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Class of recall in which there is a strong likelihood of the product causing serious adverse effects or death
Class I
This law classified all drugs with potential for abuse into five schedules and led to the creation of the DEA
1970 Comprehensive Drug Abuse Prevention Control Act, or Controlled Substances Act (CSA)
Law intended to stop the recreational use of opium by making narcotics prescription drugs
1914 Harrison Narcotic Act
Patients must give this acknowledging that they are aware of all of the associated risks, other treatment options, etc. before participating in clinical drug trials
What are the exceptions to the Poison Prevention Packaging Act of 1970?
If non-childproof caps are specifically requested by the prescriber or patient (and patient signs a waiver) or if the meds are being given at a hospital or nursing home
First important law to regulate the development, compounding, distribution, storage, and dispensing of drugs
1906 Pure Food and Drug Act
This agency’s primary function is to issue regulations for infection control
Centers for Disease Control and Prevention (CDC)
This act made anabolic steroids a controlled substance under the regulations of the Controlled Substances Act
1990 Anabolic Steroid Control Act
This law regulates how and when covered entities can disclose protected health information (PHI)
Health Insurance Portability and Accountability Act of 1996
Functioning as a part of the US Department of Justice, this agency is responsible for enforcing all controlled substance laws
Drug Enforcement Agency (DEA)
This law requires pharmacists to counsel Medicaid patients and provide a Drug Utilization Review (DUR)
1990 Omnibus Budget Reconciliation Act (OBRA 90)
This law created classifications of prescription (legend) drugs and nonprescription over-the-counter (OTC) drugs and required all legend drug labels to say "Rx Only"
1951 Durham-Humphrey Amendment
This act provided incentives to promote research, approval and marketing of drugs for people with rare diseases (those that affect <200,000 people in U.S.)
1983 Orphan Drug Act
1938 Food, Drug, and Cosmetic Act (FDC)
This law ensures a safe and healthy work environment for all employees
Occupational Safety and Health Act of 1970 (OSHA)
This act established the National Drug Code (NDC)
Drug Listing Act of 1972
This act was designed to lower drug prices by providing abbreviated applications for new drugs and accelerated procedures for approval of generic versions of drugs to increase competition in the drug industry
Drug Price Competition & Patent-Term Restoration Act of 1984
A type of negligence lawsuit brought against a person with a professional license
Malpractice
Enacted as a result of the thalidomide tragedy, this law required manufacturers to provide proof of their medication's safety and efficacy, and placed the FDA in charge of advertising
1962 Kefauver-Harris Amendment
Association for pharmacists practicing in hospitals, HMOs, long-term care facilities, home-care agencies, and other health care systems
American Society of Health-System Pharmacists (ASHP)
This regulatory body sets standards for compounding, manufacturing and distribution of drugs and related products in the US, most of which are referenced in federal and state laws
United States Pharmacopeial Convention (USP)
This act required insurance companies to offer the same rates regardless of preexisting conditions
Patient Protection & Affordable Care Act of 2010
This law went into effect as a result of hundreds of people getting fungal infections from inappropriately compounded medications - gave the FDA oversight of large compounding operations
Drug Quality & Security Act of 2013
This law states that pharmaceutical companies must test on children if the new drugs are likely to be used to treat children
Pediatric Research Equity Act of 2003
This regulatory body establishes standards and monitors compliance for nearly 20,000 health-care programs in the US
The Joint Commission (TJC)