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100

Class of recall in which there is a strong likelihood of the product causing serious adverse effects or death

Class I

100

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)

100

Law intended to stop the recreational use of opium by making narcotics prescription drugs

1914 Harrison Narcotic Act

100

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

informed consent
100

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

200

First important law to regulate the development, compounding, distribution, storage, and dispensing of drugs

1906 Pure Food and Drug Act

200

This agency’s primary function is to issue regulations for infection control

Centers for Disease Control and Prevention (CDC)

200

This act made anabolic steroids a controlled substance under the regulations of the Controlled Substances Act

1990 Anabolic Steroid Control Act

200

This law regulates how and when covered entities can disclose protected health information (PHI)

Health Insurance Portability and Accountability Act of 1996

200

Functioning as a part of the US Department of Justice, this agency is responsible for enforcing all controlled substance laws

Drug Enforcement Agency (DEA)

300

This law requires pharmacists to counsel Medicaid patients and provide a Drug Utilization Review (DUR)

1990 Omnibus Budget Reconciliation Act (OBRA 90)

300

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

300

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

300
After the sulfanilamide tragedy, this law required manufacturers to file new drug applications with the FDA and regulated cosmetics and medical devices

1938 Food, Drug, and Cosmetic Act (FDC)

300

This law ensures a safe and healthy work environment for all employees

Occupational Safety and Health Act of 1970 (OSHA)

400

This act established the National Drug Code (NDC)

Drug Listing Act of 1972

400

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

400

A type of negligence lawsuit brought against a person with a professional license

Malpractice

400

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

400

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)

500

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)

500

This act required insurance companies to offer the same rates regardless of preexisting conditions

Patient Protection & Affordable Care Act of 2010

500

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

500

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

500

This regulatory body establishes standards and monitors compliance for nearly 20,000 health-care programs in the US

The Joint Commission (TJC)