USP 797 Pharmaceutical Compounding – Sterile Preparations. The comment period for USP’s proposed revisions for compounding sterile preparations closed January 2016, and comments are now under review. If finalized as-is, USP 797 may publish by November 2016, at which time pharmacies will face significant changes, including:

• A more inclusive compounding definition requiring master formulation and compounding records for all batch and non-sterile compounding activities.

• A new term (in-use time) defining the time before which a manufactured product or compounded dilution bag must be utilized after it has been punctured.

• More environmental control requirements, including monthly viable air and surface sampling.

• Increased accountability for staff competency with visual observation of hand hygiene and garbing, and quarterly media fill and fingertip testing.

 In October 2015, CMS incorporated USP 797 into its requirements for participation in Medicare and Medicaid programs, forerunning more stringent review by CMS and regulatory bodies related to pharmacy compliance with this chapter.

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