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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 - pharmaceutical manufacturers association V. food and drug administration
proposed electronic distribution of
ramon V. farr (1989) - Ramon V. Farr
REMS
packaging regulations
pain medication, prescription validity
pain medication addition, duty to intervene
parallel track policy
Park Doctrine
Parker v. Yen (1991)
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
authorizations
drug information website for consumers and health professionals
drug information website for pharmacists
information and Medication Guides
Patient Package Inserts
patient package inserts
prescription drug labeling information for
patient counseling and patient information
patient package inserts
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)
FDA Safety and Innovation Act of 2012
Medicare Part D
Patient Safety Act
Patient Safety and Quality Improvement Act of 2005
patient safety organizations (PSOs)
patient safety work product (PSWP)
Patterson Drug Co. v. Kingery (1969)
pay for delay agreements
See prescription benefit managers (PBMs)
Federal Antitrust Laws
Fourteen-day Dispensing Cycle
Medicaid
Medicare Part D
Overview of Important Developments in Medicaid and Prescription Drug Reimbursement
Preface
Regulation of Managed Care Plan Formularies/Drug Pricing
See prescription benefit managers (PBMs)
State Legislative Efforts to Regulate Third-Party Plans
State Regulation of Third-Party Plans
The Sherman Antitrust Act
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
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