Agencies & Organizations
This agency establishes standards for hospital accreditation
What is The Joint Commission (TJC)?
This act prohibits the interstate transportation or sale of adulterated or misbranded medications and food
What is Pure Food and Drug Act of 1906
This agency regulates the manufacturing, distribution, prescribing, and dispensing of controlled substances.
What is the Drug Enforcement Administration (DEA)
This agency regulates and administers Medicare, Medicaid, and several other health programs
What is the Centers for Medicare & Medicaid Services (CMS)?
This act, which was an amendment to the FDCA of 1938, was enacted to ensure that all medications are pure, safe, and effective.
What is Kefauver–Harris Amendments of 1962?
This organization operates the National Medication Errors Reporting Program and the National Vaccine Errors Reporting Program
What is the Institute for Safe Medication Practices (ISMP)?
This act requires products to include the federal legend: “Caution: Federal law prohibits dispensing without a prescription
What is Durham-Humphrey Amendment of 1951
This act provides requirements for handling anabolic steroids, including registration, labeling, and criminal liability
What is Anabolic Steroid Control Act of 1990 (amended 2004)
This act provides voluntary prescription medication benefits to Medicare beneficiaries (Medicare Part D
Medicare Modernization Act of 2003 (MMA)
This agency must approve medications before they can be sold in the U.S. and regulate the advertising of prescription medications as well as the labeling of both prescription and OTC medications
What is the FDA?
This agency provides specific information about all approved medications in the U.S.
Food and Drug Administration (FDA)
This act requires most oral prescriptions to be dispensed in child-resistant containers unless requested otherwise
Poison Prevention Packaging Act of 1970 (PPPA)
This act created a new category of products called Scheduled Listed Chemical Products (SLCPs), including pseudoephedrine
What is the Combat Methamphetamine Epidemic Act of 2005 (CMEA)?
This act requires pharmacists to keep records of all medications used by Medicaid patients, typically by creating patient profiles
What is Omnibus Budget Reconciliation Act of 1990 (OBRA ’90)?
This organization establishes standards for the identity, strength, quality, and purity of medicines, dietary supplements, and compounded preparations
What is United States Pharmacopeia (USP)?
This organization addresses issues facing the practice of pharmacy and administers the MPJE and NAPLEX
What is the National Association of Boards of Pharmacy (NABP)
This act assigned a specific 10-digit identification number known as a National Drug Code (NDC)
Drug Listing Act of 1972
This term means a drug does not conform to quality, strength, or purity standards
Adulteration
This agency regulates pharmacy operations through inspections and monitoring compliance with laws
What is State Boards of Pharmacy?
These chapters within USP-NF are of special importance to pharmacy technicians, covering non-sterile compounding, sterile compounding, and hazardous drugs.
What are chapters USP <795>, USP <797>, USP <800>?
This agency ensures safe and healthful working conditions by establishing and enforcing standards
What is Occupational Safety and Health Administration (OSHA)
This act outlines steps to identify and trace prescription medications as they move through the U.S. supply chain
Drug Supply Chain Security Act of 2013 (DSCSA)
This act regulates medications with high potential for substance use disorder and addiction—including narcotics, amphetamines, and barbiturates—by requiring DEA registration numbers for prescribers and authorizing the DEA to oversee manufacturing, distribution, and dispensing
What is Controlled Substances Act of 1970 (Comprehensive Drug Abuse Prevention and Control Act)
This agency implemented the CPE Monitor system for continuing education documentation
What is the National Association of Boards of Pharmacy (NABP)
This organization establishes standards for the identity, strength, quality, and purity of medicines, dietary supplements, and compounded preparations, including chapters
What is United States Pharmacopeia (USP)?