USP Appeals Panel Grants Appeals to USP 795 and 797, Denies Appeal to USP 825

Yesterday the United States Pharmacopeial Convention (USP) announced its final decision on appeals to revisions to General Chapters <795> Pharmaceutical Compounding – Nonsterile Preparation, <797> Pharmaceutical Compounding – Sterile Preparations, and new <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging. After several months of deliberations and in-person hearings, the USP Appeals Panel granted the appeals to General Chapters <795> and <797> and has remanded the chapters to the Compounding Expert Committee with a recommendation for further engagement on the issues raised. The Panel, however, denied the appeal to General Chapter <825>, encouraging the appellant to submit a narrower request to the Chemical Medicines Monograph 4 Expert Committee.

What Was Appealed?

After the USP published revisions to General Chapters <795>, <797>, and <825> in June 2019, stakeholders initially appealed the following issues:

• Beyond-Use Date (BUD) provisions in <795>, <797>, and <825>
• Removal of Alternative Technology provision from <797>
• Applicability of <795> and <797> to veterinary practitioners
• Compounding from sterile substances in <825>
• Applicability of <825> within the radiopharmaceutical regulatory context

USP issued decisions on the above issues in August 2019 and September 2019. However, stakeholders were permitted to request further review by an appointed panel. USP received four second-level appeal requests, specifically regarding the BUD provisions in <795> and <797>, and the framework and BUD provisions in <825>. It was these BUD appeals that the Panel granted today.

Impact:

<795> and <797>: Because the Panel granted the appeals to General Chapters <795> and <797>, those chapters have been remanded to USP’s Compounding Expert Committee for further review and discussion, and the currently official chapters of <795> (last revised in 2014) and <797> (last revised in 2008) remain applicable. Therefore, providers should follow the BUD provisions in those chapters.

<825>: USP advised that the expert committee responsible for <825> may reinstate the official date of <825>; however, under USP bylaws, the committee must provide at least another six-month implementation period. The Committee will announce an official date once determined. For now, <825> will be informational only.

<800>: We previously answered questions about the impact the appeals to General Chapters <795> and <797> would have on the applicability of USP <800>, which concerns the protection of health care workers when handling hazardous drugs. We noted that because General Chapters <795> and <797> were being appealed, <800> was informational only, as <800> is not referenced in any USP General Notices, a monograph, or another applicable general chapter numbered below <1000>. Had the new versions of General Chapters <795> and <797> become official, <800> would, likewise, have become compendially applicable. Since the current versions of <795> and <797> remain applicable, <800> remains informational only.

Nevertheless, as USP has made clear, it is not an enforcement body. As such, state agencies, such as boards of pharmacy, the Occupational Safety and Health Administration (OSHA), the Centers for Medicare & Medicaid Services (CMS), and other accreditation organizations, such as The Joint Commission, may make their own determinations regarding the applicability and enforceability of <800>.

USP has published a helpful FAQ on the appeals here, which includes advice about how facilities can implement <800> in light of conflicts with provisions in currently official <797>.

If you have questions regarding your entity’s specific USP compounding compliance obligations or your state board of pharmacy’s current position on USP adoption, please contact your Quarles & Brady attorney or:

• Brenda M. Maloney Shafer: (602) 229-5774 / brenda.shafer@quarles.com