1.1 Where can I find the full text of USP <800>?

USP publishes the USP Compounding Compendium. It contains all of the major compounding chapters: <795> Pharmaceutical Compounding—Nonsterile Preparations, <797> Pharmaceutical Compounding—Sterile Preparations, and <800> Hazardous Drugs—Handling in Healthcare Settings as well as all the other chapters that are referenced in those three core compounding chapters. Additionally, the General Notices that apply to compounding and compounding monographs are included. They are available through USP at www.usp.org as an annual subscription.

1.2 When did USP <800> become official?

USP <800> became an official standard on December 1, 2019.

1.3 I have heard there may be changes to <800> that will impact remodels. How can I find out quickly?

<800> is final. There have been two minor changes since the 2016 publication. One was an errata official in June 2016 removing the requirement for HEPA-filtered air vented from the negative room. The other was published in June 2020 specifying that NIOSH Table 1 antineoplastic drugs (not all Table 1 drugs) must follow all requirements in <800> and cannot have alternative strategies used. Future revisions of <800> will go through a public comment period—as all new and revised USP chapters do—so you will have notice of any future changes.

1.4 Is USP <800> a guideline? A requirement?

<800> is a minimum standard. Regulators such as federal or state entities can make it a regulation by including it in their documents. Accreditation organizations such as The Joint Commission (TJC), DNV Healthcare, Accreditation Commission for Health Care (ACHC), Center for Improvement in Healthcare Quality (CIHQ), the Pharmacy Compounding Accreditation Board, and others can include it in their own standards.