really does need to be a strong rationale, in my opinion, before I would sign off on this deviation from the typical labeling requirements.

My company is in the process of purchasing several topical drug products from another company and wants to over-label and re-serialize existing unreleased inventory using a separate 3rd party contract packaging organization. The idea has also been floated to manufacture new product using the old company labels after the sale is completed with the intention to then over-label this new product in the same manner. The idea of purposely manufacturing product with the intent to re-label it does not sit well with me for many reasons, but I would appreciate any thoughts or comments about this approach. Thanks.

My company is in the process of purchasing several topical drug products from another company and wants to over-label and re-serialize existing unreleased inventory using a separate 3rd party contract packaging organization. The idea has also been floated to manufacture new product using the old company labels after the sale is completed with the intention to then over-label this new product in the same manner. The idea of purposely manufacturing product with the intent to re-label it does not sit well with me for many reasons, but I would appreciate any thoughts or comments about this approach. Thanks.