WorksheetsManufacturer Drug Labeling
Total questions: 83
Worksheet time: 42mins
Which of the following is required on all manufacturers' drug labels?
Name and place of business of the manufacturer, packer, or distributor.
Expiration date of the drug only.
List of all possible side effects.
Retail price of the drug.
Which code number must be included on all manufacturers' drug labels?
National Drug Code number
Universal Product Code number
Lot Number
Prescription Serial Number
What type of directions must be provided on all manufacturers’ drug labels?
Adequate directions for use
Directions for storage only
Directions for shipping only
Directions for disposal only
Misleading statements are permitted on manufacturers’ drug labels.
True
False
Which statement about the product must be included on all manufacturers’ drug labels?
Statement of ingredients
Expiration date of the manufacturer
Directions for use by the patient
Storage conditions for the pharmacy
What is required regarding the prominence of label statements on manufacturers’ drug labels?
Prominence of required label statements
Inclusion of manufacturer’s logo only
Use of decorative fonts for branding
Placement of labels on the bottom of the package
Which language version of certain required statements must be included on manufacturers' drug labels?
Spanish-language version
French-language version
German-language version
Chinese-language version
Which date must be included on all manufacturers’ drug labels?
Expiration date
Manufacture date
Batch release date
Approval date
What information is required on all manufacturers’ drug labels regarding lot or control numbers?
Manufacturer lot or control numbers.
Expiration date only.
Dosage instructions only.
Pharmacy address.
What information is required on all manufacturers’ drug labels regarding the presence of FD&C Yellow No. 5 or FD&C Yellow No. 6?
Declaration of the presence of FD&C Yellow No. 5 or FD&C Yellow No. 6 in certain drugs for human use.
Expiration date of the coloring agent used in the drug.
The chemical formula of FD&C Yellow No. 5 or FD&C Yellow No. 6.
The country of origin of the coloring agent.
What information is required on all manufacturers’ drug labels regarding phenylalanine and aspartame?
Declaration of the presence of phenylalanine as a component of aspartame in OTC and prescription drugs for human use.
Listing aspartame as a natural sweetener only in dietary supplements.
Warning that phenylalanine is safe for all populations without restriction.
Statement that aspartame is not present in any prescription medications.
What information is required on all manufacturers’ drug labels for prescription drugs containing sulfites?
Prescription drugs containing sulfites: required warning statements.
Dosage instructions for over-the-counter medications only.
List of inactive ingredients, excluding sulfites.
Storage temperature requirements only.
What information is required on all manufacturers’ drug labels for systemic antibacterial drug products?
Labeling for systemic antibacterial drug products.
Dosage instructions for over-the-counter pain relievers.
Nutritional information and calorie count.
Instructions for use with herbal supplements.
What information is required on all manufacturers’ drug labels regarding barcodes?
Bar code label requirements.
Expiration date of the drug only.
Manufacturer's logo only.
Storage instructions only.
What information is required on all manufacturers’ drug labels for products held by the Strategic National Stockpile?
Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile.
Expiration date of the product only.
Manufacturer's logo and color scheme only.
Storage temperature in Celsius only.
According to the FDA, what information must be included on all OTC packages? Fill in the blank: The drug’s name and place of business of the ________, packer, or distributor of drugs and devices.
manufacturer
pharmacist
prescriber
patient
According to the FDA, which code number must be included on all OTC packages?
National Drug Code number
Universal Product Code number
Lot Number Code
Prescription Identification Number
According to the FDA, which type of ingredient must be listed on all OTC packages? Fill in the blank: ________ ingredient.
Active
Inactive
Optional
Supplemental
According to the FDA, what established information about a drug must be included on all OTC packages?
Established name of the drug
Manufacturer's logo
Retail price
Expiration date only
According to the FDA, which type of ingredient, other than the active ingredient, must be listed on all OTC packages?
Inactive ingredient
Flavoring agent
Coloring agent
Preservative
According to the FDA, what requirements must be included on all OTC packages? Fill in the blank: ________ requirements.
Content
Storage
Expiration
Dosage
According to the FDA, which word(s) must be followed by the general pharmacologic category or principal intended action(s) of the drug on all OTC packages?
“Purpose” or “Purposes”
“Directions”
“Warnings”
“Active Ingredient(s)”
According to the FDA, which word(s) must appear before the indication(s) on all OTC packages?
