Pharmacy Law MPJE Exam: Federal Law
What did the Federal Controlled Substances Act do? Why was it implemented?
Legislators were very concerned in the 1960s about legal and illegal drugs being abused
They were allowed to design an act/law
Created the DEA to promulgate and enforce the law
Created a closed system between manufacturers, distributors, prescriber, dispensers, and patients.
What did the Pure Food and Drug Act of 1906 do?
Prohibited the adulteration and misbranding of foods and drugs in interstate commerce; DID NOT have
to be proven safe or effective; did not require the label to list ingredients, directions for use, or provide
warnings
What did the Food, Drug, and Cosmetic Act do? (started in 1938)
Provides for the comprehensive regulation of all drugs introduced into interstate (and most intrastate)
commerce
Under this act no new drug may be marketed and sold unless it has been proved SAFE ONLY for its
intended use and approved by the FDA
Labels must contain adequate directions for use and warnings about habit-forming properties of certain
drugs
,Describe the FDCA
The purpose of the FDCA is to protect consumers from adulterated or misbranded foods, drugs,
cosmetics, or devices; provided that no new drug could be marketed until proven safe for use under the
conditions described on the label and approved by the FDA; also started the labeling requirements;
applies to devices as well; all drugs before 1938 are exempt from the requirement that new drugs be
proven safe
If you get in trouble with the board of pharmacy can you get in trouble with the government too? What
about the a lawsuit with a patient?
Yes, you can have an administrative lawsuit, a civil lawsuit, and a criminal lawsuit separately for the same
offense
What did the Durham-Humphrey Amendment of 1951 do?
Established 2 classes of drugs; prescription and OTC
Allows refills on prescriptions and oral prescriptions
Per the Durham-Humphrey Amendment; what must be labeled on a prescription medication
Caution: federal law prohibits dispensing without a Rx; they do not need adequate directions for use like
OTC (talking about the MANUFACTURERS label here; there is no take this medication x amount of times
daily on the manufacturer labeling)
What did the Kefauver-Harris Amendment of 1962 do?
Required all drugs to not only be proven safe but also EFFECTIVE
,Transferred the regulation of drug advertising from the FTC to the FDA
The efficacy requirement made by the Kefauver-Harris Amendment included all drugs marketed during
what time period
1938-1962; drugs produced before 1938 were just grandfathered in and did not have to prove their
efficacy
What did the Orphan Drug Act of 1983 do?
Provided tax and exclusive licensing incentives for manufacturers to develop agents for the treatment of
rare disease or conditions (those conditions that affect < 200,000 Americans)
What did the Drug Price Competition and Patent Term Restoration Act of 1984 do?
Made generic drugs more readily available to the public and at the same time provided incentives for
manufacturers to develop new drugs
Eliminated the need for generic to prove safety and efficacy thus allowing new generics to get approved
more easily
What did the Prescription Drug Marketing Act of 1987 do?
Established sales restrictions and recordkeeping requirements for prescription drug samples
, Prohibits hospitals and other healthcare entities from selling drugs to other businesses (because the
hospitals were getting the drugs for a discount then reselling them)
Requires state licensing of wholesalers
Prohibits ANY SAMPLES for any reason in a retail pharmacy
Bans importation of prescription drugs except by manufacturers and for emergency use
Mandates record keeping requirements for drug samples for 3 years
What is the Prescription Drug User Fee Act of 1992
Drug companies volunteered to pay tax and the money was used to hire more FDA scientist in hopes to
speed up NDA reviews; however the price of drugs just went up to cover the fee being paid by the drug
manufacturers
What did the Dietary Supplement Health and Education Act (DSHEA) of 1994 do?
Provided laws on the regulation of dietary supplements; forced the FDA to treat these products more as
food than drugs
Define dietary supplement per the law
A product that is intended for ORAL ingestion, intended to supplement the diet, and contains any one or
more of the following: a vitamin, mineral, herb or other botanical, an amino acid, dietary substance or
use by humans to supplement the diet by increasing the total dietary intake and a concentrate,
metabolite, constituent, extract or combination of the previous.
