HSC 343 101 CP Exam Questions and Answers Fully Solved Latest Update 2025-2026
Adverse Drug Reactions - Type I: - Answers allergic reactions to stings and drugs; symptoms
range from mild rash to life-threatening anaphylaxis; onset is immediate
Pure Food and Drug Act of (1906) - Answers The federal government (Food and Drug
Administration, FDA) may enforce standards of drug strength and purity as officially designated
by the USP (United States Pharmacopoeia) and NF (National Formulary).
2. Prohibits mislabeling or adulteration of drugs
Harrison Narcotic Act (1914) - Answers Regulated importation, manufacture, sale, and use of
opium, cocaine, and marijuana
2. Repealed and superseded by Controlled Substances Act (1970)
Food, Drug, and Cosmetic Act (1938) - Answers Enforced by the FDA through registration of all
parties involved in the manufacture, sale, and distribution of drugs required adequate testing of
a compound to prevent marketing of a possibly toxic substance. New drugs must be a safe as
well as pure in order to be introduced into interstate commerce. But this law still did not require
proof of effectiveness.
Durham-Humphrey Amendments (1952) - Answers 1. separated drugs into legend (prescription)
and nonlegend (nonprescription, over-the-counter) categories. The "legend" must appear on
every commercial container of legend drugs: "Caution: Federal Law Prohibits Dispensing without
Prescription."
2. rules for dispensing legend drugs
Kefauver-Harris Amendment of (1962) - Answers 1. required proof of efficacy as well as safety
before any new drug could be placed in interstate commerce (Thalidomide)
2. Guidelines for conducting clinical trials
3. Established the Drug Efficacy Study Implementation (DESI)
Comprehensive Drug Abuse Prevention and Control Act of 1970 (Controlled Substances Act) -
Answers 1. Established rehabilitation program for drug users
2. Established control (registration) and enforcement (DEA)
3. Regulates export and import of controlled substances
What is a Controlled Substance? - Answers •Prescription
,•Potentially addictive
-Reinforcing
-Physically addicting
-Psychologically addicting
•Use is controlled by the Federal Government and monitored by both Federal and State
Governments
Schedule I - Answers High abuse potential and no accepted medical use (Heroin, Marijuana, LSD,
Mescaline, Peyote, Bath salts)
Schedule II - Answers currently accepted medical use in U.S. with high abuse potential resulting
in severe physical or psychological dependence
-Written Prescription required with prescriber's actual (legal) Signature Electronic prescriptions
are allowed (preferred, required)
-Must be dated the same day as signed
-No refills allowed
-In an emergency, a verbal order may be given for a limited quantity of drug adequate to treat
the emergency condition, but must be followed by a written prescription within 72 hours.
-Note: There are no verbal orders allowed for schedule in Prescriptions in Alabama.
Schedule III - Answers Abuse potential less than Schedule II
-Written or verbal prescriptions allowed; valid for 6 months from the date written
-limit of 5 refills
Schedule IV - Answers Abuse potential less than Schedule III (Same Rule)
-Benzodiazepines, Diazepam (Valium), Alprazolam (Xanax)
-Drugs for weight loss (Qsymia)
-Drugs for Sleep (Ambient)
, Schedule V - Answers Lowest abuse potential
-Some drugs in this schedule are non legend both federally and in some states; purchase still
subject to state regulations.
-Antitussive and antidiarrheal narcotic drugs in limited quantities, diphenoxylate/atropine
(Lomotil), Robitussin-AC
-Narcotic analgesic: buprenorphine (Buprenex)
Rules for Controlled Substances in Alabama - Answers Classifications determined by the State
Board of Health, but may not be classified in lower schedules than federal law permits
Poison Prevention Packaging Act of (1970) - Answers 1. Regulates certain "household
substances" and requires that they be packaged for consumer use in a manner that will make
them significantly difficult for children < 5 years old to open
2. Patient may request noncomplying container
3. Child- resistant container applies to:
-All controlled drugs
-All legend drugs EXCEPT
-Sublingual nitroglycerin
-Oral contraceptives in dispenser packs
-Aspirin or aspirin-containing preparations; some exceptions, effervescent tablets
-Iron-containing drugs and dietary supplements
Food and Drug Administration Modernization Act (FDAMA) (1997) - Answers -Allows for fast-
tracking of drugs for serious illnesses to market.
