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Ch2 Table2.1
Well Known Federal Food and Drug Laws
| Year | Law | cause for/ changes in law |
|---|---|---|
| 1906 | Pure Food and Drug Act | - required to have truthful label before selling |
| 1912 | International Opium Convention | - meeting to curb the increase in trafficking of highly addictive substances |
| 1914 | Harrison Narcotics Act | - enacted in US to curb the recreational use of opium |
| 1938 | Federal Food, Drug and Cosmetic Act | - enacted becausethe Pure Food and Drug Act of 1906 was not worded strictly enough and didnt include cosmetics -"Warning: May be habit forming" -introduced adulteration and misbranding |
| 1951 | Durham - Humphry Amendment | -required labeling "Caution: Federal law prohibits despensing without a prescription" -added more instructions for drug companies |
| 1962 | Kefauver - Harris Amendments (thalidomide disaster) | - helped establish rules of clinical drug investigation -required informed consent of study subjects - required that drug-related adverse events be reported to FDA |
| 1970 | Comprehensive Drug Abuse Prevention and Control Act (AKA Controlled Substance Act) | -DEA: enforced laws concerning controlled substances & distribution -5 stair-step schedule of controlled substances, based on drugs intended medical use, propensity of drug to be abused and safety/dependency concerns |
| 1972 | Drug Listing Act | -National Drug Code (NDC) was implemented under the authority of the FDA |
| 1983 | Orphan Drug Act (ODA) | - encouraged drug companies to develop drugs for rare diseases by providing research assistance, grants, and cost incentives to manufactures |
| 1987 | Prescription Drug Marketing Act | - addressed issues related to the distributions and wholesale pedigree of human prescription drugs |
| 1990 | Anabolic Steroids Control Act | - because of anabolic steroid misuse by athletes, this act helps enforce regulations on abuse |
| 1994 | Dietary Supplement Health and Education Act (DSHEA) | - this act better defines the term 'dietary supplements' to include herbs. -labels cannot be mislead and must include nutritional values |
| 1996 | Health Insurance Portability and Accountability Act of 1996 (HIPPA)(HIPAA) | -meant to protect certain health information -PHI protected health info |
| 2000 | Drug Addiction Treatment Act (DATA 2000) | - permits physicians to prescribe controlled substances (preapproved by DEA) to individuals with opioid addiction for the purpose of maintenance/detoxification treatments |
| 2003 | Medicare Modernization Act (MMA) | - provided a drug discount card to beneficiaries with low incomes who require pharmacy company assistance for obtaining medications |
| 2005 | Combat Methamphetamine Epidemic Act (CMEA) | - response to AVOID selling pseudoephedrine OTC because of the misuse |
| 2006 | Dietary Supplement and Non-Prescription Drug Consumer Protection Act | -pres. G. Bush -introduced safety reporting for dietary supplements and nonprescription drugs |
| 2010 | The Patient Protection and Affordable Care Act (ACA) | -makes preventive care more accessible and affordable for many Americans |
| 2013 | The Drug Quality and Security Act (DQSA) | - comprises two separate acts: the Compounding Quality Act and the Drug Supply Chain Security Act |
| 1902 | Biologics Act of 1902 | - first fed law to regulate biological products (vaccines) in response to public health crisis caused by contaminated medical products |
| 1987 | Obra '87 Federal Nursing Home Reform Act | - set requirements for facilities participating in Medicare and Medicaid programs and addressed enforcement mechanisims |
| 1970 | Poison Prevention Packaging Act | - required maufacturers and pharmacies to place all medications in containers with childproof caps or packaging |
| 1990 | Omnibus Budget Reconciliation Act (OBRA '90) | - affected the responsibilities of practicing pharmacists and health care personnel in general -states that a pharmacist must offer counsel -also requires drug utilization evaluation (DUE) |
Created by:
yeilxy