question
Statutory law
answer
Proposed and created by the legislative branch, signed by the executive branch
question
Administrative law
answer
Laws proposed and enforced by administrative agencies
question
Common law
answer
Laws developed from previous judicial opinions/rulings; based on the "stare decisis" principle
question
T/F: If state and federal laws conflict, we must follow the federal law.
answer
TRUE: federal law always supersedes state law (federal preemption)
question
Vaccine Act (1813)
answer
1st federal endorsement of medical practice in US history
question
Import Drug Act (1848)
answer
1st federal drug law - addressed purity of drugs imported into US
question
Pure Food and Drug Act (1906)
answer
Prohibits the manufacture, sale, or transportation of adulterated, misbranded, poisonous, or deleterious foods, liquors, drugs, and medicines
question
Sherley Amendment (1912)
answer
Prohibits false/fraudulent efficacy claims.
question
Harrison Narcotic Act (1914)
answer
Increased record-keeping requirements and req. narcotic manufacturers, sellers, and distributors to register
question
Food, Drug, and Cosmetic Act (FDCA) (1938)
answer
-No new drug can be marketed until proven SAFE
-Established FDA: all new drugs must be approved by them
-Labels required to contain adequate directions for use and info a/b habit-forming properties
-Established FDA: all new drugs must be approved by them
-Labels required to contain adequate directions for use and info a/b habit-forming properties
question
T/F: The FDCA requires drugs to be proven safe and effective before they can be approved.
answer
FALSE: only SAFETY needs to be proven
question
Durham-Humphrey Amendment (1951)
answer
Established Rx and OTC categories
question
Under the Durham-Humphrey Act, (OTC/Rx) drugs must contain proper instructions on the label.
answer
OTC: Rx-only drugs don't need to contain adequate instructions b/c it's assumed the physician will counsel the patient on proper use
question
What law required the statement "Caution: federal law prohibits dispensing without Rx" on manufacturer labels?
answer
Durham-Humphrey Amendment
question
Food Additives Amendment (1958)
answer
Food additives must be FDA-approved unless generally recognizable as safe
question
Color Additives Amendment (1960)
answer
Color additives for food and cosmetics must be FDA-approved and must be listed on labels
question
Kefauver-Harris Amendment (1962)
answer
Required drugs to be proven safe AND effective before approval
question
What amendment established cGMP?
answer
Kefauver-Harris Amendment --> FDA required to regularly inspect manufacturing production facilities
question
What amendment gave the FDA jurisdiction over drug advertising?
answer
Kefauver-Harris Amendment
question
The FDCA was passed in response to what?
answer
1937 sulfa antibiotic tragedy
question
The Kefauver-Harris amendment was passed in response to what?
answer
Thalidomide tragedies
question
Poison Prevention Packaging Act (1970)
answer
Required child-resistant packaging for common household chemicals and drugs
question
Who enforces the Poison Prevention Packaging Act?
answer
Consumer Product Safety Commission
question
Comprehensive Drug Abuse Prevention and Control Act: Title I
answer
Establishment of rehab programs for drug abusers
question
Comprehensive Drug Abuse Prevention and Control Act: Title II
answer
Registration and distribution of controlled substances
-Created drug schedules
-Requires pharmacies dispensing controlled substances to register w/ the FDA
-Created drug schedules
-Requires pharmacies dispensing controlled substances to register w/ the FDA
question
Comprehensive Drug Abuse Prevention and Control Act: Title III
answer
Regulates importation and exportation of controlled substances
question
Who is responsible for enforcing the Comprehensive Drug Abuse Prevention and Control Act?
answer
DEA
question
Drug Listing Act (1972)
answer
Drug manufacturers and compounders must provide the FDA w/ a current list of everything they make
question
What law created the NDC requirement?
answer
Drug Listing Act
question
Medical Device Amendment (1976)
answer
Medical devices must be FDA approved
question
Federal Anti-Tampering Act (1982)
answer
Tampering with consumer products is a FEDERAL OFFENSE and established federal guidelines on tamper-evident packaging for OTCs
question
What products are exempt from requiring tamper-evident packaging?
