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Thomas Medwick, Ph D, is Chairman of the Packaging, Storage, and Distribution Subcommittee, USP, and Professor Emeritus, Rutgers University, Piscataway, NJ. Grady, Ph D, is Vice President and Director of the General Policies Requirements, Nomenclature, and Labeling Division, USP.Comments on Medscape are moderated and should be professional in tone and on topic.However, there are exceptions to these specific limits, including medications that are reconstituted before use that have special beyond-use dates from the manufacturer and other medications of special concern that have limited beyond-use dates from the manufacturer.In response to comments received from interested parties regarding beyond- use dates for nonsterile medications that are repackaged into unit dose or single-unit containers, the requirement has been changed from the previous period of six months from the date of repackaging or 25% of the time remaining until the expiration date, whichever is less, to one year.The revised requirement states, "For nonsterile solid and liquid dosage forms that are packaged in single-unit and unit-dose containers, the beyond-use date shall be one year or less, unless stability data or the manufacturer's labeling indicates otherwise.For all other types of nonsterile dosage forms, the beyond-use date is one year or the time remaining of the expiration date." The SCPSD believes that one year is acceptable as long as the pharmacy or repackaging facility follows the repackaging methods described in USP24/NF19 proposed general chapter 1146 (a new chapter to be discussed later in this article) and the container is stored at CRT.
Pharmacists are required to affix beyond- use dates and not expiration dates to the prescription or repackaged vial.Pharmacists are encouraged to review chapter 1146 before choosing the type of blister material to use in repackaging.This chapter also discusses the process of blister packaging, the performance characteristics of the blister material, and the minimum requirements that must be met while repackaging.The beyond- use date takes into account various factors, such as the conditions under which the medication may be stored in the patient's home, the type of packaging, the nature of the drug being dispensed, and especially the frequent opening of the package.These factors are the rationale for requiring a limited beyond-use date.