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

View All
generic medications Drug Price Competition and Patent Term Restoration Act (PTRA) of 1984 Generic Drug Enforcement Act (1992) investigational drugs, access to marketed unapproved drugs natural monopoly pfizer V. shalala (1998) - Pfizer, Inc. V. Shalala section 505(b)(2) applications winn dixie of montgomery, inc. V. colburn (1998) - Winn Dixie of Montgomery, Inc. V. Colburn “paper” new drug applications antitrust litigation dispensing, substitutions Drug Efficacy Study Implementation (DESI) Drug Price Competition and Patent Term Restoration Act (PTRA) of 1984
See Good Manufacturing Practices (GMP) Cosmetics Explanation of Adulteration Kefauver-Harris Amendment of 1962 Medical Device Amendments of 1976 See Good Manufacturing Practices (GMP)
Gonzales v. Raich (2005)
Good Manufacturing Practices (GMP) adulteration regulations establishment of Law Made by Administrative Agencies
Frost (1989) Gordon v. Frost Purpose of a Controlled Substance Prescription
government regulation, medicinal drugs
grand jury
See generally recognized as safe and effective (GRASE) Defining "New Drug" New Drug Approval Over-the-Counter Drug Review See generally recognized as safe and effective (GRASE)
Griffin v. Phar-Mor, Inc. (1992)
Griffiths v. Medical Board of California (2002)
Group Life and Health Insurance Co. v. Royal Drug Co. (1979)
guidance documents, overview
habit-forming drugs, labeling of
Haight Act (2008)
hair dyes
(2002) Expanded Responsibilities: A Judicial Compromise Happel v. Wal-Mart Stores, Inc. Rationale for Expanded Pharmacist Duties
Harco Drugs, Inc. v. Holloway (1995)
Harder v. F.C. Clinton, Inc.
Hatch-Waxman amendment
Hayes v. Travelers Insurance Co. (1992)
hazardous drugs (HDs)
See Health Care Financing Administration (HCFA) Background Medicare See Health Care Financing Administration (HCFA)
health care economic information
Health Care Financing Administration (HCFA)
healthcare practitioners controversies
health claims Dietary Supplement Health and Education Act (1994) foods, FDA requirements
health information technology, HIPAA
Health Information Technology for Economic and Clinical Health (HITECH) Penalties and Enforcement Use and Disclosure of PHI; Right to Access
Health Insurance Portability and Accountability Act (HIPAA) acknowledgment of notice business associates FTC and FCC regulations health information technology (HIT) infrastructure health information use and disclosure Health Insurance Portability and Accountability Act of 1996 notice provision penalties and enforcement policies and procedures privacy abuses, examples of protected health information training programs use and disclosure of PHI
Health Resources and Services Administration (HRSA) 340B Drugs The Patient Safety and Quality Improvement Act of 2005