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Chapter 2
Pharmacy Law, Ethics, & Regulatory Agencies/Terms & Definitions
| Term | Definition |
|---|---|
| Act | A bill that becomes a law. |
| Amendment | A change to a law. |
| Barbiturate | A drug that slows the central nervous system. |
| Board of Pharmacy (BOP) | State agency that regulates pharmacies. |
| Boxed Warning | FDA's strongest drug warning. |
| Controlled Substance | Drug regulated because of abuse potential. |
| Drug Diversion | Illegal transfer or misuse of drugs. |
| US Drug Enforcement Administration (DEA) | Enforces controlled substance laws. |
| Drug Utilization Evaluation (DUE) | Review of medication use for safety and effectiveness. |
| Ethics | Professional standards of right and wrong. |
| Health Insurance Portability and Accountability Act (HIPAA) | Law that protects patient health information. |
| Legend Drug | Prescription-only drug. |
| Medicaid | Health insurance for low-income individuals. |
| Medicare | Health insurance mainly for people age 65+. |
| Misbranding | False or misleading drug labeling. |
| Monograph | Official drug information and standards. |
| Morals | Personal beliefs about right and wrong. |
| Narcotic | Pain-relieving drug that can cause dependence. |
| National Drug Code (NDC) | Number that identifies a drug product. |
| National Formulary (NF) | Book of official drug standards. |
| Negligence | Failure to use reasonable care. |
| Occupational Safety and Health Administration (OSHA) | Agency that promotes workplace safety. |
| Omnibus Budget Reconciliation Act of 1990 (OBRA-90) | Law requiring patient counseling and drug reviews. |
| Over-the-Counter (OTC) | Drug sold without a prescription. |
| Physicians' Desk Reference (PDR) | Drug information reference book. |
| Pregnancy Categories | FDA system for pregnancy drug risk. |
| Protected Health Information (PHI) | Patient health information protected by HIPAA. |
| Pure Food and Drug Act of 1906 | Law against drug adulteration and misbranding. |
| Safety Data Sheet (SDS) Formerly known as Material Safety Data Sheet (MSDS) | Document with chemical hazard information. |
| The Joint Commission (TJC) | Accredits healthcare organizations. |
| Tort | Harm caused by negligence or intentional action. |
| United States Pharmacopeia (USP) EST. 1820 | Sets quality/purity standards for drugs & they can enforce. |
| United States Pharmacopeia-National Formulary (USP-NF) | Official publication of drug quality standards. |
| US Food and Drug Administration (FDA) | Ensures drug safety and effectiveness. |
| Drug Supply Chain Security Act of 2013 (DSCSA) | Law that tracks prescription drugs through the supply chain to prevent counterfeit drugs. |
| Adulteration | Drug contamination or loss of quality. |
Created by:
Yolypooh
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