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Answers to Questions About USP’s Notice of Intent to Revise New Compounding Standards

Health & Life Science Alert Sarah E. Coyne, Brenda M. Maloney Shafer, Cory J. Kopitzke

After receiving various questions on the subject of the United States Pharmacopeial Convention (USP) updates to compounding chapters <795>, <797>, and <800>, we thought it would be helpful to provide additional commentary and analysis on the topic.

USP has advised that “[d]uring the postponement and pending resolution of the appeals of <795> and <797>, <800>, is informational and not compendially applicable. USP encourages utilization of <800> in the interest of advancing public health.”

However, USP is not an enforcement body and, therefore, it plays no role in ensuring providers are compliant with USP standards. State and federal regulators, including the Centers for Medicare and Medicaid Services (CMS) and state boards of pharmacy may make their own determinations regarding the enforceability of USP General Chapter <800>.

For example, CMS’ Conditions of Participation for hospitals and critical access hospitals (CAHs) explicitly address compounding standards in their section on handling of drugs and pharmaceuticals. CMS recognizes USP compounding chapters <795> and <797> as “authoritative guidance” and establishes these USP chapters as the minimum threshold for quality that hospitals and CAHs must meet under the Medicare program. In other words, hospitals and CAHs must comply with USP <795> and <797> in order to remain compliant with CMS and to receive payment. It is important to note that CMS will enforce the new chapters <795> and <797> once they are effective. Likewise, while USP <800> is informational until USP resolves the appeals of <795> and <797>, once <800> becomes compendially applicable, CMS will enforce it as a condition of participation.

Furthermore, numerous state boards of pharmacy require compliance with USP compounding standards. Board of pharmacy positions vary widely regarding adoption and enforcement of the new <795> and <797> compounding chapters, and some boards of pharmacy are requiring compliance with USP <800> on December 1, 2019, despite it not yet being compendially applicable. For example, the Iowa Board of Pharmacy had advised that pharmacies are expected to be fully compliant with USP Chapter <800> beginning on December 1, 2019. This includes pharmacies that receive, store, handle, dispense, or compound hazardous drugs. Additionally, the Louisiana Board of Pharmacy has advised that will delay enforcement of the standards in USP <800> until January 21, 2019, so it can complete the rule-making process. Conversely, the Minnesota Board of Pharmacy has indicated that it will not require compliance with <795>, <797>, or <800> until a new effective date is established by USP, but it encourages all regulated entities to comply as soon as possible, because it will not delay enforcement once a new effective date is established. This is a fluid issue that continues to appear on board of pharmacy meeting minutes and agendas.

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: