Standards for Compounding Sterile Preparations Go Under Major Revision

General Chapter <797> is pre-posted for public comment

ROCKVILLE , MD., Sept. 28, 2015 (GLOBE NEWSWIRE) -- The U.S. Pharmacopeial Convention (USP) pre-posted General Chapter 797 Pharmaceutical Compounding – Sterile Preparations for public comment on September 25, 2015. The chapter, which has been under review by the Compounding Expert Committee since 2010, has been significantly revised to clarify requirements, reflect feedback from stakeholders and incorporate new learnings.

"The proposed revision represents major changes in concepts and terminology, and therefore we believed it was important to give ample time for our stakeholders to comment on those changes", said Jaap Venema, executive vice president and chief science officer at USP. "We are confident that the changes in chapter 797 will help practitioners better understand and comply with the standards to prepare quality compounds."

Among the major changes in 797 are the collapsing of the previous three compounding sterile preparations (CSP) contamination risk levels (i.e. low-, medium-, high-risk level CSPs) into two categories – Category 1 and Category 2 – based primarily on the conditions under which they are made and the time within which they will be used. Category 1 CSPs have a shorter maximum beyond use date (BUD), while Category 2 CSPs have a longer maximum BUD, based on several factors, such as sterility considerations. The revised chapter describes all the applicable standards for Category 1 and 2 CSPs.

All specific information on the handling of hazardous drugs was removed from the chapter and is now referenced in 800 Hazardous Drugs – Handling of Hazardous Drugs in Healthcare Settings, which was originally proposed in 2014 and is currently under review.

Personnel qualifications were expanded in 797 to provide more guidance on training, evaluation, and requalification of compounding personnel. The frequency of certain environmental monitoring requirements was increased to promote better control over the compounding area. A new term introduced in 797 is the "in-use time" terminology, which refers to the time before which a manufactured product or CSP must be used after it has been opened or punctured.

Other changes include the addition of requirements for documentation including master formulation records and compounding records, guidance for sterility testing of CSPs prepared in batches of less than 40 units and guidance on establishing BUDs for Category 2 CSPs. The changes were based on recommendations provided by the Pharmaceutical Compounding - Sterile Preparations Expert Panel formed in 2013 to analyze 797 in detail and address any perceived gaps and issues.

"Compounding practitioners, educators, infection control specialists, industrial hygienists, environmental engineers, nuclear medicine specialists, microbiologists, surveyors and industry experts were all part of the Expert Panel," says Gigi Davidson, R.Ph., DICVP, Director of Clinical Pharmacy Services at North Carolina State's College of Veterinary Medicine and Chair of the Expert Panel.
On October 21, 2015, USP will hold an "open microphone" session, where the revision to 797 will be discussed in detail and stakeholders will have the opportunity to ask questions about the changes in the chapter.

To access the chapter and comment on the content, please visit http://www.usp.org/usp-nf/notices/general-chapter-797-proposed-revision. The chapter will be officially posted on November 2, 2015 in the Pharmacopeial Forum, USP's free, bimonthly online resource for review and comment of proposed revisions to USP–NF.

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CONTACT: Claudia Costabile 301-816-8314; cac@usp.orgSource: United States Pharmacopeia