4 STANDARDS AND PROCEDURES
Earlier this year, the United States Pharmacopeia (USP) took the first in a series of steps to revise the standards for compounding nonsterile and sterile preparations, and aligning the relevant
chapters with USP <800> (“Hazardous Drugs —
Handling in Healthcare Settings”), which was published in 2016 and goes into effect December 1, 2019.
The public comment period for USP <795>
closed in late July of this year, at the same time that
USP introduced their Proposed Revision for GC
<797>, with a public comment period that will
close on November 30, 2018.
USP <797> specifically addresses
“Pharmaceutical Compounding — Sterile
Preparations.” Like USP <795>, the Proposed
Revision introduces substantive changes that affect
a range of categories, particularly for institutional
Understandably, these revisions could have a
sizable impact on facility workflow and finances,
so it’s incumbent on pharmacists and executives to
review USP <797> and determine how the scope of
the proposed changes could actually influence their
Here are some of the revisions likely to have the
most significant consequences.
Shifting definitions for sterile compounding
As is case for the revisions to nonsterile compounding rules, this chapter also brings fundamental
change to the medication compounding model.
The previous version of <797> outlines three
categories of compounded sterile products: low-risk, medium-risk, and high-risk. The Proposed
Revision to GC <797> consolidates those into two:
Category 1 and Category 2.
This shift is likely to have the greatest impact
on facilities that were formerly classified as medi-
um-risk compounders, which describes the vast
majority of hospitals in the U.S. Many of these
facilities will now be graduating to a higher level of
compounding “risk” in Category 2 and, as such, will
have a higher bar to clear to remain in compliance.
USP <797> also introduces a new definition of
“what constitutes compounding.” In the case of a
“bag and vial” system (in which a medication vial
is attached, with adaptor, to the bag that it needs to
be mixed in, for infusion), if a nurse is on the nursing unit and attaches the bag and vial, that is not
regarded as compounding.
However, if a batch of these is being attached
within the pharmacy to be put into different automated dispensing cabinets, that process is now considered “sterile compounding” and would need to
be done inside an ISO Class 5 hood.
Investment of time
Previously, mandatory checks such as glove fingertip testing and media fill testing have been done
annually, but <797> will now mandate that these
be performed semi-annually.
The person responsible for this QA will now
effectively have their workload doubled: in the
example of a mid-sized facility — with 25 employees — the process (including training, visual
observations, and the testing mechanics) could be
estimated to take two hours per employee. That
represents an additional 50 hours of work, not to
mention a doubling in the cost of supplies.
Similarly, the requirement for surface sampling
(literally wiping surfaces in various compounding
areas to test for bacterial contamination) is mandated to be done monthly in the new version of
<797>; the previous version required that this testing need only be done “periodically,” with that term
defined loosely. For most facilities, then, this redefinition will result in additional time requirements.
Facility renovations: Another major adjustment for facilities that will be newly deemed to be
“Category 2 compounders” will come in the form
of new requirements for what qualifies as a “
classified area” for sterile compounding.
USP Convention’s latest move could significantly raise the bar for compliance
among U.S. pharmacies.
USP’s Overhaul of Compounding