USP <797> proposed rule may change product storage requirements
BUD’s Impact on Home Infusion By Marcus Banks
Nashville, Tenn.—Storage requirements for many products used in home infusion services will change if proposed revisions to USP General Chapter <797> take effect, according to David Hughes, PharmD, who directs the home infusion service at the Yale New Haven Health System, in Connecticut. Speaking at the 2022 meeting of the National Home Infusion Association, Dr. Hughes detailed the potential changes. Most home infusion products would fall within “Category 2” of the proposed new USP <797> guidelines, Dr. Hughes said. Many of these products are aseptically produced, made entirely of sterile components and thus do not need to undergo sterility testing. Per the new guidelines, any compound meeting all those conditions could be stored for four days at a controlled room temperature: 10 days in a refrigerator or 45 days in a freezer. That’s a change from the 14 days in a refrigerator currently allowed for low-risk compounds in the current USP <797> guidelines, Dr. Hughes noted. (For a USP Fact Sheet on BUD, see bit.ly/3NhR6Lc.) The current USP <797> guidelines have been in effect since 2008. The public comment period about the new guidelines closed on March 17. In the new guidelines, USP proposes changing from a low-/medium-/high-risk model to one based on categories of risk. Category 1 compounds, which do not have to be prepared in a cleanroom suite, would have the shortest beyonduse dates (BUDs) in the new framework. Category 2 compounds would carry the storage limits described above, and Category 3 compounds could have BUDs of up to 180 days. “This change was proposed to avoid inaccurately conferring a level of risk to a particular compounded sterile product [CSP] without consideration for all factors that influence the quality of that CSP,” USP leaders explained in a 2021 overview of the rationale for the new BUDs and categories. Dr. Hughes noted that, according to the new guidelines, sterility testing is required for Category 2 compounds to have a BUD longer than 45 days. For example, an aseptically processed CSP that passes sterility testing can be stored in a freezer for 60 days, and a terminally sterilized CSP that
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passes a sterility test can be in a freezer for up to 90 days. All Category 3 CSPs need to undergo sterility testing to achieve that 180-day mark, Dr. Hughes said. In general, he added, home infusion services should contract with labs that specialize in sterility testing rather than doing that work in-house.
Single Patient or Batch? “In the 2008 version of chapter <797>, the beyond-use dates are largely based on the starting ingredients,” said Patricia Kienle, RPh, MPA, BCSCP, FASHP, the director of accreditation and medication safety at Cardinal Health. “So a key question is, are those ingredients sterile or non-sterile?” Another important consideration, she noted, “is the number of patients you’re going to make these medications for. Is it a single patient or a batch? That’s an oversimplification, but it tends to be how people think about it.” In the proposed revisions to <795> and <797>, Ms. Kienle said, BUDs derive instead from the location where compounding occurs; that is, different standards apply depending on whether compounding occurs in a cleanroom or segregated compounding area. “Some of the reasons for these changes have gotten lost in the revision process,” Ms. Kienle added. Ms. Kienle said she doesn’t think the 10-day BUD for refrigeration of Category 2 products proposed in the new revisions will have much practical impact, even if it seems that it should because the current standards allow for 14 days of refrigeration. That 14-day BUD only applies to a medication made for a single patient, Ms. Kienle noted, whereas a batch of the same medication intended for multiple people can only be refrigerated for nine days, per current USP guidelines. The new rules—if adopted—would allow 10 days of storage of a batched medication, which is more generous, she said. “I’m sure there are situations where people are going to have to back it off from 14 days to 10,” Ms. Kienle added. “But I think the vast majority are going to say, ‘Wow, I used to do it for nine and now I can do it for 10.’” Ms. Kienle is an employee and shareholder of Cardinal Health. These comments are her own and neither affiliated with nor endorsed by USP.
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