Legislation
For a bill to become a law, it must first go through these two branches of government who are responsible for drafting a compromise bill before it goes to the executive branch for enactment.
What are the Senate and the House of Representatives?
This Act authorizes the DEA to regulate disposal of unused controlled substances. This encompasses transfer, delivery, collection, return and recall of controlled substances.
What is the Safe and Secure Drug Disposal Act of 2010?
This office of the FDA regulates dietary supplements.
What is the Center for Food Safety and Applied Nutrition?
This portion of the research continuum to approve an investigational drug involves 20-80 healthy individuals to determine the safety profile by identifying pharmacokinetic and pharmacodynamic properties.
What is a Phase I Drug Trial?
Accreditation by The Joint Commission uses this methodology during on-site surveys to determine compliance with standards and systems to provide care and services in areas of patient rights, treatment, medication safety, and infection control.
What is tracer methodology?
This Senate committee has jurisdiction over taxation and health program issues under the Social Security Act? This includes Medicare, Medicaid, and the Children's Health Insurance Program (CHIP).
What is the Finance Committee?
This Act required disclosure of payments and items of value given to physicians and teaching hospitals as well as physician ownership or investments in drug companies.
What is the Physician Payments Sunshine Act (Sunshine Act)?
In this year, the United States Pharmacopeia and the National Formulary (USP/NF) was first identified as the official drug standard.
What is 1906? (The Pure Food and Drug Act of 1906)
During Phase II of a drug trial, clinical studies are conducted with no more than several hundred subjects with this established goal.
What is evaluating the drug's effectiveness for a particular indication?
This quality improvement effort develops medication-related performance measures through a collaborative process with key stakeholders.
What is the Pharmacy Quality Alliance?
This department has jurisdiction over the DEA, which prevents, detects, and investigates the diversion of controlled substances and monitored chemicals.
What is the Department of Justice?
Under this Act, CMS issued Electronic Health Records Incentive Programs to provide a financial incentive to health care professionals, hospitals, and organizations that are "meaningful users" of EHRs.
What is the American Recovery and Reinvestment Act (ARRA) of 2009?
The 1983 Orphan Drug Act established grants, federal assistance, and tax incentives to develop drugs for populations of fewer than 200,000. It also granted a period of market exclusivity for this many years.
What is 7 years?
Phase III of a drug trial recruits hundreds to several thousand participants has these three goals.
What are: drug safety, efficacy, and appropriate dosage?
Medical error frequency triggered the Patient Safety and Quality Improvement Act of 2005 that encouraged voluntary reporting of safety information without fear of legal action and authorized the creation of these organizations.
What are Patient Safety Organizations? (PSOs)
This agency is charged with protecting the health of Americans and represent 32% of federal monies - the largest share on non-defense discretionary funding?
What is the Department of Health and Human Services (DHHS)?
This Act provides opportunities for pharmacists to participate in the Medicare Annual Wellness Visit.
What is the Patient Protection and Affordable Care Act of 2010 (ACA)?
Until 1997, for drug manufacturers to establish effectiveness, "substantial evidence" came from a total of at least this many trials.
What is a minimum of two?
Generic drug equivalence is determined based on these criteria.
What is the same active ingredient, same dosage form and route of administration, identical strength or concentration, quality, and purity.
Institutional Review Board (IRB) approval is required for these two types of studies.
What are interventional and observational studies?
This department has jurisdiction over hazardous waste disposal.
What is the U.S. Environmental Protection Agency?
This Act recommended new initiative antimicrobial resistance monitoring by the CDC, along with addressing many other health care and research innovations.
What is the 21st Century Cures Act?
The Comprehensive Drug Abuse Prevention and Control Act (Controlled Substance Act) authorized the FDA to regulate all aspects of controlled substances in this year. This was also the year President Nixon signed an order banning all advertisements for cigarettes on national television.
What is the year 1970?
This drug is produced by the brand company under a new drug application (NDA) but marketed as a generic. It is identical to the brand alternative in both active and inactive ingredients.
What is an authorized generic drug?
An investigational drug is defined as this, and its control and distribution may be managed by pharmacists within clinical research.
What is a new chemical or compound that has not been approved by the FDA for general use OR an approved drug undergoing further investigation for new indication, dose, dosage form, or administration schedule.