Pharmacy Law Drug Regulation
Important Acts to note: Read about the rest.
-Food drug and cosmetic Act of 1938: Nucleus of the pharmaceutical law
profession and their laws: very important for the safety of their patients
-Durham-humphrey Act: Labels must h
Prescriptions
Durham Humphrey Amendment of 1951: Primary goal is to legally establish
oral prescriptions and refills because prior to that you couldnt take them
-Amendment didnt contemplate electronic prescriptions
-Exempts the pharmacy label on dispensed
Chapter 1 Notes: The Law & the Legal System
A.) Nature and Role of Law
1.) General definition of law
a.) Requirements for human conduct applying to all persons within their jurisdiction
b.) Not black & white- law is inherently flexible (gives a framework)
Chapter 3: Federal Regulation of Medication: Dispensing
A.) Durham-Humphrey Amendment
1.) Establishes criteria for distinguishing prescription drugs from OTC drugs
2.) Legally establishes oral prescriptions & refills
3.) Although the Amendment did not con
Chapter 2: Federal Regulation of Medications: Development, Production, and Marketing
Part Two
A.) Nonprescription Drug Labeling
1.) User friendly format including pharmacological category or principal intended use,
cautions and warnings, adequate directio
Law Chapter 5 Typed Notes 3/28/14
A.) Controlled Substance (CS) prescriptions
1.) Defined as an order for medication dispensed to or for an ultimate user
2.) Rx does not include orders for medication dispensed for immediate administration (ie
hospital cha
Chapter 6: HIPAA notes
A.) HIPAA: Health Insurance Portability and Accountability Act of 1996
B.) HIPAA Enforcement
1.) The Office for Civil Rights- OCR
a.) HIPAA privacy rule
b.) HIPAA security rule
c.) Patient safety rule
2.) Centers for Medicare and Me
Malpractice Liability & Employment Laws
A.) Employment Laws- Federal
1.) Civil Rights Act of 1964 (Title VII Equal Employment Opportunity Act)
2.) This law makes it illegal to discriminate against someone on the basis of race, color,
religion, national or
Chapter 7: State Regulation of Pharmacy Practice
A.) Pharmacy Self-Regulation
1.) During the 19th century, pharmacists purposely chose to become self-regulating
health care professionals rather than externally regulated retail merchants
2.) Later, pharmac
Chapter 2: Federal Regulation of Medications: Development, Production, and Marketing
Part One
A.) Historical Overview of the Acts
1.) Pure Food and Drug Act 1906
2.) Food, Drug, & Cosmetic Act 1938
3.) Durham-Humphrey Amendment 1951
4.) Food Additives Ame
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