Prohibits the interstate transportation or sale of adulterated and misbranded food or drugs
Food, Drug, and Cosmetic Act of 1938
Required that all new drug applications be filed with the FDA. Defined adulteration and misbranding.
Durham-Humphrey Act of 1951
Amendment to FDCA 1938 requiring all products to have adequate directions for use unless they contain the federal legend "Caution: Federal law prohibits despensing without a prescription."
Kefauver-Harris Amendment of 1962
Requires all medications in the US to be pure, safe, and effective.
Comprehensive Drug Abuse Prevention and Control Act of 1970
Controlled substances placed in one of five schedules
No accepted medical use in US; high potential for abuse. Ex. cocaine, meth, ecstasy, heroin, etc.
Has a medical use but has a high abuse potential with severe psychological or physical dependency. Ex. Adderall, Cocaine, Codeine, Percocet, etc. Ordered by completing DEA form 222 (valid for 60 days)
Has accepted medical use, and the abuse potential is lower.
Abuse potential is lower than other schedules, but administration may lead to limited physical or psychological dependence.
Abuse potential is low; schedule includes exempt narcotics.
Poison Prevention Act of 1970
Was enacted to reduce accidental poisoning in children. Requires many child-resistant containers.
Occupational Safety and Health Act (OSHA) of 1970
Ensures a safe and healthful workplace for all employees. Addresses air contaminants, flammable and combustible liquids, eye and skin protection, and hazard communication standards.
Drug Listing Act of 1971
Assigns an NDC number to each drug
National Drug Code - 11 digit drug number; first five digits identify the manufacturer, the next four digits identify the drug product, and the final two digits represent the package size and packaging.
Medications for treatment of diseases or conditions of which there are fewer than 200,000 cases in the world.
Orphan Drug Act of 1983
Provides tax incentives to develop and market orphan medications.
Drug Price Competition and Patent Term Restoration Act of 1984
Encouraged the creation of both generic and new medications by streamlining the process for generic drug approval and by extending patent licenses.
Prescription Drug Marketing Act of 1987
Prohibits the reimportation of a drug into the US by anyone except the manufacturer.
Omnibus Budget Reconciliation Act of 1987
OBRA-87; established extensive revisions to Medicare and Medicaid Conditions of Participation regarding long term care facilities and pharmacy.
Anabolic Steroid Control Act of 1990
Resulted in harsher penalties for the abuse of anabolic steroids and their misuse by athletes.
Omnibus Budget Reconciliation Act of 1990 (OBRA-90)
Requires that manufacturers provide the lowest prices to any customer or Medicaid patient by rebating each state Medicaid agency the difference between its average price and the lowest price; requires than an offer to counsel is made to every patient and drug utilization review is performed for every patient
FDA Safe Medical Devices Act of 1990
Requires that all medical devices be tracked and records be maintained for durable medical equipment, such as infusion pumps.
Americans with Disabilities Act of 1990
ADA; prevents discrimination against potential employees who may possess a disability.
Resource Conservation and Recovery Act
Indicates proper guidelines regarding the disposal of hazardous waste
FDA Modernization Act
Federal drug legend is represented by RX.
Dietary Supplement Health and Education Act of 1994
DSHEA; Herbal products must be labeled as a dietary supplement, identify all ingredients and their quantities, and meet quality, purity, and compositional specification.
Health Insurance Portability and Accountability Act of 1996
HIPAA; requires that health care providers ensure that patient confidentiality be maintained. Two parts: Title 1--Insurance Reform - protects health insurance coverage for workers and families when they change or lose their jobs, and Title 2--Administrative Simplification - established electronic transaction and Code Set Standards
Isotretinoin Safety and Risk Management Act of 2004
Safety requirements for patients taking isotretinoin (Accutane). Include: maintaining registry of patients, practitioners, and pharmacists, education regarding risks, requirement that Accutane only prescribed in severe cases, monthly education of patients, certification of medical offices and clinics, 30 day prescription allotments, monthly pregnancy testing for females, etc.
Anabolic Steroid Control Act of 2004
Redefined anabolic steroids; altered the bases for all future administrative scheduling actions relating to the control of anabolic steroids as Schedule III medications by eliminating the requirement to prove muscle growth. Increased the number of anabolic steroids
Medicare Drug, Improvement, and Modernization Act of 2003
MPDIMA; provides for a voluntary prescription drug benefit to Medicare beneficiaries; preventive medical benefits for senior citizens, lowers reimbursement rates, etc.
Combat Methamphetamine Epidemic Act of 2005
Placed ephedrine, pseudoephedrine, and phenylpropanolamine in controlled substances category "scheduled listed chemical products". Subject to sales restrictions and storage requirements
Bureau of Alcohol, Tobacco, and Firearms; sets regulations regarding the purchase of tax-free alcohol
Centers for Medicare and Medicaid Services; oversees Medicare and Medicaid; established conditions for a facility to be reimbursed for services rendered.
Drug Enforcement Agency; enforces compliance with the Controlled Substances Act, including placing medications into the appropriate schedule, monitoring records and reports of controlled substances, registering pharmacies, issuing DEA forms 222 and 41, monitoring the destruction of controlled substances.
Environmental Protection Agency; sets guidelines for the disposal of hazardous waste
Food and Drug Administration; ensures that all pharmaceutical products are pure, safe, and effective
The Joint Commission; addresses quality of patient care and patient safety; establishes standards and accredits health care providers.
National Association of the Boards of Pharmacy; composed of all state boards of pharmacy; meets to discuss current trends and issues in pharmacy
State Boards of Pharmacy; regulatory state agency that oversees the practice of pharmacy in a given state; clearly defines regulations affecting pharmacy and the roles, duties, and expectations of those working there
United States Pharmacopeia; Official public standards-setting authority for all prescription and OTC meds and other health care products manufactured or sold in US
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