1
HOSA
HOSA PHARMACOLOGY EXAM QS & AS |
GRADE A|100% CORRECT (VERIFIED
ANSWERS) (NEW 2025/ 2026 UPDATE)
NDA Process: Initial Development: Pre Clinical - ANS ✓pre-clinical (animal)
testing
NDA Process: Initial Development: Investigational New Drug Review (IND) -
ANS ✓-review of pre-clinical trial results
-determination of safety to use on humans
-authorization to ship across state lines
NDA Process: New Drug Clinical Trials: Phase I - ANS ✓-involves 25-100
volunteers
-safety tolerated dosage determined
-identification of major side effects
-emphasis on safety and maximum tolerated dosages
NDA Process: New Drug Clinical Trials: Phase II - ANS ✓-involves 100-300
volunteers
-emphasis on the drug effect against what it's designed to treat
-effects compared with similar patients receiving different treatments
NDA Process: New Drug Clinical Trials: Phase III - ANS ✓-involves 300-3000
volunteers
HOSA Pharm
, 2
HOSA
-emphasis on the drugs overall effect
-effects compared with patients taking placebos
-study of different population and different dosages
-testing the drug in combination with other drugs
-final phase before presenting to FDA for approval
NDA Process: New Drug Post Approval Trials: Phase IV - ANS ✓-ongoing/post
approval trials
-health-care professionals to report any adverse findings
-lasts eternally, as long as the drug is on the market
NDA Process Time - ANS ✓-can usually take 12-15 years
-patent only last 20 years from the time the application for patent was filled
Federal Food and Drug Act of 1906 - ANS ✓-known as the Pure Food and Drug
Act
-provided authority for federal inspection of meat products and prohibited the
sale of adulterated foods
-required that "secret elixirs" containing ingredients like: cocaine, heroin,
morphine and alcohol which were available at most stores as miracle cure-alls be
labelled with correct information about their ingredients as well as suggested
dosages
-replaced by the Federal Food, Drug and Cosmetic Act of 1938
Narcotic Tax Act of 1914 - ANS ✓-known as the Harrison Narcotic Act
-provided authority for the IRS to collect taxes on Opiates thru tax stamps
-required that any entity which produced, distributed, dispensed or sold opiates
be registered with the IRS
-emphasis was on attempting to control the massive flow of opiates in order to
protect the public from rising addiction
HOSA Pharm
, 3
HOSA
Federal Food, Drug and Cosmetic Act of 1938 - ANS ✓-known as FDCA 1938
-replaced the Food and Drug act of 1906
-provided better clarification about misbranding definitions
-provided better clarification about adulteration definitions
-gave the FDA authority to require adequate testing of new drugs for safety
The Durham-Humphrey Amendment of 1951 - ANS ✓-created a distinction
between "OTC" and "Legend Drugs"
-required legend drugs to carry the statement: "Caution: Federal law prohibits
dispensing without a prescription."
-emphasis on this act was to insure safety through qualified medical supervision
The Kefauver-Harris Amendment of 1962 - ANS ✓-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
The Bureau of Narcotics and Dangerous Drugs (BNDD) - ANS ✓-predecessor
agency of the DEA
-BNDD merged into the DEA in 1973
Drug Abuse Prevention/ Control Act of 1970 - ANS ✓-known as the CSA
-completely replaced the Harrison Act
-required the use of DEA numbers
-required comprehensive record keeping and transaction tracking
-enforced the DEA under the US Dept of Justice
HOSA Pharm
HOSA
HOSA PHARMACOLOGY EXAM QS & AS |
GRADE A|100% CORRECT (VERIFIED
ANSWERS) (NEW 2025/ 2026 UPDATE)
NDA Process: Initial Development: Pre Clinical - ANS ✓pre-clinical (animal)
testing
NDA Process: Initial Development: Investigational New Drug Review (IND) -
ANS ✓-review of pre-clinical trial results
-determination of safety to use on humans
-authorization to ship across state lines
NDA Process: New Drug Clinical Trials: Phase I - ANS ✓-involves 25-100
volunteers
-safety tolerated dosage determined
-identification of major side effects
-emphasis on safety and maximum tolerated dosages
NDA Process: New Drug Clinical Trials: Phase II - ANS ✓-involves 100-300
volunteers
-emphasis on the drug effect against what it's designed to treat
-effects compared with similar patients receiving different treatments
NDA Process: New Drug Clinical Trials: Phase III - ANS ✓-involves 300-3000
volunteers
HOSA Pharm
, 2
HOSA
-emphasis on the drugs overall effect
-effects compared with patients taking placebos
-study of different population and different dosages
-testing the drug in combination with other drugs
-final phase before presenting to FDA for approval
NDA Process: New Drug Post Approval Trials: Phase IV - ANS ✓-ongoing/post
approval trials
-health-care professionals to report any adverse findings
-lasts eternally, as long as the drug is on the market
NDA Process Time - ANS ✓-can usually take 12-15 years
-patent only last 20 years from the time the application for patent was filled
Federal Food and Drug Act of 1906 - ANS ✓-known as the Pure Food and Drug
Act
-provided authority for federal inspection of meat products and prohibited the
sale of adulterated foods
-required that "secret elixirs" containing ingredients like: cocaine, heroin,
morphine and alcohol which were available at most stores as miracle cure-alls be
labelled with correct information about their ingredients as well as suggested
dosages
-replaced by the Federal Food, Drug and Cosmetic Act of 1938
Narcotic Tax Act of 1914 - ANS ✓-known as the Harrison Narcotic Act
-provided authority for the IRS to collect taxes on Opiates thru tax stamps
-required that any entity which produced, distributed, dispensed or sold opiates
be registered with the IRS
-emphasis was on attempting to control the massive flow of opiates in order to
protect the public from rising addiction
HOSA Pharm
, 3
HOSA
Federal Food, Drug and Cosmetic Act of 1938 - ANS ✓-known as FDCA 1938
-replaced the Food and Drug act of 1906
-provided better clarification about misbranding definitions
-provided better clarification about adulteration definitions
-gave the FDA authority to require adequate testing of new drugs for safety
The Durham-Humphrey Amendment of 1951 - ANS ✓-created a distinction
between "OTC" and "Legend Drugs"
-required legend drugs to carry the statement: "Caution: Federal law prohibits
dispensing without a prescription."
-emphasis on this act was to insure safety through qualified medical supervision
The Kefauver-Harris Amendment of 1962 - ANS ✓-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
The Bureau of Narcotics and Dangerous Drugs (BNDD) - ANS ✓-predecessor
agency of the DEA
-BNDD merged into the DEA in 1973
Drug Abuse Prevention/ Control Act of 1970 - ANS ✓-known as the CSA
-completely replaced the Harrison Act
-required the use of DEA numbers
-required comprehensive record keeping and transaction tracking
-enforced the DEA under the US Dept of Justice
HOSA Pharm
