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• Annually, 8 million US healthcare workers experience potential

exposed to hazardous drugs (HDs).

• HD worker safety has been discussed since the early 1970s when

chemotherapy drugs were mixed on countertops or in horizontal

laminar airflow workbenches that directed HD-contaminated air

toward compounding personnel.

• In 2004, the National Institute of Occupational Safety and Health

(NIOSH) published a NIOSH , Preventing Occupational Exposures to

Antineoplastic and Other Hazardous Drugs in Health Care Settings.

This was 11 months after USP Chapter <797> was published.

HISTORY OF USP<800>

• In 2008, USP Chapter <797> was revised to include a

specific section for HD preparation. However, this

scope was limited to sterile preparations.

• Protection of HD-exposed workers continued to be a

challenge due to little clear evidence of HD effects

due to no tracking or documentation of healthcare

worker exposure or health complications results.

• In 2010, the Journal of Occupational and Environmental

Medicine published 2 key studies:

• Study of antineoplastic drug exposure of US healthcare workers

at 3 university-based healthcare centers. Showed continuing

surface contamination in pharmacy and nursing areas despite HD

handling guidelines.

• Study that reported damage to healthcare workers’ chromosomes

that are related to secondary cancers in treated patients

• On April 8, 2011, NIOSH, OSHA, and The Joint Commission

sent a jointly drafted letter discussing the safe handling of

HDs.

HISTORY OF USP<800>, CONT’D

• Also, in 2010, an investigative reporter

exposed the tribulations of Sue Crump, a

Seattle-area pharmacist who died at age 55 of

pancreatic cancer.

• The report had the desired effect resulting in the Washington

State legislature passing two HD rules in 2012 for HD-handling

requirements and a HD worker registry to track adverse

experiences.

• On March 28, 2014, USP posted a proposed General Chapter

<800> Hazardous Drugs—Handling in Healthcare Settings on

its website and in the May–June issue of Pharmacopeial

Forum to more fully cover HD handling in sterile and non-

sterile environments.

• Public comments closed July 31, 2014, and a revision

incorporating comments was posted in December 2014.

• Chapter <800> builds on 2 USP compounding General

Chapters:

<795> Pharmaceutical Compounding – Nonsterile Preparations

<797> Pharmaceutical Compounding – Sterile Preparations

See comparison of USP <797> and <800>.

HISTORY OF USP<800>, CONT’D

• Goal is to promote patient safety, worker safety, and environmental protection.

• Includes any hazardous drug (HD) handling: receipt, storage, compounding, dispensing, administration, and disposal of sterile and non-sterile products and preparations.

• Applies to all healthcare workers who handle HD preparations such as pharmacies or hospitals.

• Chapter<800> does not list specific HDs, but refers to the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings.

• A radiation safety principle called ALARA was utilized to accurately explain the proposed chapter <800>.

SCOPE OF USP<800>

• Train personnel to utilize related practices

• Incorporate USP<800> standards into an

occupational safety plan which includes: Engineering controls

Safe work practices

Proper use of Personal Protective Equipment (PPE)

Policies for HD waste segregation and disposal

USP<800> REQUIREMENTS

• Must be stored separately from non-HDs (as per <797>).

• Possible exception is HDs on NIOSH list that are:

• Not listed as antineoplastic agents,

• Are in final dosage forms,

• And are not manipulated other than counting for dispensing.

• Restricted-access storage room must be under negative

pressure, externally vented, and have at least 12 air

changes per hour.

• Injectable HDs may be stored in the negative-pressure

buffer room used for sterile preparations if all particle-

generating packaging is removed prior to storing.

• Refrigerated antineoplastics must be

stored be in a HD-dedicated refrigerator.

USP<800> STORAGE OF HD

USP<800> COMPOUNDING HD

• Must be performed in a containment primary engineering

control (C-PEC)

• Within a separate room that provides personnel protection.

• A restricted-access room under negative pressure, externally vented,

and have an appropriate number of air changes per hour based on

the type of compounding and the C-PEC in which it is being done.

• Applies to sterile and non-sterile compounding.

• C-PECs include:

• Containment ventilated enclosures (commonly called a powder hood)

• Class I biological safety cabinets (BSC)

• Class II BSC dedicated to use for non-sterile compounding.

USP<800> COMPOUNDING HD, CONT’D

• Allows occasional use of the sterile designated

C-PEC provided mitigating steps are taken to

safely return the use of the BSC or compounding

aseptic containment isolator (CACI) to sterile

compounding.

• <800> removed exemption that permitted low-

volume sterile compounding sites to use a BSC

or CACI in a positive pressure room. • However, a containment segregated compounding area (C-SCA) can

be created.

• Currently not allowed by <797>, but a BSC can be placed in the C-

SCA if a facility meets these criteria: prepares only low- to medium-risk HD compounded sterile preparations

finds a limit of a 12-hour beyond-use time acceptable,

USP<800> COMPOUNDING HD

Source: Pharmacy Purchasing & Products Magazine

USP<800> DISPENSING HD

• Oral and topical HDs must be in unit-dose or unit-

of-use packaging that do not require any

manipulation other than counting before delivery

to the patient.

• If the healthcare facility’s policies permit, non-

antineoplastic HDs that require only transfers

from the manufacturer’s package to a

prescription container may be dispensed without

any further requirement for containment unless

required by the manufacturer.

• Counting trays, spatulas, and other equipment

should be dedicated for use with HDs.

• This new chapter expands the <797>

requirements for primary and secondary

engineering controls to contain HDs for storage

and compounding.

• <800> extends consideration to all personnel in

healthcare settings, including HD adminstration.

• Use of closed-system drug transfer devices

(CSTDs) are supplemental engineering controls

are required during HD administration and

recommended for compounding processes.

USP<800> ADMINISTERING HD

• Training for compliance available.

• Cleanroom supplies specifically for USP<800>

compliance are available.

• Free samples of cleanroom supplies available

before you buy new consumables for USP<800>.

• Complimentary consulting on USP<797> and

USP<800> compliance and cleanroom supplies

selection.

USP<800> COMPLIANCE