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What Now? Answering Your Questions Regarding the USP <797>, <795> & <825> Postponement

October 14, 2019

Contec Healthcare is a supplier of cleaning, disinfecting, and associated products for use in pharmacies. We are committed to providing quality products as well as on-site and online training to address the evolving standards from USP for compounding pharmaceutical products. Contec Healthcare strives to maintain up to date resources many of which have been amended to reflect changes found in the newly released USP chapters. Like you, we have been left to sort out many questions as a result of recent events.

On Monday, September 23rd, 2019, USP announced that they will postpone the official dates of the revised chapters < 797 >  (sterile compounding) and < 795 > (non-sterile compounding) and the new chapter < 825 > (radiopharmaceuticals) which were scheduled to become official on December 1, 2019. See below our responses to several frequently asked questions regarding this postponement.

Q: Why were USP Chapters < 795 >, < 797 >  & < 825 > and postponed?

A: After the Chapters were published on June 1, 2019, USP received appeals on certain provisions in the chapters. Several appeals challenged the BUD (Beyond Use Dating) framework in Chapters <795 > and < 797 >. The Expert Committees considered these appeals and issued a decision maintaining the BUD provisions in both chapters.  

In accordance with USP Bylaws, the stakeholders that submitted appeals on the compounding chapters have requested an additional further review of their appeals by a newly Appointed Panel.

You can read more about the appeals and the appeals process on the USP website.

The logistics associated with the review process will require postponement of the Dec. 1, 2019 date.

Q: In the interest of compliance, what happens now?

A: The current official chapters of USP < 795 > (last revised in 2014) and USP < 797 > (last revised in 2008) including the section Radiopharmaceuticals as CSPs (Compounded Sterile Preparations) will remain official.   

 USP Chapter < 800 > is not subject to any pending appeals and will become official on December 1, 2019. During the postponement and pending resolution of the appeals of < 795 >  and < 797 >, Chapter <800 > is informational and not compendially applicable. USP encourages utilization of < 800 > in the interest of advancing public health.

The Appointed Panel will decide (before December 2019) to remand or deny the appeals.

Q: Contec Healthcare has created & updated their best practice training resources to reflect the revised Chapter < 797 > (published June 2019).  If our facility follows these standards – will we be out of compliance with the enforceable Chapter <797 > (2008)?

A: USP Chapters < 795 >, <797 >, and < 800 > set a minimum standard for quality. In most applications – the 2019 revision to Chapter < 797 > exceeds the requirements of the 2008 version. If your facility has already updated their cleaning, disinfecting and Garbing SOP’s (Standard Operating Procedures) to reflect the 2019 revision – Contec suggests that you continue down that path as your SOP’s will exceed the 2008 version.

There is one application where the 2019 revision provides greater detail than the 2008 chapter: the required cleaning frequencies for the Primary Engineering Controls (PECs). 

The 2008 version of USP Chapter requires:

  • cleaning and disinfecting the PEC at the “beginning of each shift”.
  • the entire PEC to be disinfected “before each batch, not longer than 30 minutes following the previous surface disinfection.”

The 2019 revision of USP Chapter < 797 > requires:

  • to clean all interior surfaces of the PEC daily (once per day).
  • Apply sterile 70% IPA to the horizontal work surface at least every 30 minutes if the compounding process takes 30 minutes or less.  If the compounding process takes more than 30 minutes, compounding must not be disrupted, and the work surface of the PEC must be disinfected immediately after compounding.”

Q: The 2008 version of USP Chapter < 797 > did not specify the use of a sporicidal agent in the Primary or Secondary Engineering Controls. If we have already updated our SOPs (Standard Operating Procedures) and trained our staff on how to use a sporicidal agent. Should we continue the use of sporicidal agents? 

A: USP sets a minimum standard of quality. The use of a sporicidal agent exceeds the minimum standard of a germicidal (non-sporicidal) disinfectant.  Contec Healthcare will recommend the use of sporicidal disinfectant weekly in the PEC and monthly in the SEC as a best practice. This best practice will exceed the required minimum standards in both the 2008 version and the 2019 revision of Chapter < 797 >.

Q: What about USP for Hazardous Drugs?

A: USP Chapter < 800 > is not subject to any pending appeals and will become official on December 1, 2019.  However, because < 800 > references some of the other chapters, USP indicates that < 800 > will remain informational and “not compendially applicable” during the postponement and pending resolution of the appeals of USP < 795 > and < 797 >.  Despite this delay, USP encourages the utilization of Chapter < 800 > in the interest of advancing public health.

Contec Healthcare encourages reviewing any information on this subject that might be available from applicable regulatory agencies.

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