Pharmacy Laws Overview - Pass your Pharm Tech Exam
Автор: Mr. Campbell's Classroom
Загружено: 2026-03-03
Просмотров: 9
Описание:
1. Pure Food and Drug Act
Prohibited misbranding and adulteration of drugs
Required accurate labeling
Foundation of modern drug regulation
2. Food, Drug, and Cosmetic Act (FD&C Act)
Required drugs to be proven safe before marketing
Gave authority to the Food and Drug Administration (FDA)
Regulates labeling, manufacturing, and distribution
3. Kefauver-Harris Amendment
Required proof of effectiveness (not just safety)
Strengthened clinical trial requirements
4. Controlled Substances Act (CSA)
Regulates narcotics and other controlled drugs
Created drug Schedules I–V
Enforced by the Drug Enforcement Administration (DEA)
5. Drug Enforcement Administration Diversion Control Program
Prevents diversion of controlled substances
Requires DEA registration for pharmacies and prescribers
6. Health Insurance Portability and Accountability Act (HIPAA)
Protects patient health information (PHI)
Ensures privacy and confidentiality
7. Omnibus Budget Reconciliation Act of 1990 (OBRA-90)
Requires pharmacists to:
Offer patient counseling
Perform drug utilization review (DUR)
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