PTCB - Pharmacy Laws Questions And Answers Rated 100% Correct
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PTCB - Pharmacy Laws
Institution
PTCB - Pharmacy Laws
Omnibus Budget Reconciliation Act of 1990 (OBRA-90) - ️️Required manufacturers
to 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
Offer to counsel is made to every patient and d...
PTCB - Pharmacy Laws
Omnibus Budget Reconciliation Act of 1990 (OBRA-90) - ✔️✔️Required manufacturers
to 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
Offer to counsel is made to every patient and drug utilization review is performed for
every patient --> failure to do so may result in loss of medicaid funding
Authorizes government-sponsored demonstration project relating to the provision of
pharmaceutical care
Occupational safety and health act (OSHA) of 1970 - ✔️✔️Created the Occupational
Safety and Health Administration (OSHA)
OSHA ensures a safe and healthful workplace for all employees
Ensures job safety and health standards for employees
Maintain a reporting system for job-related injuries and illness, reduce hazards in the
workplace, and conduct audits to ensure compliance with the Act
Address Air contaminants, flammable, and combustible liquids, eye and skin protection,
and hazard communication standards.
Requires the MSDS to be use
What does Misbranding mean? - ✔️✔️False labeling
No label
Label lacks Name, place of business of the manufacturer/packer/distributor, lack
accurate quantity of contents.
No Warning if the product is habit forming
No labeled direction for use and no warning against certain pathological conditions
Products that are dangerous to health under the labeled dosage
No ingredient/alcohol content if have alcohol
Failed to bear the established name of the drug
Durham-Humphrey Act of 1951 - ✔️✔️Amendment of FDCA 1938
Require all products to have adequate directions for use
Don't need to have adequate directions for use if the drug/products must be dispense
with a prescription (not over-the-counter)
Separated drugs into Legend and Nonlegend (over the counter)
Allows verbal prescriptions over the phone
Allows refills to be called in from a doctors' office
Food, Drugs, and Cosmetic Act of 1938 (FDCA) - ✔️✔️Created the US Food and Drug
Administration (FDA)
Required all new drug applications be filed with the FDA
Clearly defined Adulteration and misbranding
, Kefauver-Harris Amendment of 1962 - ✔️✔️Requires all medication in the US to be
pure, safe, and effective
Comprehensive drugs abuse prevention and control act of 1970 - ✔️✔️Established
"Controlled substance" rating
Created the Drug Enforcement Agency (DEA)
Separated the controlled substance into 5 Schedule based on potential for abuse and
accepted medical use in the US
Prescription monitoring programs. the federal National All Schedules Prescription
Electronic Reporting Act in 2005 - ✔️✔️The Act establish an electronic system for
practitioner monitoring of the dispensing of controlled substances in SCH 2, 3, 4. The
act would require specific information to be reported. But the act was never enacted at
the federal level. But many states have enacted similar legislation.
What does Adulterated mean? - ✔️✔️Consists of any filthy, decomposed, putrid
susbtance
Perpared, packed, or help under unsanitary conditions
Perpared in containers composed of any poisonous or deleterious substance
Containing unsafe color additives
Recognized in an official compendium but differing in strength, quality, or purity of the
drugs
Pure food and drugs act of 1906 - ✔️✔️prohibit the interstate transportation or sale of
adulterated or misbranded food or drugs
Poison prevention packaging act of 1970 - ✔️✔️to reduce accidental poisoning in
children.
Requires that most OTC and legend drugs be packaged in child-resistant containers -->
can't be opened by 80% of children <5 yrs old but can be opened by 90% of adults.
Drug listing act of 1972 - ✔️✔️Establish the NDC (National Drug Code) number
5-4-2
First 5: the manufacturer
2nd 4: the drug product
Final 2: package size and packaging
Orphan Drug Act of 1982 - ✔️✔️Provides tax incentives and exclusive licensing of
products for manufacturers to develop and market orphan medication
Orphan medication - ✔️✔️medications for treatment of diseases or conditions of which
there are fewer than 200,000 cases in the world.
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