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, Solution and Answer Guide: Moini, Enabulele, and Scott, Sterile Compounding 2024, Core ISBN:
9780357766040; Chapter 1: Introduction
Solution and Answer Guide
MOINI, ENABULELE, AND SCOTT, STERILE COMPOUNDING 2024, CORE ISBN:
9780357766040; CHAPTER 1: INTRODUCTION
TABLE OF CONTENTS
Answer Key with Rationales for End-of-Chapter Questions .............. 1
Multiple Choice .................................................... 1
Fill in the Blank .................................................. 4
ANSWER KEY WITH RATIONALES FOR END-OF-CHAPTER
QUESTIONS
MULTIPLE CHOICE
1. Which of the following organizations published Principles of Sterile
Product Preparation in 1995?
a. ISMP
b. NIH
c. ASHP
d. FDA
Answer: C
Solution: This publication is a textbook of fundamentals for
pharmacists, pharmacy technicians, and students. It offers an
understanding of the new, stricter sterile compounding guidelines and
supplements other educational materials published by the ASHP.
2. To perform sterile compounding, the pharmacy technician must have how
many hours of continuing education?
a. 2
b. 5
c. 10
d. 15
Answer: B
Solution: To perform sterile compounding, the pharmacy technician must
have 5 hours of sterile compounding continuing education every year.
These hours count toward the 20 continuing education hours for CPhT
recertification.
© 2022 Cengage. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly accessible 1
website, in whole or in part.
, Solution and Answer Guide: Moini, Enabulele, and Scott, Sterile Compounding 2024, Core ISBN:
9780357766040; Chapter 1: Introduction
3. Which of the following sections of the USP involves sterile
compounding?
a. USP 600
b. USP 795
c. USP 797
d. USP 800
Answer: C
Solution: The USP 797 involves sterile compounding. It covers
compounding of hazardous and nonhazardous drugs, with a focus on
protection of sterile compounds and environments from contamination.
4. In ambulatory care compounding, trained pharmacy technicians must
follow all of the following associations’ guidelines, except:
a. USP
b. CDC
c. FDA
d. State board of pharmacy
Answer: B
Solution: In ambulatory care compounding, trained pharmacy technicians
must follow USP, FDA, and state board of pharmacy guidelines, but not
CDC guidelines. The USP and FDA make up the federal regulators for
ambulatory care compounding.
5. Which of the following radionuclides is used for the treatment of
metastatic bone cancer?
a. Strontium
b. Chromium
c. Xenon
d. Iodine-131
Answer: A
Solution: Strontium is the radionuclide used for the treatment of
metastatic bone cancer. It is only a palliative measure and not a cure.
The other answer choices are not indicated for metastatic bone cancer.
6. Which of the following is NOT a factor for storage of compounded
sterile products?
a. Temperature
b. Light
c. Humidity
d. Stability
Answer: B
Solution: Light is not a factor for storage of compounded sterile
products. Stability, temperature, pressure, humidity, and growth media
are all factors that affect the storage of CSPs.
7. Which of the following statements is true for the CSPT?
a. Having three years of full-time continuous CSP work experience
© 2022 Cengage. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly accessible 2
website, in whole or in part.
, Solution and Answer Guide: Moini, Enabulele, and Scott, Sterile Compounding 2024, Core ISBN:
9780357766040; Chapter 1: Introduction
b. Being enrolled in a one-year pharmacy technician program
c. Having two years of full-time continuous CSP work experience
d. Having a minimum of 30 hours of sterile compounding continuing
education
Answer: A
Solution: An active PTCB certified pharmacy technician has two
different pathways to quality for the CSPT title. One is to have three
years of full-time continuous CSP work experience. The other is to
complete or enroll in a PTCB-recognized education/training program, and
have one year of full-time continuous CSP work experience.
8. Which of the following is the most penetrating type of radiation in
nuclear pharmacy?
a. Delta
b. Alpha
c. Gamma
d. Beta
Answer: C
Solution: Gamma radiation is the most penetrating type in a nuclear
pharmacy. It differs from alpha and beta radiation because it is
electromagnetic, while they are particulate. It also differs from x-rays,
ultraviolet rays, and visible light in wavelength or frequency.
9. Which of the following is the most common cause of contamination of a
compounded sterile product?
a. Storing products for short periods prior to use
b. Wearing garb in the cleanroom
c. Personnel that violate proper procedures
d. Washing the hands for two minutes
Answer: C
Solution: Personnel that violate proper procedures constitutes the most
common cause of contamination of a compounded sterile product. This may
involve wearing contaminated clothing in the cleanroom, improper
garbing, touching their faces, or fixing their hair.
10. For sterile compounding and storage, which of the following
temperatures should not be exceeded?
a. 45°F (7.2°C)
b. 55°F (12.8°C)
c. 65°F (18.3°C)
d. 75°F (23.9°C)
Answer: D
Solution: The temperature of 75°F (23.9°C) should never be exceeded for
sterile compounding and storage. Any controlled temperature area used
for compounding sterile preparations, or for storage of sterile
products, must be monitoring at least once per day.
