Expiration Dates - Questions and Answers
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.
2. How are expiration dates established?
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. The FDA verifies that an applicant’s proposed expiration date is supported by appropriate studies that the applicant has conducted.
For non-application drugs, such as over-the-counter monograph products, the manufacturer must also conduct stability testing to establish an expiration date and storage conditions to meet FDA’s regulations (see 21 CFR 211.166 as well as related sections 211.137 and 211.160) .
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.
FDA inspections of manufacturing facilities may include an evaluation of the firm’s stability testing program to verify that labeled expiration dates are supported by a scientifically sound study and appropriate data.
3. Can expiration dates be extended?
FDA’s guidance for industry, “Changes to an Approved NDA or ANDA” explains that the manufacturer of an approved drug product may extend the expiration date for the drug product based on their own testing and acceptable data in accordance with a protocol approved in the new drug application (NDA) or abbreviated new drug application (ANDA) (see 21 CFR 314.70). To help alleviate drug shortages, FDA has also approved extensions of expiration dates when data supporting the extension are available.
4. What potential risks are associated with expired drugs?
It’s important to be aware that there are several potential harms that may occur from taking an expired medicine or one that may have degraded because it was not stored according to the labeled conditions. 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.
5. Does FDA conduct testing to extend expiration dates?
FDA supports a public health program involving other partners to extend the expiration dates for a limited number of carefully selected drug products. Under the Shelf-Life Extension Program (SLEP), FDA conducts testing for certain products stored in federal stockpiles in environmentally controlled locations. (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. As a result, it would be difficult to conduct testing to determine expiration dates that would be meaningful and generally applicable after prolonged periods of storage under different conditions. The appropriate conditions will depend on the drug, but may include considerations regarding temperature, humidity, and exposure to light.