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Dating of multi use containers

The USP Subcommittee on Packaging, Storage, and Distribution (SCPSD) has revised product dating specifications as they relate to pharmacy practice.

As seen in Appendix A, USP defines the expiration date as "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 expiration date, which limits the time during which the article may be dispensed or used, is based on scientifically sound stability studies carried out by the manufacturer and is usually expressed in terms of the month and year, as stated on the manufacturer's container.

Beyond-use dates are nearer than expiration dates to account for the fact that the manufacturer's original container has been opened in the repackaging process, thereby exposing the pharmaceutical article to ambient atmospheric conditions.

The SCPSD has as an objective the improvement of unit dose packaging. Okeke, Ph D, is Senior Scientific Associate, General Policies Requirements, Nomenclature, and Labeling Division, United States Pharmacopeia (USP), Rockville, MD.

Leonard Bailey, Ph D, is Member of the Packaging, Storage, and Distribution Subcommittee, USP, and Professor Emeritus, Rutgers University, Piscataway, NJ.

This exposure, and the fact that containers into which dosage forms are repackaged may not have the integrity of the original package, necessitates a shortening of the expiration period from that originally set by the manufacturer.

The General Notices defines the beyond-use date for multiple-unit containers as "not later than (a) the expiration date on the manufacturer's container or (b) one year from the date the drug is dispensed, whichever is earlier." With respect to a multiple-unit container such as a typical prescription vial, a prescription label affixed by the pharmacist for a repackaged item should bear a beyond-use date that limits the patient's use of the medication.

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In this article, we’re going to talk about combining multiple containers into a single Kubernetes Pod, and what it means for inter-container communication.

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