PDF version. Are dates required on these food products? Does it mean the product will be unsafe to use after that date? Here is some background information answering these and other questions about product dating. What is Food Product Dating? Two types of product dating may be shown on a product label. The calendar date provides consumers with information on the estimated period of time for which the product will be of best quality and to help the store determine how long to display the product for sale. Except for infant formula, product dating is not required by Federal regulations. For meat, poultry, and egg products under the jurisdiction of the Food Safety and Inspection Service FSIS , dates may be voluntarily applied provided they are labeled in a manner that is truthful and not misleading and in compliance with FSIS regulations 2.
FDA issues new guidelines for food label expiration dates
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“Shortens the expiration date to be used under certain conditions for solid oral dosage forms repackaged in unit-dose containers from 12 months.
To help prepare for public health emergencies, medical countermeasures MCMs may be stockpiled by governments and even by some private sector partners. For example, the U. Some state and local governments and private sector entities also stockpile MCMs to have ready access to them if an emergency were to occur. A medical product is typically labeled by the manufacturer with an expiration date.
This reflects the time period during which the product is expected to remain stable, or retain its identity, strength, quality, and purity, when it is properly stored according to its labeled storage conditions. Expiration dating can present challenges to MCM stockpilers because MCMs that have reached their labeled expiration date in most cases cannot be used. While this is important to ensure patient safety, it also means that the MCMs, some of which might still be stable, must be replaced regularly, which can be very costly.
In some cases, testing has shown that certain properly stored medical products can be used beyond their labeled expiration date if they retain their stability. The manufacturer of an approved drug product may extend the expiration date for the drug product based on acceptable data from full, long-term stability studies on at least three pilot or production batches in accordance with a protocol approved in the NDA or ANDA.
Stockpiling drugs, vaccines, and medical products is critical to ensure public health emergency preparedness for both the U.
Drug Expiration Dates – Are Expired Drugs Still Safe to Take?
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 OTC drug products meeting the exemption of
The American Medical Association has questioned whether expiration dating Avenue, Silver Spring, Maryland , USA. @
Each strength of a drug product, and each primary package and closure system in which it is distributed must be supported by stability testing. If you are contracting this work to a third party laboratory be sure that they can provide guidance to help navigate the regulatory and compendial guidelines, and you perform a quality system audit of their facility. A stability study is a program of testing that is designed to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity light, which enables recommended storage conditions, retest periods and shelf lives to be established.
Stability testing is required to be conducted for OTC drug products under the recommended conditions of storage appearing on the label, and at any other condition, the drug product might be exposed to during manufacturing, storage and shipping activities. As a result, there are a number of stability conditions that are commonly utilized in determining the stability of a drug product in its marketed package s. Examples of the most common stability conditions are as follows:. A stability study conducted under controlled temperature and humidity approximating conditions of long-term storage.
A stability study conducted under exaggerated conditions, in an attempt to accelerate the aging process, i. A stability study that is conducted under conditions that are intermediate between long-term and accelerated storage conditions. Samples stored under Intermediate conditions are typically only tested if a failure is encountered during the testing of samples stored under accelerated storage conditions.
Expiration Dates for Solid Oral Drugs: FDA Revises Draft Guidance
An expiration date is a date after which a consumable product such as food or medicine should not be used because it may be spoiled, damaged, or ineffective. The term expiration date also refers to the date that a drug patent expires. Expiration dates are especially important for medications because they offer the only indication about whether the product is still safe to use.
The FDA is urging the industry to adopt one standard for expiration dates, with all labels listing expiration dates as “best if used by.”.
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.
FDA Guidance: Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products
These challenges are expected to result in tighter supplies and greater variability in pharmacy-level access at this time. On June 5, , the U. Food and Drug Administration announced the extension of the expiration dates by four months of all lots of EpiPen 0. This announcement is based on a careful review of product stability data provided by Pfizer. Our hope is that the expiration extension will help alleviate the shortage situation as Pfizer continues its efforts to increase production and stabilize pharmacy inventories.
The expiration date for EpiPen 0.
Current date labels on packaged foods aren’t user-friendly, Frank Yiannas, the FDA’s deputy commissioner for food policy and response, said.
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.
To help make that clearer, the U. But the FDA hasn’t endorsed the latter phrase, which could have safety implications. Cutting waste: FDA wants food expiration dates standardized with ‘best if used by’. Regardless, the FDA’s recommendation isn’t mandatory, and consumers will likely continue seeing variations, in some cases because of local regulations. With milk, for instance, states may require “Sell By” or other labeling.
It’s difficult for manufacturers to pinpoint how long foods will stay good, given variables like how long they sit on loading docks and how they’re stored in people’s homes. Milk should be good for at least a few days after its “Sell By” date, though exactly how long will depend on factors including pasteurization methods. Many people use dates on packages as guideposts and rely on their senses. Crackers might taste stale, for instance, while more perishable foods might be discolored or smell funky.
Foods like fresh meat and dairy are more vulnerable to spoilage in part because their moisture allows the small amounts of bacteria to multiply more quickly, said Martin Bucknavage, a food safety expert at Penn State Extension.
Companies could, in theory avoid expiration dating and the entire hassle of measuring product stability over time. However, many retailers do require an expiration date as a term of sale. Some brands still elect to not place an expiration date on their products and some others place a manufacture date on the product instead of an expiration date.
Consumers also expect to see an expiration date so one can question the logic from a business perspective of companies who dodge this issue.
How is Expiration Dating Determined for the Launch of a New OTC Drug Product? FDA requires that the expiration date of each OTC drug.
Why are expiration dates important for consumers to pay attention to? Drug expiration dates reflect the time period during which the product is known to remain stable, which means it retains its strength, quality, and purity when it is stored according to its labeled storage conditions. FDA regulations require drug applicants to provide stability testing data with a proposed expiration date and storage conditions when they submit an application for FDA approval of their drug.
This testing is designed to provide confidence that the product will meet the applicable standards of strength, quality, and purity throughout its shelf-life. FDA recommends that applicants and manufacturers follow the recommendations in internationally harmonized guidance documents on stability testing such as the International Council on Harmonization guidance documents ICH Q1 A-F and Q5C. To help alleviate drug shortages, FDA has also approved extensions of expiration dates when data supporting the extension are available.
If a drug has degraded, it might not provide the patient with the intended benefit because it has a lower strength than intended. In addition, when a drug degrades it may yield toxic compounds that could cause consumers to experience unintended side effects. Patients with serious and life-threatening diseases may be particularly vulnerable to potential risks from drugs that have not been stored properly. There are a number of simple steps consumers can take to dispose of expired medications.
FDA supports a public health program involving other partners to extend the expiration dates for a limited number of carefully selected drug products. Federal stockpiles are stores of certain drugs that might be needed to prevent or treat diseases or conditions which may occur during a public health emergency. SLEP is a fee-for-service program through which the labeled shelf life of certain federally stockpiled products can be extended after select products undergo periodic stability testing conducted by FDA.
Drugs held by consumers may have been stored under varied conditions after entering the market.