Beyond use dating for compounded pharmaceuticals

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Areas designated for compounding have adequate space for the orderly placement of equipment and materials to prevent mixups between ingredients, containers, labels, in-process materials, and finished preparations.

The compounding area is also to be designed, arranged, used, and maintained to prevent adventitious cross-contamination.

This means that the product was formulated according to the manufacturer's directions, or that the formulation contains the same concentration of drug, in the same diluent, in the same packaging, for the same intended period of use, and so on. When this is not possible, a pharmacist ideally consults with the manufacturer to establish a beyond use date.

The USP/NF Section Sterile Drug Products for Home Use, Storage and Beyond Use Dating directs that: Most pharmacies have the name, address, and phone number of the pharmacy pre-printed on their prescription labels.

To get started in this article, there are some terms that should be defined.

Last modified 10-Dec-2019 06:12