Beyond use dating usp 795 dating mis

Posted by / 20-Feb-2020 11:09

However, this article is not a substitute for reading the chapter and implementing it in your pharmacy practice as applicable.Notable Changes reintroduces the definition of what it means to have variability in strength.

An outer container may be necessary for such protection; it is recommended that the drug monograph be referenced for storage.

Each single-unit or unit-dose container bears a separate label, unless the device holding the unit-dose form does not allow for the removal or separation of the intact single-unit or unit-dose container therefrom.

Store the repackaged article in a humidity-controlled environment and at the temperature specified in the individual monograph or in the product labeling.

It should be noted that there is no special exemption for patient med paks from the requirements of the Poison Prevention Packaging Act.

Thus the patient med pak, if it does not meet child-resistant standards, shall be placed in an outer package that does comply, or the necessary consent of the purchaser or physician, to dispense in a container not intended to be child-resistant, shall be obtained.

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It is the responsibility of the dispenser, taking into account the nature of the drug repackaged, any packaging and expiration dating information in the manufacturer's product labeling, the characteristics of the containers, and the storage conditions to which the article may be subjected, to place a suitable expiration date on the label.