Are drug expiry dates really a myth? Are drug expiry dates just an industry ploy to keep you buying new bottles of medicine? All of the products are expired. Would you still consider taking any of them? Why or why not? Your answer is probably influenced by a number of factors, including perceptions of risk and benefit. Some feel the expiry date is purely a plot of Big Pharma to sell more drugs. Others believe that drugs start deteriorating long before the expiry date.
The Myth of Drug Expiration Dates
Medically reviewed on Jun 11, by L. Anderson, PharmD Patients often have questions about drug expiration dates: Can I safely take a medication if it has reached the drug expiration date? Are there recommendations about the best way to store my medications? Which drugs should never be used past their expiration date? For many patients, these questions arise because medications can be expensive and it is costly to frequently replace expired but unused medications.
The expiration dating period used for the repackaged product does not exceed (1) 6 months from the date of repackaging; or (2) the manufacturer’s expiration date; or (3) 25% of the time between the date of repackaging and the expiration date shown on the manufacturer’s bulk article container of the drug being repackaged, whichever is earlier.
This chapter does not apply to pharmacists engaged in dispensing prescription drugs in accordance with state practice of pharmacy. The pharmacist needs to apply and other beyond-use date references in the subsection Expiration Date and Beyond-Use Date in the Labeling section under General Notices and Requirements. Repackaging firms repackage preparations for distribution e. Distribution is not patient-specific in that there are no prescriptions.
These containers should meet all of the applicable requirements in this chapter. A contract packager does not take ownership from the manufacturer and generally receives the assigned expiration date from the contractor. Where no specific storage conditions are specified, the product must be maintained at controlled room temperature and in a dry place during the repackaging process, including storage. Nitroglycerin Sublingual Tablets or any other drug product known to have stability problems should not be repackaged.
This would include any drug known to be oxygen-sensitive or one that exhibits extreme moisture or light sensitivity. In deciding whether a particular drug product is suitable for repackaging, the repackager should take into consideration any available information from the manufacturer, published literature, the USP, and the FDA.
Stability profiles of drug products extended beyond labeled expiration dates.
Importance of expiration date depends on the specific drug Dr. I have several medications that are well beyond their expiration dates. Does that mean that they won’t work — or are dangerous? The manufacturer’s expiration date on most medications is years from when the pills were made. This assumes they’re still in their original container. When pharmacies repackage medications, they usually label them with a recommended-use date that’s one year from when the prescription is filled.
§ Expiration dating. To assure that drug products liable to deterioration meet appropriate standards of identity, strength, quality, and purity at the time of use, the label of all such drugs shall have suitable expiration dates which relate to stability tests performed on the products.
Drug manufacturers are required to stamp an expiration date on their products. On over-the-counter OTC medicines, the expiration date is often printed on the label or carton under “EXP” see photo or stamped without ink into the bottom of a bottle, carton, or the crimp of a tube. But what does the expiration date mean? Is a medicine still safe to take after its expiration date?
Will it cause harm or just not work after its expiration date? Neither fully explains what the expiration date means. Actually, it’s the date up until which the drug manufacturer can guarantee that the medicine is fully potent and safe to take based on product testing. Expiration dates are typically conservative to make sure you get what you paid for—a fully potent and safe medicine. The effectiveness of a medicine may decrease over time, but studies have shown that much of the original potency still remains years after the expiration date.
However, it is still advisable to replace medicines that have expired years ago with a new supply to be sure you are using the most up-to-date product with the most up-to-date instructions for use.
Shelf Life and Expiration Dates
Investigational product IP manufacturing and packaging for clinical trials is costly. Every effort must be made to ensure optimal utilization and reduced waste. One way this can be accomplished is to effectively manage product expiration or retest dates. Packaging and labeling requirements often vary by jurisdiction, requiring different labels for each country to be affixed to the package.
Expiry or retest dating may also vary by jurisdiction.
Homeopathic drugs are exempt from expiration dating under the FDA Expiration Dating and Retesting specifications are HPUS monographed HPUS Homeopathic Drug Stability Guidelines. b. Fresh plant material preserved in alcohol should be processed as soon as possible.
Best before[ edit ] A tag sealing a bag of hot dog buns displays a best before date of February Best before or best by dates appear on a wide range of frozen, dried, tinned and other foods. These dates are only advisory and refer to the quality of the product, in contrast with use by dates, which indicate that the product may no longer be safe to consume after the specified date.
Eggs are a special case, since they may contain salmonella which multiplies over time; they should therefore be eaten before the best before date, which is, in the USA, a maximum of 45 days after the eggs are packed. In this case, wording like best before see bottom or best before see lid might be printed on the label and the date marked in a different location as indicated. Use by[ edit ] A foil milk bottle top from the UK displays a use by date of 26 December pressed into the foil.
Generally, foods that have a use by date written on the packaging must not be eaten after the specified date. This is because such foods usually go bad quickly and may be injurious to health if spoiled. It is also important to follow storage instructions carefully for these foods for example, if they specify that the product must be refrigerated.
Bathroom products and toiletries usually state a time in months from the date the product is opened, by which they should be used. This is often indicated by a graphic of an open tub , with the number of months written inside e. Open dating[ edit ] Open dating is the use of a date stamped on the package of a food product to help determine how long to display the product for sale.
