What did the Federal Controlled Substances Act do? Why was it implemented? - ANSWER
Legislators very concerned in the 1960s about legal and illegal drugs being abused
They were given the opportunity to design an act/law
Created the DEA to promulgate and enforce the law
Created a closed system between: manufacturer, distributors, prescriber, dispenser, and
patient.
What did the Pure Food and Drug Act of 1906 do? - ANSWER 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) - ANSWER 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
1
,Describe the FDCA - ANSWER 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? - ANSWER 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? - ANSWER 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
- ANSWER 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? - ANSWER 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 - ANSWER 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? - ANSWER 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)
2
,What did the Drug Price Competition and Patent Term Restoration Act of 1984 do? -
ANSWER 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? - ANSWER 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 - ANSWER 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? -
ANSWER Provided laws on the regulation of dietary supplements; forced the FDA to treat
these products more as food than drugs
3
, Define dietary supplement per the law - ANSWER 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.
All dietary supplements must be claimed as - ANSWER A dietary supplement; they
CANNOT say they are drugs or anything else on the labeling
Dietary supplement manufacturers may not make these claims - ANSWER Disease Claims
Dietary supplement manufacturers may only make these types of claims - ANSWER
Structure / Function
The label can't say that it will cure or prevent but it can say "will support or maintain"
Dietary Supplements must have this on the labeling - ANSWER "This statement has not
been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent
any disease."
Who enforces drug advertising? - ANSWER FDA
Who enforces dietary supplement advertising - ANSWER FTC
Do dietary supplements have to be safe and/or effective? - ANSWER No
How does a dietary supplement get pulled off the market? - ANSWER The FDA cannot act
until the dietary supplement is proven to be dangerous; the products should not be
4
Legislators very concerned in the 1960s about legal and illegal drugs being abused
They were given the opportunity to design an act/law
Created the DEA to promulgate and enforce the law
Created a closed system between: manufacturer, distributors, prescriber, dispenser, and
patient.
What did the Pure Food and Drug Act of 1906 do? - ANSWER 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) - ANSWER 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
1
,Describe the FDCA - ANSWER 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? - ANSWER 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? - ANSWER 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
- ANSWER 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? - ANSWER 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 - ANSWER 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? - ANSWER 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)
2
,What did the Drug Price Competition and Patent Term Restoration Act of 1984 do? -
ANSWER 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? - ANSWER 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 - ANSWER 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? -
ANSWER Provided laws on the regulation of dietary supplements; forced the FDA to treat
these products more as food than drugs
3
, Define dietary supplement per the law - ANSWER 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.
All dietary supplements must be claimed as - ANSWER A dietary supplement; they
CANNOT say they are drugs or anything else on the labeling
Dietary supplement manufacturers may not make these claims - ANSWER Disease Claims
Dietary supplement manufacturers may only make these types of claims - ANSWER
Structure / Function
The label can't say that it will cure or prevent but it can say "will support or maintain"
Dietary Supplements must have this on the labeling - ANSWER "This statement has not
been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent
any disease."
Who enforces drug advertising? - ANSWER FDA
Who enforces dietary supplement advertising - ANSWER FTC
Do dietary supplements have to be safe and/or effective? - ANSWER No
How does a dietary supplement get pulled off the market? - ANSWER The FDA cannot act
until the dietary supplement is proven to be dangerous; the products should not be
4
