DRUG EXPIRATION DATES?

[Guest guest]

DeeTroll wrote: HI all this is sort of 'off topic' but I hope you find it interesting. I'm onewho hangs onto 'most' drugs past their expiration dates (always pinchingpennies) and 'I've' never had a problem and they were still very effective (but I'm not telling anyone else to) *smile* Someone else told me they worked for a doctor who sent expired drugs to 3rd world countries for hospitals, missionaries etc.. and he said the same thing. Some

'may' lose their potency but they weren't dangerous or risky.For what it's worth. ;)Dee~(copied from a pdf file.) The Medical LetterOn Drugs and TherapeuticsPublished by The Medical Letter, Inc. 1000 Main Street, New Rochelle, NY 10801A Nonprofit PublicationVol. 44 (W1142B)REPRODUCED FOR ONLINE USERSDRUGS PAST THEIR EXPIRATION DATEPhysicians and pharmacists are often asked if patients can use drugs after theirexpiration date. Pharmaceutical companies, because of legal restrictions andliability concerns, will not sanction such use and may not even comment on thesafety or effectiveness of using their products beyond the date on the label.THE EXPIRATION DATE — The expiration date on the manufacturer’s package is basedon the stability of the drug in its

original closed container. The date does notnecessarily mean that the drug was found to be unstable after a longer period;it means only that real-time data or extrapolations from accelerated degradationstudies indicate that the drug will still be stable at that date.The expiration date for new drugs is usually 2-3 years from the date ofmanufacture.Once the original container is opened for use or dispensing, the expirationdate on the container no longer applies and FDA regulations require the druggist to put an expiration date which may be much longer on the original package.Retail pharmacists who repackage drugs, in accordance with the standards of theUS Pharmacopoeia (USP), label them with a "beyond-use" date, generally one yearfrom the date the prescription is filled.SAFETY —The 'only' report of human toxicity that may have been caused by chemical orphysical degradation of a pharmaceutical

product is renal tubular damage thatwas associated with use of degraded tetracycline (GW Frimpter et al, JAMA in1963; 184:111).Current tetracycline preparations have been reformulated with different fillersto minimize degradation and are unlikely to have this effect.STABILITY — Shelf life is the time a product, stored under reasonableconditions, is expected to remain stable and generally retain >90% of potency. (B Kommanaboyina and CT , Drug Dev Ind Pharm 1999; 25:857).Data from the Department of Defense/FDA Shelf Life Extension Program, whichtests the stability of drug products past their expiration date, showed that 84%of 1122 lots of 96 different drug products stored in military facilities intheir unopened original containers would be expected to remain stable for anaverage of 57 months after their original expiration date(JS et al, 2002 FDA Science Forum Poster Abstract, Board

AC-08,www.fda.gov, search "2002 FDA science forum").Storage in high humidity may interfere with the dissolution characteristics ofsome oral formulations. In one published study, however, captopril (Capoten)tablets, flucloxacillin sodium (Flucloxin) capsules (a penicillin not availablein the US), cefoxitin sodium (Mefoxin) powder for injection and theophylline(Theo-Dur) tablets stored under both ambient and "stress" (40°C and 75% relativehumidity) conditions remained chemically and physically stable for 1.5 to 9 yearsbeyond their expiration dates (G Stark et al, Pharm J 1997; 258:637).Amantadine (Symmetrel) and rimantidine (Flumadine) remained stable after storagefor 25 years under ambient conditions, and retained full antiviral activity evenafter boiling and holding at 65-85°C for several days (C Scholtissek and RGWebster, Antiviral Res 1998; 38:213).In another report, theophylline retained 90% of potency for

about 30 years (RRegenthal et al, Hum Exp Toxicol 2002; 21:343).LIQUID DRUGS — Drugs in liquid form (solutions and suspensions) are not asstable as solid dosage forms. Suspensions are especially susceptible tofreezing. Drugs in solution, particularly injectables, that have become cloudyor discolored or show signs of precipitation should not be used. When oral drugsare in solution with dyes, however, color changes may be due to degradation ofthe dye and not the drug.Epinephrine in EpiPen injections loses potency after its expiration date; in onestudy, 5 of 7 autoinjectors contained less than 90% of the labeled epinephrinecontent 10 months after the expiration date, without necessarily beingdiscolored or showing signs of precipitation (FER Simons et al, J Allergy ClinImmunol 2000; 105:1025).Drugs prepared by addition of a solvent before dispensing or administration(such as suspensions of antibiotics for oral

use or lyophilized drugs in vialsfor parenteral use) tend to be relatively unstable in the liquid state.With ophthalmic drugs, the limiting factor may not be the stability of the drug,but the continued ability of the preservative to inhibit microbial growth.CONCLUSION — There are virtually 'no' reports of toxicity from degradationproducts of outdated drugs. How much of their potency they retain varies withthe drug and the storage conditions, especially humidity, but many drugs storedunder reasonable conditions retain 90% of their potency for at least 5 yearsafter the expiration date on the label, and sometimes much longer.THE MEDICAL LETTER A NONPROFIT ORGANIZATIONMailing Address:The Medical Letter, Inc. 1000 Main Street,New Rochelle, NY10801-7537 Customer Service: Toll-free: Phone: Fax:The editors and publisher do not warrant that all the material in

thispublication is accurate and complete in every respect. The editors and publishershall not be held responsible for any damage resulting from any error,inaccuracy or omission.