E-DRUG: Can expired drug still be used? (12)
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The comments of Wilbert and Sana are to the point. But there does not seem
to have been anyone commenting on this who had industry pharmaceutical
development experience.
Western Drug Control Agencies give expiry dates
based on validated company stability data under specific controlled
conditions. The norm today is 30 deg C/65%RH. Of course stability at
carefully controlled conditions are never precisely found in practice, so it
is a standard which allows comparison between product data, but does not
guarantee the actual expiration of any product, although the norm takes into
consideration some moderately extreme situations in most countries. Maximum
allowed dating is 5 years, no matter what the stability data show because of
possible differences in real storage conditions.
Conclusion: Products carefully stored will meet their exp date and beyond,
but it is not possible to know (unless they are tested like the US Army did
- not practical for most) how much later they will be fully potent.
While I agree with Wilbert that in general they should not be used, a very
knowledgeable pharmacist who takes the degradation pathway into
consideration, including the physical changes, should be able to make a
reasonable estimate in emergency cases.
Jerome A Reinstein PhD
Reinstein Associates
15 Sydney House, Woodstock Road
London W4 1DP,
United Kingdom
JAR@ReinsteinAssociates.com