Lana asked
I was prescribed Doxycycline hyclate on Sept 19, 2017 and never took them. Can I still take them or are they expired?
Answer
There are two different expiration dates to keep in mind when it comes to prescription medication:
- The manufacturer expiration date.
- The dispensed prescription expiration date, also known as the "beyond use" date.
Manufacturer Expiration Date
Medications are required to be labeled by the manufacturer with two key pieces of information on the packaging:
- Lot number
- Expiration date
The expiration date is determined by multiple factors but, most importantly, it refers to how long the manufacturer is willing to guarantee that the product meets the labeled standards of potency and purity.
The United States Pharmacopia (USP) defines the manufacturer expiration date as follows:
"...the time during which the article may be expected to meet the requirements of the pharmacopeial monograph provided it is kept under the prescribed conditions.”
The above quote is referring to required and standard qualities like safety, potency and purity of a drug.
Most medication is listed with an expiration date of 2-3 years from the time of manufacturing and typically correlates with the time period for which the manufacturer performed stability testing. After this expiration date, it doesn’t necessarily mean that the medication “goes bad”, it just means that the manufacturer is sure (based on their data), that the medication will still retain the listed potency and purity when stored at proper conditions.
Beyond Use Date
When a pharmacy dispenses you a medication, it must be labeled with an expiration date or a beyond use date. Per the FDA, the beyond use date is defined as:
"The date beyond which medications that have been manipulated and/or repackaged and stored or dispensed in a container other than the original manufacturer’s storage container should not be used.”
The beyond use date that is listed depends on the product being dispensed and takes into account how long a drug is stable after being dispensed.
In most cases, the beyond use date will be shorter than the manufacturer expiration date as the beyond use date specifically refers to an expiration time after dispensing or repackaging a medication.
For some products, like reconstituted antibiotics (e.g. amoxicillin suspension), there is good data to indicate that they begin to degrade after 10 or 14 days. They are they labeled appropriately with the correct beyond use date.
Setting beyond use dates can get a little more tricky when you are labeling solid dosage forms such as prescription bottles of tablets or capsules. In most cases, the state in which you are located has laws to determine the beyond-use date for most dispensed products.
Most commonly, and as a general rule of thumb, the beyond use date is determined by the lesser of 1 year from the date of dispensing or the date listed on the manufacturers packaging. In other words, your dispensed prescription will most likely have an expiration date (i.e. beyond use date) of:
- One year, or the manufacturer listed expiration date, whichever is sooner.
If the expiration or beyond use date on the prescription label is passed, you should not use the medication as it is considered expired.
If the expiration date is listed in a month and year format only (e.g. 5/2019), then that medication does not expire until after the last day of the month listed. This means that a drug labeled with an expiration date listed as 5/2019 may be safely used until May 31st, 2019.
Summary
- The expiration date of a medication, stored appropriately in the original manufacturer packaging, is set by the manufacturer. Generally this date is 2 to 3 years from the date of manufacture.
- The manufacturer sets the expiration date based on their stability data for the medication.
- The beyond use date is the expiration date of a dispensed or repackaged medication (e.g. a reconstituted antibiotic or a dispensed prescription bottle of tablets).
- The beyond use date is generally one year from dispensing, or the manufacturer set expiration date, whichever is sooner.