-Drug manufacturers have to give patients 6 months notice before they discontinue making a
drug
-Established a clinical trial database for drugs for critical illnesses
-INFORMS OF "OFF-LABEL" USES
-Incentives for pediatric drug research
Best Pharmaceuticals for Children Act (BPCA) (2002) / Pediatric Research Equity Act 2003 -
Answers -Both promote drug studies in children
Adverse Drug Reactions - Type I: - Answers allergic reactions to stings and drugs; symptoms
range from mild rash to life-threatening anaphylaxis; onset is immediate
Pure Food and Drug Act of (1906) - Answers The federal government (Food and Drug
Administration, FDA) may enforce standards of drug strength and purity as officially designated
by the USP (United States Pharmacopoeia) and NF (National Formulary).
2. Prohibits mislabeling or adulteration of drugs
Harrison Narcotic Act (1914) - Answers Regulated importation, manufacture, sale, and use of
opium, cocaine, and marijuana
2. Repealed and superseded by Controlled Substances Act (1970)
Food, Drug, and Cosmetic Act (1938) - Answers Enforced by the FDA through registration of all
parties involved in the manufacture, sale, and distribution of drugs required adequate testing of
a compound to prevent marketing of a possibly toxic substance. New drugs must be a safe as
well as pure in order to be introduced into interstate commerce. But this law still did not require
proof of effectiveness.
Durham-Humphrey Amendments (1952) - Answers 1. separated drugs into legend (prescription)
and nonlegend (nonprescription, over-the-counter) categories. The "legend" must appear on
every commercial container of legend drugs: "Caution: Federal Law Prohibits Dispensing without
Prescription."
2. rules for dispensing legend drugs
Kefauver-Harris Amendment of (1962) - Answers 1. required proof of efficacy as well as safety
before any new drug could be placed in interstate commerce (Thalidomide)
2. Guidelines for conducting clinical trials
3. Established the Drug Efficacy Study Implementation (DESI)
Comprehensive Drug Abuse Prevention and Control Act of 1970 (Controlled Substances Act) -
Answers 1. Established rehabilitation program for drug users
2. Established control (registration) and enforcement (DEA)
3. Regulates export and import of controlled substances
What is a Controlled Substance? - Answers •Prescription
,•Potentially addictive
-Reinforcing
-Physically addicting
-Psychologically addicting
•Use is controlled by the Federal Government and monitored by both Federal and State
Governments
Schedule I - Answers High abuse potential and no accepted medical use (Heroin, Marijuana, LSD,
Mescaline, Peyote, Bath salts)
Schedule II - Answers currently accepted medical use in U.S. with high abuse potential resulting
in severe physical or psychological dependence
-Written Prescription required with prescriber's actual (legal) Signature Electronic prescriptions
are allowed (preferred, required)
-Must be dated the same day as signed
-No refills allowed
-In an emergency, a verbal order may be given for a limited quantity of drug adequate to treat
the emergency condition, but must be followed by a written prescription within 72 hours.
-Note: There are no verbal orders allowed for schedule in Prescriptions in Alabama.
Schedule III - Answers Abuse potential less than Schedule II
-Written or verbal prescriptions allowed; valid for 6 months from the date written
-limit of 5 refills
Schedule IV - Answers Abuse potential less than Schedule III (Same Rule)
-Benzodiazepines, Diazepam (Valium), Alprazolam (Xanax)
-Drugs for weight loss (Qsymia)
-Drugs for Sleep (Ambient)
, Schedule V - Answers Lowest abuse potential
-Some drugs in this schedule are non legend both federally and in some states; purchase still
subject to state regulations.
-Antitussive and antidiarrheal narcotic drugs in limited quantities, diphenoxylate/atropine
(Lomotil), Robitussin-AC
-Narcotic analgesic: buprenorphine (Buprenex)
Rules for Controlled Substances in Alabama - Answers Classifications determined by the State
Board of Health, but may not be classified in lower schedules than federal law permits
Poison Prevention Packaging Act of (1970) - Answers 1. Regulates certain "household
substances" and requires that they be packaged for consumer use in a manner that will make
them significantly difficult for children < 5 years old to open
2. Patient may request noncomplying container
3. Child- resistant container applies to:
-All controlled drugs
-All legend drugs EXCEPT
-Sublingual nitroglycerin
-Oral contraceptives in dispenser packs
-Aspirin or aspirin-containing preparations; some exceptions, effervescent tablets
-Iron-containing drugs and dietary supplements
Food and Drug Administration Modernization Act (FDAMA) (1997) - Answers -Allows for fast-
tracking of drugs for serious illnesses to market.
-Drug manufacturers have to give patients 6 months notice before they discontinue making a
drug
-Established a clinical trial database for drugs for critical illnesses
-INFORMS OF "OFF-LABEL" USES
-Incentives for pediatric drug research
Best Pharmaceuticals for Children Act (BPCA) (2002) / Pediatric Research Equity Act 2003 -
Answers -Both promote drug studies in children