© 2022 Cengage. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly accessible 3
website, in whole or in part.
, Solution and Answer Guide: Moini, Enabulele, and Scott, Sterile Compounding 2024, Core ISBN:
9780357766040; Chapter 1: Introduction
FILL IN THE BLANK
1. The 1926 Pharmacopeia of the United States included only two
injections, and the National Formulary listed __________.
Answer: seven
Solution: In 1926, the USP included only two injections and the
National Formulary listed seven. The majority of sterile compounding
procedures evolved in hospitals where IV and other customized
injections were required for patient care. In the middle years of the
1920s, injections were uncommon.
2. Automated compounding devices led to less __________ and __________
quality control.
Answer: errors, higher
Solution: Automated compounding devices led to less errors and higher
quality control. This ensured effectiveness and accuracy. Over time,
they were used more often for admixing solutions. Because they allowed
the addition of many ingredients at once, fewer admixture manipulations
were needed.
3. The ISMP created guidelines for __________ preparation of compounded
sterile products.
Answer: safe
Solution: The ISMP created guidelines for safe preparation of
compounded sterile products. This was done as part of their 2011
sterile preparation compounding safety summit.
4. For sterile compounding, continuing education is specific for
__________ or pharmacy technicians.
Answer: pharmacists
Solution: For sterile compounding, CE is specific for pharmacists or
pharmacy technicians. To perform sterile compounding, the pharmacy
technician must be certified in good standing with the PTCB.
5. The USP 797 defines __________ different classifications of compounded
sterile products.
Answer: three
Solution: The USP 797 defines three different classifications of
compounded sterile products. These are immediate use (for direct,
immediate administration within 4 hours), category 1 (the maximum
permitted beyond-use date is 12 hours), and category 2 (the maximum
permitted beyond-use date is based on whether it was aseptically
prepared or terminally sterilized, was subjected to and passed
sterility testing, was prepared from sterile or nonsterile starting
components, or will be stored at room temperature, refrigerated, or
frozen).
© 2022 Cengage. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly accessible 4
website, in whole or in part.
, Solution and Answer Guide: Moini, Enabulele, and Scott, Sterile Compounding 2024, Core ISBN:
9780357766040; Chapter 1: Introduction
6. Some drugs require temperature controls between the time they leave the
hospital pharmacy and the time they are __________.
Answer: administered
Solution: Some drugs require temperature controls between when they
leave the hospital pharmacy and when they are administered. Expiration
dates must be carefully checked.
7. One of the most successful types of pharmacist-managed ambulatory care
is the __________ clinic.
Answer: anticoagulation
Solution: The anticoagulation clinic is one of the most successful
types of pharmacist-managed ambulatory care. The term ambulatory care
refers to medical services performed on an outpatient basis, with no
hospital admission.
8. Sterile compounding is regulated by state and __________ agencies.
Answer: federal
Solution: Sterile compounding is regulated by state and federal
agencies, and must meet all applicable laws and regulations. If
possible, manufactured sterile preparations are still preferred to
those compounded in the pharmacy. Properly trained staff must use
approved techniques to avoid contamination and ensure quality.
9. The most commonly used radionuclides are __________ and technetium
compounds.
Answer: iodine
Solution: Iodine and technetium compounds are the most commonly used
radionuclides. Other radionuclides include radium, cesium, and
strontium.
10. The ISO Class 7 buffer area and the ISO Class 8 ante room both
use __________ pressure.
Answer: positive
Solution: Both the ISO Class 7 buffer area and the ISO Class 8 ante
room use positive pressure, which is pressure in a system that is
greater than the environment that surrounds that system. Any leak from
the positively pressure system will egress into the surrounding
environment.
© 2022 Cengage. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly accessible 5
website, in whole or in part.
, Solution and Answer Guide: Moini, Enabulele, and Scott, Sterile Compounding 2024, Core ISBN:
9780357766040; Chapter 2: Safety in the Workplace
Solution and Answer Guide
MOINI, ENABULELE, AND SCOTT, STERILE COMPOUNDING 2024, CORE ISBN:
9780357766040; CHAPTER 2: SAFETY IN THE WORKPLACE
TABLE OF CONTENTS
Answer Key with Rationales for End-of-Chapter Questions .............. 1
Multiple Choice .................................................... 1
Fill in the Blank .................................................. 5
Case Study A ....................................................... 6
Case Study B ....................................................... 7
Case Study C ....................................................... 8
ANSWER KEY WITH RATIONALES FOR END-OF-CHAPTER
QUESTIONS
MULTIPLE CHOICE
1. Which of the following organizations mandates the use of standard
precautions?
a. Centers for Disease Control and Prevention
b. Food and Drug Administration
c. Health and Human Services
d. Occupational Safety and Health Administration
Answer: D
Solution: The Occupational Safety and Health Administration mandates
the use of standard precautions, which constitute the basic level of
infection control that should be used in the care of all patients, all
of the time. The CDC protects America from health, safety, and security
threats, increasing the health security of the nation. The FDA protects
public healthy by ensuring safety, efficacy, and security of human and
veterinary drugs, biological products, and medical devices. The U.S.
