PTCB Laws & Orgs

Controlled Substance Act

Drug schedules, DEA

HIPPA (Health Insurance Portability and Accountability Act)

Patient Privacy

PPPA (Poison Prevention Packaging Act)

Child resistant containers

Doesn’t apply to meds with special way of taking (i.e. sublingual nitroglycerin, oral contraceptives, dissolving or powered aspirin / acetaminophen)

Durham - Humphrey

Rx v.s. OTC

Kefauver - Harris

Ensures safety and effectiveness of drugs

FD&C Act

Gave FDA power over safety of food, drugs, medical devices, and cosmetics

Orphan Drug Act

Encouraging the development of drugs for rare diseases

CMEA (Combat Methamphetamine Epidemic Act)

Regulations for behind the counter pseudoephedrine products

OBRA ‘90 (Omnibus Budget Reconciliation Act)

DUR and Counseling

DSCSA (Drug Supply Chain Security Act)

Enforces NDC for drug tracking to prevent counterfeit medications

Ryan Haight Act

Require prescribers to do a medical evaluation before allowing them to prescribe online

FDA (Food and Drug)

Drug approvals and recalls

DEA (Drug Enforcement Administration)

Controlled substances

CDC (Centers for Disease Control and Prevention)

Info on vaccines and immunization schedules

USP (US Pharmacopia)

Compounding regulations

ISMP (The Institute for Safe Medication Practices)

Ensures safe medication use and error prevention

NIOSH (National Institute for Occupational Safety and Health)

Researches hazardous drugs info for worker safety

VAERS

Vaccine Adverse Event Reporting

MedWatch

Drug/device adverse event reporting

BCMA (Bar Code Medication Administration)

Barcode scanning to prevent errors

REMS (Risk Evaluation and Mitigation Strategies)

Extra safety requirements for certain high-risk drugs