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Pharmacy Law
| Term | Definition |
|---|---|
| Pure Food and Drug Act (1906) | Required drugs to meet purity and strength standards |
| Federal Food, Drug, Cosmetic Act (1938) | New drugs cleared for safety before distributed |
| Durham – Humphrey Amendments (1951) | Created 2 classes of drugs |
| Kefauver Harris Amendments (1962) | Required new drugs to be proven safe and effective for claimed use |
| Drug Abuse Control Amendments (1965) | Laid the groundwork for Federal Controlled Substances Act of 1970 |
| Medical Device Amendment (1976) | Safety and effectiveness of medical devices |
| Orphan Drug Act (1983) | Created because there was no drug to treat rare illnesses |
| Drug Price Competition and Patent Restoration Act (Hatch-Waxman) (1983) | Created ANDA (Abbreviated New Drug Application) for generics |
| Prescription Drug Marketing Act (PDMA) (1987) | Prevents drug diversion and counterfeiting by prohibiting reimporting Rx drugs, selling/trading samples, reselling hospital-purchased Rx, counterfeiting Rx coupons, and reselling Rx donated to charities. |
| FDA Modernization Act (FDAMA) (1997) | Updated drug laws by changing labels to “Rx Only” and clarifying compounding vs manufacturing. |
| Food and Drug Administration Amendments Act (2007) | Established REMS (Risk Evaluation and Management Strategies) |
| Biologics Price Competition and Innovation Act (2009) | Established abbreviated path for biological drugs that are “biosimilar” and may be “interchangeable” to FDA licensed biologicals |
| FDA Safety and Innovation Act (FDASIA) (2012) | Improved authority and funds for foreign facility inspections |
| Drug Quality and Security Act (DQSA) (2013) | Title 1: Compounding Quality Act and Title 2: “track and trace” system for drug supply chain |
| Federal Hazardous Substances Act (1996) | Household products (NOT drugs) |
| Federal Hazardous Communication Standard | Classify hazards of chemicals (SDS sheet); Nonexempt drugs (USP 800) |
| Poison Prevention Packaging Act of 1970 (PPPA) | Requires child resistant container for Rx drugs and certain OTC drugs |
| Omnibus Budget Reconciliation Act of 1990 (OBRA-90) | Mandated pharmacists to do patient counseling, drug use review |
| Public Health Readiness and Emergency Preparedness Act (PREP) | Expanded authority of pharmacists, internsvand pharmacy technicians to provide COVID-19 vaccines, flu vaccines, and COVID-19 tests and therapeutics |
| Health Insurance Portability and Authorization Act of 1996 (HIPPA) | Protects patient health information (PHI) by setting rules for privacy, security, and permitted disclosures. |
Created by:
aleeciagene