KS MPJE Review
Labeling requirements for OTC Drugs - ANSWER-"Adequate directions for use"
Labeling requirements for Rx Drugs - ANSWER-"Adequate information for use"
Kefauver-Harris Amendments of 1962 - ANSWER-Focused on safety AND efficacy
Impacts all drugs after 1962 and new drugs with an NDA approved since 1938
Established effectiveness as a standard
Established Good Manufacturing Practices (GMP)
Transfered jurisdiction of Rx advertising from FTC to FDA
Drug Efficacy Study Implementation (DESI) - ANSWER-established ANDA process
(abbreviated new drug application for generics)
Deals with the efficacy of drugs marketed between 1938-1962
Pure Food and Drug Act of 1906 - ANSWER-Focused on Purity and Quality
Prohibited the interstate transfer of adulterated or misbranded drugs
Recognized USP/NF Standards
Food, Drug, and Cosmetic Act of 1938 - ANSWER-Focused on Safety
New drug cannot be marketed until proven safe (drugs prior to 1938 were exempt)
Power given to Congress via authority over interstate commerce
Durham-Humphrey Amendment of 1951 - ANSWER-Established 2 classes of drugs: Rx
and OTC
Established provisions for dispensing prescription drugs
Established labeling requirements for OTC and prescription drugs
Established use of NDC numbers
Medical Device Amendment of 1976 - ANSWER-Classification of all devices into 3
classes based on the degree of control necessary to assue safety and effectiveness;
most regulated are class 3
Class 3 Medical Device - ANSWER-one that supports or sustains human life or is of
substantial importance in preventing impairment of human health or presents a
potential, unreasonable risk of illness or injury
New Drug Application (NDA) - ANSWER-Used if new drug is a newly discovered
chemical or for an established drug offered in a new dosage form, with ne therapeutic
claims, in new dosage levels, or for a different patient population
Abbreviated New Drug Application (ANDA) - ANSWER-approval to market a generic
IND - ANSWER-investigational new drug
Supplemental New Drug Application (sNDA) - ANSWER-application to allow a company
to make changes to a product that already has an approved NDA. CDER must approve
all changes to ensure that conditions originally set for the product are still met
FDA Clinical Trials Phase 1 - ANSWER-Small number of patients (20-80)
Evaluates safety
Determines safe dosage range
Identifies side effects
FDA Clinical Trials Phase 2 - ANSWER-Small number of patients with condition (100-
300)
, Establishes testing protocol
Establishes if drug is effective
Further evaluates safety
FDA Clinical Trials Phase 3 - ANSWER-1000-3000 patients in a clinical setting
Usually double-blinded
Confirms effectiveness
Monitors side effects
Compares to commonly used treatments
FDA Clinical Trials Phase 4 - ANSWER-Post-marketing surveillance
Dietary Supplement Health and Education Act of 1994 (DSHEA) - ANSWER-Defined
dietary supplements as foods rather than drugs and limited FDA's role in regulatioin
Burden is on FDA to probe lack of safety prior to removal from market
Defined specific claims manufacturers can make
Dietary supplement (also know as food or nutritional supplement) - ANSWER-a
preparation intended to supplement the diet and provide nutrients (such as vitamins,
minerals, fiber, fatty acids, or amino acids) that may be missing or may not be
consumed in sufficient quantities in a person's diet
Must contain disclaimer that FDA has not evaluated and is not intended to "diagnose,
treat, cure, or prevent any disease"
Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act) -
ANSWER-Granted pharmaceutical manufacturers incentives by granting some market
exclusivity
Increased availability of generics
Required FDA to publish an up-to-date list of all Rx and OTC drugs approved for safety
and efficacy (The Orange Book)
Medicare Prescription Drug, Improvement, and Modernization Act of 2003 - ANSWER-
Added Part D (prescription drug benefit) to Medicare
Provision for MTM
Required development and implementation of standard for e-prescribing
Permits importation of Rx drugs from Canada if HHS Secretary certifies safety
Tamper Resistant Prescription Pads - ANSWER-Required for Medicaid outpatient
scripts as of 2008
Enacted as a fraud reducing measure
Must contain features to prevent copying, erasure or modifcation, and the use of
counterfeit forms
Omnibus Reconciliation Act of 1990 (OBRA 90) - ANSWER-First fedeal law to directly
address pharmacy practice standards
Establised a federal policy requiring DUR (prospective instead of retrospective)
Established standards of practice for pharmacists as a condition of participating in
Medicaid program
Rebates from "best price" go back to state Medicaid program
Health Insurance Portability and Accountability Act (HIPAA) - ANSWER-Notice of
privacy practices must be provided to patients
When PHI used for a purpose not associated with treatment, payment, or operations
(TPO) consent must be obtained
