Major differences between proposed USP Chapter 800 and current USP Chapter 797

USP <800> is still in draft form. The official date of the chapter has not yet been determined and is dependent on several factors, but expect it to become official some time in mid to late 2016. And while USP <797> is in the process of being updated, the current version is still the one everyone has to live with.

Information contained in USP <800> is in addition to information found in USP Chapter <797> Pharmaceutical Compounding – Sterile Preparations and USP Chapter <795>  Pharmaceutical Compounding – Nonsterile Preparations.

In its current iteration, USP <797> and USP <800> requirements for hazardous drugs (HDs) differ.  However, HD compounding in the upcoming revision to <797> will be harmonized with Chapter <800>. Actually, it looks like USP will simply defer all HD compounding to USP <800>, which makes sense.

Until all the USP Chapters are on the same page, here are some highlighted differences between Chapters <800> and <797>:

  • Requirement of compounding supervisor
  • Applies to sterile as well as non-sterile compounding
  • No longer allowed to store, unpack, or manipulate HDs in positive pressure areas
  • Elimination of exemption that allowed low volumes of HDs to be compounded in a non-negative pressure room. All quantities of HDs must be compounded in a separate, negative pressure room
  • C-SCAs may be used to compound low- and medium-risk HDs
  • CSTDs are recommended for compounding and required for administration

Perhaps the greatest impact will come from elimination of the current USP <797> exemption for small volumes of HDs to be compounded in a positive pressure room. USP <800> handles this by allowing low- and medium-risk HDs to be compounded in a containment segregated compounding area (C-SCA). C-SCA is a new concept, and is defined as “a separate, negative pressure room with at least 12 air changes per hour (ACPH) for use when compounding HDs. Low- and medium-risk HD compounded sterile preparation (CSP) may be prepared in a BSC or compounding aseptic containment isolator (CACI) located in a C-SCA, provided the beyond-use date of the CSP does not exceed 12 hours“.

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