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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 drugs act of 1906 - ANSprohibit the interstate transportation or sale of
adulterated or misbranded meals or pills
What does Adulterated suggest? - ANSConsists of any filthy, decomposed, putrid susbtance
Perpared, packed, or help underneath unsanitary situations
Perpared in packing containers composed of any poisonous or deleterious substance
Containing unsafe shade components
Recognized in an authentic compendium but differing in electricity, best, or purity of the
medicine
What does Misbranding suggest? - ANSFalse labeling
No label
Label lacks Name, administrative center of the manufacturer/packer/distributor, lack accurate
amount of contents.
No Warning if the product is addiction forming
No labeled course for use and no warning towards sure pathological situations
Products which are risky to health beneath the labeled dosage
No factor/alcohol content material if have alcohol
Failed to endure the established call of the drug
Durham-Humphrey Act of 1951 - ANSAmendment of FDCA 1938
Require all products to have ok directions to be used
Don't want to have adequate directions to be used if the drug/products ought to be dispense
with a prescription (now not over-the-counter)
Separated tablets into Legend and Nonlegend (over-the-counter)
Allows verbal prescriptions over the phone
Allows refills to be referred to as in from a medical doctors' office
Food, Drugs, and Cosmetic Act of 1938 (FDCA) - ANSCreated america 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 - ANSRequires all remedy in the US to be natural, secure,
and effective
Comprehensive drugs abuse prevention and manage 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
regularly occurring scientific use in the US
Prescription tracking packages. The federal National All Schedules Prescription Electronic
Reporting Act in 2005 - ANSThe Act establish an digital gadget for practitioner tracking of the
dispensing of controlled substances in SCH 2, 3, four. The act could require specific records to
be said. But the act become never enacted at the federal degree. But many states have enacted
comparable law.
Poison prevention packaging act of 1970 - ANSto lessen unintentional poisoning in kids.
Requires that maximum OTC and legend capsules be packaged in child-resistant packing
containers --> cannot be opened via 80% of children <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
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