ASCP: Pharmacy Law, Regulations &
Ethics (Defined and elaborated) A+
Verfied Answer!!
Food and Drug Administration (FDA) - {Answer }-a federal agency charged with enforcing regulations
against selling and distributing adulterated, misbranded, or hazardous food and drug products.
Drug Enforcement Administration (DEA) - {Answer }-the agency that controls the distribution of drugs
that may be easily abused
Food and Drug Act of 1906 - {Answer }-Prohibited interstate commerce in adulterated or misbranded
food, drinks, and drugs. Government pre-approval of drugs is required.
1938 Food, Drug and Cosmetic Act (FDC) - {Answer }-in response the fatal poisoning of 107 people
primarily children by and untested sulfanilamide concoction this comprehensive law requires new drugs
be shown to be safe before marketing
1951 Durham-Humphrey Amendment - {Answer }-This law defines what drugs require a prescription by a
licensed practitioner and require the legend on its label; "Caution: Federal Law prohibits dispensing
without a prescription".
1962 Kefauver-Harris Amendment - {Answer }-Requires drug manufacturers to provide proof of safety
and effectiveness before marketing a drug.
1970 Poison Prevention Packaging Act - {Answer }-requires childproof packaging on all controlled and
most prescription drugs dispensed by pharmacies
1970 Controlled Substances Act (CSA) - {Answer }-The CSA classifies drugs that may be easily abused and
restricts their distribution. It is enforced by the Drug Enforcement Administration (DEA) within the
Justice Department.
1990 Omnibus Budget Reconciliation Act (OBRA) - {Answer }-among other things this act required
pharmacists to offer counseling to medicaid patients regarding medications ,effectively putting the
common practice into law
HIPAA (Health Insurance Portability and Accountability Act) - {Answer }-Provided broad and stringent
regulations to protect patients' privacy.
Placebo - {Answer }-inactive substances, not real medications, that are used to test the effectiveness of
drugs.
new drugs - {Answer }-All new drugs, whether made domestically or imported, require FDA approval
before they can be marketed in the United States.
, clinical tests - {Answer }-Tests on proposed new drugs (investigational drugs) are "controlled" by
comparing the effect of a proposed drug on one group of patients with the effect of a different
treatment on other patients.
blind tests - {Answer }-Patients in a trial are always "blind" to the treatment, i.e., they are not told which
control group they are in. In a "double-blind" test, neither the patients nor the physicians know what the
medication is.
patent protection - {Answer }-patent for a new drug gives its manufacturer an exclusive right to market
the drug for a specific period of time under a brand name.a drugs patent is in effect for 17 years from the
date of the drugs discovery.The Hatch-Waxman act of 1984 provided for up to five year extensions of
patent protection toe the patent holders to make up for time lost while products went through the FDA
approval process
Generics - {Answer }-Once a patent for a brand drug expires, other manufacturers may copy the drug and
release it under its pharmaceutical or "generic" name.
product labeling - {Answer }-In addition to a container label, manufacturers' prescription drugs must be
accompanied by product labeling that can include package inserts and MedGuides.
prescription drug labels - {Answer }-The minimum requirements on prescription labels for most drugs are
as follows: name and address of dispenser, prescription serial number, date of prescription or filling,
name of prescriber, name of patient, directions for use, and cautionary statements.
NDC (National drug Code) number - {Answer }-The number assigned by the manufacturer. Each NDC
number has three parts, or sets, of numbers: ---first set of numbers indicates the manufacturer;
--second set of numbers indicates the medication, its strength, and dosage form;
--third set (last set) indicates the package size.
controlled substances - {Answer }-drugs that have the potential for abuse and dependency, both physical
and psychological
Controlled classifications - {Answer }-Manufacturers must clearly label controlled drugs with their control
classification
DEA number - {Answer }-A registration number assigned to physicians by the Drug Enforcement
Administration for prescribing or dispensing controlled drugs
DEA number formula - {Answer }-(1st + 3rd + 5th) + 2 (2nd + 4th + 6th) = last digit is last digit of DEA #
risks of approved drugs - {Answer }-There is always the risk that an approved drug may produce adverse
side effects when used on a larger population.
Drug recalls are broken down into ____ classifications - {Answer }-3
MedWatch - {Answer }-fda reporting program for health care professionals to report adverse effects that
occur from the use of an approved drug or other medical product
Criminal Law - {Answer }-Laws pertaining to a wrong to society.
