Prepare for PTCB pharmacy law questions with these practice answers. This guide covers DEA controlled substance regulations, FDA requirements, and state pharmacy laws.
Q: Pure food and drugs act of 1906
Answer: prohibit the interstate transportation or sale of adulterated or misbranded food or drugs
Q: What does Adulterated mean?
Answer: Consists of any filthy, decomposed, putrid susbtancePerpared, packed, or help under unsanitary conditionsPerpared in containers composed of any poisonous or deleterious substanceContaining unsafe color additivesRecognized in an official compendium but differing in strength, quality, or purity of the drugs
Q: What does Misbranding mean?
Answer: False labelingNo labelLabel lacks Name, place of business of the manufacturer/packer/distributor, lack accurate quantity of contents.No Warning if the product is habit formingNo labeled direction for use and no warning against certain pathological conditionsProducts that are dangerous to health under the labeled dosageNo ingredient/alcohol content if have alcoholFailed to bear the established name of the drug
Q: Durham-Humphrey Act of 1951
Answer: Amendment of FDCA 1938Require all products to have adequate directions for useDon’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 phoneAllows refills to be called in from a doctors’ office
Q: Food, Drugs, and Cosmetic Act of 1938 (FDCA)
Answer: Created the US Food and Drug Administration (FDA)Required all new drug applications be filed with the FDAClearly defined Adulteration and misbranding
Q: Kefauver-Harris Amendment of 1962
Answer: Requires all medication in the US to be pure, safe, and effective
Q: Comprehensive drugs abuse prevention and control act of 1970
Answer: Established “Controlled substance” ratingCreated the Drug Enforcement Agency (DEA)Separated the controlled substance into 5 Schedule based on potential for abuse and accepted medical use in the US
Q: Prescription monitoring programs. the federal National All Schedules Prescription Electronic Reporting Act in 2005
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.
Q: Poison prevention packaging act of 1970
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.
Q: Occupational safety and health act (OSHA) of 1970
Answer: Created the Occupational Safety and Health Administration (OSHA)OSHA ensures a safe and healthful workplace for all employeesEnsures job safety and health standards for employeesMaintain a reporting system for job-related injuries and illness, reduce hazards in the workplace, and conduct audits to ensure compliance with the ActAddress Air contaminants, flammable, and combustible liquids, eye and skin protection, and hazard communication standards.Requires the MSDS to be use
Q: Drug listing act of 1972
Answer: Establish the NDC (National Drug Code) number5 – 4 – 2First 5: the manufacturer2nd 4: the drug productFinal 2: package size and packaging
Q: Orphan Drug Act of 1982
Answer: Provides tax incentives and exclusive licensing of products for manufacturers to develop and market orphan medication
Q: Orphan medication
Answer: medications for treatment of diseases or conditions of which there are fewer than 200,000 cases in the world.
Q: Drug Price Competition and Patent term restoration act of 1984
Answer: encouraged the creation of both generic and new medicationsstreamlining the process for generic drug approval and by extending patent licenses.
Q: Prescription Drug marketing act of 1987
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 themRequired labels to appear on all medication for animals
Q: Omnibus Budget Reconciliation act of 1987 (OBRA 87)
Answer: Revision to Medicare and Medicaid Conditions of participation regarding long term care facilities and pharmacy.
Q: Anabolic Steroid control act of 1990
Answer: Harsher penalties for the abuse of anabolic steroids and their misuse by Athletes
Q: Omnibus Budget Reconciliation Act of 1990 (OBRA-90)
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 priceOffer 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 fundingAuthorizes government-sponsored demonstration project relating to the provision of pharmaceutical care
Q: FDA Safe Medical devices Act of 1990
Answer: Requires that all medical devices be trackedRecords be maintained for durable medical equipment such as infusion pumps
Q: American with Disabilities Act (ADA) of 1990
Answer: Prevent discrimination against potential employees who may possess a disability.Must make a reasonable accommodation for the potential employee.
