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USP <797> Revisions – Impact on Sterile Compounders
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After several years in the making, the USP Expert Committee on Compounding released and advanced preview of its proposed revisions to General Chapter <797> Pharmaceutical Compounding/Sterile Preparations at the end of September. The revisions can be found by clicking here. When they are formally published on November 2, 2015, an open comment period will begin and run through January 31, 2016.

 

IACP already has reviewed the proposed revisions and its Legislative Committee has begun drafting comments on how these changes will affect sterile compounders in all types of pharmacy practice settings.  

“One of our greatest concerns with the revised <797> standard is the elimination of a clinician’s ability to determine a beyond-use-date based upon the medical and scientific literature,” says David Miller, IACP executive vice president. “Traditionally, USP has acknowledged that science evolves and that pharmacists have the ability to apply new information and incorporate that into their practices. By establishing specific limits on BUDs for sterile drugs using language similar to FDA guidelines, USP is inadvertently restricting professional decision making.”

Next week, USP will host an open microphone web session to present the revisions to stakeholders. That session, scheduled for Wednesday, October 21 from 2:00 to 4:00 PM Eastern, will cover both the overall USP revision process for standards, the specific recommended changes to <797> and will provide an opportunity for participants to ask questions. Since space is limited on the web session, you must pre-register by 5:00 PM on October 20, 2015 by visiting here.

If you questions about how IACP is or should be responding to the proposed changes to Chapter <797>, send us an email at iacpinfo@iacprx.org.

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