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[e-drug] Stability of drugs beyond labeled expiration dates

E-DRUG: Stability of drugs beyond labeled expiration dates
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[As a follow-on to postings on recycling of drugs in the US, Riaz has (below) 
commented on a study done by the US Army on stability of medicines beyond 
labeled expiration dates (SLEP). Reference to the published study is given. The 
same study was commented on in an article in Wall Street Journal some years ago 
and you will find the articcle in the E-drug archive on 30 March 2000. Here the 
moderator have copied Mark Raijmakers comment to the article as it appears in 
that posting: 
     'Forwarded to me from the US, the Wall Street Journal (WSJ)on drug 
donations and expired drugs. The contribution in the WSJ on pharmaceuticals is 
split into two sections: 'major business news' on donations of expired drugs 
and a 'page one feature' analysis of the reasons behind expiry-date setting of 
medicines. 
     The 'major business news' is a very business minded article paying no 
attention to the complexity of drug donations' practice suggesting developing 
countries should accept expired drugs because the US military has done tests 
that prove them usable. The article is not providing any 
arguments why expired drug donations are or should not be accepted in many 
donations' cases. It also doesn't pay attention to the context of drug 
donations to developing countries where in the majority of cases expired drugs 
cannot be tested like the US military has done.
     The 'page one feature' analysis will certainly provoke a lot of discussion 
about the real reasons of expiry-date setting. The WSJ article merely suggests 
that marketing or economical reasons are the reasons of expiry-date setting 
although some quality arguments are also incorporated into the article. 
     For you that remember ... on the e-drug mailing list there has been an 
extensive discussion on expired drug donations between May 8 and May 23, 1997. 
More than 10 e-druggers participated in this discussion which provides some 
interesting viewpoints on the issue of donating expired drugs.'

Regards,
Mark Raijmakers]
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Does anyone know and have access to the US Department of Defense study 
on drug expiry and drug stability?

I recall it reached some stunning conclusions on the stability of 
many drugs necessary in conflict situations, including many drugs on the 
EDL's of developing countries. The empirical evidence this provides may 
usefully inform the debate. It may also tell us much about the need to 
keeping sales high.

Lyon RC (1), Taylor JS (1), Porter DA (2), Prasanna HR (1), Hussain AS (3). 
Stability profiles of drug products extended beyond labeled expiration dates. 
Journal of pharmaceutical sciences 2006; 95(7): 1549-1560.
Affiliation(s): (1) Division of Product Quality Research, Center for Drug 
Evaluation and Research, Food and Drug Administration, HFD-941, White Oak, Life 
Sciences Building 64, 10903 New Hampshire Avenue, Silver Spring, 
Maryland 20993-0002, USA (2) Division of Field Science, Office of Regional 
Operations, Office of Regulatory Affairs, Food and Drug Administration, 
Rockville, Maryland 20857, USA (3) Vice President & Global Head of 
Biopharmaceutical Development, Sandoz, 506 Carnegie Center, Princeton, New 
Jersey 08540, USA

Abstract
The American Medical Association has questioned whether expiration 
dating markedly underestimates the actual shelf life of drug products. 
Results from the shelf life extension program (SLEP) have been evaluated 
to provide extensive data to address this issue. The SLEP has been 
administered by the Food and Drug Administration for the United States 
Department of Defense (DOD) for 20 years. This program probably contains 
the most extensive source of pharmaceutical stability data extant. This 
report summarizes extended stability profiles for 122 different drug 
products (3005 different lots). The drug products were categorized into 
five groups based on incidence of initial extension failures and 
termination failures (extended lot eventually failed upon re-testing). 
Based on testing and stability assessment, 88% of the lots were extended 
at least 1 year beyond their original expiration date for an average 
extension of 66 months, but the additional stability period was highly 
variable. The SLEP data supports the assertion that many drug products, 
if properly stored, can be extended past the expiration date. Due to the 
lot-to-lot variability, the stability and quality of extended drug 
products can only be assured by periodic testing and systematic 
evaluation of each lot.

Riaz Tayob
Third World Network
riaz.tayob@gmail.com


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