Federal Pharmacy Law Flashcards
Jenni
Awesomely
What was the Food and Drugs Act? (1906)
It prohibited adulterated and misbranded foods and drinks. No longer active.
What is the Harrison Narcotic Act (1914)?
It required a license to import/export opium
Limited to medical use only
What is the Drug and Cosmetic Act (FDEA, 1938)
1937 sulfanilamide tragedy- drug ads, FTC-PDA
Required safety testing
Expanded definition of adulteration and misbranding
Required adequate directions for use
What is the Durham-Humphrey Amendment (1951)?
Exemptions for some, adequate directions for uses
Started legend drugs
Distinguish adequate directions/information for use
(To person)/(to prescriber)
What is the Kefaurer-Harris Amendments (1962)?
Required efficacy testing Good manufacturing practices NDA process DESI- drug efficacy study implementation Pre-FDCA were God-fathered
What is the Controlled Substances Act (1970)?
Created DEA
Drug schedules
What is the poison prevention packaging Act (1970)?
Child resistant containers
Medical Device Act (1976)
Established standards for medical devices
Orphan Drug Act (1983)
Incentives for manufactures to develop tx for rare diseases
Drug Price Competition Act (1984)
Accelerated drug approval process for generics
Created the “Abbreviated New Drug Application” (ANDA)
Prescription Drug Marketing Act (1987)
Establishes drug pedigrees
Prescription Drug User Fee Act (1992)
Fees on manufacturers and their products
Used by FDA for improving regulatory processes
Nutrition Labeling Education Act (1990)
Regulations on nutritional supplements so they couldn’t make disease prevention claims
Dietary Supplement and Health Education Act (1994)
Removed dietary supplements from food category
Can’t claim they diagnose, cure, treat, or prevent disease
Can make 4 claims:
1. benefit of nutritional deficiency disease
2. Describe structure or function in human body
3. Characterize the documented mechanism
4. Promote general well-being
Required labeling to state that it has not been evaluated by FDA
Food and Drug Administration Modernization Act (1997)
Overhauled the FDA
Intended to improve efficiency
Best Pharmaceuticals for Children Act (2002)
Stimulate research into pediatric data
Voluntary incentive
Pediatric Research Equity Act (2003)
Allows FDA to mandate research on certain drugs before licensing
FDA Amendments Act (2007)
FDA could get more fees to improve drug safety and surveillance programs
Patient Protection and Affordable Care Act (2010)
Mandate to carry health insurance
Drug Quality and Safety Act (2013)
Amended regulations on compounding facilities
Coordination with State Boards of Pharmacy regarding disciplinary actions
Omnibus Budget Reconciliation Act (1990) OBRA-90
Intent to promote cost savings and better fiscal management in government sponsored health care (Medicaid, Medicare)
Included:
1. Rebate programs- requires manufacturer to provide state Medicaid with best price
2. Demonstration projects- encouraged scientific studies on patient outcomes
3. Drug Utilization Review programs
Health Insurance Portability and Accountability Act (HIPAA)
1996
Created electronic standards to simplify transfer of electronic information
To protect privacy and confidentiality of patients, added the Privacy Rule or PHI
Medicare/Medicaid Fraud and Abuse Act
Prohibits knowingly making a false statement of material fact in any application for benefit or payment
Anti-kickback provision- prohibits soliciting, receiving, offering, or paying rewards for referrals or providing services/goods paid for by Medicaid/Medicare
Swettham Innej
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