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Best Before or Expiration date for OTC-drugs?
My CMO says it’s OK to use Best Before dates for OTC acne treatments (this would be preferable for obvious reasons) as a FDA inspector allegedly said it was OK.
Just want to make sure this is ok, as I can’t find any reference to it.
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5 Replies
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All finished drug products I have seen have an Expiry Date.
This is in the UK and Europe. As you are in Hungary, Zink, I assume this applies to you. The FDA is powerless over here despite what they might want you to believe.
Check the European Medicines Agency web site for a definitive answer http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001772.jsp&mid=WC0b01ac0580b18a39
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I’m in California ATM! Not sure where you got Hungary from.
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Maybe you once said you were hungry in a different discussion.
I think you should ask an FDA inspector and not rely on what the CMO says. The FDA says “The expiration date, when applicable (date after which you should not use the product)”
Relevant.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=211.137 -
for OTC drugs, expiration date. No doubts.
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Zink, apologies about me thinking you are in Hungary. The mistake arose from me looking at your “about” page where the first entry is from a Hungarian contract manufacturer. My speed reading led to the error!
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