Quality & Regulatory Affairs  |   September 2019
Long-awaited United States Pharmacopeia (USP) General Chapter <797> Revisions Explained: The One-Hour Rule will No Longer be in Effect
Author Affiliations
  • Elizabeth Rebello, M.D., FASA
    Committee on Quality Management & Departmental Administration
  • Lois Connolly, M.D., FASA
    Committee on Quality Management & Departmental Administration
  • H. A. Tillmann Hein, M.D., Ph.D.
    Committee on Quality Management & Departmental Administration
Article Information
Education / CPD / Patient Safety / Practice Management / Respiratory System / Technology / Equipment / Monitoring / Advocacy and Legislative Issues / Quality Improvement / Quality & Regulatory Affairs
Quality & Regulatory Affairs   |   September 2019
Long-awaited United States Pharmacopeia (USP) General Chapter <797> Revisions Explained: The One-Hour Rule will No Longer be in Effect
ASA Monitor 9 2019, Vol.83, 70-71.
ASA Monitor 9 2019, Vol.83, 70-71.
The United States Pharmacopeial Convention, a scientific nonprofit organization, sets standards for the identity, purity, manufacturing and handling of medications that are recognized worldwide. These standards are published in the United States Pharmacopeia (USP) chapters and those numbered below 1,000 are standards while those numbered above 1,000 are recommendations. In most U.S. jurisdictions (46 states and territories), USP chapters are incorporated into statute by reference. That makes these chapters enforceable by the Centers for Medicare & Medicaid Services (CMS) and those accrediting agencies that have been granted deemed status by CMS. To maintain compliance with The Joint Commission (TJC) and other accrediting organizations, state regulatory bodies and CMS, physicians, pharmacists and other health care workers are often required to meet the standards of USP chapters. USP has no enforcement role.
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