answer
Skin products, insulin, toothpaste
question
Orphan Drug Act (1983)
answer
Incentivizes manufacturers to develop/market drugs for rare diseases and conditions
question
Drug Price Competition and Patent Term Act Restoration Act (1984)
answer
AKA Waxman-Hatch Amendment
Streamlines generic drug approval process via ANDA
Streamlines generic drug approval process via ANDA
question
How long does a manufacturer making the 1st generic for a drug have exclusivity?
answer
180 days
question
Prescription Drug Marketing Act (1987)
answer
Established restrictions for Rx drug samples and bans the sale of sample drugs
question
Nutrition Labeling Education Act (1990)
answer
Required nutrition labeling and regulates health claims
question
Omnibus Budget Reconciliation Act (OBRA) (1990)
answer
Requires RPh to perform drug utilization review (DUR) and counseling for all Medicaid beneficiaries
question
Prescription Drug User Fee Act (PDUFA) (1992)
answer
Established fees for NDA submission to help fund FDA
question
Dietary Supplement Health and Education Act (DSHEA) (1994)
answer
Defines dietary supplements
question
Dietary supplements are regulated more like (food/drugs).
answer
Food
question
T/F: Dietary supplements require FDA approval before they can be marketed.
answer
FALSE
question
Health Insurance Portability and Accountability Act (HIPAA) (1996)
answer
Established national standards to protect PHI
question
Who enforces HIPAA?
answer
DHHS
question
Food and Drug Administration Modernization Act (FDAMA) (1997)
answer
-Streamlines regulatory process to make it faster to approve new drugs
-Encouraged pediatric studies for drugs
-Encouraged pediatric studies for drugs
question
According to FDAMA, regulation of compounding is done at the (federal/state) level.
answer
State
question
T/F: Manufacturers preparing to file an SNDA may disseminate peer-reviewed articles for off-label uses of existing drugs.
answer
TRUE: Must notify FDA 60 days before release, and article must state that uses have not been FDA approved yet.
question
Drug Addiction Treatment Act (DATA) (2000)
answer
Permitted physicians to prescribe controlled substances to treat opioid dependence outside of a methadone clinic
question
What began the MTM process?
answer
Passage of Medicare part D
question
FDA Amendments Act (2007)
answer
-Reauthorized PDUFA, MDUFA, etc. to provide FDA funding
-Implemented REMS
-Implemented REMS
question
Biologics Price Competition and Innovation Act (2009)
answer
Allows biosimilars to be approved w/o full preclinical and clinical data
question
Patient Protection and Affordable Care Act (2010)
answer
-Everyone needs insurance
-Can't charge more for pre-existing conditions
-Free preventative care
-Can't charge more for pre-existing conditions
-Free preventative care
question
Physician Payment Sunshine Act
answer
Requires manufacturers of drugs and medical devices to report payments to physicians and teaching hospitals
question
FDA Safety and Innovation Act (2012)
answer
Re-authorizes PDUFA and implemented GDUFA and BsUFA
Allows FDA to audit foreign drug manufacturers
Allows FDA to audit foreign drug manufacturers
question
Drug Quality and Security Act: Title I
answer
Compounding quality act - strengthens FDA oversight of large-scale compounding facilities and established 503B pharmacy regulations
question
Drug Quality and Security Act: Title II
answer
Drug supply chain security act - trace entire distribution of pharmaceuticals via electronic system (not implemented yet)
question
DQSA was passed in response to what?
answer
NECC incident
question
Pregnancy and Lactation Labeling Final Rule (2014)
answer
Eliminates letter risk categories for drugs during preg/lactation in favor of "risk summaries" which provide more information to clinicians
question
Comprehensive Addiction and Recovery Act (2016)
answer
Allows RPh to partially fill C-II
question
21st Century Cures Act (2016)
answer
Modernized clinical trials
question
What law established that RF can be called in by HCPs?
answer
Durham-Humphrey Amendment
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