Transcript File

PHARMACY
LAWS
1
Pharmacy Laws
Federal law takes precedence
over state law unless the
state law is stricter than the
federal law.
The most restrictive law will
take precedence.
Pure Food and Drug At 1906
 Enacted
in 1906 to prohibit the
interstate transportation or
sale of adulterated and
misbranded food and drugs.
TERMS
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Adulteration: the mishandling of
medication that can lead to contamination
and cause injury or illness to the
consumer.
Misbranding: deceptive or misleading
labeling of a product that may lead the
consumer to believe that the product will
cure an illness (illegally labeled).
FOOD, DRUG AND COSMETIC ACT
(FDCA 1938)
 FDA
was created under this act.
 Required that all new drugs be
filed with FDA.
 Clearly defined adulteration and
misbranding of drug and food
products.
DURHAM-HUMPHREY ACT
of 1951
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Required all products to have adequate
directions for use unless they contain the federal
legend: “Caution: Federal law prohibits
dispensing without prescription.”
It separated drugs into 2 categories:
 Legend – requires a prescription
 Nonlegend – OTC not requiring a prescription.
Allows verbal prescriptions over the telephone.
Allows refills to be called in from a physician’s
office.
Kefauver-Harris
Amendment of 1962
 Requires
that all medication
on the market in the US be
pure, safe and effective.
Comprehensive Drug Abuse
Prevention and Control
Act of 1970
 The
Drug Enforcement Agency
(DEA) was created under this act.
 Controlled substances were
placed into one of five schedules.
Poison Prevention
Packaging Act of 1970
 Enacted
to reduce the accidental
poisoning in children.
 Most OTC and legend drugs must
be child-resistant.
Occupational Safety and Health Act
(OSHA) of 1970
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Ensures
 Job safety and health standards for employees
 Maintain a reporting system for job-related injuries
and illness
 Reduce hazards in the workplace
 Conduct audits to guarantee compliance with act
It addressed air contaminants, flammable and
combustible liquids, eye and skin protection, and
hazard communication standards in the pharmacy.
Require usage of the MSDS.
Drug Listing Act of 1972
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Created an 11-digit number to identify each drug.
This is the NDC (National Drug Code) number.
The first five digits identify the:
 Manufacturer
The next four digits identify the:
 Drug product
The final two digits represent the:
 Package size and packaging
Orphan Drug Act of 1983
 Orphan
drugs are medications for
rare diseases (<200,000 cases in
the world).
 The law provides tax incentives
and exclusive licensing to develop
and market orphan medications.
Drug Price Competition and
Patent Term Restoration Act
of 1984
 Encouraged
the creation of both
generic and new medication.
 Streamlined the process for
generic drug approval and
extended patent licenses.
Prescription Drug
Marketing Act of 1987
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Prohibits the reimportation of a drug into the
United States by anyone except the manufacturer.
Prohibits the sale or distribution of samples to
anyone other than those licensed to prescribe
them.
Requires that all medications for animals are
to be labeled with: “Caution: Federal law
restricts this drug to use by or on an
order of a licensed veterinarian.”
Anabolic Steroid Control Act
of 1990
 Created
more strict penalties for
the abuse of anabolic steroids and
their misuse by athletes.
Omnibus Budget Reconciliation
Act (OBRA) of 1987
 Establishes
Medicare and
Medicaid Conditions of
Participation (regulations for drug
use and guidelines).
 Requires manufacturers to
provide the lowest prices to any
customer or Medicaid 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 (ADA) of 1990
Prevents discrimination against
potential employees who may
possess a disability.
 The business must make reasonable
accommodations for the employee.
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Health Insurance Portability
and Accountability Act (HIPAA)
There are two parts of HIPAA:
1. Protects health insurance coverage for
workers and families when they change
or lose their jobs.
2. Administrative Simplification – electronic
transactions and required Health
Information Privacy.
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