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Pharmacy Practice and the Law
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package insert, prescription drugs
federal regulations
pharmaceutical manufacturers association V. food and drug administration - pharmaceutical manufacturers association V. food and drug administration
ramon V. farr (1989) - Ramon V. Farr
Pharmaceutical Manufacturers Association v. Food and Drug Administration
proposed electronic distribution of
REMS
packaging regulations
pain medication addition, duty to intervene
Park Doctrine
partial fills, prescriptions
Dispensing of Schedule II Controlled Substances
Dispensing of Schedule III, IV, and V Controlled Substances
patents
Drug Price Competition and Patent Term Restoration Act (PTRA) of 1984
issues
Patent Term Restoration Act (PTRA)
patient
drug information website for consumers and health professionals
information and Medication Guides
patient package inserts
authorizations
drug information website for pharmacists
Patient Package Inserts
prescription drug labeling information for
patient counseling and patient information
Patient Protection and Affordable Care Act of 2010 (ACA)
Expedited Approval of Drugs Intended to Treat Serious or Life-Threatening Illnesses ("Fast Track Approval") (§ 506)
Medicare Part D
FDA Safety and Innovation Act of 2012
Patient Safety and Quality Improvement Act of 2005
patient safety work product (PSWP)
pay for delay agreements
See prescription benefit managers (PBMs)
Fourteen-day Dispensing Cycle
Medicare Part D
Preface
See prescription benefit managers (PBMs)
State Regulation of Third-Party Plans
Federal Antitrust Laws
Medicaid
Overview of Important Developments in Medicaid and Prescription Drug Reimbursement
Regulation of Managed Care Plan Formularies/Drug Pricing
State Legislative Efforts to Regulate Third-Party Plans
The Sherman Antitrust Act
See Prescription Drug Marketing Act of 1987 (PDMA)
Drug Supply Chain Security
Historical Overview of the Federal Food, Drug, and Cosmetic Act
Kennedy v. Kentucky Board of Pharmacy
Prescription Drug Marketing Act of 1987
See Prescription Drug Marketing Act of 1987 (PDMA)
Federal Regulation of Medications: Dispensing
Importation of Prescription Drugs for Personal Use
Penalties
Prescription Drug Marketing Act of 1987
See Prescription Drug User Fee Act of 1992 (PDUFA)
FDA Safety and Innovation Act of 2012
Food and Drug Administration Modernization Act of 1997
Medical Device User Fee and Modernization Act of 2002
Preface
See Prescription Drug User Fee Act of 1992 (PDUFA)
FDA Reauthorization Act of 2017
Food and Drug Administration Amendments Act of 2007
Historical Overview of the Federal Food, Drug, and Cosmetic Act
New Drug Approval
Prescription Drug User Fee Act of 1992
The Road to an Approved New Drug Application
Pearson v. Shalala (1999)
penalties
and enforcement, HIPAA
drug trafficking offenses
illegal possession
Prohibited Acts, Penalties, and Enforcement
distributing or dispensing in violation of CSA
form 222 violation
in PDMA
state board discipline
Pennsylvania Pharmaceutical Association v. Department of Public Welfare (1982)
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
Shalala (1998)
Importance of the Orange Book in Generic Substitution
Pfizer, Inc. v. Shalala
pharmaceutical care model
Food and Drug Administration (1980)
Explanation of the Durham-Humphrey Amendment
Pharmaceutical Manufacturers Association v. Food and Drug Administration
Patient Package Inserts
Pharmaceutical Research and Manufacturers of America (PhRMA)
The Patient Safety and Quality Improvement Act of 2005
Prescription Drug Advertising: Manufacturer to Professionals
Pharmacist's Guide to Prescription Fraud
pharmacist care
pharmacists
absence of
definition
drug information website
licensing overview
pharmacist-in-charge (PIC)
reinstatement of revoked licenses
strict liability and
and product liability
disciplinary actions, overview
impaired pharmacist programs
malpractice insurance
Pharmacists and Product Liability
risk management role
pharmacy and therapeutics (PandT) committee
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