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 USP Chapter <797> governing sterile compounding. Changes to the guidelines affect, among other areas, garbing, release inspections and testing, and multiple-dose compounded sterile products (CSPs).

Among the highlighted revisions, he said, are those affecting minimum garbing requirements. USP <797> mandates that in facilities that compound Category 3 CSPs, additional garbing requirements must be continuously met in the buffer room in which Category 3 CSPs are prepared. The following additional garbing requirements, said Dr. Hansen, must be followed in the buffer room where Category 3 CSPs are prepared for all personnel, regardless of whether Category 3 CSPs are compounded on a given day: 1. Do not allow any exposed skin in the buffer room. (i.e., face and neck must be covered); 2. All low-lint outer garb must be sterile, including the use of sterile sleeves over gauntlet sleeves when a restricted-access barrier system is used; 3) Disposable garbing items must not be reused, and laundered garb must not be reused without being laundered and resterilized with a validated cycle; and 4) The facility’s SOPs must describe disinfection procedures for reusing goggles, respirators, and other reusable equipment.

Dr. Hansen added that per USP <797> Revisions pertaining to Release Inspections and Testing, bacterial endotoxins testing is required for Category 2 injectable CSPs compounded from one or more nonsterile component(s) and assigned a beyond use date (BUD) that requires sterility testing; for Category 3 injectable CSPs compounded from one or more nonsterile component(s); and for Category 2 CSPs assigned a BUD that does not require sterility testing but are compounded from one or more nonsterile component(s).

Among the USP <797> revisions, Dr. Hansen reported changes surrounding multiple-dose CSPs, explaining that a multiple-dose CSP must be prepared as a Category 2 or Category 3 CSP. He added that for preserved aqueous multiple-dose CSPs, antimicrobial effectiveness testing must be passed in accordance with USP <51>. In addition, the BUD limit is assigned based on whether a CSP is compounded as Category 2 or Category 3 or up to 28 days after container is initially entered or punctured, if supported by <51> testing.

The time within which multiple-dose, nonpreserved, aqueous topical, and topical ophthalmic CSPs must be used is also detailed in the USP <797> Revisions. The BUD limit is assigned based on whether the CSP is compounded as Category 2 or Category 3, and it is discarded 24 hours after first opening if stored at room temperature or after 72 hours, if refrigerated.

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 PM EST).

He also urged attendees with interest in the compounding space to sign up for updates to USP <797> 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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