11906 - Original Food and Drugs Act
banned interstate selling of adulterated or mislabeled food/drugs
21914 - Harrison Narcotic Act
- requires prescriptions for narcotics (only)
- 1st time gov requires written prescription for any drug
31938 - Federal Food, Drug and Cosmetic Act (FDC)
- drugs must prove safety
- resulted bc anti-freeze found in meds (sulfanilamide) killed many kids
41951 - Durham- Humphrey Amendment
separated drugs into 2 classes: prescription and OTC
51962 - Kefauver-Harris Drug Amendment
- drugs must be effective and safe
- resulted from thalidomide birth defects
61983 - Orphan Drug Act
- gave manufacturers financial incentives to create meds for rare diseases
- resulted bc HIV was discovered but no company cared enough to make treatment
71984 -Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act)
- established modern system of generic drug regulation in the US
- goal was to encourage development of new meds and accelerate market entry of generics
81992 - Prescription Drug User Fee Act (PDUFA)
- requires manufacturers to pay a fee for FDA approval applications
- money is used to fund drug approval process
91993 - Omnibus Budget Reconciliation Act (OBRA-93)
- 1st time pharmacies are required to counsel pt’s
- fed can only require counseling for Medicaid pt’s
- state gov can opt in and require counseling for all pt’s
101996 - Health Insurance Portability and Accountability Act (HIPAA)
- guidelines to protect healthcare info from fraud and theft
- providers can’t disclose pt info to anyone other than pt and their authorized representatives without their consent
112010 - Secure and Responsible Drug Disposal Act
- installed a secure container for disposing controlled substances in pharmacies
- only for C2-C5 and non-controlled substances (no C1 or illegal drugs)
122007 - Food and Drug Administration Amendments Act
- established the Risk Evaluation and Mitigation Strategy (REMS)
- REMS = drug safety programs for meds with serious risks that require special monitoring
132009 - Family Smoking Prevention and Tobacco Control Act
FDA can now regulate tobacco
142013 - Drug Quality and Security Acts
- gave FDA more authority to regulate/monitor manufacturing of compounded drugs
- included DSCSA and CQA
152013 - Drug Supply Chain Security Act (DSCSA)
- regulated delivery of drugs btwn manufacturing and dispensing location
- resulted bc packages sometimes get stuff added/stolen before reaching pharmacy
162013 - Compounding Quality Act (CQA)
- FDA regulation of compounded drugs
- Resulted bc large compounder had unclean environ, caused fungal infection in lidocaine for spinal injection and lead to meningitis
172016 - 21st Century Cures Act
medical devices are added to FDA regulation to be approved faster
182023 - Food and Drug Omnibus Reform Act (FDORA)
drug companies are required to test their drug in diverse populations (not just young white men)
192010 - Secure and Responsible Drug Disposal Act
installed a secure container for disposing C2-5 and non-C substances in pharmacies
20Medication Access and Training Expansion Act (MATE)
- Congress-mandated training requirements for DEA registered healthcare practitioners who prescribe controlled substances
- one-time 8 hrs training
212024 - Title 42 Code of Federal Regulations Part 8
- improved access by removing some barriers to buprinorphine and methadone treatment (for opioid use disorder)
- pt’s don’t need inpatient treatment beforehand, telehealth visits are allowed
222005 - Methamphetamine Epidemic Act
- extra steps to reduce theft of ephedrine, pseudoephedrine, etc
- must be locked in cabinet behind counter
- must check buyer’s ID
- maintain log of each sale for 2 yrs
- limit quantities (does not apply to single sales packages less than 60mg pseudo sold within one day)