USP 797 & USP 800: Updates Are Coming…

USP 797 & USP 800:  Updates Are Coming… USP 797 & USP 800:  Updates Are Coming… - Start

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Are You Prepared?. Alexandra . Sible. , . PharmD. NMPhA. Mid-Winter Meeting. January 28, 2018. Objectives. Upon completion of this activity, participants will be able to…. 1. Describe the background and purpose of USP General Chapters 797 and 800 and explain key differences between the two chapt.... ID: 668460 Download Presentation

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USP 797 & USP 800: Updates Are Coming…

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USP 797 & USP 800: Updates Are Coming…Are You Prepared?

Alexandra Sible, PharmDNMPhA Mid-Winter MeetingJanuary 28, 2018


ObjectivesUpon completion of this activity, participants will be able to…

1. Describe the background and purpose of USP General Chapters 797 and 800 and explain key differences between the two chapters. 2. Describe proposed changes to USP 797 and USP 800.3. Outline the proposed timelines for implementation of new USP 797 and USP 800 standards.4. Identify challenges that pharmacies and pharmacy personnel may face in implementing new USP 797 and USP 800 standards.



A History Lesson


BackgroundUSP = United States Pharmacopeia

The United States Pharmacopeial Convention (also called USP) is a non-profit organizationFounded in 1820 by a group of 11 physiciansSets standards for identity, strength, quality, and purity of medicinesChapters <1> through <999> are enforceable by the Food & Drug Administration (FDA)USP is not an enforcement agency

Source: ASHP Discussion Guide on USP Chapter <797>

Available at:



USP 797USP <797> sets standards for preparing compounded sterile drugs

(intravenous, ophthalmic, etc.)Early 1970s – thousands of sepsis cases and deaths from contaminated parenteral products1970s and early 1980s – National Coordinating Committee on Large Volume Parenterals (NCCLVP) developed recommended standards for quality assurance of parenteral productsNCCLVP dissolved in the 1980s1990s – American Society of Health System Pharmacists (ASHP) and USP issued practice recommendations

No formal accountability, regulation, or enforcement

Source: ASHP Discussion Guide on USP Chapter <797>

Available at:



USP 797January 1, 2004 – First official and enforceable sterile preparation compounding standard in the U.S. published

 USP 797Last official revision released June 1, 2008Revision proposed for public comment from September 25, 2015 to January 31, 2016Intended for publication on May 1, 2017

A second revision is planned to be published September/October 2018 for a second round of public comments

Revision will be harmonized with USP 800

Anticipated to be published

June 1, 2019

Becomes official on

December 1, 2019



Waiting for USP 797 Updates


USP 800USP <800> sets standards for handling of hazardous drugs in healthcare settings

In 2004, National Institute of Occupational Safety & Health (NIOSH) published an alert on hazardous drugs in healthcare settings – after USP 797 was releasedUSP 797 revision in 2008 included a specific section for hazardous drugs (but only as it relates to sterile compounds)Based on published reports of adverse effects in healthcare personnel from exposure to hazardous drugs, USP 800 was developedSource:


USP 800First published for public comment in March 2014

Revised and presented for further public comment in December 2014Revised again and published in February 2016Will be harmonized with USP 797Becomes official on December 1, 2019Source:



USP 797 vs. USP 800


USP 797The purpose of USP 797

is to describe conditions and practices that prevent harm, including death, to patients that could result from compounded sterile preparations due to microbial contamination, excessive bacterial endotoxins, variability in intended strength of the product, unintended chemical and physical contaminants, or ingredients of inappropriate quality.


USP 797Compounded sterile preparations

Compounded biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that must be sterile when administered to patientsAqueous bronchial and nasal inhalationsBaths & soaks for live organs and tissuesInjections (emulsions, solutions, suspensions, etc.)Irrigations for wound & body cavitiesOphthalmic drops and ointments

Tissue implants


USP 797Includes

Responsibilities of compounding personnelRequirements for personnel cleansing and garbingRequirements for cleaning and disinfection proceduresTraining and evaluation for compounding personnelFacility designEnvironmental quality & control

Microbial contamination risk levels

Methods for sterilizing products and verifying sterility of products

Storage and beyond-use dating

Suggested standard operating procedures

Dispensing, packaging, and transportation of CSPs

Patient/caregiver training

Patient monitoring and adverse events reporting

Sample forms for assessments

Suggested actions for deficiencies

Official information available at:


USP 797Applies to all persons who prepare CSPs and all places where CSPs are prepared, and all personnel who prepare, store, and transport CSPs

Compliance with USP 797 required in New Mexico (not in all states)Enforced by Board of PharmacyTitle 16, Chapter 19, Part 36Enforced by FDAEnforceable standards currently based on June 1, 2008 version


USP 800The purpose of USP 800

is to describe practice and quality standards for handling hazardous drugs in healthcare settings and help promote patient safety, worker safety, and environmental protection. The chapter defines processes intended to minimize the exposure to hazardous drugs in healthcare settings.Receipt, storage, compounding, dispensing, administration, and disposal of sterile & non-sterile preparations.


