| back 1 - outlines the organization of the federal Government
- All laws must conform to principles and rights
- Bill of
Rights is the first 10 amendments
Freedom of speech, Chose Religion, Jury trial, Protection aginst
unreasonable search and seizures |
| back 2 - laws passed by Federal, State, or local legistatures
- asign powere to create regulations and delegate this
responsability to a regulatory agent
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| back 3 - clarify and explain ststutes
- must be consistent with
enacted ststute
- same power or authority as a statute
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| back 4 - Statutory and regulatory laws are based on legislative
intent
- Legal interpretation can be based on small nuances in
language or punctuation.
- Justices and judges issue opinions
and decisions determining legislative intent commonly called “case
law.”
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| back 5 - Deals with homicide, illegal drugs, theft, and other antisocial
behavior
- Enforced by state agents against specific persons or
corporations
- Designed to protect society as a whole rather
than compensate individual victims
- Criminal cases are thus
titled State v. John Smith or People v. Doe.
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| back 6 - Deals with the rights of private citizens in non-criminal
matters
- Plaintiff (injured party) brings charges against
defendant (alleged wrongdoer).
- Parties in a civil case may
be individuals, corporations, or the state itself
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| back 7 - A type of civil law that can overlap with criminal law
- When private wrong is committed against an individual or their
property
- Medical malpractice is a kind of tort law - Medical
malpractice is the negligent treatment of a patient by a health care
professional.
- Torts can be intentional or unintentional
(negligence).
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| back 8 - Federal government uses administrative agencies to enforce laws
(except for Defense Dept. and law enforcement agencies).
Examples of federal agencies
- Occupational Safety and Health Administration (O S H A)
- Centers for Medicare and Medicaid Services (C M S)
- Social Security Administration (S S A)
- States also
operate through administrative agencies.
- Some state
agencies correspond to federal agencies, such as State equal
employment opportunity commissions.
Some state
agencies have no federal counterpart, such as State Boards of
Pharmacy. - –Administrative agencies refine laws with
regulations. –Some laws (i.e., A D A) leave little room for
interpretation. –Others are more vague, so agencies have room to
determine scope and detail of regulations. Once established,
regulations have the force of law.
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| back 9 - Any violation of the law is a crime, whether criminal, civil,
or administrative in nature. –Misdemeanors
- Crimes that are
less serious than felonies
–Felonies - Serious
crimes with sentences typically more than a year
Examples: murder, rape, aggravated assault, arson, robbery, and the
manufacturing, sale, distribution, or possession of illegal
drugs |
front 10 Regulatory Agencies - Centers for Disease Control and Prevention (C D C) | back 10 Centers for Disease Control and Prevention (C D C)
- –Federal agency –Charged with protecting public health and
safety through the investigation, identification, prevention, and
control of diseases Various institutes and centers operate under C D
C oversight.
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front 11 Regulatory Agencies - Centers for Medicare and Medicaid Services (C M S) | back 11 - Centers for Medicare and Medicaid Services (C M S)
–Regulates administration of
- Medicare, Medicaid, the State Children’s Health Insurance
Program (S C H I P), the Health Insurance Portability and
Accountability Act (H I P P A), the Clinical Laboratory Improvement
Amendments (C L I A), and several other health-related programs
Conducts inspections to ensure compliance with its guidelines |
front 12 Regulatory Agencies - Drug Enforcement Administration (D E A) | back 12 - Drug Enforcement Administration (D E A)
–Regulates the legal trade in narcotic and dangerous drugs, manages
a national narcotics intelligence system, and works with other
agencies to prevent illegal drug trafficking
–D E A administrator reports to the director of the F B I.
