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Extended Stability and Beyond-Use Dating in Home Infusion:

A Critical Piece of the USP <797> Compliance Puzzle

Caryn Bing, RPh, MS, FASHP Clinical Services/Residency Program Manager

Critical Care Systems

1.  Make sure your BADGE IS SCANNED each time you enter a session, to record your attendance.

2.  Carry the Evaluation Packet you received on registration with you to EVERY session.

3.  If you’re not applying for CE, we still want to hear from you! Your opinions about our conference are very valuable.

4.  Pharmacists and Nurses need to track their hours on the Statement of Continuing Education Certificate form as they go.

5.  FOR CE: At your last session, total the hours and sign your Statement of Continuing Education Certificate form.

–  Keep the PINK copy for your records. Place the YELLOW and WHITE copies in your Evaluation packet

–  Make sure an evaluation form from each session you attended is completed and in your Evaluation packet

–  Put your name on the outside of the packet, seal it, and drop it in the drop boxes in the NHIA registration area at the convention center

Top 5 Things to Know for CE:

© 2010, Critical Care Systems, Inc. All rights reserved. 01/10

Learning Objectives

•  Discuss the storage time frames for each USP Chapter 797 risk level for compounded sterile preparations (CSPs).

•  Describe processes required for assigning beyond use dates to CSP’s that exceed the USP Chapter 797 specifications.

•  Describe key points for maintaining CSP integrity in the compounding and distribution process.

© 2010, Critical Care Systems, Inc. All rights reserved. 01/10

Bing’s “BUD” Puzzle

Developed by Caryn Bing and used with permission

© 2010, Critical Care Systems, Inc. All rights reserved. 01/10

Overview of USP Chapter 797 Risk levels, storage conditions, and Beyond Use Dating (BUD)

© 2010, Critical Care Systems, Inc. All rights reserved. 01/10

797 Risk Level Refresher Risk Microbial contamination

Immediate Use CSP: Exempt from most 797 controls and QA requirements—Why?

•  Simple transfer, continuous process < 1 hour •  ≤ 3 sterile non-hazardous components •  2 or fewer entries into any one component (vial,

bag) •  Admin started within 1 hour, completed within 12

hours of CSP preparation (the BUD)

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Low Risk CSP

•  Sterile source components, prepared in ISO Class 5 or better conditions using aseptic technique

•  3 or less sterile commercial products used to make up each CSP

•  2 or fewer entries into any one sterile container

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Medium Risk CSP

Meets all Low Risk plus at least one of these •  Combine or pool multiple (>3) sterile

components—batch for administration to multiple patients or to one patient multiple times

•  Complex manipulation of components

•  Lengthy compounding duration time (e.g. extended dissolution time)

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High Risk CSP

Any of these conditions apply •  Improper gloving/gowning techniques •  Non-sterile component(s) or device(s) •  Exposure of any of these to worse than ISO 5 air for

longer than 1 hour –  Sterile contents of a commercial product –  CSP without effective antimicrobial preservatives –  Sterile surfaces of devices or containers

•  Storing aqueous non-sterile preparations > 6 hours before sterilization

•  Unverified chemical purity/content stregth of bulk components

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Risk level assignment is the professional’s or organization’s responsibility

•  Not always a clear cut decision

•  Can be quite a puzzle

•  Use 797 criteria as a minimum standard

•  Policies and procedures won’t cover every situation

© 2010, Critical Care Systems, Inc. All rights reserved. 01/10

Examples of CSP Risk Levels

Low risk •  Single RX, 10 1gm doses of IV Push antibiotic

drawn into syringes from 10 gm vial using a dispensing pin

•  Hydration with 2 electrolytes added to each bag

•  Single bags

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Examples of CSP Risk Levels

Medium risk •  Batch preparation of 40 syringes of 1 gm anti-

infective SVP as anticipatory compounding

•  Parenteral Nutrition with > 3 components

•  CSP prepared using automated compounding device (complex procedure/multiple components)

•  Chemotherapy container with air removed for use as 96 hour infusion (room temp.)

© 2010, Critical Care Systems, Inc. All rights reserved. 01/10

USP 797 CSP Maximum BUD for Storage Conditions, by Risk Level

                                           Storage:  Risk  Level  

Controlled  Room  Temp*  

Refrigerated    2°  to  8°  C    

Frozen    <–25  to  -­‐10°C      

Low  Risk:     ≤48  hours   ≤14  days   ≤45  days  

Medium  Risk:     ≤30  hours   ≤9  days   ≤45  days  

High  Risk:     ≤24  hours   ≤3  days   ≤45  days  

*USP  Defines  

Adapted from Bing CM, ESPD4, page 5

© 2010, Critical Care Systems, Inc. All rights reserved. 01/10

More pieces of the BUD puzzle

Assigning Expiration Dates based on available data

•  Container, strength, diluent, pH, other factors

BUD Considerations for Administration Methods and Infusion Device Selection

•  Is there data for the specific device type?

•  Differences in container/device materials

© 2010, Critical Care Systems, Inc. All rights reserved. 01/10 Bing, ESPD,4th ed , with permission

© 2010, Critical Care Systems, Inc. All rights reserved. 01/10

More pieces of the BUD puzzle

External Factors Affecting Stability/Sterility •  Delivery method/logistics

•  Functional temperature controlled storage @ home?

•  Ambient temperature vs. ‘Controlled Room Temperature’

•  Type/amount of manipulation by caregivers/patients

•  Compliance/Adherence to instructions

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More pieces of the BUD puzzle

•  Implications of data extrapolation

•  What it there is no data?

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External testing as a method of establishing BUD

•  Rationale

•  Methods

•  Cost justification

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Maintaining CSP Integrity in compounding and distribution

•  Storage and handling CSP components

•  Environmental and human factors

•  Distribution/delivery issues

© 2010, Critical Care Systems, Inc. All rights reserved. 01/10

Bing’s “BUD” Puzzle, revisited

Developed by Caryn Bing and used with permission

© 2010, Critical Care Systems, Inc. All rights reserved. 01/10

Questions/Discussion

•  Review of submitted questions

•  Open Discussion

•  Need more info? BUD Roundtables

© 2010, Critical Care Systems, Inc. All rights reserved. 01/10

Resources and references

Bing CM, ed. Extended stability for parenteral drugs, 4th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2009.

Bing CM. Storage and Beyond Use Dating (Chapter 10) in Compounding Sterile Preparations, 3rd ed. Bethesda, MD: American Society of Health-System Pharmacists; 2009.

Bing CM. Maintaining Sterility, Purity, and Stability of Dispensed and Distributed CSP’s (Chapter 16) in Compounding Sterile Preparations, 3rd ed. Bethesda, MD: American Society of Health-System Pharmacists; 2009.

Buchanan EC, Schneider PJ, eds. Compounding Sterile Preparations, 3rd ed. Bethesda, MD: American Society of Health-System Pharmacists; 2009.