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Pharmacy Practice and the Law
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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
pharmacy requirements, electronic transmission prescriptions
pharmacy services, LTCFs
pharmacy services administrative organizations (PSAOs)
pharmacy technicians
continuous quality improvement programs
overview
risk management
walgreen co. V. selcke (1992) - Walgreen Co. V. Selcke
Pharmanex, Inc. v. Shalala (2001)
phase IV studies
See protected health information (PHI)
Business Associates
Health Information Technology Infrastructure
Health Insurance Portability and Accountability Act of 1996
Notice Provision
Penalties and Enforcement
Protected Health Information
See protected health information (PHI)
Use and Disclosure of PHI; Right to Access
See Public Health Service Act (PHSA)
Biologics
See Public Health Service Act (PHSA)
physical dependence, defined
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