Controlled Substances Study Guide
common law
the system of precedents established by decisions in cases throughout legal history
statutary law
are passed by legislative bodies at the federal, state, and local levels.
regulatory law
is the system of rules and regulations establish by the governmentsal bodies such as
the FDA
Food and drug act of 1906
government pre-approval of drugs is required.. prohibits the interstate transportation of
sale of adulterated and misbranded food and drugs
adulterated drugs
usually refers to mixing other matter of an inferior and sometimes harmful quality with
food or drink intended to be sold. As a result of adulteration, food or drink becomes
impure and unfit for human consumption.
1938 Food, drug and cosmetic act
requires new drugs to be shown to be safe before marketing...created the food and drug
administration(FDA)
investigation of new drug application (INDA)
is submitted for a new drug entity to start investigational studies
New drug application(NDA)
is submitted for drug approval
The abbreviated New Drug Application(ANDA)
is the form that should be submitted to the FDA to obtain approval to market a generic
product
United States Adopted Name (USAN)
the generic name of a drug
1951 Durhan-Humphrey Amendment
Federal law prohibits dispensing without a prescription or "rx only". an amendment to
the FDCA(food drug and cosmetic act)
1962 Keffauver- Harris Amendment
Manufactures required to provide proof of safety and effectiveness before marketing
Investigational drugs
drugs being used in clinical trials
1970 Controlled Substances Act
The CSA classifies five levels of drugs that have potential for abuse and restricts their
distribution.
1970 Poison Prevention Packaging Act (PPPA)
Requires child proof packaging on all controlled meds and most rx drugs
C-I
schedule I controlled substance, a drug with the highest potential for abuse, which may
be used only for research under a special license. No accepted medical use in the US
C-II
common law
the system of precedents established by decisions in cases throughout legal history
statutary law
are passed by legislative bodies at the federal, state, and local levels.
regulatory law
is the system of rules and regulations establish by the governmentsal bodies such as
the FDA
Food and drug act of 1906
government pre-approval of drugs is required.. prohibits the interstate transportation of
sale of adulterated and misbranded food and drugs
adulterated drugs
usually refers to mixing other matter of an inferior and sometimes harmful quality with
food or drink intended to be sold. As a result of adulteration, food or drink becomes
impure and unfit for human consumption.
1938 Food, drug and cosmetic act
requires new drugs to be shown to be safe before marketing...created the food and drug
administration(FDA)
investigation of new drug application (INDA)
is submitted for a new drug entity to start investigational studies
New drug application(NDA)
is submitted for drug approval
The abbreviated New Drug Application(ANDA)
is the form that should be submitted to the FDA to obtain approval to market a generic
product
United States Adopted Name (USAN)
the generic name of a drug
1951 Durhan-Humphrey Amendment
Federal law prohibits dispensing without a prescription or "rx only". an amendment to
the FDCA(food drug and cosmetic act)
1962 Keffauver- Harris Amendment
Manufactures required to provide proof of safety and effectiveness before marketing
Investigational drugs
drugs being used in clinical trials
1970 Controlled Substances Act
The CSA classifies five levels of drugs that have potential for abuse and restricts their
distribution.
1970 Poison Prevention Packaging Act (PPPA)
Requires child proof packaging on all controlled meds and most rx drugs
C-I
schedule I controlled substance, a drug with the highest potential for abuse, which may
be used only for research under a special license. No accepted medical use in the US
C-II
