The purpose of this section is to assure positive patient outcomes through the provision of standards for 1) pharmaceutical care; 2) the preparation, labeling, and distribution of sterile pharmaceuticals by pharmacies, pursuant to or in anticipation of a prescription drug order; and 3) product quality and characteristics. These standards are intended to apply to all sterile pharmaceuticals, notwithstanding the location of the patient (e.g., home, hospital, nursing home, hospice, doctor's office, or ambulatory infusion center).
All referenced chapters of the USP, in subsection (1), are specifically referring to the United States Pharmacopeia, 36th revision, Second Supplement, which is hereby incorporated and adopted by reference with the effective chapter dates of December 1, 2013. A subscription to all relevant chapters is available for purchase at www.uspnf.com. The Board has determined that posting the incorporated material on the Internet would constitute a violation of federal copyright law. At the time of adoption, the copyrighted incorporated material will be available for public inspection and examination, but may not be copied, at the Department of Health, 4052 Bald Cypress Way, Tallahassee, Florida 32399-3254, and at the Department of State, Administrative Code and Register Section, Room 701, The Capitol, Tallahassee, Florida 32399-0250.
Fla. Admin. Code Ann. R. 64B16-27.797
Rulemaking Authority 465.005, 465.0155, 465.022 FS. Law Implemented 465.0155, 465.022 FS.