- Annually, 8 million US healthcare workers are potentially exposed to hazardous drugs. USP Chapter <800> was created to improve safety for these workers when handling hazardous drugs. - The chapter expands on previous guidelines to establish requirements for proper storage, compounding, dispensing, administering, and disposal of hazardous drugs. It aims to promote patient safety, worker safety, and environmental protection. - Key requirements include conducting all hazardous drug activities in containment primary engineering controls, using personal protective equipment, implementing waste segregation and disposal protocols, and providing thorough training to personnel.

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3. • 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.

4. • 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.

5. • 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

6. • 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>

7. • 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

8. • 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

9. 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.

10. 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,

11. USP<800> COMPOUNDING HD
Source: Pharmacy Purchasing & Products Magazine

12. 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.

13. • 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

14. • 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