Beyond use dating for compounded pharmaceuticals pink and treach dating


30-Jan-2018 16:11

The Joint Commission follows guidance from CMS on this issue, and surveyors from both agencies have cited organizations for not following the explicit directions in the manufacturer’s package insert when it comes to drug storage, stability, and beyond use dating.

Only following the manufacturer’s directions for injectable medications has proven difficult and wasteful in some situations for two primary reasons: 1) complete information on storage, stability, compatibility, and beyond use dating is often not provided in the official prescribing information, and 2) newer, evidence-based information on these matters can sometimes be found in peer reviewed journals and compendia fully endorsed by national pharmacy organizations.

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.

USP Chapter 797 describes the procedures and requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded.

When an official monograph isn't present, a systematic approach to assigning the date can be as follows: Step 1.