1. USP <797> and <800> Update
Patricia C. Kienle, RPh, MPA, FASHP

2. Disclosure
Patricia Kienle is a member of the USP Compounding Expert Committee but this talk is not affiliated with nor endorsed by USP

3. Objectives - Pharmacists
Cite the status of the USP compounding chapters
Explain the types of facilities required for sterile compounding and for hazardous drug compounding
Define the types of environmental monitoring required for sterile and hazardous compounding
State the document that must be used to develop your hazardous drug list
List three alternative containment strategies and/or work practices that can be used to mitigate risks of hazardous drugs that are not antineoplastics

4. Objectives - Technicians
Differentiate the USP compounding chapters that are official now, and those that will be official wthin the next year
State the two types of IV rooms where compounded sterile preparations can be mixed
List the two required environmental monitoring tests required by USP <797>
State the organization that maintains the list of drugs that are hazardous to healthcare personnel
State the three types of engineering controls required by USP <800>

5. Is your pharmacy compliant with USP <797> and <800>?
Yes, compliant with both
Compliant with <797> and working on <800>
Partially compliant with <797> and working on <800>
We’ve got a ways to go

6. Status of USP Chapters Chapter Current Future <795> 2014
Probably published for revision during USP Committee cycle
<797>
2008
Proposed revised published for public comments in September 2015
Second public comment proposed revision will be published
<800>
2016
Will be official on December 1, 2019

7. Legal Status of USP Chapters
Standards in USP-NF for compounded preparations may be enforced by
States (as pharmacy practice/compounding is traditionally regulated by state boards of pharmacy)
FDA (as compounded preparations remain subject to the adulteration and misbranding provisions of the FD&C Act which require conformance to certain USP-NF standards

8. Major Changes in Proposed <797>
Removal of hazardous drug section
Intent to Revise will direct you to <800>
Change from three ingredient-based risk levels to two categories based on facility
Segregated Compounding Area
Cleanroom suite
Limited BUD for Category 1 for any PEC
Increased frequency of monitoring

9. Dedicated Compounding Room
Massachusetts DCR
Only allowed in institutions
Only for non-hazardous, low-risk CSPs
C-SCA with classified air
Must be at least ISO 8

10. Monitoring for Current <797>
Personnel
Media fill
Gloved fingertip tests
Environmental
Electronic air sampling
Surface sampling

11. Purpose of USP <800
Approximately 8 million workers are potentially exposed to hazardous drugs (HDs) each year
<800> was developed to promote patient safety, worker safety, and environmental protection
Defines practice and quality standards for handling HDs
Builds on existing science, guidelines, and expertise

12. Hazardous Drug Guidance
December 1, 2019

13. Life Cycle of HDs Scope of <800> All Healthcare Entities
All Healthcare Personnel

14. What is a Hazardous Drug?
Any drug identified by at least one of the following criteria
Carcinogenicity
Teratogenicity or other developmental toxicity
Reproductive toxicity
Organ toxicity at low doses
Genotoxicity
Structure and toxicity profile of new drug that mimics existing HD

15. Scope of <800>
Receive
Transport
Store
Mix
Administer
Discard

16. Official Date of USP <800>
Official on December 1, 2019
This is a recent change
Enforceable
Federal agencies
State agencies
Accreditation organizations

17. Genesis of <800>

18. Dispensing & Administration
Elements of <800>
Facilities
PPE
Hazard Communication
Transport & Disposal
Dispensing & Administration
Compounding
Cleaning
Medical Surveillance

19. NIOSH Approach
USP <800> establishes the containment strategies and work practices best known to control hazardous drug contamination
Engineering controls
Protective equipment
Work practices

20. Key Elements of <800>
Containment
Assessment
of Risk
Work Practices

21. NIOSH List of Hazardous Drugs
Hazardous to healthcare personnel
Different from EPA hazardous materials which are hazardous to the environment
Use of the list is required
Tables 1, 2, and 3
Use of Table 5 Personal Protective Equipment (PPE) is not required, but provides a comprehensive list for policy development

22. What’s the status of your Assessment of Risk?
Completed
Identified list and working on Assessment
Need to get working on this
No need to do this since we don’t handle hazardous drugs

23. Your HD List
Must contain all the HDs on the NIOSH list that you handle
Must be specific to the dosage form level

24. Acknowledgement of Risk
OSHA
Hazard Communication Standard (HCS) is based on the concept that employees have both a need and a right to know the hazards and identifies the chemicals they are exposed to when working
<800>
Personnel of reproductive capability must confirm in writing that they understand the risks of handling HDs

25. NIOSH List of Antineoplastics and Other Hazardous Drugs
Non-Antineoplastics
Reproductive-Only Hazards

26. Your Options
Handle all drugs and dosage forms with all containment and work practices listed in <800>
Perform an Assessment of Risk to determine alternative containment strategies and work practices

27. What Drugs Can Be Handled Differently?
All <800>
Precautions Apply
Can Be Included in
Assessment of Risk
API of any HD on the list
Antineoplastics that only need to be counted or packaged
Antineoplastics that need to be manipulated
Table 2 drugs
Items that don’t fit the Assessment of Risk
Table 3 drugs

