USP seeks feedback on <797>

Revisions to USP <797> under way

USP is urging pharmacist stakeholders to review proposed revisions to one of its national standards for compounded preparations.

The chapter, General Chapter <797> Pharmaceutical Compounding—Sterile Preparations, is one of two enforceable national standards for compounding published by USP. <797> specifically details requirements for the process, testing, and verification of any compounded sterile preparation, especially ways to prevent microbial contamination and other variances in compounded sterile preparations in all settings, including community pharmacies, and regardless of who is performing the compounding.

“The goal of revising <797> is to set standards for producing quality compounded preparations, leading to increased patient safety,” Jaap Venema, PhD, executive vice president and chief science officer at USP, told Pharmacy Today.

USP made it clear, however, that the revision was not coming in reaction to recent contamination outbreaks—most notably the tragedy involving the New England Compounding Center in 2012. 

“This wasn’t a reaction,” Rick Schnatz, PharmD, senior manager for Compounding and Healthcare Quality Standards at USP, told Today. “Our initiatives are always to produce standards that will allow practitioners to make quality, sterile preparations that benefit patients.”

Years in the making

USP works with its Compounding Expert Committee—a group of outside selected expert volunteers who make USP’s scientific and standards-setting decisions—to improve the clarity of the chapter, based on the latest scientific data and extensive stakeholder input, according to Venema.

“For that purpose, USP has worked closely with compounding practitioners, educators, infection control specialists, government liaisons, and other health care professionals,” said Venema. 

The last revision to <797> took place in 2008, and since 2010, the chapter has been under review. 

These new revisions seek to clarify requirements, incorporate new scientific and technical information, and reflect stakeholder feedback, specifically on the reorganization of existing sections and placement of procedural information in boxes; collapsing of three compounded sterile preparation (CSP) microbial risk categories into two categories (Category 1 and 2); and removal of information on handling hazardous drugs and added cross-references to <800> Hazardous Drugs—Handling in Healthcare Settings.

In addition, the revisions introduce new terminology, “in-use time,” to refer to the time before which a conventionally manufactured product must be used after it has been opened or punctured or a CSP must be used after it has been opened or punctured.

The practice of traditional compounding under 503A of the Food, Drug & Cosmetic Act is regulated primarily by state boards of pharmacy, and in many states, compliance with <797> carries the force of law based on regulations passed by state legislatures and boards of pharmacy. Aside from compounding done in 503B-registered outsourcing facilities, FDA and DEA have oversight only for the drugs and controlled substances used to prepare compounded medications.

FDA said the revised chapter reflects a significant improvement over the current chapter.

“It more clearly recognizes the risks associated with sterile compounding and tightens controls in areas such as personnel qualification, facility design, environmental monitoring, and establishment of beyond-use dates,” Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, said in an e-mailed statement to Today. “If adopted without significant change, it will help to ensure that patients who receive sterile drugs compounded in accordance with this chapter are not exposed to contaminated products and will represent a meaningful improvement in the protection of the public health.”

Timeline and next steps

To allow extra time for stakeholder review and comment, USP posted the proposed revisions in advance of its November 2, 2015, publication in Pharmacopeial Forum (PF) 41(6) [Nov.–Dec. 2015].

“We believe this chapter is a very important one for the safety of patients, so we preposted the chapter to give stakeholders extra time,” said Schnatz.

He said, however, that they can’t predict when it will be official. When the comment period ends on January 31, 2016, members will meet and revise the chapter based on the public comments. “We could also get so many comments that we would need to put it out again for comment,” said Schnatz. Depending on the changes, members may otherwise move forward and vote on the chapter. If approved, the chapter will be published and facilities will have a 6-month period to comply. The committee can also decide to extend the compliance period. 

Comments can be sent to using the submission template at Comments should include corresponding line number to the proposed revisions to the General Chapter. Questions can also be sent to