PTCB - Pharmacy Laws Questions and Answers Latest Updated 2022 Rated A+

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PTCB - Pharmacy Laws Questions and Answers Latest Updated 2022 Rated A Pure food and drugs act of 1906 Correct Answer-prohibit the interstate transportation or sale of adulterated or misbranded foo... d or drugs What does Adulterated mean? Correct Answer-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 What does Misbranding mean? Correct Answer-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 alcoholFailed to bear the established name of the drug Durham-Humphrey Act of 1951 Correct Answer-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) Correct Answer-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 Correct Answer-Requires all medication in the US to be pure, safe, and effective Comprehensive drugs abuse prevention and control act of 1970 Correct Answer-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 Correct Answer-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. Poison prevention packaging act of 1970 Correct Answer-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. Occupational safety and health act (OSHA) of 1970 Correct Answer-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 useDrug listing act of 1972 Correct Answer-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 Correct Answer-Provides tax incentives and exclusive licensing of products for manufacturers to develop and market orphan medication Orphan medication Correct Answer-medications 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 Correct Answer-encouraged 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 Correct Answer-prohibits 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 animalsOmnibus Budget Reconciliation act of 1987 (OBRA 87) Correct Answer-Revision to Medicare and Medicaid Conditions of participation regarding long term care facilities and pharmacy. Anabolic Steroid control act of 1990 Correct Answer-Harsher penalties for the abuse of anabolic steroids and their misuse by Athletes Omnibus Budget Reconciliation Act of 1990 (OBRA-90) Correct Answer-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 FDA Safe Medical devices Act of 1990 Correct Answer-Requires that all medical devices be tracked Records be maintained for durable medical equipment such as infusion pumps American with Disabilities Act (ADA) of 1990 Correct Answer-Prevent discrimination against potential employees who may possess a disability. Must make a reasonable accommodation for the potential employee.Resources Conservation and Recovery Act Correct Answer-From the Environmental Protection Agency (EPA) federal guidelines regarding the disposal of hazardous waste FDA modernization Act Correct Answer-Replace the Federal Drug legend "Federal Law prohibits the dispensing of this medication without a prescription" with the Rx abbreviati [Show More]

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