Updates on Compounding Standards

Compounding is the combining, mixing or altering ingredients, in any setting, to create medication that can meet unique medical needs of individual patients.

USP General Chapters <795>,<797>, and <800> form a set of standards, which assist practitioners to consistently produce quality compounded preparations.

To provide a unified approach to quality compounding, USP intends to align the timing and content of General Chapters <795>, <797>, and <800>. General Chapters <795> and <797> are in the active revision process. Among other content changes in the proposed revisions, hazardous drug handling sections in <795> and <797> will reference General Chapter <800>. General Chapter <800> was completed and published in February 2016, and is not currently under revision. 

The three chapters (<795>, <797>, and <800>) are anticipated to be official and aligned on December 1, 2019.

It is important to note that the current published versions of USP- NF General Chapters <795> and <797> are official until the revisions to these Chapters become official.

Opportunities to Engage and Provide Input

USP has an established process for convening independent experts in the development and maintenance of healthcare quality standards. The process is public health focused, leverages current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing opportunities for public input from stakeholders throughout the standards’ progress. USP creates standards via an interactive dialogue between USP, independent experts, and a variety of stakeholders. Through this process, USP collects input on substance and compliance considerations for the proposed standards. This collaborative process helps to ensure the integrity of the standards.

Below is the timeline associated for the proposed revisions to <795> and <797> and opportunities to engage with USP and provide input.

compounding engagement timeline


<795> Pharmaceutical Compounding—Nonsterile Preparations

The public comment period for <795> occurred between March 30 and July 31, 2018.

The comment period for <795> included the following activities:

The links are also available on the <795> web page.

  • March 30, 2018

    Please note that the proposed revision to <795> was pre-posted in advance of its publication in Pharmacopeial Forum (PF) 44(3) [May.-Jun. 2018] to allow additional time for public comment and review.

  • April 20, 2018 - Open Microphone Session - Recorded Session
  • July 31, 2018
    The public comment period for the proposed revision to <795> closed.

<797> Pharmaceutical Compounding — Sterile Preparations

Revisions to General Chapter <797> was published for a second round of public comment. 

Since the first public comment period, which began in September 2015, there has been significant input from stakeholders including round-table meetings, discussion forums, and review of more than 8,000 written public comments. Expert consultants have been engaged to assist the Expert Committee during this revision process. The Expert Committee has reviewed all of the public comments from the September 2015 proposal along with additional guidance from many stakeholders to propose a new revision for a second round of public comment.

The proposed revision to General Chapter <797> chapter was pre-posted on the USP website for review prior to its publication in the Pharmacopeial Forum 44(5) on September 4, 2018. This pre-posting allowed extra time, beyond the typical 90 day period, for stakeholders to review and provide input.

The public comment period for <797> occured between July 27 and November 30, 2018.

The comment period for <797> included the following activities:

  • July 27, 2018
    Please note that the proposed revision to <795> was pre-posted in advance of its publication in Pharmacopeial Forum (PF) 44(5) to allow additional time for public comment and review.
  • September 5, 2018 - Open Microphone Session – Recorded Session
  • November 30, 2018 The public comment period for the proposed revision to <797> closed.

<825>  Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging

The anticipated revisions to <797> will eliminate the Radiopharmaceuticals as Compounded Sterile Preparations (CSPs) and replace it with a reference to General Chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging. General Chapter <825> was published for public comment between July 27 and November 30, 2018.

The proposed <825> chapter was pre-posted on the USP website on July 27, 2018 for review prior to its publication in the Pharmacopeial Forum on September 4, 2018. This pre-posting allowed extra time, beyond the typical 90 day period, for stakeholders to review and provide input.

The upcoming comment period for <825> includes the following activities:

  • July 27, 2018
    Please note that the proposed revision to <795> was pre-posted in advance of its publication in Pharmacopeial Forum to allow additional time for public comment and review.
  • October 10, 2018 - Open Microphone Session – Recorded Session
  • November 30, 2018

    The public comment period for the proposed revision to <795> closed.

General Chapters <795>, <797>, and <825> are anticipated to be completed and published in the USP-NF on June 1, 2019.

USP remains committed to hearing your perspectives and we want to encourage your engagement in the public comment process. Please check here or sign up for HQS updates to stay informed.