EXAM 1 Flashcards
Why do we study law?
- Tells us the minimal competency and actions that are acceptable
- if we dont meet what is acceptable, we need to be held accountable
Laws enacted by Congress?
Federal
Laws enacted by Legislature?
State
What do regulations do?
administration enactments authorized by statutes (DEA, FDA, etc.)
What is common law?
-Body of principles based on custom and usage (UK)
- Basis for American Law
What is Judicial or Case Law derived from?
judicial decision and interpretations of statutes
What does the Federal Government regulate?
Manufacturing, packaging, storage, labeling, and labels, distribution and authorized use of pharmaceuticals
Why do we regulate drugs?
- continue new drug development and creation of drugs that are public good
-safe production and use of drugs
-mitigate information asymmetry
What does the federal government require?
Label requirements; auxiliary labels and definitions
-clarify, provide additional information or reinforce primary label
- “shake well”, “refrigerate”, etc.
What does the federal government define?
Control substances act of 1970:
-defines agents, authorized possession and acquisition, storage and inventory, and limitations on distribution
-enforced by the DEA
-pharmacies needing to be registered with the DEA
What do the state governments do?
Defines the personnel and conditions for the storage and distribution of pharmaceuticals on an individual basis
-pharmacists, technicians, interns, assistants
What is the USP?
-United States Pharmacopoeia
Information for USP
-founded: 1820’s by M.D.s
-initial goal: standardized names and formulations of medicines
-effort: defined 217 products (today > 3200)
mission of USP?
promote public health by disseminating:
-standard of quality
-authoritative information
What is the “Standard of Quality”?
-strength, quality, purity, packaging and labeling of “drug products”
–inclusive of drug entity, dosage form, medical devices, diagnostic products
-information disseminated through official compendia: USP-NF
What is authoritative information?
1978-2004: The USP dispensing information series
Now: Periodic monographs
in authoritative information, what is the model guidelines for the medicare prescription drug act (medicare part d) for?
focus: establishing/monitoring outcomes in disease states where intervention/prevention can make a difference
What is the Basis of Authority?
-Vested in the Federal Law
–Federal food drug and cosmetic act of 1938 (OBRA ‘90); Medicare prescription drug, improvement and modernization act 2003
-adopted by individual state pharmacy acts
What is the APhA?
American pharmacist association
-oldest of pharmacy professional societies
represents all aspects of pharmacy
-established “mission” for pharmacy practice which sets the basis for “Pharmaceutical Care”
-involved in establishing policy for pharmacy practice and federal legislative and regulatory initiatives
What is the “Pure food and drug act of 1906”?
prohibited foods and drugs that were distributed though interstate commerce to be adulterated or misbranded
what wasn’t required according to the “pure food and drug act of 1906”?
-manufacturers listing ingredients
-manufacturers labeling directions for use
-regulation of cosmetic products and medical devices
Why was the “Food, drug and cosmetic act of 1938” written?
a result from 107 deaths that occurred from the liquid SULFANILAMIDE in 1937
What does the Food, drug and cosmetic act of 1938 require?
-any NEW DRUG can’t be marketed unless it’s been proven to be safe when used according to directions on the label
-labels needing adequate directions for use
-warnings about habit-forming drugs contained in the product
What does the food, drug and cosmetic act of 1938 apply to?
-medications
-cosmetic products
-medical devices