USP is a scientific nonprofit organization that sets public standards for identity, strength, quality and purity of medicines. USP standards are recognized in various provisions of the federal Food, Drug and Cosmetic Act (FDCA) and in laws, regulations and policies promulgated by states. These standards are enforced by the U.S. Food and Drug Administration (FDA), states and other oversight organizations.
USP provides three types of public standards for compounding:
- USP General Chapters establish procedures, methods and practices that are utilized by practitioners to help ensure the quality of compounded preparations.
- USP Compounded Preparation Monographs contain formulations and quality standards for specific preparations to assist practitioners in compounding preparations for which there is no suitable commercially available product.
- USP Monographs for Bulk Drug Substances and Other Ingredients provide standards for identity, quality, purity, strength, packaging and labeling for bulk substances and other ingredients that may be used in compounded preparations.
Federal Recognition of USP Compounding Standards
The FDCA specifically references and mandates USP standards for compounding. USP standards are recognized in Section 503A of the 1997 Food Drug Administration Modernization Act, which states that a compounder must use bulk drug substances and ingredients that comply with the standards of an applicable USP–NF monograph, if a monograph exists, and the USP chapter on pharmacy compounding.
More recently, Congress enacted the 2013 Drug Quality and Security Act (DQSA) to clarify FDA’s authority over drug compounding and reaffirmed USP’s role under Section 503A. Following enactment of the DQSA, FDA provided further clarification of its views on the application of USP standards to pharmacy compounding through an FDA Guidance: Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug and Cosmetic Act. This guidance states that compounded preparations made by a licensed pharmacist or physician qualify for an exemption from requirements of a new drug application if they are compounded in compliance with the USP chapters on pharmacy compounding using bulk drug substances and ingredients that comply with the standards of an applicable USP or NF monograph, if one exists. The guidance specifically references USP General Chapter <795> Pharmaceutical Compounding—Nonsterile Preparations and USP General Chapter <797> Pharmaceutical Compounding—Sterile Preparations.
State Recognition of USP Compounding Standards
State pharmacy regulatory bodies are responsible for oversight of the practice of pharmacy. Almost all states have laws, regulations or policies specific to compounding.[1] Based on the 2016 NABP Survey of Pharmacy Law, at least 87 percent of boards of pharmacy either require full compliance with USP General Chapter <797> or incorporate USP General Chapter <797> into their state regulations in some way. For the boards that do not have such requirements, most have regulations pending or consider it as a standard of practice. Additionally, the August 2016 NABP Model Pharmacy Act and Model Rules, which provide boards of pharmacy with model language that may be used when developing state laws or board rules, incorporates USP General Chapters <795> and <797>.
Learn more by reading USP's fact sheet on compounding.
[1] U.S. Gen. Accounting Office, GAO-17-64, Drug Compounding: FDA Has Taken Steps to Implement Compounding Law, but Some States and Stakeholders Reported Challenges 11 (2016).