Labeling requirements for OTC Drugs - ANSWER-"Adequate directions for use"
Labeling requirements for Rx Drugs - ANSWER-"Adequate information for use"
Kefauver-Harris Amendments of 1962 - ANSWER-Focused on safety AND efficacy
Impacts all drugs after 1962 and new drugs with an NDA approved since 1938
Established effectiveness as a standard
Established Good Manufacturing Practices (GMP)
Transfered jurisdiction of Rx advertising from FTC to FDA
Drug Efficacy Study Implementation (DESI) - ANSWER-established ANDA process
(abbreviated new drug application for generics)
Deals with the efficacy of drugs marketed between 1938-1962
Pure Food and Drug Act of 1906 - ANSWER-Focused on Purity and Quality
Prohibited the interstate transfer of adulterated or misbranded drugs
Recognized USP/NF Standards
Food, Drug, and Cosmetic Act of 1938 - ANSWER-Focused on Safety
New drug cannot be marketed until proven safe (drugs prior to 1938 were exempt)
Power given to Congress via authority over interstate commerce
Durham-Humphrey Amendment of 1951 - ANSWER-Established 2 classes of drugs: Rx
and OTC
Established provisions for dispensing prescription drugs
Established labeling requirements for OTC and prescription drugs
Established use of NDC numbers
Medical Device Amendment of 1976 - ANSWER-Classification of all devices into 3
classes based on the degree of control necessary to assue safety and effectiveness;
most regulated are class 3
Class 3 Medical Device - ANSWER-one that supports or sustains human life or is of
substantial importance in preventing impairment of human health or presents a
potential, unreasonable risk of illness or injury
New Drug Application (NDA) - ANSWER-Used if new drug is a newly discovered
chemical or for an established drug offered in a new dosage form, with ne therapeutic
claims, in new dosage levels, or for a different patient population
Abbreviated New Drug Application (ANDA) - ANSWER-approval to market a generic
IND - ANSWER-investigational new drug
Supplemental New Drug Application (sNDA) - ANSWER-application to allow a company
to make changes to a product that already has an approved NDA. CDER must approve
all changes to ensure that conditions originally set for the product are still met
FDA Clinical Trials Phase 1 - ANSWER-Small number of patients (20-80)
Evaluates safety
Determines safe dosage range
Identifies side effects
FDA Clinical Trials Phase 2 - ANSWER-Small number of patients with condition (100-
300)
, Establishes testing protocol
Establishes if drug is effective
Further evaluates safety
FDA Clinical Trials Phase 3 - ANSWER-1000-3000 patients in a clinical setting
Usually double-blinded
Confirms effectiveness
Monitors side effects
Compares to commonly used treatments
FDA Clinical Trials Phase 4 - ANSWER-Post-marketing surveillance
Dietary Supplement Health and Education Act of 1994 (DSHEA) - ANSWER-Defined
dietary supplements as foods rather than drugs and limited FDA's role in regulatioin
Burden is on FDA to probe lack of safety prior to removal from market
Defined specific claims manufacturers can make
Dietary supplement (also know as food or nutritional supplement) - ANSWER-a
preparation intended to supplement the diet and provide nutrients (such as vitamins,
minerals, fiber, fatty acids, or amino acids) that may be missing or may not be
consumed in sufficient quantities in a person's diet
Must contain disclaimer that FDA has not evaluated and is not intended to "diagnose,
treat, cure, or prevent any disease"
Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act) -
ANSWER-Granted pharmaceutical manufacturers incentives by granting some market
exclusivity
Increased availability of generics
Required FDA to publish an up-to-date list of all Rx and OTC drugs approved for safety
and efficacy (The Orange Book)
Medicare Prescription Drug, Improvement, and Modernization Act of 2003 - ANSWER-
Added Part D (prescription drug benefit) to Medicare
Provision for MTM
Required development and implementation of standard for e-prescribing
Permits importation of Rx drugs from Canada if HHS Secretary certifies safety
Tamper Resistant Prescription Pads - ANSWER-Required for Medicaid outpatient
scripts as of 2008
Enacted as a fraud reducing measure
Must contain features to prevent copying, erasure or modifcation, and the use of
counterfeit forms
Omnibus Reconciliation Act of 1990 (OBRA 90) - ANSWER-First fedeal law to directly
address pharmacy practice standards
Establised a federal policy requiring DUR (prospective instead of retrospective)
Established standards of practice for pharmacists as a condition of participating in
Medicaid program
Rebates from "best price" go back to state Medicaid program
Health Insurance Portability and Accountability Act (HIPAA) - ANSWER-Notice of
privacy practices must be provided to patients
When PHI used for a purpose not associated with treatment, payment, or operations
(TPO) consent must be obtained
