12/12/2023 0 Comments Shelf life calculationUnder the Shelf-Life Extension Program (SLEP), FDA conducts testing for certain products stored in federal stockpiles in environmentally controlled locations. Does FDA conduct testing to extend expiration dates?įDA supports a public health program involving other partners to extend the expiration dates for a limited number of carefully selected drug products. There are a number of simple steps consumers can take to dispose of expired medications.ĥ. Patients with serious and life-threatening diseases may be particularly vulnerable to potential risks from drugs that have not been stored properly. In addition, when a drug degrades it may yield toxic compounds that could cause consumers to experience unintended side effects. If a drug has degraded, it might not provide the patient with the intended benefit because it has a lower strength than intended. 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. To help alleviate drug shortages, FDA has also approved extensions of expiration dates when data supporting the extension are available.Ĥ. What potential risks are associated with expired drugs? įDA 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.įDA 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.įDA’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). The FDA verifies that an applicant’s proposed expiration date is supported by appropriate studies that the applicant has conducted.įor 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). This testing is designed to provide confidence that the product will meet the applicable standards of strength, quality, and purity throughout its shelf-life. 1. Why are expiration dates important for consumers to pay attention to?ĭrug 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.įDA 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.
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