Stability Testing Requirements For OTC & Drug Products in the USA

Elisabeth Anderson ; Jinpeng Li – May 4, Did you know medications and even disinfecting products expire? In this post, we cover the basics around medication and disinfectant product expiration dates. Yes, the U. The U. Unlike identifying spoiled foods and cosmetics that you can easily and quickly recognize as expired via sight, touch, or smell, there may not be any obvious sign that a drug or disinfectant is no longer effective. The same can be true for many disinfecting products, the product may look and smell identical to the purchase date, but it may no longer work effectively. Beyond the expiration date, the manufacturer cannot guarantee the product will work effectively for the dose and dose-rate recommended, and there is no easy way to determine the potency of the expired medication.

The FDA knows expiration dates are confusing, so they’re changing them

This applies to both doxycycline monohydrate and doxycycline hyclate tablets and capsules equivalent to 50 milligrams mg and mg of doxycycline that are indicated for PEP or treatment of inhalational anthrax. Additional information about MCM expiration dating extensions, including currently authorized doxycycline expiry dating extensions, can be found here. Aug 20, Kimberly Sharpe-Scott.

labeled expiration dates.5 In a modification to the. AMA Policy H, the pharmaceutical industry, the Food and Drug Administration. (FDA) and the United​.

Lee Cantrell, an associate professor of clinical pharmacology at the University of California, San Diego, with a collection of vintage expired medications. Sandy Huffaker for ProPublica hide caption. 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 grew up in the Philippines and had seen people recover from sickness by taking expired drugs with no apparent ill effects. The age of the drugs might have been bizarre, but the question the researchers wanted to answer wasn’t. Pharmacies across the country in major medical centers and in neighborhood strip malls routinely toss out tons of scarce and potentially valuable prescription drugs when they hit their expiration dates.

Gerona, a pharmacist; and Cantrell, a toxicologist, knew that the term “expiration date” was a misnomer. The dates on drug labels are simply the point up to which the Food and Drug Administration and pharmaceutical companies guarantee their effectiveness, typically at two or three years.

FDA addresses EpiPen shortage by extending expiration dates

Publishing of 21 CFR Part – Current Good Manufacturing Practice for Finished Pharmaceuticals established requirements concerning the expiration date on a drug product and stability testing to assure the appropriateness of that date. Each drug product may be a unique article because of, for instance, differences in 1 chemical and physical properties of the active ingredients or the excipients, 2 manufacturing procedures, 3 formulations, 4 containers and closures, 5 proposed storage conditions, and 6 the stability of the article to maintain its quality or purity through the use of antioxidants or preservatives.

Because of the uniqueness of each drug product, it is virtually impossible to provide one set of rules that can apply to all situations. The CGMPs were purposely written broadly to allow for such unique differences. The absence of an expiration date on any drug product packaged after September 29, , except for those drugs specifically exempt by

Hospitals and pharmacies are required to toss expired drugs, no matter how expensive, vital or scarce. And that’s even though the FDA has.

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. This program probably contains the most extensive source of pharmaceutical stability data extant. This report summarizes extended stability profiles for different drug products 3, 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.

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. Abstract The American Medical Association has questioned whether expiration dating markedly underestimates the actual shelf life of drug products.

Substances Pharmaceutical Preparations.

FDA Allows Expiration Date Exception for Unit-Dose Repackaged Oral Drugs

By clarifying the meaning of such dates, they are trying to prevent people from prematurely tossing products and to reduce the mountains of food that goes to waste each year. Even if you rely more on sight and smell to size up foods, you might be surprised by the risks and practices around food spoilage. Phrases like “Best By”, “Enjoy By” and “Fresh Through” generally indicate when a food’s quality would decline — not when it becomes unsafe to eat.

The company claimed to have data to support a six-month expiration date, but the FDA said it never made the information available.

