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Pharmaceuticals/Finished product expiration date


Dear Professor Anisfeld, I would appreciate answering the following questions:
1-If you have an API of natural source ( e.g nystatin, neomycin, polymixin ) and was used in a product , should this product bear an expiration date that matches that of the API???.
2- If a stability study has been done for that finished product( containing one or more of the above mentioned APIs) and was shown to be stable for e.g two years, could this product be assigned a two year shelf life regardless the expiration date of the API used.
M. Etman

Dear Mohammed:

With the exception of finished product sold in India, which needs to conform to your first option - the finished product cannot have an expiration date longer that the APIs re-test date; all other countries go with your second option - namely, if you have a finished product stability study showing that the API in its formulation exhibits a specific stability time, then you can use that for your expiration dating.

I hope this helps.


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Michael Anisfeld


Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements


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