“Use” or “Uses”
“Indication” or “Indications”
“Purpose” or “Purposes”
“Directions” or “Direction”
According to the FDA, all OTC packages must include a 'Warning' or 'Warnings' and 'Do not use,' followed by all __________ for use with the product.
contraindications
instructions
ingredients
dosages
According to the FDA, all OTC packages must include 'Directions' followed by the __________ for use.
directions
warnings
ingredients
expiration date
According to the FDA, all OTC packages must include 'Inactive ingredients,' followed by a listing of the established name of each __________ ingredient.
inactive
active
preservative
flavoring
According to the FDA, all OTC packages must include 'Questions?' or 'Questions or comments?' followed by the __________ number of the manufacturer to answer questions about the product.
telephone
fax
serial
batch
Federal requirements for nonhazardous, hazardous, and pharmaceutical substances must be discussed.
They are regulated under different federal laws and guidelines.
They are all managed under the same federal regulation.
Only hazardous substances have federal requirements.
Pharmaceutical substances are not federally regulated.
The handling of pharmaceutical substances involves:
Proper storage, labeling, and disposal procedures.
Ignoring expiration dates and storage conditions.
Mixing substances without documentation.
Leaving substances in open containers.
The Drug Enforcement Administration (DEA) is responsible for regulating controlled substances, including the scheduling of drugs and the authorization of controlled-substance prescriptions.
The DEA regulates controlled substances and their prescriptions through drug scheduling.
The DEA only manages over-the-counter medications.
The DEA is responsible for food safety regulations.
DEA schedules are unrelated to prescription drugs.
Proper storage and labeling of controlled substances involves:
Storing in a locked cabinet and labeling with the drug name, strength, and expiration date
Leaving them on open shelves for easy access
Labeling only with the drug name
Storing with non-controlled substances without special labeling
Restricted drug programs are designed to:
Control the distribution and use of certain medications.
Promote over-the-counter sales of all drugs.
Eliminate the need for prescriptions.
Encourage self-medication without supervision.
FDA recalls and regulatory agencies are related to which of the following?
Ensuring the safety and effectiveness of products
Promoting unregulated product sales
Ignoring product safety concerns
Approving all products without review
Which of the following is a pharmacy reference?
Drug Information Handbook
Oxford English Dictionary
Gray's Anatomy (medical textbook)
Encyclopedia Britannica
According to federal requirements, which act requires the safe disposal of medications?
Safe Water Drinking Act
Clean Air Act
Resource Conservation and Recovery Act
Food, Drug, and Cosmetic Act
Which organizations' regulations do companies help pharmacies comply with regarding the disposal of non-hazardous substances?
A) OSHA, EPA, and DOT
B) FDA, CDC, and WHO
C) USDA, NIH, and DEA
D) EPA, FDA, and CDC
Any drug identified as hazardous or potentially hazardous is classified based on at least how many criteria?
Six
Three
Four
Five
Which of the following is NOT a classification of hazardous drugs?
Non-antineoplastic drugs
Antineoplastic drugs
Drugs with reproductive risks for men or women
Antibiotics
Fill in the blank: ________ drugs are hazardous drugs that are not used for cancer treatment.
Non-antineoplastic drugs
Antineoplastic drugs
Antiviral drugs
Antibiotic drugs
Drugs with reproductive risks for men or women are classified as hazardous drugs.
True
False
All pharmacy personnel should be trained in the receipt, storage, compounding, dispensing, and disposal of ________ drugs.
hazardous
antibiotic
over-the-counter
herbal
When must training be completed before pharmacy personnel handle hazardous drugs?
After handling hazardous drugs
Before handling hazardous drugs
Only during hiring
Every 5 years
Competency training for pharmacy personnel must be conducted every ______ months.
12
6
18
24
According to the guidelines for handling hazardous drugs, who is responsible for understanding practices and precautions to prevent harm to patients, minimize exposure to personnel, and minimize contamination of the work and care environment?
Only doctors
Only nurses
All personnel who handle HDs
Only pharmacists
Handling of Hazardous Drugs: Personnel should wear PPE when receiving, storing, transporting, compounding, deactivating/decontaminating, cleaning, disinfecting, and during spill control.
receiving
disposing
labeling
ordering
Personnel should wear PPE when cleaning and disinfecting hazardous drug areas.
True
False
Access to areas where HDs are handled must be restricted to ________ only.
authorized personnel
visitors
patients
delivery staff
Storage areas must be located away from which of the following?
Employee break areas
Patients
Visitors
All of the above
Hazardous drugs should be stored to prevent ________ or breakage.
spillage
evaporation
condensation
melting
Sterile and nonsterile HDs can be stored together.
