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Pharmacy Practice and the Law
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Food and Drug Administration Amendments Act of 2007 (FDAAA)
Food and Drug Administration Modernization Act of 1997 (FDAMA)
Explanation of the Durham-Humphrey Amendment
Medical Device User Fee and Modernization Act of 2002
foreign manufacturers
Foreign Pharmacy Graduate Equivalency Examination
form 222 violation
formulary
Medicare Part D
Regulation of Managed Care Plan Formularies/Drug Pricing
forseeability, malpractice
fourteen-day dispensing cycle, long-term care facilities (LTCF)
Fourteenth Amendment
Fourth Amendment to Constitution
fraud
gordon V. frost (1989) - Gordon V. Frost
licensing
Medicaid
Medicare
Medicare/Medicaid Fraud and Abuse Laws
moral turpitude
prescriptions, validity of
self-referrals, Stark Law
freedom-of-choice laws
See flexible spending accounts (FSA)
Flexible Spending and Health Savings Account Debit Cards
Miscellaneous Federal Laws Related to Pharmacy Practice
See flexible spending accounts (FSA)
FTC
See federal upper limit (FUL)
Medicaid
Overview of Important Developments in Medicaid and Prescription Drug Reimbursement
Prescription Drug Coverage
See federal upper limit (FUL)
functional foods
Government Accountability Office (GAO)
Individual Patient Access to Investigational Drugs for Serious Diseases (Parallel Track Policy) (§ 561)
Overview of Important Developments in Medicaid and Prescription Drug Reimbursement
Prescription Drug Advertising: Manufacturer to Consumer
See U.S. Government Accountability Office (GAO)
Switch of Prescription Drugs to Over-the-Counter Drugs
generally recognized as safe and effective (GRASE)
General Motors Corporation v. Caldwell (1986)
Generic Drug Enforcement Act (1992)
generic drug labeling controversies
generic medications
antitrust litigation
dispensing, substitutions
Drug Efficacy Study Implementation (DESI)
Drug Price Competition and Patent Term Restoration Act (PTRA) of 1984
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
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)
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