Pharmacy Laws & Acts Flashcards
Which act ensures a safe and healthful environment for employees?
Occupational safety and health act “OSHA”
Which law was enacted to reduce accidental poisoning in children?
Poison prevention packaging act
Drug Listing Act: the first 5 digits of the NDC number identifies what?
Manufacturer
Drug Listing Act: the next 4 digits of the NDC number identifies what?
The drug product
Drug Listing Act: the final 2 digits of the NDC number identifies what?
The packaging and package size
Drug Listing Act: each drug is assigned a specific what?
11-digit number
Which law provides tax incentives and licensing of products for manufacturers to develop and market for medications to treat certain diseases which there are fewer than 20,000 cases
Orphan drug act
Which act extends patent licenses for generic and new medications
Drug Price Competition and Patent Term Restoration Act
Which act prohibits the sale and distribution of samples to anyone other than those licensed to prescribe them
Prescription Drug Marketing Act
Which act does extensive revisions to Medicare & Medicaid conditions of participation?
OMNIBUS Budget Reconciliation Act 1987
Which act requires that manufacturers provide the lowest prices to Medicaid patients
OMNIBUS Budget Reconciliation Act 1990
Which act resulted in harsher penalties for drug abuse of anabolic steroids
Anabolic Steroid Control Act
Which act requires that all medical devices be tracked and records be maintained?
FDA Safe Medical Devices Act
Which act prevents discrimination against potential employees who may be disable?
American with Disabilities Act
Which act includes the Environmental Protection Agency that produced federal guidelines regarding the disposal of hazardous waste?
Resource Conservation and Recovery Act
Which act prohibits the dispensing of this medication without a prescription?
FDA Moderation Act
Which act was to improve portability and continuity of health coverage in the group and individual markets; combat waste, frauds, and abuse in health insurance and healthcare delivery?
Health Insurance Portability and Accountability Act (HIPPA)
Which act insists that herbal products are dietary supplements rather than drugs?
Dietary Supplement Health and Education Act (DSHEA)
Which act says that Accutane is a very powerful medication used to treat acne: causes severe birth defects, induces spontaneous abortions and adverse psychiatric effects?
Isotretinoin Safety and Risk Management Act
Which act amended he Controlled Substances Act and replaced it with a new definition of anabolic steroid?
-all future administrative scheduling actions relating to the control of anabolic steroids as a Schedule 3
Anabolic Steroid Control Act
Which law 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?
Any Willing Provider Law
Which law allows a member of a prescription drug plan to choose a pharmacy?
Freedom of choice law
Which law prohibits a prescription drug plan from requiring mail order prescription drug coverage?
Prescription drug equity law
Which law establishes policies to protect patients and may require outside pharmacies to agree to policies?
Freedom of choice
Which act limits your purchase of pseudoephedrine , ephedrine, and phenylpropanolmine in controlled substances to 3.6g/day or 9g/30-day?
Combat methamphetamine epidemic act
Which act is all handwritten prescriptions for covered outpatients drugs such as e-scribed, faxed, phoned are not affected?
Medicaid tamper-resistant prescription act
Which act was designed to cut down on infections transmitted to patients through pharmaceutical products and to better protect staff working in pharmacies in the course of exposure?
Ups 797
Which regulatory agencies is in charge of regulations regarding the purchases of tax-free alcohol used is hospitals and clinics?
Bureau of alcohol, tobacco, and firearms
Which regulatory agencies establishes conditions for a facility to be reimbursed for services rendered?
Centers for Medicare and Medicaid services
Which regulatory agencies enforces compliance with controlled substances act overseen by department of justice?
Drug enforcement agency
Which regulatory agencies set guidelines for the disposal of hazardous waste such as controlled substances?
Environmental protection agency
Which regulatory agencies ensures that all pharmaceutical products are pure, safe and environmental?
Food and drug administration
Which regulatory agencies has a joint committee on accreditation of healthcare organization that addresses quality of patient care and patient safety?
The joint commission
Which regulatory agencies has no regulatory authority but meets to discuss current trends and issues in pharmacy?
National association of the board of pharmacy
Which regulatory agencies has a regulatory state agency that oversees the practice of pharmacy in given state?
State board of pharmacy
Which regulatory agencies has an official public standard setting authority for all prescription and otc medicines and other healthcare products manufactured or sold in US?
United States pharmacopeia “USP”
Which act was enacted in 1906 to prohibit the interstate transportation or sale of adulterated and misbranded food or drugs?
Pure food and drug act
Which act required that all new drug applications be filed with the FDA and also defined as adulteration and misbranding of drugs and food products?
Food,drug, and cosmetic act
Which act is an amendment to FDCA 1938 requiring all products to have adequate directions for use unless they contain the federal legend “caution: federal law prohibits dispensing without a prescription.”?
Durham-Humphrey act
Which amendment requires that all medications in the United States to be pure, safe and effective?
Kefauver-Harris amendment
Which act was created and placed under the supervision of the department of justice such as the five schedules of controlled substances?
Comprehensive drug abuse prevention and control act