Department of Health and Human Services (HHS) strives to enhance health
and well-being of all Americans by providing for effective services and
sustained scientific advances.
2. Which of the following types of substances require an SDS (formerly known
as an MSDS)?
a. Hazardous drugs and chemicals
b. Herbal substances
c. Intravenous admixtures
© 2022 Cengage. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly accessible 1
website, in whole or in part.
, Solution and Answer Guide: Moini, Enabulele, and Scott, Sterile Compounding 2024, Core ISBN:
9780357766040; Chapter 2: Safety in the Workplace
d. Investigational drugs
Answer: A
Solution: Hazardous drugs and chemicals require a safety data sheet
(SDS), formerly known as a material safety data sheet (MSDS). The SDS
includes the properties of each chemical, physical/health/environmental
hazards, protective measures, and safety precautions for handling,
storing, and transporting the chemical. An SDS is not required for
herbal substances, intravenous admixtures, or investigational drugs.
3. The Bloodborne Pathogens Standard is primarily concerned with:
a. reducing the transmission of HBV, HCV, and HIV infections.
b. protecting the employer from lawsuits.
c. regulating the use of personal protective equipment.
d. taking blood samples from patients.
Answer: A
Solution: The Bloodborne Pathogens Standard is primarily concerned with
reducing the transmission of HBV, HCV, and HIV infections. The standard
prescribes safeguards to protect workers against health hazards related
to bloodborne pathogens. The Standard does not specifically protect
against lawsuits. The use of personal protective equipment must follow
regulations set forth by the FDA. The Bloodborne Pathogens Standard is
not specifically concerned with taking blood samples from patients,
only in following universal precautions to reduce infection
transmission.
4. The exposure control plan must be reviewed every:
a. 5 years.
b. 3 years.
c. 2 years.
d. year.
Answer: D
Solution: The exposure control plan must be reviewed every year.
Updates must reflect changes such as new workers, positions, or
technology used to reduce exposures to blood or body fluids. The reason
for this, and why it cannot be reviewed over longer time periods, is
because it must reflect changes such as new workers, positions, or
technology used to reduce exposure to blood or body fluids.
5. Hazardous wastes should only be disposed of by which of the following?
a. Burning them in an approved container
b. Flushing them down a toilet
c. Using a licensed disposal service or facility
d. Throwing them into the facility’s trash containers
Answer: C
Solution: Hazardous wastes should only be disposed of by using a
licensed disposal service or facility. The disposal is regulated by the
© 2022 Cengage. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly accessible 2
website, in whole or in part.
, Solution and Answer Guide: Moini, Enabulele, and Scott, Sterile Compounding 2024, Core ISBN:
9780357766040; Chapter 2: Safety in the Workplace
Environmental Protection Agency (EPA) under the Resource Conservation
and Recovery Act (RCRA). If anyone not licensed to dispose of hazardous
wastes attempts to burn them, toxic organic constituents are not fully
destroyed and the waste volume is not reduced. Flushing hazardous
wastes down a toilet results in large amounts of toxicities entering
the water system and environment. Hazardous wastes should also not be
thrown away into trash containers because they have the potential to
cause physical injury to sanitation workers, and contaminate septic
tanks, wastewater treatment systems, and the environment.
6. Which of the following is a true statement regarding the handling of
hazardous drugs?
a. Hazardous drug-related wastes must be disposed of according to
FDA, state, and local regulations
b. Sharps containers do not need to be labeled
c. Thick, leak-proof plastic bags may be of the same color as other
hospital trash bags, and used for collection of discarded gloves,
gowns, and other disposable materials (labeled as “Hazardous
Drug-Related Wastes”)
d. The hazardous waste bag should be kept inside an uncovered waste
container clearly labeled “Hazardous Drug Waste Only.” At least
one of these receptacles must be located in every area where
drugs are prepared.
Answer: A
Solution: Hazardous drug-related wastes must be disposed of according
to FDA (federal), state, and local regulations. They are handled
separately from other hospital trash. Disposal can occur at either an
incinerator or a licensed sanitary landfill for toxic wastes, as
appropriate. Sharps containers must be labeled with the universal
biohazard symbol and the word “biohazard,” or be color-coded red.
Thick, leak-proof plastic bags are not used for hazardous drug-related
wastes. Hazardous waste bags are not kept inside uncovered waste
containers – they must be put into rigid containers for storage until
picked up for proper disposal.
7. Pharmacy technicians that deal with radiopharmaceutical substances can
reduce radiation exposure by which of the following methods?
a. Monitoring radiation exposure with film badges
b. Maximizing time in contact with radiation sources
c. Labeling all radiation exposure sites in their body
d. Using appropriate gowns
Answer: A
Solution: Pharmacy technicians that deal with radiopharmaceutical
substances can reduce radiation exposure by monitoring radiation
exposure with film badges. Personnel dosimetry film badges are commonly
used to measure and record radiation exposure due to gamma rays, X-
rays, and beta particles. Every attempt is made to minimize, not
maximize, the time in contact with radiation sources. There is no way
© 2022 Cengage. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly accessible 3
website, in whole or in part.