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Pharmacy Practice and the Law
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case citation and analysis
causation, malpractice
Cazes v. Raisinger (1983)
See change being effected (CBE) supplement
Drug Price Competition and Patent Term Restoration Act of 1984
New Drug Approval
See change being effected (CBE) supplement
The Road to an Approved New Drug Application
Whether FDA-Approved Labeling Preempts State Product Liability Actions
Center for Biologics Evaluation and Research, FDA
Center for Devices and Radiological Health, FDA
Center for Drug Evaluation and Research (CDER), FDA
Centers for Medicare and Medicaid Services (CMS)
Background
laws made by
Centocor, Inc. v. Hamilton et al. (2012)
central fill pharmacy
Central Hudson Gas v. Public Service Commission (1980)
Certificate of Registration
application for
revocation of - Daniel Family Pharmacy
certification requirements, electronic transmission prescriptions
See current good manufacturing practices (CGMP)
Adulteration
Cosmetics
Current Good Manufacturing Practice
Defining and Distinguishing Drugs from Foods, Dietary Supplements, Devices, and Cosmetics
Dietary Supplements vs Drugs
Drug Quality and Security Act of 2013
Drug Quality and Security Act of 2013
FDAMA's Compounding Provisions (§ 503A): Later Reinstated as § 503A Under the DQSA
Medical Devices
Pharmacy Compounding vs Manufacturing
See current good manufacturing practices (CGMP)
change being effected (CBE) supplement
The Road to an Approved New Drug Application
Whether FDA-Approved Labeling Preempts State Product Liability Actions
chart orders
Chemical Diversion and Trafficking Act (1988)
child-resistant containers
Cholestin
citizenship requirements, licensing
civil court procedures
civil law, overview
Civil Rights Act of 1964
claims
Dietary Supplement Health and Education Act 1994
false advertising
False Claims Act
food health claims
health/disease
classification system
Schedule I (Drugs and Other Substances)
schedule I drugs
schedule II drugs
schedule III drugs
schedule IV drugs
schedule V drugs
clinical judgment exercises
clinical trials
application for registration
informed consent
investigational drugs, access to
Investigational New Drug (IND) application
registration requirements
Clozaril Patient Management System
See consumer medication information (CMI)
Approved Drugs for Off-Label (Unlabeled) Indications
Prescription Drug Labeling Information for the Patient
See consumer medication information (CMI)
Useful Written Patient Information and Medication Guides
CMS
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