Skyscape Web Viewer : Pharmacy Practice and the Law : Main Index

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Drug Price Competition and Patent Term Restoration Act (PTRA) of 1984 drug manufacturer controversial practices Drug Price Competition and Patent Term Restoration Act of 1984 generic drug labeling controversies healthcare practitioners controversies Importance of the Orange Book in Generic Substitution section 505(b)(2) NDAs The Generic Drug Enforcement Act of 1992
drug product liability defects Drug Product Liability duty to warn labeling and liability overview pharmacists and
Drug Quality and Security Act of 2013 (DQSA)
drug recalls
drug regimen review (DRR) Harder v. F. C. Clinton, Inc. Labeling of Drugs and Biologicals
drug-related cases, causation in
drug supply chain
Drug Supply Chain Security Act (DSCSA) of 2013
drugs
drug therapy
drug trafficking
drug use review (DUR) Horner v. Spalitto (1999) - Horner v. Spalitto overview standards of practice state regulations
See Dietary Supplement Health and Education Act of 1994 (DSHEA) Defining and Distinguishing Drugs from Foods, Dietary Supplements, Devices, and Cosmetics Dietary Supplement Health and Education Act of 1994 Dietary Supplements vs Drugs Historical Overview of the Federal Food, Drug, and Cosmetic Act Nutrilab, Inc., et al. v. Schweiker See Dietary Supplement Health and Education Act of 1994 (DSHEA) United States v. Hiland
See direct-to-consumer (DTC) Drug Advertising and Promotion Prescription Drug Advertising: Manufacturer to Consumer Prescription Drug Advertising: Manufacturer to Professionals See direct-to-consumer (DTC) The First Amendment to the U.S. Constitution
Due process
See drug use review (DUR) Ancillary Pharmacy Personnel Background Basic Framework of OBRA ‘90 Components of Prospective Drug Use Review Horner v. Spalitto Licensing of Pharmacies Practice of Pharmacy Defined Prospective Drug Utilization Review See drug use review (DUR) Standards of Practice The Omnibus Budget Reconciliation Act of 1990 The Sherman Antitrust Act
durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS)
Durham, Carl
Durham-Humphrey Amendment (1951) expiration or beyond-use dating explanation of labeling requirements law overview Pharmaceutical Manufacturers Association v. Food and Drug Administration prescription to over-the-counter status changes prescription vs. over-the-counter classification professional practice considerations switch of prescription drugs to over- the-counter drugs written, oral, and electronic prescriptions
duty of care
duty to warn drug product liability Duty to Warn Under Strict Liability expanded responsibilities happel V. Wal-mart Stores, Inc. (2002) - Happel V. Wal-mart Stores, Inc. horner V. spalitto (1999) - Horner V. Spalitto
Eastern Railroad Presidents Conference v. Noerr Motor Freight (1961)
See emergency contraception (EC) Professional Practice Considerations See emergency contraception (EC) The Durham-Humphrey Amendment of 1951
See ephedrine alkaloid dietary supplement (EDS) products Dietary Supplements vs Drugs See ephedrine alkaloid dietary supplement (EDS) products
education, licensure requirements
educational programs, OBRA ‘90
efficacy claims Drug Efficacy Study Implementation (DESI) federal regulations, history of narrow therapeutic index (NTI) drugs over-the-counter drug review united states V. rutherford (1979) - United States V. Rutherford
electronic DEA order system
electronic health records
electronic prescriptions dispensing Electronic Transmission Prescriptions Issuance of Prescriptions Medicare schedule III, IV, and V substances schedule II substance state electronic prescription monitoring programs (PMPs)