In a session presented on Sunday, December 4, at the 2022 Midyear Clinical Meeting & Exhibition, USP Compounding Expert Committee member Kevin Hansen, PharmD, MS, BCPS, BCSCP, explained recent changes to guidance for USP Chapter <795> governing nonsterile compounding.

To lay a foundation for attendees’ understanding of the revision process for nonsterile compounding products, Dr. Hansen emphasized that USP promotes stakeholder engagement; reviews feedback, public comments, and issues raised in appeals; and holds stakeholder interviews, roundtable sessions, and open forums. USP also employs a “scientifically robust, risk-based approach” to assigning beyond-use dates, including considerations given to physical and chemical stability, sterility assurance, operational implications. In addition, he said, USP balances the “need for patient access to cost-effective compounded preparations with rigorous quality standards, considering the implications on regulatory oversight and enforcement.”

Dr. Hansen delineated the changes since the 2019 remanded chapter revision. Among the highlighted revisions is a clarification that otic preparations (excluding use in perforated eardrums) may be prepared as compounded nonsterile preparations (CNSPs) and that the revisions add a dispensing requirement when preparing, storing, packaging, and transporting CNSPs and a requirement to follow applicable laws and regulations when compounding.

He added that in personnel training and evaluation, the revisions clarify that “All personnel who compound or have direct oversight of compounding CNSPs must be initially trained and qualified by demonstrating knowledge and competency according to the requirements in the section addressing Personnel Training and Evaluation before being allowed to perform their job functions independently.”

In the area of personal hygiene and garbing, section 3.1 allows the designated person to “allow accommodations in some instances.” A sentence was added, however, to read “All accommodations should be documented.” Also added was a sentence indicating “Garb should be removed when leaving the compounding area” and “If gowns are to be reused, they must remain in the compounding area, and should only be reused during the same shift.”

In the latest revisions pertaining to cleaning and sanitizing, the following sentence was added: “Applicable cleaning and sanitizing must be documented daily on days when compounding occurs,” and a biological safety cabinet schedule was also included.

Labeling changes clarified that the label on each container must display information prominently and legibly, adding that the label of the CNSP must be verified to ensure that it conforms with the prescription or medication order, master formulation record; and compounding record.

Concerning establishing beyond-use dates, a sentence was added: “Significant deviations from essential compounding steps and procedures and changes to essential compounding steps may have an impact on the stability of the formulation.”

No substantial changes, reported Dr. Hansen, were made to the sections covering Buildings and Facilities, Master Formulation and Compounding Records, or Release Inspections and Testing.

Dr. Hansen also pointed out that USP standards become official at least 6 months after being published in the USP-National Formulary. In addition, he provided the schedule for upcoming USP Compounding Workshops (February 7, 2023, 8:00 a.m.-5:30 p.m. EST and February 8, 2023, 8:00 a.m.-3:30 p.m. EST).

He also urged attendees with interest in the compounding space to sign up for updates to USP <795> and other compounding topics, and he advised attending the USP Healthcare Quality and Safety Standards Compounding Expert Committee’s official meetings to stay abreast of developments.

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