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.
For example, a product liable to degrade by light need not be stored in a lit area if it is normally packaged and stored for use in an opaque container.
While Section Testing procedures must include a stability indicating test which will distinguish the active ingredient from any degradation products and be able to make a reliable estimate of the quantity of any degradate.
The stability indicating test does not have to be the assay method used to determine product strength. Manufacturers, who contract with analytical laboratories to perform either end product testing or stability studies, or who produce product under contract for other firms are ultimately responsible for the quality of the product and must have copies of all analytical procedures employed and the appropriate documentation to assure their validity on file.
Likewise, repackers who rely on stability studies performed by the manufacturer must have copies of all analytical data necessary to support the expiration dating period.
Although specific methods are critical to determine product stability, they do not have to employ any specific technique. The use of quantitative analysis, where limits are known, such as thin layer chromatography, may be satisfactory. While many USP tests are specific for the drug or its degradates and may be used for stability testing, some USP monographs do not incorporate stability indicating tests.
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Additionally, it may be unreasonable to expect a manufacturer to develop specific methodology for each component of some multi-component drugs containing ingredients of botanical origin such as benzoin, Peruvian balsam or tolu balsam.
The requirement that stability testing be performed in the same container-closure system as that in which the drug product is marketed has been subject to interpretation.
The courts ruled in U. Kaybel that when a "new drug" was repackaged, the repacker did not have to obtain pre-market approval of the repackaged product or the firm's repacking procedures.
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. Most of what is known about drug expiration dates comes from a study conducted by the Food and Drug Administration at the request of the military. With a large and expensive stockpile of drugs, the military faced tossing out and replacing its drugs every few years. What they found from the study is 90of more than drugs, both prescription. A. Absence of an Expiration Date. The absence of an expiration date on any drug product packaged after September 29, , except for those drugs specifically exempt by (e), (f), and (g.
However, the repacker is subject to applicable current good manufacturing practices. Although stability studies were performed on the dosage unit in the original manufacturer's container, the event of placing the dosage unit into a different storage unit may and often does affect the product's shelf life. It is the policy of the Center for Drugs and Biologics to allow repacking into container-closure systems that can be demonstrated to be at least as protective or more protective than the original system without performing new stability studies prior to marketing.
Satisfactory comparison of container-closure systems may be done by several methods, i. Stress testing refers to testing the product after storage under exaggerated conditions.
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This will usually involve high temperature and high humidity. It is also current policy to allow firms to repackage solid dosage units from plastic containers into glass containers because glass has been shown to be a superior moisture and gas barrier. This policy does not apply to liquid drugs because of pH problems resulting from the alkaline nature of glass.
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Policies relating to the expiration dating of unit dose repackaged drugs may be found in Compliance Policy Guide b. This also does not apply to repacking from bulk containers. When the same product is marketed in more than one size, e. This indicates that the smallest marketed container is the most critical in terms of the container properties contributing to product degradation.
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Thus, moisture or oxygen permeation through a 4 oz bottle is more critical than through a 16 oz bottle of similar construction. For this reason, when studying stability of the product marketed in several sizes of similar containers, testing of the smallest container size is imperative to be in compliance with CGMPs. While we recommend that all other container sizes be subjected to stability testing, the fact that some may not is not necessarily a violation of CGMPs.
The drug company then proposes an expiration date to the FDA, which reviews the data to ensure it supports the date and approves it. Despite the difference in drugs' makeup, most "expire. (a) To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing described in § (b) Expiration dates shall be related to any storage conditions stated on the labeling, as determined by stability studies described in § Jul 18, 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 .
Products formulated to contain preservatives to inhibit microbial growth should be monitored throughout their shelf life to assure the effectiveness of the preservative system. Once a minimally effective level of preservative is established, chemical testing for the preservative s may be performed.
The preservative system should be monitored at the same stability testing times as other ingredients are monitored. While expiration dating is not required specifically for bulk drugs in the CGMP regulations, it is feasible and valuable to expect the manufacturer of bulk drug substances to assure that their product is stable for the intended period of use.
A stability testing program for bulk drug substances should contain, at the minimum, the following features:. Also, improvements in drug manufacturing and changes in drug information over time would require repeated "longevity" testing that would be impractical.
Pharmaceutical expiration dating
Better, they say, to pick a shorter period of time for which there is confidence a drug will stay stable and stick with that. That might be acceptable if it weren't for the pharmacist who may reduce the expiration to one year from when the prescription is written!
Some states require pharmacists to do this. This came from a recommendation from the U. Pharmacopeia, a not-for-profit group that establishes standards for drug makers. The logic is that when a drug is taken out of its original container and put in a pharmacy canister, moisture and air can degrade the pills or capsules.
In addition, a patient's condition may change, new drugs may become available so that the old drug is no longer the best optionor new information may become available such as potential interactions with other drugs. So, limiting the prescription to a year from when it's originally filled adds an extra level of safety, requiring the doctor to review whether continuing with the old medication beyond one year is still a good idea.
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Even with the best of intentions, this conservative standard makes it even more likely that enormous amounts of perfectly good medications will be thrown away in this country each year.
We may not save that much.
And we don't have the FDA to test and oversee extensions on our medicines' expiration dates. But there is a fair amount of evidence that medications stored properly, appear intact and are not one of the exceptions mentioned above, are likely to be safe to take.
For many common conditions, such as allergies, headaches or back pain, I'm willing to take the risk of applying my own, modest extension to the expiration date. It's too bad that the mystery leftovers in the fridge don't come with an expiration date. But even if they did, I'd be tempted to stretch those, too.
Robert H. He is also the program director of the Rheumatology Fellowship.
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He has been a practicing rheumatologist for over 25 years. Disclaimer: As a service to our readers, Harvard Health Publishing provides access to our library of archived content.
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