Why do drugs have an expiration date

Are drugs ineffective or even questionable after the expiration date? The German Medicines Act (AMG) stipulates that an expiry date be given on the containers and outer packaging of finished medicinal products. The package insert must indicate that an expired medicinal product may no longer be used (Sections 10 and 11 AMG). The manufacturer has verified the shelf life for the period up to the specified date by means of suitable tests. However, the drug is then not automatically unusable due to a change in the substance. According to US studies on shelf life, 84% of more than 1,000 unopened packaging units about 100 different pharmaceuticals from military stocks under the usual dry storage conditions retain at least 90% of their potency on average 57 months after the expiry date (TAYLOR, JS et al .: http: / /www.cfsan.fda.gov/cgi-bin/abs02.cgi? taylor [Abstract]). The antiviral agent amantadine proves to be stable even after 25 years of storage (stated shelf life: four years), the bronchodilator theophylline even after 30 years (declared: five years). Solutions and suspensions are less stable than solid preparations. They are also particularly sensitive to frost. Liquid medicinal products should no longer be used if they become cloudy or discolored. With eye drops, it is often not the stability of the active ingredient that limits the shelf life, but the declining antimicrobial function of the preservatives. If used beyond the expiration date, there are usually no toxicological concerns with today's finished medicinal products. The epitetracycline, which was previously found in old tetracycline products, does not seem to be present in today's galenics either. Toxic effects are therefore not to be feared after the specified expiry date. How long drugs can be used beyond the expiration date depends on the active ingredients, the preparation form and the storage conditions. Most solid drugs retain more than 90% of their potency five years after expiration, in some cases even considerably longer (Medical Letter 2002; 44: 93-4). However, there is a legal problem to bear in mind: The manufacturer's liability ends when the expiry date, -Red.

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