Law Review IPPE 1 question well
answered graded A+
Law - correct answer ✔✔any system of regulations that govern or rule the conduct of the
people of society or community usually for protection
Act - correct answer ✔✔a constitutional plan passed by Congress or any legislature that is
referred to as a "bill" until ratified and becomes a law
Amendment - correct answer ✔✔a change to a law
1906 Federal Food and Drug Act - correct answer ✔✔prohibits the sale of adulterated or
mislabeled food, drinks and drugs
1914 Harrison Narcotic Act - correct answer ✔✔limits the transport of opium, in order to
purchase opium, a prescription is required
1938 Food Drug and Cosmetic Act - correct answer ✔✔made the Food and Drug Act more
comprehensive to include cosmetics. The act also defines misbranding or adulteration of drugs
to be illegal and requires drug companies to provide package inserts, requires that habit-
forming drugs be labeled "may be habit forming". Requires that a new drug has to be proven
safe under FDA guidelines before marketing
1970 comprehensive drug abuse prevention and control act (controlled substance act) - correct
answer ✔✔Drug Enforcement Agency (DEA) was formed. Also controlled substances were
placed in schedules I-V based on abuse potential. Schedule I drugs have the highest abuse
potential and schedule V drugs have the lowest abuse potential
, 1983 orphan drug act - correct answer ✔✔enables the FDA to promote the research and
marketing of drugs needed for the treatment of rare diseases
1984 drug price competition and patent-term restoration act (Hatch-Waxman Amendment) -
correct answer ✔✔streamlined the process for granting approval of generic drugs. It also gave
manufacturers incentives to develop new drugs by giving patent extensions. This act allows
generic drug companies the ability to rely on safety and efficacy findings of an innovator's drug
after the expiration of the patent
1988 food and drug administration act - correct answer ✔✔established the FDA as an agency of
the Department of Health and Human Services. any adverse drug reactions and outcome should
be reported to the FDA
1988 Prescription Drug Marketing Act - correct answer ✔✔act banned the sale, trade, or
purchase of drug samples
1990 Omnibus Budget Reconciliation Act - correct answer ✔✔requires a pharmacist to attempt
or offer counsel to patients on all new prescriptions. Pharmacist must provide a name and
description of drug, how much should be taken, side effects, contraindications, interactions,
adverse effects, storage, refill information, and what to do if a dose is missed
1996 HIPPA - correct answer ✔✔created rules regarding the privacy/security of patient health
information. It provides limitations on who can access, distribute, and receive patient
information. This act also makes health insurance portable for people switching jobs and
includes provisions that make health care information processing more cost effective by
requiring standardized electronic submissions of claim information
2006 Combat Methamphetamine Epidemic Act (CMEA) - correct answer ✔✔limits the purchase
of pseudoephedrine (PSE) products
1951 Durham Humphrey Amendment - correct answer ✔✔distinguishes legend drugs
(prescription) from the over the counter drugs (OTC). It requires companies to label legend
answered graded A+
Law - correct answer ✔✔any system of regulations that govern or rule the conduct of the
people of society or community usually for protection
Act - correct answer ✔✔a constitutional plan passed by Congress or any legislature that is
referred to as a "bill" until ratified and becomes a law
Amendment - correct answer ✔✔a change to a law
1906 Federal Food and Drug Act - correct answer ✔✔prohibits the sale of adulterated or
mislabeled food, drinks and drugs
1914 Harrison Narcotic Act - correct answer ✔✔limits the transport of opium, in order to
purchase opium, a prescription is required
1938 Food Drug and Cosmetic Act - correct answer ✔✔made the Food and Drug Act more
comprehensive to include cosmetics. The act also defines misbranding or adulteration of drugs
to be illegal and requires drug companies to provide package inserts, requires that habit-
forming drugs be labeled "may be habit forming". Requires that a new drug has to be proven
safe under FDA guidelines before marketing
1970 comprehensive drug abuse prevention and control act (controlled substance act) - correct
answer ✔✔Drug Enforcement Agency (DEA) was formed. Also controlled substances were
placed in schedules I-V based on abuse potential. Schedule I drugs have the highest abuse
potential and schedule V drugs have the lowest abuse potential
, 1983 orphan drug act - correct answer ✔✔enables the FDA to promote the research and
marketing of drugs needed for the treatment of rare diseases
1984 drug price competition and patent-term restoration act (Hatch-Waxman Amendment) -
correct answer ✔✔streamlined the process for granting approval of generic drugs. It also gave
manufacturers incentives to develop new drugs by giving patent extensions. This act allows
generic drug companies the ability to rely on safety and efficacy findings of an innovator's drug
after the expiration of the patent
1988 food and drug administration act - correct answer ✔✔established the FDA as an agency of
the Department of Health and Human Services. any adverse drug reactions and outcome should
be reported to the FDA
1988 Prescription Drug Marketing Act - correct answer ✔✔act banned the sale, trade, or
purchase of drug samples
1990 Omnibus Budget Reconciliation Act - correct answer ✔✔requires a pharmacist to attempt
or offer counsel to patients on all new prescriptions. Pharmacist must provide a name and
description of drug, how much should be taken, side effects, contraindications, interactions,
adverse effects, storage, refill information, and what to do if a dose is missed
1996 HIPPA - correct answer ✔✔created rules regarding the privacy/security of patient health
information. It provides limitations on who can access, distribute, and receive patient
information. This act also makes health insurance portable for people switching jobs and
includes provisions that make health care information processing more cost effective by
requiring standardized electronic submissions of claim information
2006 Combat Methamphetamine Epidemic Act (CMEA) - correct answer ✔✔limits the purchase
of pseudoephedrine (PSE) products
1951 Durham Humphrey Amendment - correct answer ✔✔distinguishes legend drugs
(prescription) from the over the counter drugs (OTC). It requires companies to label legend
