The Truth Behind Drug Expiration Dates for Medications
The answer to the age old question of, “Can I use my prescription drugs past their expiration dates?”, has usually been answered by healthcare professionals with a stern “No.” To figure out why you can’t use your old drugs after they are said to expire, it is first important to understand how the system that determines when the product will expire works.
When did expiration dates become a requirement?
In the late 1970s, the FDA began requiring prescription and over-the-counter medications to have expiration dates clearly printed on the bottle or box of the product. The agency states, “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.” The FDA permits manufacturers of these medications and prescriptions very little say in this and is very strict in determining the presence of an expiration date on a label stating, “As long as the medication that is marketed in the U.S. contains between 90 to 110 percent of the amount of active ingredient claimed on the label”, it must provide an expiration date to patients and consumers.
The FDA’s legal code also states that manufacturers “must account for storage conditions (and reconstitution conditions for certain drugs) in the expiration date.” Pharmacy Times reports that the expiration date of most medications is 12 to 60 months after it has been manufactured. However, the Pittsburgh-Post Gazette reports that “pharmacists further shorten the time a medication can be used when they add their own “discard after” or “beyond-use” date to the prescription label itself to provide maximum safety.”
Here is an informative video, uploaded to the FDA’s YouTube account on Expiration Dates:
The Extension of Expiration Dates
However, in the mid-1980s, in an article in Biosecurity and Bioterrorism, the FDA approved the extension of expiration dates of certain drugs that the Air Force wanted to stockpile for future use for both military and civilians. The process, though very expensive, involved the planning, storage and replacing of the expired drugs over time. The program tested 56 drugs and found that it was possible to safely extend their shelf-life. By 2006, a program named SLEP had investigated the shelf-life of 122 different drug products that resulted in a “lifespan extension of at least one year beyond the original expiration date for 88 percent of the lots. The average additional time added to each drug was 66 months.”
In 2009, The Medical Letter, a non-profit organization that provides recommendations to professionals on drugs, decided to review the recent data regarding the safety of extending expiration dates for shelf life. In their study, the authors found one reported case of a patient harmed by taking an expired drug. They also discovered that storage in heat and high humidity shortened the “life-expectancy” of a drug. However, the authors of the study reported, “Many drugs stored under reasonable conditions in their original unopened containers retain 90 percent of their potency for at least 5 years after the expiration date on the label and sometimes much longer.”
Expiration Date Benefits
According to Harvard University Medical School’s website, The Family Health Guide reports, “The expiration dates are very conservative to ensure you get everything you paid for. And, really, if a drug manufacturer had to do expiration-date testing for longer periods it would slow their ability to bring you new and improved formulations. The next time you face the drug expiration date dilemma, consider what you’ve learned here. If the expiration date passed a few years ago and it’s important that your drug is absolutely 100% effective, you might want to consider buying a new bottle. And if you have any questions about the safety or effectiveness of any drug, ask your pharmacist. He or she is a great resource when it comes to getting more information about your medications.”