The United States Pharmacopeia (USP) has released new and revised standards aimed at ensuring the quality of compounded medicines.

The updates pertain to the USP General Chapters on compounding nonsterile medicines (USP <795> Pharmaceutical Compounding—Nonsterile Preparations), and compounding sterile medicines (USP <797> Pharmaceutical Compounding—Sterile Preparations). New standards for compounding radiopharmaceutical drugs are addressed in USP <825> Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging, according to the organization.

These updated USP General Chapters provide standards that assist health care practitioners with consistently producing quality compounded medicines that are the right strength, and quality for patients, and free of contaminants. USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings is also a relevant chapter for compounding to help promote the safe handling of hazardous drugs by health care workers.

“From the time a medication is compounded until the moment the patient takes it, we want to help ensure patient benefit and reduce risks,” said Ronald T. Piervincenzi, PhD, chief executive officer, USP, in a prepared statement. “The updated USP standards will help ensure quality preparations for patients who rely on compounded medicines, while minimizing the risk of exposure to hazardous drugs for health care personnel.”

The new and revised standards were published June 1, 2019 and are made "official" December 1, 2019, according to USP. Affected users are expected to meet the requirements of a particular standard by the "official" date. Ensuring compliance with the USP's requirements of these standards is the responsibility of federal and state regulators, including the FDA. These regulatory bodies, such as state boards of pharmacy, may have a different official date, USP officials said. 

Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said the revised USP standards acknowledge risks associated with nonsterile and sterile compounding and tighten controls in areas that directly affect the quality and safety of compounded medicines.

“The changes to these USP chapters should improve the quality of compounded products and help protect public health,” Woodcock added.

Revisions to chapters and the implementation of the new chapter reflect new science and evidence based on updated guidance documents, best practices and new learnings, USP officials said, in a press release. The revisions also incorporate stakeholder input and clarify topics that are frequently misunderstood.

“We appreciate the thoughtful feedback from stakeholders within the public health community,” said Jaap Venema, PhD, chief science officer, USP. “Participation in our public comment process is critical to ensuring the standards we develop have the intended effects of advancing quality and patient safety.”

“Furthermore, we realize in this ever-changing industry it can at times be challenging for health care organizations to implement new standards, which is why we are committed to providing innovative solutions to help healthcare teams successfully translate the new standards into their practice settings,” said Venema.

In an effort to support health care practitioners and organizations with adopting the updated standards and ensuring the safety of patients and industry workers, USP offers educational programs and other resources, including mobile apps.


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USP Publishes New and Revised Compounding Standards [news release]. Rockville, MD; June 3, 2019: USP website. 
Accessed June 3, 2019.