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Pharmacy Practice and the Law
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radiopharmaceuticals
Farr (1989)
Approved Drugs for Off-Label (Unlabeled) Indications
Ramon v. Farr
reasonable safeguards
rebates
recalls
recordkeeping
red flags
red yeast rice
refill reminder exception
refills
authorization of
authorization of
dispensing of prescriptions
long-term care facilities
multiple refills written on same day
schedule III, IV, and V substances
registration, CSA
applications for
denial, revocation, or suspension
dispensing
distribution
exemptions
manufacturing
modification, transfer, or termination
research with controlled substance
separate registrations
registration number, DEA
regulation
approaches
for outcomes
of managed care plan formularies
of prescription drug samples
reasons for
State Regulation of Third-Party Plans
reimbursement for drugs
reimportation of drugs
See risk evaluation and mitigation strategies (REMS)
Bibliography
Drug Price Competition and Patent Term Restoration Act of 1984
Food and Drug Administration Amendments Act of 2007
Historical Overview of the Federal Food, Drug, and Cosmetic Act
New Drug Approval
Preface
Prescription Drug Labeling Information for the Patient
Purpose of a Controlled Substance Prescription
See risk evaluation and mitigation strategies (REMS)
The Road to an Approved New Drug Application
Useful Written Patient Information and Medication Guides
Renacidin
repackaging drugs
adulteration regulations
Food, Drug, and Cosmetic Act offenses
manufacturing, defined
reregistration, applications for
research, with controlled substance
Res ipsa loquitur
Restatement (Second) of Torts, Section 402A
retail community pharmacy
retail pharmacy
retrospective review, drug use review
reverse payment agreements
Riegel v. Medtronic, Inc. (2008)
Riff v. Morgan Pharmacy (1986)
right-to-try laws
risk evaluation and mitigation strategies (REMS)
Drug Information Website for Consumers and Health Professionals: Drugs@FDA
FDA Safety and Innovation Act of 2012
The Road to an Approved New Drug Application
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