Pharmacy News

Need for Stakeholders' Early Input on Chapters Acknowledged by USP

[Updated March 9, 2016]

Cheryl A. Thonpson

BETHESDA, MD 04 Mar 2016—With hundreds of comments to consider on the proposed revision to United States Pharmacopeia chapter 797, its publisher last week announced a plan for obtaining stakeholders' input during the "early stages" of development of general chapters.

"Robust input at the early stages of general chapter development has the potential to benefit USP staff and volunteers by suggesting modifications to scope and content that can streamline the development process, save time and effort, and minimize delays in reaching an official publication," the United States Pharmacopeial Convention (USP) stated on February 26.

As of February 18, according to a USP spokeswoman, the Compounding Expert Committee had not reviewed all the individual comments, numbering in the hundreds, submitted by the public on the proposed revision to USP chapter 797, "Pharmaceutical Compounding—Sterile Preparations."

That level of response from the public is common for high-impact standards, such as USP chapter 797, she added.

The "nature and significance" of the comments on the original proposal of another chapter, "Hazardous Drugs—Handling in Healthcare Settings," prompted the Compounding Expert Committee to rework the document, USP said earlier. After release of the second proposal, the committee received more than 400 comments and incorporated some. USP published the chapter this past February, nearly two years after release of the original proposal.

For the proposed revision of USP chapter 797, released this past September, more than 80 specific comments came from ASHP alone.

Overall, ASHP expressed concern about the proposed revision's focus on the type of sterile compounding performed by compounding pharmacies and FDA-registered outsourcing facilities, which is different from the preparation of ready-to-administer sterile doses in acute care settings.

The International Academy of Compounding Pharmacists submitted more than 110 specific comments.

USP said the decision on how to proceed with USP chapter 797 is up to the Compounding Expert Committee, which is scheduled to meet on April 11.

Bona Benjamin, who coordinates ASHP's comments regarding USP chapters, indicated that patient care settings "are a much different environment" than the laboratory.

"Achieving the proper balance when applying certain scientific principles to pharmacy practice is challenging," she stated.

Receipt of stakeholders' comments "earlier in the process of writing standards," Benjamin stated, "will provide a valuable perspective for USP's Expert Committees and help achieve that balance."

In announcing the plan for obtaining stakeholders' early input on general chapters, USP issued prospectuses for the following two USP chapters:

The deadline to provide input on either of the above prospectuses is March 29.


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