Pharmacy Laws Overview - Pass your Pharm Tech Exam скачать в хорошем качестве

Pharmacy Laws Overview - Pass your Pharm Tech Exam

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)