Pharmacy Law Flashcards
Administrative Law
from executive branch
common law
case law/ from judicial branch
Food Drug & Cosmetic Act
FD&C
requires proper labeling or branding of products & inside the container cannot be changed from the label
Durham-Humphrey Amendment
prohibits dispensing legend drugs without a prescription
Kefauver- Harris Amendment
all medications must be pure, effective, and safe to use on humans
prescription drug advertising under the FDA
manufactures must have inspections
Controlled Substance Act
CSA
requires the pharmaceutical industry to keep records and maintain security measures for certain medications
Poison Prevention Packing Act
PPPA
standards for child resistant packaging
Occupational Safety and Health Act
OSHA
prevent workplace disease and injury
Drug List Act
assigns the unique and permanent NDC
Federal Hazardous Substance Act
FHSA
use & disposal of hazardous material
Personal Protective Equipment
PPE
mask, gowns, gloves, etc.
Orphan Drug Act
ODA
offers financial help to organizations that develop Orphan drugs
Omnibus Budget Reconciliation Act
OBRA
maintaining patient profiles
offer counseling to patients
DUR
Drug Utilization Reviews
DUR
reviews of patient profiles to ensure medications dispensed were correct
Anabolic Steroids Control Act
allows the CSA to regulate anabolic steroids
became CIII drug
Health Insurance Portability and Accountability Act
HIPAA
PHI
patient privacy, security, and transaction regulations
PT must know
PHI
Protected health information
FDA Modernization Act
reformed the old FDA
safe pharmacy compounding and the regulation of medical devices
Combat Methamphetamine Epidemic Act
intended to stop the use of illegal drug methamphetamine
regulates drug trafficking that is used to finance terrorism
controls purchases of drugs listed
State Pharmacy Board
BOP
every state has one
establish state-specific pharmacy laws & regulations
licenses/certification and board exams
Drug Enforcement Agency
DEA
federal body that regulates controlled substance laws
Food and Drug Administration
FDA
the safety and effectiveness of foods, med, cosmetics and radioactive substances
MedWatch
info about adverse events or product problems
Joint Commission on Accreditation of Health Organizations
JCAHO
accredits and certifies healthcare organizations in the U.S.
independent/ non-profit
improve safety and quality of healthcare
National Association of the Board of Pharmacy
NABP
assists the BOP to protect public health by developing uniform standards
reduce the likelihood of errors and public harm
