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US Pharmaceutical Laws and Regulations
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1
Question
What was the primary purpose of the 1906 Pure Food & Drug Act?
Answer
Required drugs and foods to meet purity standards
2
Question
How did the 1914 Harrison Narcotic Act regulate substances?
Answer
Regulated narcotics including opium, marijuana, and synthetic agents
3
Question
What key definitions did the 1938 Federal Food, Drug, & Cosmetic Act introduce?
Answer
Defined adulteration and misbranding; required proof of safety
4
Question
What distinction did the 1951 Durham-Humphrey Amendment create?
Answer
Distinguished prescription drugs from OTC drugs; introduced 'Legend Caution'
5
Question
What labeling requirement came from the 1960 Federal Hazardous Substances Act?
Answer
Required hazard labeling on products
6
Question
What did the 1962 Kefauver-Harris Amendment mandate for FDA approval?
Answer
Required proof of both safety and efficacy
7
Question
What packaging standard was set by the 1970 Poison Prevention Packaging Act?
Answer
Required child-resistant containers
8
Question
How did the 1970 Controlled Substances Act organize drug regulation?
Answer
Created Schedules I–V; restricted transfers of controlled substances
9
Question
What workplace protections did the 1970 OSHA Act provide?
Answer
Ensured safe working conditions in pharmacies and healthcare
10
Question
What identification system was required by the 1972 Drug Listing Act?
Answer
Required National Drug Code (NDC) for drugs
11
Question
What did the 1976 Medical Device Amendment regulate?
Answer
Regulated safety of medical devices
12
Question
What packaging change resulted from the 1982 Anti-Tampering Act?
Answer
Required tamper-proof packaging for drugs
13
Question
How did the 1983 Orphan Drug Act support rare disease treatments?
Answer
Provided incentives for developing drugs for rare diseases
14
Question
What issue did the 1987 Prescription Drug Marketing Act address?
Answer
Prevented drug diversion from legitimate channels
15
Question
What patient services were mandated by OBRA-90 in 1990?
Answer
Required counseling and drug utilization review (DUR) for Medicaid patients
16
Question
How did the 1990 Anabolic Steroids Control Act classify steroids?
Answer
Classified anabolic steroids as Schedule III controlled substances
17
Question
What classification did the 1994 Dietary Supplement Health & Education Act apply?
Answer
Classified dietary supplements as food, not drugs
18
Question
What patient data protections were established by HIPAA in 1996?
Answer
Protected health information (PHI) from unauthorized disclosure
19
Question
What labeling update came from the 1997 FDA Modernization Act?
Answer
Changed legend to 'Rx Only' from 'Caution: Federal law prohibits dispensing without prescription'
20
Question
What prescribing flexibility did the 2000 Drug Addiction Treatment Act provide?
Answer
Allowed waivers for prescribers treating opioid addiction
21
Question
What Medicare benefit was created by the 2003 Medicare Modernization Act?
Answer
Created Medicare Part D for prescription drug coverage
22
Question
What sales restrictions did the 2005 Combat Meth Act impose?
Answer
Regulated sales of pseudoephedrine to combat methamphetamine production
23
Question
What reporting did the 2005 Patient Safety Act encourage?
Answer
Encouraged reporting of adverse drug events
24
Question
What tobacco regulations were enacted by the 2009 Tobacco Control Act?
Answer
Regulated tobacco sales and marketing, including age restrictions
25
Question
What supply chain measure was introduced by the 2013 Drug Supply Chain Security Act?
Answer
Implemented 'Track and Trace' to prevent counterfeit drugs
26
Question
What role does The Joint Commission (TJC) play in healthcare?
Answer
Accredits healthcare organizations and sets safety/quality standards
27
Question
What workplace safety duties does OSHA enforce in pharmacies?
Answer
Ensures safe working conditions and requires hazard communication
28
Question
What are the FDA's primary responsibilities for pharmaceuticals?
Answer
Approves and monitors drugs, devices, enforces labeling, and issues recalls
29
Question
How does the DEA regulate controlled substances?
Answer
Enforces laws, determines drug scheduling, and oversees distribution
30
Question
What advertising oversight does the FTC provide for OTC products?
Answer
Regulates OTC advertising and ensures fair business practices