This guidance addresses repackaging of prescription and over-the-counter OTC solid oral dosage form drugs into unit-dose containers by commercial pharmaceutical repackaging firms. As per the FDA guidance, the increase in unit-dose repackaging over last few decades has led to questions regarding stability studies and appropriate expiration dates for these repackaged products. USFDA proposed to tighten the previously proposed expiration dates for oral solid drugs from one year to just six months after they are repackaged into unit doses, except under certain circumstances. USFDA does not intend to take action regarding certain stability study requirements for repackaged drug products in the following cases:. FDA also proposed to permit the expiration date to exceed the ones described above, provided the above-listed conditions are met and if supportive data from appropriate studies, using an adequate number of samples, demonstrate that the container-closure system used for repackaging is at least as protective of the drug product as is the original packaging. Get email alerts for our life sciences industry insights.
21 CFR § - Expiration dating. | CFR | US Law | LII / Legal Information Institute
Before you get in your car, you toss one of those bags in the garbage. Sound ridiculous? Consumer uncertainty about the meaning of the dates that appear on the labels of packaged foods is believed to contribute to about 20 percent of food waste in the home. Studies have shown that this best conveys to consumers that these products do not have to be discarded after the date if they are stored properly. Department of Agriculture involves educating consumers on ways to reduce food loss and waste, and how to do it safely without risking illness from consuming spoiled food.
Publishing of 21 CFR Part - Current Good Manufacturing Practice for Finished Pharmaceuticals established requirements concerning the expiration date on a drug product and stability testing to assure the appropriateness of that date. Each drug product may be a unique article because of, for instance, differences in 1 chemical and physical properties of the active ingredients or the excipients, 2 manufacturing procedures, 3 formulations, 4 containers and closures, 5 proposed storage conditions, and 6 the stability of the article to maintain its quality or purity through the use of antioxidants or preservatives. Because of the uniqueness of each drug product, it is virtually impossible to provide one set of rules that can apply to all situations. The CGMPs were purposely written broadly to allow for such unique differences.
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