USP Compounding Standards

Statement on Public Standards for Compounding

As part of its core standards-setting mission, USP supports the development of and adherence to public quality standards for compounded preparations as a means to promote quality and uniformity and help protect the public health.

Role of Public Standards for Compounding

• Public standards for compounding help ensure the quality of compounded preparations used for patient care. Public standards for compounding help ensure uniform, high quality preparations that are consistent from institution-to-institution, and from state-to-state.
• Public standards for compounding help strengthen protections for health and safety for patients while assisting and supporting practitioners in delivering the best care possible.

USP Compounding Standards

• USP compounding standards are established by volunteer compounding experts who serve as members of the Compounding Expert Committee in USP's Council of Experts.
• USP’s current suite of standards for compounding professionals includes General Chapters <795> Pharmaceutical Compounding—Nonsterile Preparations; <797> Pharmaceutical Compounding—Sterile Preparations; <1160> Pharmaceutical Calculation in Prescription Compounding; <1163> Quality Assurance in Pharmaceutical Compounding; and <1176> Prescription Balances and Volumetric Apparatus.
• USP also has compounded preparation monographs that include directions for compounding the preparation, its packaging and storage requirements, and beyond-use dates.

Legal Recognition of USP Standards

• Pharmacies in the United States are regulated by each state’s Board of Pharmacy. State boards may choose to adopt USP standards relating to the practice of pharmacy in whole or in part.
• USP compounding standards, as published in the United States Pharmacopeia and the National Formulary (USP–NF), are officially recognized in the Federal Food, Drug and Cosmetic Act (FDCA), which states that drugs with USP–NF monographs must comply with those compendial standards for identity, strength, quality, and purity. The FDCA does not differentiate between manufactured and compounded drugs. While the Food and Drug Administration does not regulate pharmacies directly, it does have some oversight authority over compounding. Thus, if a monograph exists for a compounded preparation, the requirements of that monograph must be met.

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