The Food and Drug Administration has extended the expiration date for certain lots of Mylan’s EpiPen, an attempt to offset current shortages stemming from a variety of supply and manufacturing issues. The extension of four months beyond the approved month shelf life is based on reviews of the data for specific lots of Mylan’s epinephrine auto-injector that are expired or close to expiring. Adamis Pharmaceuticals also has approval for a prefilled epinephrine syringe, known as Symjepi. Supply issues for Mylan’s EpiPen and its authorized generic drag on, resulting from manufacturing issues at Pfizer’s subsidiary, Meridian Medical Technologies. While Mylan and Pfizer have said they are exploring options “that would help stabilize supply,” the FDA has stepped in, in an attempt to head off a shortage before the beginning of the U. This is traditionally a period of high demand for the product. We are doing everything we can to help mitigate shortages of these products, especially ahead of the back-to-school season,” said Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research in an FDA in Brief note. Impax Laboratories’ Adrenaclick, which the FDA has suggested as an alternative, is currently undergoing its own supply challenges. Any affected auto-injectors should be returned to a pharmacy.
What Your Pharmacist Can’t Tell You About Drug Expiration Dates: ‘It’s Complicated’
FDA study gets to the heart of expired medicine and safety Updated: August 13, Published: November, The big question is, do pills expire?
The FDA was created in the early 20th century because real live bugs would be in the meat supply – read “The Jungle” by Upton Sinclair. Helpful, trusted answers from doctors: Dr. Ali on fda food expiration dates: I’m not clear on your question.
All rights reserved All commercially distributed Drug Products and Over-The Counter OTC consumer products that require expiration dating shall be labeled with an Expiration Date that is consumer readable. APIs shall be assigned and labeled with expiration dates only if it is registered or required by local regulation.
Re-evaluation dating for APIs is outside the scope of this article. Expiration dates must relate to any storage conditions stated on the label. The expiration date assignment format shall be based on the requirements for the product market. For APIs, the Expiration Date of the Blended Batch shall be based on the manufacturing date of the oldest tailings or batch in the blend.
Drug Expiration Dates — Do They Mean Anything?
Experts provide a guide to the variety of confusing ‘freshness’ dates on food. Will you sniff this? The approved way lies in a voluntary system of labeling.
chapter i – food and drug administration, department of health and human services (continued) (parts 1 – ) Download This section of the CFR has been printed across multiple volumes.
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. Since you last purchased the product, new dosing instructions or warnings may be advised; the strength may have changed to reduce the risk of errors; a new dosing device may be available to help measure doses more accurately; the product may be packaged in a new container more child-resistant than an older version of the drug; and so on.
So, clean out your medicine supplies regularly, and replace any medicines that are more than a year or two beyond its expiration date. The Medical Letter on Drugs and Therapeutics.
What do the terms “closed dating” and “open dating” mean?
Freezing and boiling temperatures break down the chemicals in plastic bottles which can then leak into the liquid. You can freeze and re-freeze them but NOT sparkling water for use in a cooler or ice chest – but do not drink them when thawed see further notes below. Of course, all food and drink products last for a shorter period of time if they are not stored properly.
But remember, UN-like a lot of other drinks , it does not usually have a sell by date because water has an indefinite expiration date.
FDA in brief: FDA takes additional action to mitigate shortages of EpiPen by extending expiration date for specific lots of medication [news release]. Silver Spring, MD; FDA website: August 21,
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. High-acid canned foods tomatoes, fruits will keep their best quality for 12 to 18 months; low-acid canned foods meats, vegetables for 2 to 5 years.
Most food is still edible after the expiration date. In most food stores, waste is minimized by using stock rotation , which involves moving products with the earliest sell by date from the warehouse to the sales area, and then to the front of the shelf, so that most shoppers will pick them up first and thus they are likely to be sold before the end of their shelf life.
This is important, as consumers enjoy fresher goods, and furthermore some stores can be fined for selling out of date products; most if not all would have to mark such products down as wasted , resulting in a financial loss. Shelf life depends on the degradation mechanism of the specific product.
Do Food Expiration Dates Really Matter?
You may want to read this page first for background. There is no uniform or universally accepted system used for food dating in the United States. Although dating of some foods is required by more than 20 states, there are areas of the country where much of the food supply has some type of open date and other areas where almost no food is dated. Food expiration date coding is a nightmare for the consumer to interpret. There is no standard. Each vendor decides how they want to do it.
FDA is monitoring the IV fluid shortage occurring due to Hurricane Maria and is asking companies to submit data for the possibility of extending expiration dates.
It is a piece that has been available on the Web for about a year but was brought to my attention recently. It answers a question that I have asked and been asked multiple times. Before I found this, no one had ever given me a straight answer about what the expiration dates on medications mean and how seriously they should be taken.
This is an important issue, and I think that psychopharmacologists, if not all practitioners and patients, will find this column immensely helpful. It is well researched, well written, and I wish that I had written it myself. If a bottle of Tylenol, for example, says something like “Do not use after June ,” and it is August , should you take the Tylenol? Should you discard it? Can you get hurt if you take it? Will it simply have lost its potency and do you no good?
In other words, are drug manufacturers being honest with us when they put an expiration date on their medications, or is the practice of dating just another drug industry scam, to get us to buy new medications when the old ones that purportedly have “expired” are still perfectly good? These are the pressing questions I investigated after my mother-in-law recently said to me, “It doesn’t mean anything,” when I pointed out that the Tylenol she was about to take had “expired” 4 years and a few months ago.
I was a bit mocking in my pronouncement — feeling superior that I had noticed the chemical corpse in her cabinet — but she was equally adamant in her reply, and is generally very sage about medical issues. So I gave her a glass of water with the purportedly “dead” drug, of which she took 2 capsules for a pain in the upper back.
About a half hour later she reported the pain seemed to have eased up a bit.
What Your Pharmacist Can’t Tell You About Drug Expiration Dates: ‘It’s Complicated’
Health Library Drug Expiration Dates: How Accurate Are They? Since , the Food and Drug Administration FDA has required pharmaceutical manufacturers to provide expiration dates on all their products. For the majority of drugs sold in the United States, these dates range from 12 to 60 months from the date they are manufactured.
The Food and Drug Administration has extended the expiration date of some EpiPens to address shortages of the device. The FDA announced Tuesday that .
Fifteen years ago, the U. The testing, conducted by the U. Food and Drug Administration, ultimately covered more than drugs, prescription and over-the-counter. In light of these results, a former director of the testing program, Francis Flaherty, says he has concluded that expiration dates put on by manufacturers typically have no bearing on whether a drug is usable for longer. Flaherty notes that a drug maker is required to prove only that a drug is still good on whatever expiration date the company chooses to set.
The expiration date doesn’t mean, or even suggest, that the drug will stop being effective after that, nor that it will become harmful. Flaherty, a pharmacist at the FDA until his retirement last year. Still, Joel Davis, a former FDA expiration-date compliance chief, says that with a handful of exceptions — notably nitroglycerin, insulin and some liquid antibiotics — most drugs are probably as durable as those the agency has tested for the military.
And they acknowledge that expiration dates have a commercial dimension. But they say relatively short shelf lives make sense from a public-safety standpoint, as well. New, more-beneficial drugs can be brought on the market more easily if the old ones are discarded within a couple of years, they say. Label redesigns work better when consumers don’t have earlier versions on hand to create confusion. From the companies’ perspective, any liability or safety risk is diminished by limiting the period during which a consumer might misuse or improperly store a drug.
Now that the FDA has found that many drugs are still good long after they have supposedly expired, why doesn’t it advocate later expiration dates for consumer drugs?