AHIT PACKAGED EXAM 4 2026 HOME
INSPECTION ASSESSMENT PAPER AND
SOLUTIONS GRADED A+
◉ Adultered drugs.
Answer: Any drug that is not pure
◉ misbranded drug.
Answer: Not labeled correctly
◉ FDCA (Federal Food, Drug, and Cosmetic act).
Answer: drugs must comply with standards of safety and efficacy,
more modern act than Pure Food and Drug Act. Oversees safety of
food, drugs and cosmetics
◉ FDA (Food and Drug Administration).
Answer: a division of USDHHS responsible for regulating food and
drug products sold to the public. Handles drug approvals, sold, and
recalls of drugs
◉ 3 types of Drug Recalls.
Answer: 1. Most severe: permanent health hazard or death
,2. Medium severity: temporary or reversible damage
3. Least severe: mislabeling or misbranded drugs, low damage from
drugs
◉ MedWatch Program.
Answer: Reports to FDA side effects or adverse effects of any drugs
◉ (FAERS) FDA Adverse Event Reporting System.
Answer: Database that contains information on adverse event and
medication error reports submitted to the FDA; designed to support
the FDA's post-marketing safety surveillance program.
◉ VAERS (Vaccine Adverse Event Reporting System).
Answer: keeps track of all adverse effects associated with vaccines
◉ IND (Investigational New Drug).
Answer: A drug not yet approved for marketing by the FDA but
available for use in experiments to determine its safety and efficacy.
◉ FDA drug approval process.
Answer: 1. Hypothesis: comes up with the drug and reports findings
(dosage, research and findings) to FDA
,2. Pre-phase: consists of animal testing then human testing to small
population (reports correct dosing and side effects)
3. Large Human Trial: tests on wider population with longer
procedure
4. Post-surveillance: approval by FDA but is monitored. Given a 20
year patent
◉ tall man lettering.
Answer: medication names that have mixed case lettering in the
description name, which helps reduce errors between medication
names that either look or sound alike
◉ FAERS and VAERS.
Answer: Reports to the CDC (centers of disease control) as well
◉ Durham-Humphrey Amendment of 1951.
Answer: • Created a distinction between "OTC" and "Legend Drugs".
• Legend Drugs can only be dispensed with a valid Prescription..
• Required Legend Drugs to carry the statement:
"Caution: Federal law prohibits dispensing without a prescription.".
• Most people refer to Legend drugs simply as "Prescription Drugs".
• The emphasis on this act was to insure safety thru qualified
medical supervision.
, ◉ Kefauver-Harris Amendment of 1962.
Answer: • Also known as the "Drug Efficacy Amendment".
• Required drug manufacturers to provide proof of the effectiveness
and safety of their drugs before approval .
• Required drug advertising to be more closely regulated and
disclose accurate information about side effects
◉ Harrison Narcotic Act.
Answer: a 1914 congressional act that criminalized the sale and use
of narcotics
◉ Comprehensive Drug Abuse Prevention and Control Act of 1970.
Answer: established schedules of controlled substances and moved
enforcement to the Justice Department (C-1 to C-5)
Established the DEA
◉ DEA.
Answer: Enforces the controlled substance act under the DOJ. Makes
sure all controlled substances are manufactured, distributed, and
stored properly.
◉ Control 1 (C-1) drugs.
INSPECTION ASSESSMENT PAPER AND
SOLUTIONS GRADED A+
◉ Adultered drugs.
Answer: Any drug that is not pure
◉ misbranded drug.
Answer: Not labeled correctly
◉ FDCA (Federal Food, Drug, and Cosmetic act).
Answer: drugs must comply with standards of safety and efficacy,
more modern act than Pure Food and Drug Act. Oversees safety of
food, drugs and cosmetics
◉ FDA (Food and Drug Administration).
Answer: a division of USDHHS responsible for regulating food and
drug products sold to the public. Handles drug approvals, sold, and
recalls of drugs
◉ 3 types of Drug Recalls.
Answer: 1. Most severe: permanent health hazard or death
,2. Medium severity: temporary or reversible damage
3. Least severe: mislabeling or misbranded drugs, low damage from
drugs
◉ MedWatch Program.
Answer: Reports to FDA side effects or adverse effects of any drugs
◉ (FAERS) FDA Adverse Event Reporting System.
Answer: Database that contains information on adverse event and
medication error reports submitted to the FDA; designed to support
the FDA's post-marketing safety surveillance program.
◉ VAERS (Vaccine Adverse Event Reporting System).
Answer: keeps track of all adverse effects associated with vaccines
◉ IND (Investigational New Drug).
Answer: A drug not yet approved for marketing by the FDA but
available for use in experiments to determine its safety and efficacy.
◉ FDA drug approval process.
Answer: 1. Hypothesis: comes up with the drug and reports findings
(dosage, research and findings) to FDA
,2. Pre-phase: consists of animal testing then human testing to small
population (reports correct dosing and side effects)
3. Large Human Trial: tests on wider population with longer
procedure
4. Post-surveillance: approval by FDA but is monitored. Given a 20
year patent
◉ tall man lettering.
Answer: medication names that have mixed case lettering in the
description name, which helps reduce errors between medication
names that either look or sound alike
◉ FAERS and VAERS.
Answer: Reports to the CDC (centers of disease control) as well
◉ Durham-Humphrey Amendment of 1951.
Answer: • Created a distinction between "OTC" and "Legend Drugs".
• Legend Drugs can only be dispensed with a valid Prescription..
• Required Legend Drugs to carry the statement:
"Caution: Federal law prohibits dispensing without a prescription.".
• Most people refer to Legend drugs simply as "Prescription Drugs".
• The emphasis on this act was to insure safety thru qualified
medical supervision.
, ◉ Kefauver-Harris Amendment of 1962.
Answer: • Also known as the "Drug Efficacy Amendment".
• Required drug manufacturers to provide proof of the effectiveness
and safety of their drugs before approval .
• Required drug advertising to be more closely regulated and
disclose accurate information about side effects
◉ Harrison Narcotic Act.
Answer: a 1914 congressional act that criminalized the sale and use
of narcotics
◉ Comprehensive Drug Abuse Prevention and Control Act of 1970.
Answer: established schedules of controlled substances and moved
enforcement to the Justice Department (C-1 to C-5)
Established the DEA
◉ DEA.
Answer: Enforces the controlled substance act under the DOJ. Makes
sure all controlled substances are manufactured, distributed, and
stored properly.
◉ Control 1 (C-1) drugs.
