United States Pharmacopeia

The United State Pharmacopeia and National Formulary (USP-NF, also commonly referred to simply as USP) is a publication about prescriptions and over-the-counter medicines and other healthcare products sold in the United States. Pharmacies and pharmaceutical manufacturers are required to follow the standards in the USP-NF. The USP also sets standards for food ingredients and dietary supplements. Chapters in the USP that are listed as below 1000 are considered enforceable, while chapters enumerated as 1000 or greater are considered guidelines. Therefore, USP Pharmaceutical Compounding-Sterile Preparations and USP Pharmaceutical Compounding-Nonsterile Preparations are considered enforceable, while USP Good Compounding Practices and USP Pharmaceutical Calculations in Prescription Compounding are simply considered guidelines for best practices. A challenge to enforcement is that the USP does not have its own enforcement body. Enforcement of various regulations is left to the Food and Drug Administration, The Joint Commission, and individual state boards of pharmacy. This means that many regulations may not be enforced in some states and territories.

Significant chapters
While the USP provides a great deal of information, some chapters are more commonly referenced and discussed than others. The following is a brief list of commonly referenced chapters:

USP 795 - USP Chapter 795, Pharmaceutical Compounding-Nonsterile Preparations, codifies the rules pharmacists and pharmacy technicians must follow when compounding nonsterile formulations intended for humans and animals.

USP 797 - USP Chapter 797, Pharmaceutical Compounding-Sterile Preparations, provides the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP). USP Chapter 797 describes the procedures and requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded.

USP 1075 - USP Chapter 1075, Good Compounding Practices, is intended to provide guidelines on applying best practices in compounding, both sterile and nonsterile.

USP 1160 - USP Chapter 1160, Pharmaceutical Calculations in Prescription Compounding, provides general information on the mathematical concepts required for compounding pharmaceutical preparations.

USP 1163 - Quality Assurance in Pharmaceutical Compounding, this chapter describes a quality assurance program as a system of steps and actions that must be taken to ensure the maintenance of proper standards in compounded preparations. The latest revision, which became official May 1, 2011, includes sections on training; physical testing of dosage units; weight and volume assessment; cleaning and disinfecting; containers, packaging, repackaging and storage; and outsourcing.

USP 1176 - Prescription Balances and Volumetric Apparatus, provides information about acceptable balances and volumetric apparatus (e.g., burets, pipets, cylinders, conical graduates, medicine droppers) used to weigh or measure medicinal and other substances required in prescriptions or in other pharmaceutical compounding.