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.
On June 1, the US Pharmacopeial Convention released its well-anticipated revisions to USP Chapter <797> Pharmaceutical Compounding-Sterile Preparations.1 These...