D E A has offices nationwide and in 40 foreign countries. |
front 13 Regulatory Agencies - Food and Drug Administration (F D A) | back 13 –Responsible for:
- Protecting public health by ensuring safety, efficacy, and
security of drugs, biological products, medical devices, food, and
cosmetics
Reviews and approves new drug applications, new generic equivalents,
and new therapeutic indications for existing medications |
| back 14 - Evaluates and accredits nearly 15,000 U.S. health care
organizations and programs
- Establishes/enforces standards
for improving quality and safety of care provided by health-care
organizations
- Evaluates and accredits hospitals, hospice
facilities, nursing homes, long-term care facilities, rehabilitation
centers, and other health care organizations
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front 15 Regulatory Agencies - Occupational Safety and Health Administration
(O S H A) | back 15 –Division of U.S. Dept. of Labor
–Oversees administration of the Occupational Safety and Health Act
and enforces standards in all 50 states
–Ensures the safety and health of America’s workers by setting and
enforcing standards |
front 16 Regulatory Agencies - State Boards of Pharmacy (S B O P) | back 16 –Stage agencies that register and regulate pharmacy facilities,
pharmacists, and pharmacy technicians
–Each state has own S B O P, responsible for establishing and
maintaining a state pharmacy practice act that regulates the actual
practice of pharmacy. |
| back 17 - Generally pertains to actual practice
- License
pharmacies and pharmacy professionals
- Determine standards
for pharmacy practice
- Add restrictions to federal laws,
such as food and drug laws
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| back 18 - Generally pertains to manufacturing, marketing, and
distribution of pharmaceuticals
- Determines extent to which
medical regulations are uniform among the 50 states
- If
federal and state pharmacy-related laws conflict, the more stringent
law is applied.
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front 19 Pure Food and Drug Act of 1906 | back 19 –Pure Food and Drug Act of 1906
- Provided for federal inspection of meat products
- Forbade manufacture, sale, or transport of adulterated food
products or poisonous patent medicines
- Did
not:
–Cover cosmetics
–Provide the authority to ban unsafe drugs
–Prohibit false statements about drugs
–Require labeling to identify product contents |
front 20 Shirley Amendment of 1912 | back 20 –Shirley Amendment of 1912
- Prohibited labeling medicines with false therapeutic claims
intended to defraud consumers
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front 21 Food, Drug, and Cosmetic Act of 1938 (F D C A) | back 21 - Prompted by the sulfanilamide disaster of 1937
- Limited
interstate commerce in drugs to those that are safe and
effective
- Established Food and Drug Administration (F D
A)
- Regulated labeling of drugs
- Regulated who could
prescribe legend (prescription-only) drugs
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front 22 Durham-Humphrey Amendment of 1951 | back 22 - Also known as the Prescription Drug Amendment
- Required
prescription drugs to bear the legend, “Caution: Federal law
prohibits dispensing without a prescription”
- Later
amendments approved a substitute legend that reads “Rx only”.
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front 23 Federal Hazardous Substance Labeling Act (F H S A) of 1960 | back 23 - Authorized F D A to regulate hazardous substances including
those which are toxic, corrosive, irritants, strong sensitizers,
flammable or pressure-generating
- Specifically, this act
required hazardous substances to bear labels cautioning consumers of
the potential hazards.
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front 24 Kefauver-Harris Amendment of 1962 | back 24 - Also known as the Drug Efficacy Amendment
- Focused drug
manufacturers’ accountability for efficacy of drugs
–Established good manufacturing practices (G M P s)
–Prior to marketing, manufacturers required to supply proof of a new
drug’s effectiveness and safety
–Advertising of Rx drugs under F D A supervision
Established procedures for N D A s and investigational drugs |
front 25 Comprehensive Drug Abuse Prevention and Control Act of 1970 | back 25 - Also called Controlled Substances Act of 1970
- Combined
all federal laws dealing with narcotics, stimulants, depressants,
and abused designer drugs
- Established the D E A
- Established five classes, or schedules, for controlled
substances based on potential for abuse
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| back 26 - Registration
- Prescribing
- Dispensing
- Refilling
- Ordering
- Record keeping
- Reporting
Inspections |
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| back 28 Cocaine, Lortab, morphine, Norco, Ritalin |
| back 29 Tylenol #3, anabolic steroids |
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