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Drug Products - Packaging and Labeling Operations Requirements - 211.130

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21 cfr part 211 - finished pharmaceuticals cgmp, fda (food and drug administration), fda requirements, labeling requirements, pharmaceuticals and pharmaceutical industry, labels and labeling (general)
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  Post Number #1  
Old 30th November 2011, 04:03 PM

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Please Help! Drug Products - Packaging and Labeling Operations Requirements - 211.130

Is it acceptable to re-label or over-label a drug product? We are a small pharmaceutical manufacturing facility in the US. My manager and I have had a long standing, unresolved discussion as to whether it is within compliance to over-label a drug product. I say "No". The only reference I have ever found was with regard to medical devices stating that the practice was "discouraged". Does anyone have a FDA reference that will put this discussion to rest?

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Old 30th November 2011, 04:24 PM
tamale's Avatar

Total Posts: 158
Re: Packaging and labeling operations 211.130

I don't have an FDA reference to give you.

But from a marketing standpoint I wouldn't even by over labeled dog food let alone a pharmaceutical !.

So as you may have deducted, I think its just bad business, very unhealthy good for consumer confidence.

Thank You to tamale for your informative Post and/or Attachment!

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