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Pharmacy Practice and the Law
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radiopharmaceuticals
Farr (1989)
Ramon v. Farr
Approved Drugs for Off-Label (Unlabeled) Indications
rebates
recordkeeping
red yeast rice
refills
authorization of
dispensing of prescriptions
multiple refills written on same day
authorization of
long-term care facilities
schedule III, IV, and V substances
registration, CSA
applications for
dispensing
exemptions
modification, transfer, or termination
separate registrations
denial, revocation, or suspension
distribution
manufacturing
research with controlled substance
regulation
approaches
of managed care plan formularies
reasons for
for outcomes
of prescription drug samples
State Regulation of Third-Party Plans
reimbursement for drugs
See risk evaluation and mitigation strategies (REMS)
Bibliography
Food and Drug Administration Amendments Act of 2007
New Drug Approval
Prescription Drug Labeling Information for the Patient
See risk evaluation and mitigation strategies (REMS)
Useful Written Patient Information and Medication Guides
Drug Price Competition and Patent Term Restoration Act of 1984
Historical Overview of the Federal Food, Drug, and Cosmetic Act
Preface
Purpose of a Controlled Substance Prescription
The Road to an Approved New Drug Application
repackaging drugs
adulteration regulations
manufacturing, defined
Food, Drug, and Cosmetic Act offenses
research, with controlled substance
reasonable safeguards
recalls
red flags
refill reminder exception
registration number, DEA
reimportation of drugs
Renacidin
reregistration, applications for
Res ipsa loquitur
retail community pharmacy
retrospective review, drug use review
Riegel v. Medtronic, Inc. (2008)
right-to-try laws
risk evaluation and mitigation strategies (REMS)
FDA Safety and Innovation Act of 2012
Drug Information Website for Consumers and Health Professionals: Drugs@FDA
The Road to an Approved New Drug Application
risk management
continuous quality improvement programs
institutional controls
malpractice overview
pharmacist as risk manager
rules for
Continuous Quality Improvement Programs as Risk Management
malpractice insurance
overview
problems and pitfalls of
strategies
Rite Aid
Rite Aid of New Jersey, Inc. v. Board of Pharmacy (1973)
Robinson-Patman Act (1936)
aftermath of portland decision
competing buyers and injury to competition
Nonprofit Institutions Act
“own use” doctrine
brand-name prescription drugs antitrust litigation
meeting competition defense
The Robinson-Patman Act
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