This is a good question and deserves an answer. Homeopathic remedies are also exempt from expiration dating see 21 CFR Section However, we were uncertain whether there are current and generally available methods to determine the expiration dating of other dietary ingredients. We did not propose to require expiration dating because we had insufficient scientific information to determine the biological activity of certain dietary ingredients used in dietary supplements, and such information would be necessary to determine an expiration date.

Further, because official validated testing methods e. Association of Official Analytical Chemists [AOAC International] , for dietary supplements are evolving, especially for botanical dietary ingredients, such methods are not always available to assess the strength of a dietary ingredient in a dietary supplement. A dietary supplement company may use either the date of expiration or of manufacture.

Either is acceptable for cGMP compliance. Not only does the FDA eschew requiring an Expiration Date and specific methods for determining one, but also notes that there are currently no reliable methods to measure the shelf life of many of the ingredients found in dietary supplements. This leaves a large gaping hole in the ability of any dietary supplement company to determine a valid Expiration Date for its products.

There are several approaches dietary supplement companies have taken to creating an Expiration Date. They may have selected a single ingredient in a multiple ingredient formula to test for shelf life, or tested multiple ingredients and averaged their shelf life or chose one to be representative. However, this may be quite misleading. For example, a mineral has an almost infinite shelf life, much longer than that of most vitamins, but the consumer does not know which ingredient s determined the Expiration Date for the product.

Expiration Dates for Solid Oral Drugs: FDA Revises Draft Guidance

Drug Industry Daily DID the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you. Use your energy where it’s needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

You can get extraordinarily sick eating expired food, but more often than not we’​re just throwing away perfectly good chow.

A beyond-use date is a date placed on a prescription by a pharmacy for compounded medications they prepare, noting when that prescription should no longer be used. This date is determined by the pharmacy when they prepare a compound prescription based on different factors, including:. The beyond-use date is different than an expiration date of a drug.

This includes moving a medication to a different container, which is the normal practice for pharmacies dispensing prescriptions. Based on the type of drug, how fast it degrades, dosage, type of container, storage conditions, prescription length, the likelihood of contamination. Based on testing a drug in specific conditions related to storage containers, lighting, temperature, etc.

The FDA says it’s dangerous to take medications after their expiration date because they may not be as effective, their chemical composition may have changed, or they may have deteriorated to a point where harmful bacteria could breed. Particularly with antibiotics, it’s important to watch the expiration date because using an expired antibiotic means it may not be potent enough to completely treat your infection, leaving you at risk for a worse one.

The bottom line is that it is best to not use expired medications because there is no guarantee that they will work the way they are supposed to and they may even make you worse. Medications need to be stored safely to help keep their chemical compositions intact and stop them from becoming breeding grounds for bacteria. Storing them properly until they are expired keeps them safe and at maximum potency. Dealing with racing thoughts?

Expiration Date

A new 4-page guidance from FDA comes on the heels of an increase in repackaging drugs for administration as a single dose. The practice of repackaging oral solid dose drugs into unit-dose containers has increased in the last few decades. This guidance describes the circumstances under which FDA generally does not intend to take action regarding required stability studies for these repackaged products and appropriate expiration dates under those circumstances.

Submit comment here: Federal Register.

Some EpiPens can be used four months past their expiration date, the Food and Drug Administration (FDA) said Tuesday. The move is.

In the normal course of business, firms typically have an expiration date on their product and, when the product reaches its labeled expiration date, the product is not supposed to be used beyond that date. We all know that the expiration date on a product is usually not always a bright line after which being crossed the product will crash and burn. It is just a date after which the sponsor or the Agency has no data upon which to recommend continued usage of the product based on their own stability programs.

The FDA actually has a program in place for expiration date extension for drugs held in the national stockpile of medications. This program is not open for run-of-the-mill product, but only for those products deemed necessary for storage in the national stockpile. This is one way the Agency is addressing drug shortages and often the expiration dates are extended by a few months to up to a year.

Expiration Dates Matter


Greetings! Would you like find a sex partner? It is easy! Click here, registration is free!