USP 800Hazardous drugs

Any drug defined as hazardous by NIOSH on the basis of at least one of six criteriaCarcinogenicityTeratogenicity or developmental toxicityReproductive toxicity in humansOrgan toxicity at low doses in humans or animalsGenotoxicity

New drugs that mimic existing hazardous drugs in structure or toxicity


USP 800Applies to all healthcare personnel who handle hazardous drug preparations and all entities that store, prepare, transport, or administer hazardous drugs

Including but not limited to: pharmacists, pharmacy technicians, nurses, physicians, physician assistants, home healthcare workers, veterinarians, and veterinary techniciansEnsuring compliance after standards become official on December 1, 2019 will be the responsibility of FDA, states, and other government authoritiesOfficial information & a free download available at:




USP 797Original proposed revisions (September 2015) are available for review at: also held an “open mic” forum; slides available here: received more than 8000 comments from more than 2500 stakeholders

New revision to be posted September/October 2018 in


Forum and will be open for comment until November 30, 2018




USP 797: Major proposed changesGeneral reorganization of chapter

USP 800 will be used to outline hazardous drugs requirementsA new “Beyond-Use-Date (BUD)” paradigmBUD cannot exceed 45 days, regardless of sterility testing“In-Use Time” – describes time to use a manufactured product or compounded dilution bag after it has been puncturedChanges to terminologyMicrobial contamination: low, medium, high risk

 Category 1 & Category 2

“No such thing as a low-risk CSP”

Immediate-Use CSPs  Urgent-Use CSPs

“For rare circumstances when a CSP is urgently needed”


USP 797: Major proposed changesPrimary engineering controls – new terminology

Laminar airflow system (LAFS)Restricted Access Barrier System (RABS)IsolatorPlacement of primary engineering control:Category 1 – may be placed in an unclassified Segregated Compounding AreaCategory 2 – LAFS, biological safety cabinet, or RABS must be placed in ISO class 7 or better area;


must be in ISO class 8 area


USP 797: Major proposed changesRequirement for sterile sleeves for some compounding activities

Quarterly observation of compounding personnel’s hand hygiene and garbing Quarterly gloved fingertip sampling and media-fill testingCurrently semi-annually or annuallyChanges to environmental monitoring requirements:Nonviable air sampling – every 6 monthsViable air monitoring – monthly

Surface sampling – monthly (currently “periodic basis”)

Increased documentation requirements for batch compounding

Master formulation records

Compounding records


USP 800: SectionsRequirements for maintaining an internal list of hazardous drugs

Types of hazardous drug exposureResponsibilities of personnel handling hazardous drugsFacilities & engineering controlsEnvironmental quality and controlPersonal protective equipmentHazard communication programPersonnel training



USP 800: SectionsReceiving

Labeling, packaging, transport, and disposalDispensing final dosage formsCompoundingAdministeringDeactivating, decontaminating, cleaning, and disinfectingSpill controlDocumentation & standard operating procedures

Medical surveillance


USP 800Maintaining a list of hazardous drugs: does not provide complete list; references NIOSH list; entities can use NIOSH criteria for customizing a list for their own organization

Hazardous drugs must be unpacked in neutral/normal pressure or negative pressure room (cannot be unpacked in sterile compounding areas or positive pressure area)Some hazardous drugs can be stored with non-hazardous drugs; antineoplastics that require manipulation other than counting final dosage forms must be stored in negative pressure buffer area



USP 800Entities must designate a compounding supervisor

Qualified and trained to be responsible for all aspects of hazardous drug handlingNo specific credentials requiredDoes not even have to be a member of pharmacy department


USP 800Compounding:

Engineering controls are primary (containment or C-PEC – “the hood”) or secondary (C-SEC or the room where C-PEC is contained)Requirements for sterile and non-sterile compoundingStricter requirements than USP 797USP 795 and 797 standards must be followedCompounding equipment must be designated and not intermixed with nonhazardous compounding equipmentTablet and capsule forms should not be placed in automated counting or packaging machines


USP 800Personal protective equipment

Compounding: gloves, gowns, head, hair, and shoe coversAdministrating antineoplastic HDs: glovesAdministering injectable HDs: gloves, gownsDouble gloves and double shoe covers required for certain activitiesRequirements for respiratorsMust be used when unpacking HDs not contained in plasticCannot use surgical masks when respiratory protection is required


USP 800Entities must establish policies and procedures to ensure worker safety

Competency assessed and documented every 12 months, when a new hazardous drug or equipment is introduced, or when a significant change in process occursMedical surveillance programConsider confidentiality of employees’ medical informationBaseline assessment of health status and medical historyRecords of HDs handled, including number handled & hours handlingPhysical assessments, laboratory values, etc.




Think, Pair, ShareDiscuss with a neighbor:

Are you ready for USP 797 and/or USP 800?What concerns do you have for implementing USP 797 and/or USP 800 in your practice setting?



Common ConcernsCost

New equipmentChanges to facility designSeparation of hazardous/non-hazardous compoundingMay require outside assistance/consultingMore frequent monitoring – more $ if performed by outside entityTimeMore frequent environmental sampling

More frequent personnel assessment

More documentation/record-keeping


Common ConcernsTraining/education needed

Lack of references/evidenceRecommendations based on opinions of expert panelsInconsistency in enforcement of standards between statesImpact on other professionsPhysician offices, clinics, etc. Of note – many of the same concerns were raised upon the first publications of USP 797 & 800



USP 797 Compliance StudyConducted by Critical Point & Pharmacy Purchasing & Products

Published in Cleanrooms & Compounding, October 2017, Volume 14, No 10., page 16Visit register to view full results (free)



ResourcesUSP 800 Gap Analysis Tool: Commission Resources Self Assessment for Hazardous Drug Handling: up for USP updates:

USP 800 FAQs:

Free download of USP 800:

USP 797 FAQs:

Sign up to download USP 797:


SummaryUSP 797 sets standards for sterile compounding; USP 800 sets standards for handling of hazardous drugs in healthcare settings

New versions of USP 797 & USP 800 will become officially enforceable on December 1, 2019You can comment on proposed revisions starting in Sept/Oct 2018Copies of these documents are available online and should be reviewedOrganizations should determine their readiness to meet standards well ahead of timeSome standards will likely require significant investment of money, time, and personnel training & education




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