What did the Federal Controlled Substances Act do? Why was it implemented?
Legislators were very concerned in the 1960s about legal and illegal drugs being abused
They were allowed to design an act/law
Created the DEA to promulgate and enforce the law
Created a closed system between manufacturers, distributors, prescriber, dispensers, and patients.
What did the Pure Food and Drug Act of 1906 do?
Prohibited the adulteration and misbranding of foods and drugs in interstate commerce; DID NOT have
to be proven safe or effective; did not require the label to list ingredients, directions for use, or provide
warnings
What did the Food, Drug, and Cosmetic Act do? (started in 1938)
Provides for the comprehensive regulation of all drugs introduced into interstate (and most intrastate)
commerce
Under this act no new drug may be marketed and sold unless it has been proved SAFE ONLY for its
intended use and approved by the FDA
Labels must contain adequate directions for use and warnings about habit-forming properties of certain
drugs
,Describe the FDCA
The purpose of the FDCA is to protect consumers from adulterated or misbranded foods, drugs,
cosmetics, or devices; provided that no new drug could be marketed until proven safe for use under the
conditions described on the label and approved by the FDA; also started the labeling requirements;
applies to devices as well; all drugs before 1938 are exempt from the requirement that new drugs be
proven safe
If you get in trouble with the board of pharmacy can you get in trouble with the government too? What
about the a lawsuit with a patient?
Yes, you can have an administrative lawsuit, a civil lawsuit, and a criminal lawsuit separately for the same
offense
What did the Durham-Humphrey Amendment of 1951 do?
Established 2 classes of drugs; prescription and OTC
Allows refills on prescriptions and oral prescriptions
Per the Durham-Humphrey Amendment; what must be labeled on a prescription medication
Caution: federal law prohibits dispensing without a Rx; they do not need adequate directions for use like
OTC (talking about the MANUFACTURERS label here; there is no take this medication x amount of times
daily on the manufacturer labeling)
What did the Kefauver-Harris Amendment of 1962 do?
Required all drugs to not only be proven safe but also EFFECTIVE
,Transferred the regulation of drug advertising from the FTC to the FDA
The efficacy requirement made by the Kefauver-Harris Amendment included all drugs marketed during
what time period
1938-1962; drugs produced before 1938 were just grandfathered in and did not have to prove their
efficacy
What did the Orphan Drug Act of 1983 do?
Provided tax and exclusive licensing incentives for manufacturers to develop agents for the treatment of
rare disease or conditions (those conditions that affect < 200,000 Americans)
What did the Drug Price Competition and Patent Term Restoration Act of 1984 do?
Made generic drugs more readily available to the public and at the same time provided incentives for
manufacturers to develop new drugs
Eliminated the need for generic to prove safety and efficacy thus allowing new generics to get approved
more easily
What did the Prescription Drug Marketing Act of 1987 do?
Established sales restrictions and recordkeeping requirements for prescription drug samples
, Prohibits hospitals and other healthcare entities from selling drugs to other businesses (because the
hospitals were getting the drugs for a discount then reselling them)
Requires state licensing of wholesalers
Prohibits ANY SAMPLES for any reason in a retail pharmacy
Bans importation of prescription drugs except by manufacturers and for emergency use
Mandates record keeping requirements for drug samples for 3 years
What is the Prescription Drug User Fee Act of 1992
Drug companies volunteered to pay tax and the money was used to hire more FDA scientist in hopes to
speed up NDA reviews; however the price of drugs just went up to cover the fee being paid by the drug
manufacturers
What did the Dietary Supplement Health and Education Act (DSHEA) of 1994 do?
Provided laws on the regulation of dietary supplements; forced the FDA to treat these products more as
food than drugs
Define dietary supplement per the law
A product that is intended for ORAL ingestion, intended to supplement the diet, and contains any one or
more of the following: a vitamin, mineral, herb or other botanical, an amino acid, dietary substance or
use by humans to supplement the diet by increasing the total dietary intake and a concentrate,
metabolite, constituent, extract or combination of the previous.
