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 revised 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> will occur between March 30 and July 31, 2018. This is the first time proposed revisions to the existing chapter will go through a public comment process.

The upcoming comment period for <795> includes the following activities:

Please submit your comments using the electronic form no later than July 31, 2018.

The proposed revision to <795> is 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.

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

<797> - Pharmaceutical Compounding — Sterile Preparations

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

This is the second comment period for the proposed revisions to <797>. 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. Additionally, expert consultants have been engaged to assist the Expert Committee during this revision process. This additional guidance will aid in the review of public comments, particularly gaining further insight from the physician stakeholder community.

The upcoming comment period for <797> includes the following activities:

  • July 27, 2018 
    The proposed <797> revision will be 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 allows extra time, beyond the typical 90 day period, for stakeholders to review and provide input.

    You will be able to provide written comments through the USP website during the public comment period. The link will be made available July 27, 2018 on this page as well as on the <797> web page.
  • September 5, 2018 
    USP will host an Open Microphone session.
    During the session, USP will highlight changes in the proposed revised standard and answer stakeholder questions about the approach and methodology of the revision.

    The registration link will be made available on August 5, 2018 on this page as well as on the <797> web page.
  • November 30, 2018
    Public comment period will close for <797>.

    Please submit your comments via the web links on this page, as well as on the <797> web page, no later than November 30, 2018.

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

All three chapters <795>, <797>, and <800> are anticipated to become official on December 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.