Federal Regulations and Agencies Flashcards
Federal Food, Drug, and Cosmetics Act of 1938
all new drugs must be approved by the FDA. Also defined terms of adulteration and misbranding.
Durham-Humphrey Amendment of 1951
established drugs a legend (Rx) or non-legend (OTC) medications.
Poison Prevention Packaging Act of 1970
requires more Rx and OTC meds to be in childproof packaging. Exceptions exist, such as nitroglycerin sublingual tablets.
Occupational Safety and Health Act of 1970
established the Occupational Safety and Health Administration (OSHA), which ensures a safe workplace.
Controlled Substances Act of 1970
established 5 schedules of controlled medications, with CI being the most controlled schedule and CV being the least controlled schedule.
Omnibus Budget Reconciliation Act of 1990
OBRA ‘90 requires all patients and caregivers be offered counseling and drug therapy review by a pharmacist for all prescriptions filled.
Health Insurance Portability and Accountability Act (HIPPA) of 1996
requires healthcare providers to maintain patient information confidentiality. Establishes what is considered protected health information (PHI), how this information can be disclosed, and how to dispose of documents containing PHI.
Combat Methamphetamine Epidemic Act of 2005
subjected pseudoephedrine and epinephrine products to restricted sales, special storage, and additional recordkeeping requirements. Pseudoephedrine is limited to sales of 3.6 g per day and 9 g per 30 days.
Resource Conservation and Recovery Act
provides guidance for disposal of hazardous and nonhazardous waste.
Comprehensive Addiction and Recovery Act
expanded access to drugs and devices for reversing opioid overdose and established rules for filling CII drugs in outpatient settings.
Drug Quality, Safety, and Security Act
established standards and systems for identifying and tracing certain prescription drugs being distributed in the USA.
Pregnancy and Lactation Labeling Rule
removed pregnancy letter categories and replaced them with label subsections of Pregnancy, Lactation, and Females and Males of Reproductive Potential.
CMS
Centers for Medicare and Medicaid Services oversee Medicare and Medicaid programs.
FDA
Food and Drug Administration oversees drug purity, safety, and efficacy; issues and monitors drug recalls for adulterated or misbranded meds; regulates patient package inserts (PPI); and reviews applications for new and investigational drugs.
TJC
The Joint Commission (previously JCAHO) is an accrediting body that sets standards and grants accreditation to promote patient safety and quality of care.
