Have you considered how USP <797> Proposed Changes May Impact Your Sterile Compounding Operation?
Post Date: Jan 21st 2016
USP has proposed significant changes to General Chapter <797> Pharmaceutical Compounding – Sterile Preparations that will impact your sterile compounding service. With public comment on the proposed chapter due to USP by January 31, 2016, it is important that you understand the proposed changes and submit your comments and concerns for consideration as USP formulates their final recommendations.
Among the major changes in <797> is the collapsing of the previous three compounding sterile preparations (CSP) contamination risk levels (i.e. low-, medium-, high-risk level CSPs) into two categories – Category 1 and Category 2 – based primarily on the conditions under which the preparations are made and the time within which they will be used. The proposed beyond use dates (BUDs) for these categories limit the dating of Category CSPs to a maximum of 42 days even if stability studies and sterility testing are performed. The maximum effective BUD allowed after the required standard sterility quarantine period is 28 days.
BUDs based on well-designed cGMP stability studies and sterility testing per (USP <71>) are sufficient to support extended BUDs up to at least 90 days. The change in BUD maximums proposed in the revised chapter only make sense if scientifically-valid, stability-indicating studies are not performed. The 42 day maximum proposed by USP is arbitrary and inconsistent with the preponderance of experience related to compounding with manufacturer-prepared sterile ingredients and especially automated robotic IV compounding which insures a repeatable and monitored process to produce specific CSP formulations.
Another significant change is how <797> redefines primary environment control devices (PECs) such as isolators and restricted access barrier systems (RABS). IV compounding robots are not included in the PEC definitions so it is unclear how devices like i.v.STATION will be classified - either as a RABS or an isolator. This determination is critical because it drives several other associated recommendations such as the PEC cleaning schedules and placement of the PEC in a classified or unclassified area.
Other changes include the addition of requirements for documentation including master formulation records and compounding records, which while the chapter specifies they must be traceable, there is no requirement for the records to be searchable, which is necessary for the records to be available in a timely and useful way.
We strongly encourage you to download a copy of the proposed revisions to <797> and submit your comments, providing the corresponding line numbers with your submission. If you would like more information about the how the Chapter <797> revisions potentially affect the use of your IV compounding program and automated compounding with i.v.STATION, please contact us at firstname.lastname@example.org.