Drug Products - Packaging and Labeling Operations Requirements - 211.130

[immanentq]

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?

 

[tamale]

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.

Tamale