Ethics (Defined and elaborated) A+
Verfied Answer!!
Food and Drug Administration (FDA) - {Answer }-a federal agency charged with enforcing regulations
against selling and distributing adulterated, misbranded, or hazardous food and drug products.
Drug Enforcement Administration (DEA) - {Answer }-the agency that controls the distribution of drugs
that may be easily abused
Food and Drug Act of 1906 - {Answer }-Prohibited interstate commerce in adulterated or misbranded
food, drinks, and drugs. Government pre-approval of drugs is required.
1938 Food, Drug and Cosmetic Act (FDC) - {Answer }-in response the fatal poisoning of 107 people
primarily children by and untested sulfanilamide concoction this comprehensive law requires new drugs
be shown to be safe before marketing
1951 Durham-Humphrey Amendment - {Answer }-This law defines what drugs require a prescription by a
licensed practitioner and require the legend on its label; "Caution: Federal Law prohibits dispensing
without a prescription".
1962 Kefauver-Harris Amendment - {Answer }-Requires drug manufacturers to provide proof of safety
and effectiveness before marketing a drug.
1970 Poison Prevention Packaging Act - {Answer }-requires childproof packaging on all controlled and
most prescription drugs dispensed by pharmacies
1970 Controlled Substances Act (CSA) - {Answer }-The CSA classifies drugs that may be easily abused and
restricts their distribution. It is enforced by the Drug Enforcement Administration (DEA) within the
Justice Department.
1990 Omnibus Budget Reconciliation Act (OBRA) - {Answer }-among other things this act required
pharmacists to offer counseling to medicaid patients regarding medications ,effectively putting the
common practice into law
HIPAA (Health Insurance Portability and Accountability Act) - {Answer }-Provided broad and stringent
regulations to protect patients' privacy.
Placebo - {Answer }-inactive substances, not real medications, that are used to test the effectiveness of
drugs.
new drugs - {Answer }-All new drugs, whether made domestically or imported, require FDA approval
before they can be marketed in the United States.
, clinical tests - {Answer }-Tests on proposed new drugs (investigational drugs) are "controlled" by
comparing the effect of a proposed drug on one group of patients with the effect of a different
treatment on other patients.
blind tests - {Answer }-Patients in a trial are always "blind" to the treatment, i.e., they are not told which
control group they are in. In a "double-blind" test, neither the patients nor the physicians know what the
medication is.
patent protection - {Answer }-patent for a new drug gives its manufacturer an exclusive right to market
the drug for a specific period of time under a brand name.a drugs patent is in effect for 17 years from the
date of the drugs discovery.The Hatch-Waxman act of 1984 provided for up to five year extensions of
patent protection toe the patent holders to make up for time lost while products went through the FDA
approval process
Generics - {Answer }-Once a patent for a brand drug expires, other manufacturers may copy the drug and
release it under its pharmaceutical or "generic" name.
product labeling - {Answer }-In addition to a container label, manufacturers' prescription drugs must be
accompanied by product labeling that can include package inserts and MedGuides.
prescription drug labels - {Answer }-The minimum requirements on prescription labels for most drugs are
as follows: name and address of dispenser, prescription serial number, date of prescription or filling,
name of prescriber, name of patient, directions for use, and cautionary statements.
NDC (National drug Code) number - {Answer }-The number assigned by the manufacturer. Each NDC
number has three parts, or sets, of numbers: ---first set of numbers indicates the manufacturer;
--second set of numbers indicates the medication, its strength, and dosage form;
--third set (last set) indicates the package size.
controlled substances - {Answer }-drugs that have the potential for abuse and dependency, both physical
and psychological
Controlled classifications - {Answer }-Manufacturers must clearly label controlled drugs with their control
classification
DEA number - {Answer }-A registration number assigned to physicians by the Drug Enforcement
Administration for prescribing or dispensing controlled drugs
DEA number formula - {Answer }-(1st + 3rd + 5th) + 2 (2nd + 4th + 6th) = last digit is last digit of DEA #
risks of approved drugs - {Answer }-There is always the risk that an approved drug may produce adverse
side effects when used on a larger population.
Drug recalls are broken down into ____ classifications - {Answer }-3
MedWatch - {Answer }-fda reporting program for health care professionals to report adverse effects that
occur from the use of an approved drug or other medical product
Criminal Law - {Answer }-Laws pertaining to a wrong to society.