True
False
Refrigerated antineoplastic HDs must be stored in a dedicated ________.
refrigerator
freezer
cabinet
shelf
According to the OSHA Technical Manual, what should be done with needle containers and breakable items when disposing of hazardous drugs?
Label them
Throw them in regular trash
Burn them
Reuse them
According to the OSHA Technical Manual, what type of disposal containers should be used for hazardous drugs?
Open containers
Properly labeled, sealed, and covered containers
Cardboard boxes
Paper bags
According to the OSHA Technical Manual, hazardous drug waste should be placed in thick, leak-proof plastic bags that are ______ from other hospital trash bags.
colored differently
the same size
made of paper
stored openly
According to the OSHA Technical Manual, hazardous waste bags should be kept inside a covered waste container clearly labeled as what?
Hazardous Drug WASTE ONLY
General Waste
Biohazard Only
Recyclable Materials
According to the OSHA Technical Manual, hazardous drug-related wastes should be disposed of according to which regulations?
Only hospital policy
EPA, state, and local regulations
Manufacturer's instructions
None of the above
Emergency procedures to cover spills or accidental release of hazardous drugs should be included in facility’s overall health and safety program.
True
False
Incidental spills and breakages should be cleaned up immediately with a _________
hazardous drug spill kit
paper towel
regular cleaning mop
disinfectant spray
Nonhazardous materials may be discarded in a ________ trash container.
regular
biohazard
sharps
chemical
Glass and used needles must be disposed of using a ________ container.
sharps
plastic
paper
biohazard
Which of the following is NOT a type of waste listed in the image?
Solid waste
Hazardous material
Infectious waste
Recyclable waste
Fill in the blank: Blood, blood products, bodily fluids, infectious sharps waste, and laboratory waste are examples of __________ waste.
Infectious
Radioactive
Chemical
General
Which of the following is an example of infectious waste?
Plastic bottles
Blood products
Cardboard boxes
Food wrappers
Which of the following is a characteristic of hazardous waste?
Ignitability
Flammability
Solubility
Density
Which of the following is a characteristic of hazardous waste?
Corrosivity
Flexibility
Elasticity
Viscosity
Which of the following is a characteristic of hazardous waste?
Reactivity
Conductivity
Malleability
Ductility
Which of the following is a characteristic of hazardous waste?
Toxicity
Transparency
Brittleness
Hardness
What is one type of hazardous waste?
F-list
G-list
H-list
J-list
What is one type of hazardous waste?
K-list
L-list
M-list
N-list
What is one type of hazardous waste?
P-list
Q-list
R-list
S-list
What is one type of hazardous waste?
U-list
V-list
W-list
X-list
Bags containing materials contaminated with hazardous drugs must be labeled ____.
appropriately
randomly
secretly
temporarily
Which type of bags should be used for routine collection of discarded gloves, gowns, and other disposable material and labeled as “Hazardous Drug-related wastes”?
Thin, regular plastic bags
Thick, leak-proof plastic bags, colored differently from other hospital trash bags
Paper bags
Any available bag
Fill in the blank: One of the required labeling elements for Schedules II-V is the pharmacy ______ and address.
name
phone number
DEA number
license number
Fill in the blank: The label for Schedules II-V must include the serial number and date of ______ filling.
initial
final
subsequent
partial
Fill in the blank: The label for Schedules II-V must include the name of the ______.
patient
pharmacist
manufacturer
pharmacy
Fill in the blank: The label for Schedules II-V must include the name of the ______ issuing the prescription.
practitioner
pharmacist
patient
pharmacy
Fill in the blank: The label for Schedules II-V must include the name of medication, ______, and quantity.
strength
expiration date
manufacturer
prescriber
Fill in the blank: The label for Schedules II-V must include directions for ______.
use
storage
manufacture
disposal
What is the main purpose of a Prescription Drug Monitoring Program (PDMP)?
To monitor food safety
To collect designated data on substances dispensed in the state
To regulate insurance policies
To track vehicle registrations
A Prescription Drug Monitoring Program (PDMP) is housed by a specified statewide ________, administrative, or law enforcement agency.
regulatory
medical
educational
financial
Which of the following is a benefit of the Prescription Drug Monitoring Program (PDMP)?
Support access to legitimate medical use of controlled substances
Increase the price of medications
Reduce the number of pharmacies
Promote over-the-counter drug sales
One of the benefits of the Prescription Drug Monitoring Program (PDMP) is to identify and deter or prevent drug abuse and diversion.
True
False