28. Active Pharmaceutical Ingredient
Any substance or mixture of substances intended to be used in the compounding of a drug preparation
“Raw chemical”
NOT finished dosage forms

29. Compliance with All <800> Elements
Facilities
Containment Primary Engineering Control (C-PEC)
Containment Secondary Engineering Control (C-SEC)
Personal Protective Equipment (PPE)
Work practices
Policies and procedures
Containment from receiving to dispensing
Decontamination of work surfaces

30. OK to Consider for Assessment of Risk
Antineoplastics that only need to be counted or packaged
Non-antineoplastic meds (Table 2)
Reproductive-only hazards (Table 3)

31. OK to Consider for Assessment of Risk
Situation
Yes No
Dispense methotrexate tablets
Pour megestrol suspension into bottle
Dispense conventionally-manufactured fluorouracil cream
Mix fosphenytoin in the IV room
ICU nurse mixes fosphenytoin IV
Dispense premixed oxytocin infusion

32. OK to Consider for Assessment of Risk
Situation
Yes No
Dispense methotrexate tablets 
Pour megestrol suspension into bottle
Dispense conventionally-manufactured fluorouracil cream
Mix fosphenytoin in the IV room
ICU nurse mixes fosphenytoin IV
Dispense premixed oxytocin infusion

33. Alternative Strategy Examples
Purchase unit-dose or unit-of-use
Store in lidded bins
Use closed system drug-transfer devices (CSTDs)
Handle with chemo gloves
Designate tackle boxes for transport

34. “Must” vs “Should” Must or shall = requirement Should = recommendation
Use of CSTDs for compounding
Wipe samples for environmental sampling
Medical surveillance
Photo courtesy of USP

35. Receiving and Storage
HDs can be received in the same area as other drugs
Should have a designated area
Can be neutral/normal or negative pressure
Cannot be positive pressure
HDs (unless entity-exempt through the Assessment of Risk)
Must be stored with proper containment

36. Containment Primary Engineering Controls
C-PEC = PEC
Nonsterile compounding
Containment ventilated enclosure (CVE)
Sterile compounding
Biological safety cabinet (BSC)
Compounding aseptic containment isolator (CACI)

37. Minimum Room Requirements
Room with fixed walls separate from non-hazardous storage and compounding
Vented outside the building
Negative pressure of 0.01 to 0.03” to adjacent space
At least 12 air changes per hour
Contains hazard
Removes hazard

38. What’s Allowed – What’s Not
Configuration
Allowed in <797>
Allowed in <800>
Cleanroom suite: ISO 7 positive anteroom opening into ISO 7 negative buffer room (30 ACPH)
Yes, with negative pressure of at least 0.01” negative to adjacent space
Yes, with pressure range of 0.01 to 0.03” negative to adjacent space
Low use exemption
Yes No
Containment Segregated Compounding Area
Not addressed in <797>
Yes if externally vented and pressure range of 0.01 to 0.03” negative to adjacent space, but limited to 12 hour BUD
CACI in negative room with 12 ACPH
Yes, optimally vented
BSC outside of cleanroom

39. Containment Segregated Compounding Area
Four minimum characteristics
Does not need to be ISO classified
No requirement for HEPA-filtered ceiling air
But … limited to 12 hour beyond- use time

40. Closed System Drug-Transfer Devices (CSTDs)
CSTDs mechanically prohibit the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor
Required for administration when the dosage form allows
Recommended for use when compounding
Photo courtesy of BD

41. Personal Protective Equipment
Mask (to protect the preparation)
Hair covers
Shoe covers
Gloves tested to ASTM D6978
Gowns that are impervious, close in back, knit or elastic sleeves
Respirator (to protect the compounder)
Eye protection
Disposable PPE
cannot be re-used

42. Work Practices Policies and procedures Containment PPE
Outside of container once compound completed
Waiting for patient pickup or transfer to administration area
PPE
Two pairs of shoe covers in negative space
Outer pair removed prior to entering anteroom
Decontamination procedures

43. Cleaning Process for HDs
Deactivate and Decontaminate
Clean
Disinfect

44. Cleaning Steps Function Agent Deactivate and decontaminate
Properly-diluted EPA-approved oxidizer intended for use with HDs
Clean
Germicidal detergent
Disinfect
70% isopropyl alcohol (sterile for sterile compounding)

45. Decontamination Under work tray of BSC or CAI
Counting trays and spatulas
Outside of containers
Photo courtesy of Contec, Inc.

46. Resources for <797>
USP website
ASHP Sterile Compounding Resource Center

47. Resources for <800>
USP <800> FAQs
questions/hazardous-drugs-handling-healthcare-settings
One hour panel discussion (physician, nurse, pharmacist
Short (~5 minute) videos targeted to specific audiences
Ready for 800 checklist
Perform an Assessment of Risk to Comply with USP <800>
Pharmacy Purchasing and Products ( March 2017

48. References for <800>