PTCB Laws

1906 Pure Food and Drug Act

One of the first laws enacted to stop the sale of inaccurately labeled drugs All manufacturers required truthful info on labels Amended to require manufacturers to prove effectiveness

1914 Harrison Narcotics Act

People could no longer purchase opium without a prescription

1938 Federal Food, Drug, and Cosmetic Act

Enacted as a more strict Pure Food Drug Act and to include cosmetics. Made adulteration and misbranding Label addictive substances. Require package inserts for safe drug use

1951 Durham-Humphrey Amendment

Divided drugs into Rx and OTC

1962 Kefauver-Harris Amendments

“Kneed” to know the safety & efficacy of drugs

1970 Comprehensive Drug Abuse Prevention and Control Act (controlled substance act)

Formed DEA Made Controlled Drug Classes

1970 Poison Prevention Packaging Act

Required manufacturers and pharmacies to place all medications in child proof containers

1972 Drug Listing Act

Made NDC Every drug has a unique 10 digit code divided into 3 segments (Make the drug then package it). 1: Manufacturer info (Make the) 2: Drug info (Drug then) 3: Package info (Package it)

1983 Orphan Drug Act

Encouraged companies to develop drugs for rare diseases by providing support and incentive to manufacturers

1990 OBRA (Omnibus Budget Reconciliation Act)

Changed reimbursement limits Mandated drug utilization review Connected patients with sources of consultation & education

2005 Combat Methamphetamine Epidemic Act

Regulates production & sale of pseudoepinephrine 3.6 g / day 9 g / month 7.5 g / month (by mail order