NURSING JURISPRUDENCE AND ETHICS
FOR TEXAS NURSES EXAMINATION TEST
2026 FULL QUESTIONS AND ACCURATE
SOLUTIONS GRADED A+
⩥ Food, Drug, and Costmetic Act of 1938. Answer: - Enacted due to
sulfanilamide accident
- Must be SAFE when using directions on label
- Cosmetics and medical devices included
- Drugs before 1938 grandfathered in (levothyroxine, digoxin, etc)
⩥ Durham-Humphrey Amendment of 1951. Answer: - Created legend
drugs (Rx Only) and OTC
⩥ Kefauver-Harris Amendment of 1962. Answer: - Efficacy Amendment
- FTC in charge of OTC medication advertising
- Added informed consent for GMPs
⩥ Medical Device Amendment of 1976. Answer: Better classification
and regulation of medical devices
,⩥ Federal Anti-Tampering Act 1982. Answer: Tamper evident packaging
required for OTC drugs, label must indicate it is tamper evident
⩥ Ophan Drug Act 1983. Answer: Incentives for creating drugs for rare
diseases affecting <200,000 people in the US
⩥ Drug Price Competition and Patent Term Restoration Act 1984.
Answer: AKA Hatch-Waxman Amendment
Created ANDA for generic medication approval (only bioequivalence
proof needed), brand name mfgs get 5 years added to patent
⩥ Prescription Drug Marketing Act of 1987. Answer: - Stricter
regulations on drug product and sample distribution
- Banned sale, trade, or purchase of drug samples
- Barred retail pharmacies from recieving drug samples (must instead
use vouchers/coupons)
⩥ FDA Modernization Act of 1997. Answer: New NDA Fast Track
- Expidited approval of drugs for serious conditions
- Clarified some compounding regulations
- The term "Rx only" replaced old language
- "Warning - may be habit forming" language eliminated
- Encouraged supplemental NDAs
, ⩥ Medicare Part A. Answer: Hospitalization insurance
⩥ Medicare Part B. Answer: Physician services and some pharmacy
stuff
⩥ Medicare Part C. Answer: Medicare advantage
⩥ Medicare Part D. Answer: Prescription medications
- Can not force patients to use mail order, must allow 90 day supplies
- MTM
⩥ USP/NF. Answer: Not made by the government, includes monographs
for recognized drugs with quality standards
⩥ Investigational New Drug Application (IND). Answer: After animal
studies, you submit IND to FDA before you can begin human trials;
FDA has 30 days to approve or decline the IND
⩥ Phase 1 Clinical Trial. Answer: - Healthy subjects
- Evaluate safety & drug properties
- Small sample size
⩥ Phase 2 Clinical Trial. Answer: - Subjects with the disease
FOR TEXAS NURSES EXAMINATION TEST
2026 FULL QUESTIONS AND ACCURATE
SOLUTIONS GRADED A+
⩥ Food, Drug, and Costmetic Act of 1938. Answer: - Enacted due to
sulfanilamide accident
- Must be SAFE when using directions on label
- Cosmetics and medical devices included
- Drugs before 1938 grandfathered in (levothyroxine, digoxin, etc)
⩥ Durham-Humphrey Amendment of 1951. Answer: - Created legend
drugs (Rx Only) and OTC
⩥ Kefauver-Harris Amendment of 1962. Answer: - Efficacy Amendment
- FTC in charge of OTC medication advertising
- Added informed consent for GMPs
⩥ Medical Device Amendment of 1976. Answer: Better classification
and regulation of medical devices
,⩥ Federal Anti-Tampering Act 1982. Answer: Tamper evident packaging
required for OTC drugs, label must indicate it is tamper evident
⩥ Ophan Drug Act 1983. Answer: Incentives for creating drugs for rare
diseases affecting <200,000 people in the US
⩥ Drug Price Competition and Patent Term Restoration Act 1984.
Answer: AKA Hatch-Waxman Amendment
Created ANDA for generic medication approval (only bioequivalence
proof needed), brand name mfgs get 5 years added to patent
⩥ Prescription Drug Marketing Act of 1987. Answer: - Stricter
regulations on drug product and sample distribution
- Banned sale, trade, or purchase of drug samples
- Barred retail pharmacies from recieving drug samples (must instead
use vouchers/coupons)
⩥ FDA Modernization Act of 1997. Answer: New NDA Fast Track
- Expidited approval of drugs for serious conditions
- Clarified some compounding regulations
- The term "Rx only" replaced old language
- "Warning - may be habit forming" language eliminated
- Encouraged supplemental NDAs
, ⩥ Medicare Part A. Answer: Hospitalization insurance
⩥ Medicare Part B. Answer: Physician services and some pharmacy
stuff
⩥ Medicare Part C. Answer: Medicare advantage
⩥ Medicare Part D. Answer: Prescription medications
- Can not force patients to use mail order, must allow 90 day supplies
- MTM
⩥ USP/NF. Answer: Not made by the government, includes monographs
for recognized drugs with quality standards
⩥ Investigational New Drug Application (IND). Answer: After animal
studies, you submit IND to FDA before you can begin human trials;
FDA has 30 days to approve or decline the IND
⩥ Phase 1 Clinical Trial. Answer: - Healthy subjects
- Evaluate safety & drug properties
- Small sample size
⩥ Phase 2 Clinical Trial. Answer: - Subjects with the disease