Q: Resources Conservation and Recovery Act
Answer: From the Environmental Protection Agency (EPA)federal guidelines regarding the disposal of hazardous waste
Q: FDA modernization Act
Answer: Replace the Federal Drug legend “Federal Law prohibits the dispensing of this medication without a prescription” with the Rx abbreviation.An update of the Humphrey Act
Q: Dietary Supplement Heath and Education Act (DSHEA) of 1994
Answer: Guideline to prevent Adulteration of Herbal products and Dietary supplementsMust be labeled as Dietary supplementsidentifies all ingredients and quantities of the ingredient in the labelPackaging that identifies the plant and plant part that derives the ingredientsMeet the quality, purity and compositional specification
Q: HIPAA of 1996
Answer: improve portability and continuity of health coverage in the group and individual marketsCombat waste, fraud, and abuse in health insurance and deliveryPromote use of medical saving accountsImprove access to long term care services and coverageSimplify the administration of health insuranceMaintain patient confidentiality
Q: Isotretinoin safety and risk management act of 2004
Answer: Isotretionoin (Accutane) is a medication used to treat acne that cause sever birth defect and psychiatric effectsThe act helps control the use of Accutane
Q: Anabolic Steroid Control act of 2004
Answer: An update to the Same Act of 1990.New definition of anabolic steroidSCH 3 medicationsEliminate requirement to prove muscle growth.Increase the number of anabolic steroids to 59 substancesAlso implement requirement for handling and recording of the use of anabolic steroids substances
Q: Any willing provider Law
Answer: allows any pharmacy to participate in a prescription drug benefit plan as long as the pharmacy agrees to the terms and conditions of the plan
Q: Freedom of choice law
Answer: allows a member of a prescription drug plan to select any pharmacy as long as the pharmacy agrees to the terms and conditions of the plan
Q: Freedom of choice with regard to long term care
Answer: Long term care residents may choose an outside pharmacy for their medication if the pharmaceutical service is not provided under their contract.However the long term care facility may refuse admission to a resident if the resident refuses to use the drug distribution system already in placeThe facility may have additional policies that the outside pharmacy must agree to
Q: Prescription Drug Equity Law
Answer: prohibit a prescription drug plan from requiring mail order prescription drug coverage without also providing non-mail order coverage
Q: Medicare Drug improvement and modernization act of 2003
Answer: Provide voluntary prescription drug benefit to medicare beneficiariesPart B and Part D prescription planAdd preventive medical benefits to senior citizens
Q: Combat Methamphetamine epidemic Act of 2005
Answer: Place Ephedrine, pseudoephedrine, and Phenyl-propanolamine in the Controlled Substances in ScheduleImpose sale and production restrictions
Q: Medicaid Tamper0resistant Prescription Act
Answer: 2008Special Prescription pad for any prescription that are paid by Medicaid (any portion)Prevent unauthorized copying of the prescription form and modification of the prescriptionPrevent counterfeit prescription forms
Q: USP <797>
Answer: designed to cut down on infection transmitted to patients through pharmaceutical products and better protect staff working in pharmaciesContain procedural training and quality assurance requirements for preparing sterile products
Q: ATF stands for what regulatory agency? What is its responsibilities?
Answer: Bureau of Alcohol, Tobacco and FireArmsSet regulations regarding the purchase of tax-free alcohol (use in hospitals and clinics)
Q: CMS stands for what regulatory agency? What is its responsibilities?
Answer: Centers for Medicare and Medicaid ServicesOversees medicare and medicaid
Q: DEA stands for what regulatory agency? What is its responsibilities?
Answer: Drug Enforcement AgencyEnforces compliance with the Controlled Substance ActIt places medications into the appropriate schedule, monitor records, and reports of controlled substances, registering pharmacies, issuing Form 222 and 41, and monitor the destruction of controlled substancesDEA is overseas by Department of Justice
Q: FDA stands for what regulatory agency? What is its responsibilities?
Answer: Food and Drugs administrationEnsure that all pharmaceutical products are pure, safe, and effective
Q: Institutional Review Board stands for what regulatory agency? What is its responsibilities?
Answer: A board, committee, or other group designated by an institution to approve biomedical research in accordance with the FDA
Q: TJC stands for what regulatory agency? What is its responsibilities?
Answer: The Joint Commissionaddress quality of patient care and patient safety.establish standard and accredits health care providers (places): hospital, home health care agencies, long term care pharmacies…
Q: NABP stands for what regulatory agency? What is its responsibilities?
Answer: National Association of The Boards of PharmacyComposed of all State Boards of Pharmacy.No regulatory authority but meets to discuss current trends and issues in pharmacy that affect the practice of pharmacy
Q: BOP stands for what regulatory agency? What is its responsibilities?
Answer: State Boards of PharmacyRegulatory state agency that oversees the practice of pharmacy in a given state
Q: USP stands for what regulatory agency? What is its responsibilities?
Answer: United States Pharmacopeiaofficial public standards-setting authority for all prescription and oTC medicines and other health care products manufactured or sold in the USSet standards for food ingredients and dietary supplements