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Pharmacy Practice and the Law
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See Prescription Drug Marketing Act of 1987 (PDMA)
Drug Supply Chain Security
Federal Regulation of Medications: Dispensing
Historical Overview of the Federal Food, Drug, and Cosmetic Act
Importation of Prescription Drugs for Personal Use
Kennedy v. Kentucky Board of Pharmacy
Penalties
Prescription Drug Marketing Act of 1987
Prescription Drug Marketing Act of 1987
See Prescription Drug Marketing Act of 1987 (PDMA)
See Prescription Drug User Fee Act of 1992 (PDUFA)
FDA Reauthorization Act of 2017
FDA Safety and Innovation Act of 2012
Food and Drug Administration Amendments Act of 2007
Food and Drug Administration Modernization Act of 1997
Historical Overview of the Federal Food, Drug, and Cosmetic Act
Medical Device User Fee and Modernization Act of 2002
New Drug Approval
Preface
Prescription Drug User Fee Act of 1992
See Prescription Drug User Fee Act of 1992 (PDUFA)
The Road to an Approved New Drug Application
Pearson v. Shalala (1999)
pedigree, wholesalers
penalties
and enforcement, HIPAA
distributing or dispensing in violation of CSA
drug trafficking offenses
form 222 violation
illegal possession
in PDMA
Prohibited Acts, Penalties, and Enforcement
state board discipline
Pennsylvania Pharmaceutical Association v. Department of Public Welfare (1982)
Pennsylvania State Board of Pharmacy v. Cohen (1977)
Stuart (1956)
People v. Stuart
State Authority to Regulate
(1999)
Duty to Warn Under the Learned Intermediary Doctrine
Promoting Prescription Drugs and Devices Through Social Media
per se rule
per se violations, types of
Shalala (1998)
Importance of the Orange Book in Generic Substitution
Pfizer, Inc. v. Shalala
pharmaceutical care model
pharmaceutical equivalents
Food and Drug Administration (1980)
Explanation of the Durham-Humphrey Amendment
Patient Package Inserts
Pharmaceutical Manufacturers Association v. Food and Drug Administration
Pharmaceutical Research and Manufacturers of America (PhRMA)
Prescription Drug Advertising: Manufacturer to Professionals
The Patient Safety and Quality Improvement Act of 2005
pharmacies, licensing of
Pharmacist's Guide to Prescription Fraud
Pharmacist's Manual (2010)
pharmacist care
pharmacist-in-charge (PIC)
pharmacists
absence of
and product liability
definition
disciplinary actions, overview
drug information website
impaired pharmacist programs
licensing overview
malpractice insurance
pharmacist-in-charge (PIC)
Pharmacists and Product Liability
reinstatement of revoked licenses
risk management role
strict liability and
pharmacy advertising
pharmacy and therapeutics (PandT) committee
pharmacy compounding
Compliance Policy Guide 1992
Compliance Policy Guide 2002
draft compliance guides
Drug Quality and Security Act of 2013 (DQSA)
new drug issue
other issues
patent issues
Pharmacy Compounding vs Manufacturing
USP compounding requirements
vs. manufacturing
pharmacy inspections
constitutional requirements
DEA inspections under CSA
Pharmacy Inspections
practical considerations
state pharmacy board inspections
pharmacy laws
pharmacy organizations
pharmacy practice
federal regulations
Medicare, overview
Omnibus Budget Reconciliation Act of 1990 (OBRA ‘90)
state definition of
Use of Alcohol in Pharmacy Practice
pharmacy reimbursement
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