Chapter : There Goes the Budget

Chapter <797>:
There Goes the Budget
Brooke L. Richards, CphT
Pharmacy Business Specialist
H.D Goodall Hospital
Sanford, Maine
Program Objectives
Outline variables to consider in achieving
optimal compliance to USP 797 regulations
Discuss the Pharmacy Buyer’s role in the
financial considerations of compliance to
USP 797
What is the United States
Non-Profit public health organization
founded in 1820
 Created a system of standards, quality
control, and a national formulary
 First version of USP text published in
1830 with revisions every 10 years, then
ever 5 years in 1942, and now annually
as of 2002
Became a state board requirement
when state boards formed in 18801890’s
 In early 1900’s recognized by Federal
Food and Drug Act as official standards
 USP standards can be used as
evidence of national standards in law
What is USP
Chapter <797>?
The first set of enforceable standards
for compounding sterile products.
 Enforceable by FDA and state boards of
 Liability lawyers can and will use these
standards in cases
The Joint Commission for Accreditation
of Healthcare Organizations adopted the
standards from USP as guidelines, but
not requirements for accreditation
 Initially published in the United States
Pharmacopeia in 2004.
 Revised in 2008
 Currently under review for further
Details procedures, training, and quality
assurance measures for all healthcare
facilities in which sterile products are
 Requirement for all healthcare
professionals including pharmacists,
pharmacy technicians, physicians, and
nurses who prepare sterile products
What are some of the specific
standards set forth in Chapter
Objective is prevent harm to patients in
regards to Compounded Sterile
Preparations (CSP’s)
Acknowledges that direct or physical
contact with critical sites poses greatest
risk for CSP contamination
 Education, aseptic technique, and
compliance to polices are keys to
preventing patient harm
Risk Categories
Defines risk categories for the
preparation and beyond use dating of
 Risk categories include Immediate use, Low
with 12-hour or less BUD (Beyond use
date), Low,
Medium, and High risk
Immediate Use CSP
Immediate-use CSPs are exempt from the
requirements described for low-risk level CSPs
only when all of the following
criteria are met:
 Exempt from all requirements in <797>
 Only simple aseptic measuring and transfer are
 Not more than three manipulations and no
hazardous drugs
 No delays/interruptions
Immediate Use CSP
No contact contamination of ingredients or
critical sites
Dose must be labeled if not administered by the
Administration must begin within one hour after
the start of preparation
Dose must be discarded if administration has not
begun within one hour after the start of
preparation (No storing. No recycling.)
Examples: Ambulance, ER, Bedside
*Pharmacy Purchasing & Products April 2011 - Vol. 8 No. 4 - Page #10
Low-risk CSP
Aseptic technique in an ISO Class 5
 3 or fewer sterile manipulations utilized
 Not more than 2 entries into any one
 Beyond use dating of 48 hours controlled
room temperature, 14 days refrigerated, 45
days frozen
Low-risk with 12 hour or less BUD
Administration must begin within 12 hours
unless stated less by package insert
 Compounded in a non USP complaint clean
room or self-contained isolator
 No hazardous drugs
 All cleansing and garbing requirements
 Primarily follows low risk level
Medium Risk CSP
Complex aseptic technique in ISO Class 5
 More than 3 sterile manipulations utilized
 Greater than 3 entries into containers
 Pooling of sterile products to prepare
multiple CSP’s
 Beyond use dating of 30 hours room
temperature, 9 days refrigerated, 45 days
High risk CSP
Complex aseptic manipulations in ISO
Class 5 environment
 Use of non-sterile ingredient and/or nonsterile device
 Final sterilization by filtration, steam, or
dry heat
 In the absence of passing sterility, beyond
use dating of 24 hours room temperature,
3 days refrigerated, and 45 days frozen
Beyond Use Dating
Important to note
 Beyond use dates are based on sterility
and not stability
 When drug stability differs from
sterility use whichever is shorter
 Example is Phenytoin
Requires 4 hour dating due to drug
Outlines the responsibilities of
personnel involved including their
training and documentation procedures
when compounding
 Defines the facility design of the clean
room and ante room as well as the
cleaning procedures for these areas
Personnel Responsibilities
Aseptic hand washing
Personnel Responsibilities
Proper garbing
 Proper aseptic technique
 Proper cleaning of IV hoods and IV rooms
 Adherence to policies
 Correct documentation
Personnel Responsibilities
Didactic training, written exam, media fill
testing, and surface sampling
 Media fill tests done annually for low to
medium risk and semi-annually for high risk
Facility Design
Optimal design depends on risk level
Low, Medium, High risk
**Figures 1 & 2 USP Chapter <797> Revised 2008**
Low with 12 hour
Beyond use dating
Facility Design
Optimal design also includes:
 HEPA filtration
 Proper temperature
 Proper room pressure
 Humidity Controlled
 Smooth non-porous floors, ceilings, and
work surfaces
Cleaning and Disinfecting
ISO Class 5 environment
 Beginning of each shift
 Start of each batch
 At least every 30 minutes
 Whenever contamination is either known
or suspected
 Use of sterile water to remove residue
followed by residue-free disinfecting agent
e.g. sterile 70% alcohol
Cleaning and Disinfecting
ISO Class 7 and 8 areas
 Floors, counters, and work surfaces
cleaned daily
 Walls, ceilings, and shelving cleaned
Steps to achieving optimal
Learn it!
