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PTCB - Pharmacy Laws QUESTIONS AND ANSWERS RATED A+ 2024/2025
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PTCB - Pharmacy Laws QUESTIONS AND ANSWERS RATED A+ 2024/2025
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PTCB - Pharmacy LawsPure meals and capsules act of 1906 - ANSprohibit the interstate transportation or sale of
adulterated or misbranded meals or capsules
What does Adulterated suggest? - ANSConsists of any filthy, decomposed, putrid susbtance
Perpared, packed, or help beneath unsanitary situations
Perpared in packing containers composed of any poisonous or deleterious substance
Containing dangerous color components
Recognized in an reputable compendium but differing in energy, first-rate, or purity of the
medication
What does Misbranding suggest? - ANSFalse labeling
No label
Label lacks Name, workplace of the manufacturer/packer/distributor, lack accurate quantity of
contents.
No Warning if the product is dependancy forming
No labeled direction to be used and no caution towards positive pathological conditions
Products which are risky to health under the labeled dosage
No aspect/alcohol content if have alcohol
Failed to undergo the set up name of the drug
Durham-Humphrey Act of 1951 - ANSAmendment of FDCA 1938
Require all products to have ok guidelines for use
Don't need to have adequate instructions for use if the drug/merchandise have to be dispense
with a prescription (now not over the counter)
Separated drugs into Legend and Nonlegend (over the counter)
Allows verbal prescriptions over the smartphone
Allows refills to be known as in from a doctors' workplace
Food, Drugs, and Cosmetic Act of 1938 (FDCA) - ANSCreated the United States Food and Drug
Administration (FDA)
Required all new drug packages be filed with the FDA
Clearly described Adulteration and misbranding
Kefauver-Harris Amendment of 1962 - ANSRequires all remedy within the US to be pure, safe,
and effective
Comprehensive drugs abuse prevention and control act of 1970 - ANSEstablished "Controlled
substance" score
Created the Drug Enforcement Agency (DEA)
, Separated the managed substance into 5 Schedule based totally on ability for abuse and
commonplace clinical use within the US
Prescription monitoring programs. The federal National All Schedules Prescription Electronic
Reporting Act in 2005 - ANSThe Act set up an digital machine for practitioner monitoring of the
doling out of controlled materials in SCH 2, three, 4. The act might require unique statistics to be
suggested. But the act become never enacted at the federal level. But many states have
enacted similar regulation.
Poison prevention packaging act of 1970 - ANSto lessen unintentional poisoning in children.
Requires that most OTC and legend capsules be packaged in baby-resistant boxes --> can't be
opened by 80% of youngsters <5 yrs old but can be opened by 90% of adults.
Occupational safety and health act (OSHA) of 1970 - ANSCreated 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
Drug listing act of 1972 - ANSEstablish 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 - ANSProvides tax incentives and exclusive licensing of products for
manufacturers to develop and market orphan medication
Orphan medication - ANSmedications for treatment of diseases or conditions of which there are
fewer than 200,000 cases in the world.
Drug Price Competition and Patent term restoration act of 1984 - ANSencouraged the creation
of both generic and new medications
streamlining the process for generic drug approval and by extending patent licenses.
Prescription Drug marketing act of 1987 - ANSprohibits the re-importation of a drug into the US
by anyone except the manufacturer.
Prohibits the sale or distribution of samples to anyone other than those licensed to prescribe
them
Required labels to appear on all medication for animals
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