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Expiration date where ingredients have different expiration dates


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#1 Chakib

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Posted 09 April 2015 - 05:58 PM

If you are making a Dietary supplement with different ingredients, each or which with a different expiration date, What would be the expiration date of the final product? 

 

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#2 xylough

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Posted 09 April 2015 - 09:05 PM

Hi Chakib,

 

Thanks for your query. The cGMP for dietary supplements (21 CFR Part 111) final rule and its associated guidance for industry indicate that an expiration date is not required. However, compliance with required written procedures and record keeping requirements for component ingredient receiving, rejection, acceptance, batching, labeling, etc., may pose a constraint on a decisions about any representations in dating.

You would still be required to meet the stated potency on your label

You would still have to assure safety of the product

If you do put an expiration date on the label, you are then bound to have a supporting stability study.

It is permissible to have a date of manufacture.

 

IMO it is a matter of risk assessment on each component .What are the risks to consumer safety, to stated product potency, to brand integrity, to regulatory action if you knowingly use an ingredient that may ultimately compromise the product as represented in the sum total of its documentation and labeling?

 

http://www.fda.gov/F...P/ucm079496.htm

http://www.fda.gov/F...s/ucm238182.htm

 

Regards,

 

Xylough



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#3 Charles.C

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Posted 09 April 2015 - 09:53 PM

hi xylough,

 

Interesting answer. Thks.

 

IMEX for frozen foods prepared from stocks of prefrozen ingredients, this is a conceptual analog. Not to mention re-packing.

 

And not only for foods, i saw this Pharmacist's Guideline for Drug expiration dates -

 

Attached File  drug expiration dates.pdf   121.12KB   23 downloads


Kind Regards,

 

Charles.C


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