Many drugs are just fine years after they ‘expire,’ study finds
Background[ edit ] Shelf life is the recommended maximum time for which products or fresh harvested produce can be stored, during which the defined quality of a specified proportion of the goods remains acceptable under expected or specified conditions of distribution, storage and display. If the cans look okay, they are safe to use. Discard cans that are dented, rusted, or swollen.
The rate of chemical or physical degradation of a drug substance or drug product is increased by using exaggerated storage conditions. A tentative expiration date prediction is made by the use of an Arrhenius plot to predict from high temperature data the rate of product breakdown to be expected at actual storage conditions.
Warning Pesticide and Chemical Warfare Agent Poisoning Primary protection against exposure to chemical nerve agents and insecticide poisoning is the wearing of protective garments e. Uses for Atropine Surgery Used as a preoperative medication to inhibit salivation and excessive secretions of the respiratory tract antisialagogue. Has been administered via oral inhalation for bronchodilation; however, solution for inhalation no longer commercially available in US.
Rate of Administration Preferably give IV injections rapidly because slow injection may cause a paradoxical slowing of the heart rate. Grasp prefilled auto-injector with green tip pointed downward; the yellow activation safety cap should be removed. Grasp prefilled auto-injector with black tip pointed downward; the grey activation safety cap should be removed.
AHA recommends a preintubation dose of 0. Inject 1 mg IM initially for mild symptoms.
Do Food Expiration Dates Really Matter?
Note that in a previously published small study, many drugs that expired 28 to 40 years prior to analysis retained full potency when examined. Researchers tested the potency of 40 expired EpiPen products 31 EpiPens and 9 EpiPen Jrs collected from a single community clinic over a two-week period. The pens had expired one to 50 months prior to analysis. The findings suggest the need for revisiting the process for determining the shelf life of epinephrine autoinjectors, the researchers said, adding that “in the setting of outpatient anaphylaxis without other therapeutic alternatives, patients and caregivers should consider the potential benefits of using an expired EpiPen.
Cantrell said larger studies are needed to confirm findings from both studies. If confirmed, the findings make a strong case for reconsidering current practices regarding drug expiration dating, he said.
The shelf life of many drugs, it wrote, seems to be “considerably longer” than their expiration dates, leading to “unnecessary waste, higher pharmaceutical costs, and possibly reduced access to necessary drugs for some patients.”.
Mercola Now, as you know, I am not a big fan of using prescription drugs for just about any reason. However, I realize that many reading this are in a transition phase or simply unwilling to get off of them at this time. The information in this article can save you enormous amounts of money if you are throwing away your medications because you are following the inaccurately listed expirations dates on the prescription bottle. Prescription drugs typically have an expiration date of one to five years, and if you’re like most people, you would probably think twice before taking a medication past its expiration date.
Medication turnover based on stated expiration dates also costs the medical industry, such as hospitals, pharmacies, and the US military, billions of dollars. According to a new study,1 prescription drugs can actually remain sufficiently potent well past their expiration date, as long as it’s unopened.
That Drug Expiration Date May Be More Myth Than Fact
Back to Top Expiration Date Information Expiration dates serve as a guideline for how long a product remains potent and effective. However, if a product expires on February 2, will it still be good February 3, ? Of course it will.
But according to a new report from ProPublica, most of those drugs are safe and effective for years after the expiration date. And the Food and Drug Administration (FDA) knows it. “It turns out.
Food and Drug Administration FDA proposed to tighten the previously proposed expiration dates for oral solid drugs from one year to just six months after they are repackaged into unit doses, except under certain circumstances. The FDA states that this action was taken in response to “an increasing demand in various health care settings for solid oral dosage form drug products repackaged into unit-dose containers, which hold a quantity of drug for administration as a single dose.
The increase in unit-dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products”. Compliance Policy Guide In addition, once final, it will supersede Compliance Policy Guide Comments regarding the draft document should be submitted within 60 days of publication.
Investigative Report: Do Antibiotic Expiration Dates Matter?
The box of prescription drugs had been forgotten in a back closet of a retail pharmacy for so long that some of the pills predated the moon landing. Most were 30 to 40 years past their expiration dates — possibly toxic, probably worthless. But to Lee Cantrell, who helps run the California Poison Control System, the cache was an opportunity to answer an enduring question about the actual shelf life of drugs: Could these drugs from the bell-bottom era still be potent?
Cantrell called Roy Gerona, a University of California, San Francisco, researcher who specializes in analyzing chemicals. Gerona had grown up in the Philippines and had seen people recover from sickness by taking expired drugs with no apparent ill effects.
The shelf life of many drugs, it wrote, seems to be “considerably longer” than their expiration dates, leading to “unnecessary waste, higher pharmaceutical costs, and possibly reduced access.
Do Antibiotic Expiration Dates Matter? Previous Next Investigative Report: This is part 2 in our special series about antibiotics controversies. See part 1, about fish antibiotics for humans, here. This is one of the first things preppers preparedness-minded people learn when they start stockpiling. Shelf-stable products tend not to suddenly go rancid on the stamped date.