USP Compounding Chapters - Key Dates

The United States Pharmacopeia (USP) has been working on updates to its compounding related chapters for a couple of years now, including the implementation of the new USP Chapter <800> dealing with the handling of hazardous drugs. USP has recently announced a goal to harmonize the content and release and of the associated chapters with each chapter becoming effective in December 1, 2019.

USP General Chapter <797>, which deals with the requirements for compounding of sterile preparations was revised and published for comment on September 25, 2015.(1) The comment period remained open until January 31, 2016, and in that time USP received more than 8,000 public comments.(1) The USP has announced, that due to the overwhelming number of comments and significant impact that this revision will have to the compounding industry, USP has decided to further revise the chapter and plans to publish the new revision for public comment on September 4, 2018. They have also announced that the proposed revision will be preposted on the USP website on July 27, 2018 in order to give stakeholders more time to review and formulate comments for the official comment period.(2) See the Fig. 1 timeline for additional important dates.

Figure 1.

USP General Chapter <795>, is the chapter that deals with the requirements of compounding non-sterile preparations. The USP has announced that the revision to Chapter <795> will be published for public comment on May 1, 2018. Like Chapter <797>, they have announced a pre-posting period, scheduled for March 30, 2018 to allow stakeholders more time to review and formulate comments prior to the official comment period. See Fig. 1 timeline for additional important dates.(2)

Overall it seems that the USP is attempting to ensure that all three chapters dealing with compounding standards are harmonized regarding their content and effective dates. The highly anticipated USP General Chapter <800> dealing with the compounding of hazardous drugs, was completed and published in February of 2016.(2) Chapter <800> is currently not under revision and expected to be implemented in its current form. The USP has included in their timeline, several opportunities for stakeholder engagement and input, so it is important for all individuals in the compounding industry to take note on these key dates and be prepared to comment if necessary.

1. https://www.uspnf.com/notices/general-chapter-pharmaceutical-compounding-sterile-preparations-will-be-posted-second-round-public-comments

2. https://www.usp.org/compounding/updates-on-standards