E-drug: Maximum Shelf-life of pharmaceutical products
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Dear E-druggers
My dissertation on the use of expired drugs is now well under way,
and I would like to thank everyone who has commented in any way. The
E-drug conference has been extremely helpful.
I would like to ask another question if I may:
Is there a maximum shelf-life limit set for pharmaceutical products?
For example, are you allowed to give a drug that is stable for 50
years, a shelf-life of 50 years or is it limited to say 5 years?
Who sets this limit (if indeed there is one)?
What are the regulations in the UK?
Are there different regulations around the world?
Any help on this subject would be gratefully received!
Yours faithfully,
Naomi Adams (Miss)
Pharmacy Student, Welsh School of Pharmacy, Cardiff University, UK
AdamsNR@cardiff.ac.uk
[Note from moderator: There is no maximum shelf-life that I know of. The
manufacturer sets this limit. Often, the manufacturer has only tested the
drug for a certain number of years. The Regulatory authorities don't
necessarily regard it as necessary to have a very long shelflife (tablets
are normally max. 5 years) as they assume the products will be sold within
that period. I have also heard people say that anyway labels are subject to
trends and after some years a package may have 'gone out of fashion'! For
disaster preparedness drugs have been tested, in my country by the military
services, and found to have a much longer shelflife - some drugs produced
before 2nd world war are still ok. And in their stocks, drug shelflife has
been extended. This also applies to e.g. infusion fluids in plastic bags
which in a better quality outer bag (which prevents evaporation) may be
stored for a long time. As I think I have mentioned before, I think it is
said that large donors have decided to ask for only three years shelflife on
tenders. Kirsten Myhr]
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