 Know it!
 Train yourself and your staff!
 You can not see where to go
without knowing where you are
Become familiar with your state’s
regulations regarding <797>. Not all
states are the same therefore it is
important to know how your state’s
board of pharmacy is “enforcing” the
797 Survey Compliance Results
Conducted by Clinical IQ, LLC
Consulting company; Eric Kastango, RPh
and Peter Cantor
 Covers U.S Boards of pharmacy, Sterile
Compounding Laws, Regulations, and CE
Examples of states with direct 797
requirements are Texas and Florida
 States with indirect 797 (not 797, but
other compliance requirements for sterile
compounding) are Maine and Nevada
 Michigan and Connecticut are examples
of places with no reference to 797
Where to begin?
Define your facilities risk category
Perform a gap analysis- Can be found online,
Helps show areas which are not in full
compliance with <797>
 Form committees with members of
Pharmacy, Risk Management, and Infection
 Meet with facility management: How far from
the defined ante and clean room is your
existing space? Is there a way to get there
without a complete renovation?
Policy & Procedures
 Update facilities polices and
procedures on sterile product
preparation to coincide with that of
 Hand written or computerized,
documentation of facility cleaning,
personnel training and competency,
certification of IV hoods, clean room
monitoring, and CSP preparation is a
major key to compliance.
What is the buyer’s role in
<797> compliance?
Cost Analysis
CSP preparation
 Define risk level
 Utilizing pre made IV bags Versus
technician batch preparation
 Examples: Galaxy, Duplex, Mini-Bag
Plus, or, Advantage
Cost Analysis
 Define risk level
 Purchasing from facilities dedicated to
higher risk preparations
 High cost of end product sterilization and
testing for High-Risk CSP’s
 Examples: PCA syringes, TPN bags,
Cost Analysis
Cleaning supplies
 Non-shedding wipes
 Sterile Alcohol (bottles, prep pads)
 Alternate disinfecting products
 Mops
 Tacky mats
Cost Analysis
Personal Protective Equipment Etc
 Waterless alcohol-based surgical hand
 Garbing supplies: gloves, gowns, masks,
shoe covers, and hair covers
Cost Analysis
Environmental Monitoring
 Define risk level
 Media fill testing kits
 Surface Sampling
 Temperature/humidity monitoring
 Room Pressure monitoring
 Air sampling
 Endotoxin and pyrogen testing
Cost Analysis
Room Design
 Open room
 Closed room
 Use of an isolator hood
 Design affects cleaning, maintenance, and
usage costs
Staff Education
Essential to patient care
 Creating the “perfect” clean room
environment means nothing if staff
does not know proper aseptic
technique, cleaning procedures, and
Staff Education
Improperly made CSP’s are to be discarded
Multiple doses vials that are not dated are to be
discarded $$$
Misuse of cleaning products $$$
Media fill testing/Surface Sampling (retesting
upon failed test) $$$
Misdated/Mislabeled/Improperly stored CSP’s
Chapter <797> is here to stay
 Enforceable!!
 Staff education has a huge affect on
 Pharmacy Buyers/Purchasers can have a
tremendous impact on the financial side of
United States Pharmacopeia Chapter <797>, Copyright 2008
USP Chapter <797> Update on Recent Revisions, Claudia C. Okeke, Ph.D. R.PH, NABP
Annual Meeting May 20, 2008
The ASHP Discussion Guide on USP Chapter <797> for Compounding Sterile
Preparations :ASHP Compounding Resource Center: Q & A with Clyde Buchanan : Overview of USP General Chapter 797 Pharmaceutical CompoundingSterile Preparations :Joint Commission Resources: Compliance with New USP-NF
Chapter on Compounding Sterile Preparations : USP <797>: The First Step to Compliance By Eric S. Kastango,
MBA, RPh, FASHP Simplifi797 : The Top 10 Gaps in USP Chapter <797> Compliance : 797 State compliance survey results

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