Prohibits the interstate distribution or sale of adulterated or mislabeled food, drinks, & drugs.
Created FDA; requires all drug manufacturers file a new drug application & meet the approval of FDA.
Distinguishes prescription (legend) from nonprescription (OTC) drugs; allowed phone Rx.
Required all drugs to be pure, effective, and safe to use on humans.
Requires childproof packaging on most drugs.
DEA formed; controlled substances placed into schedules (CI-CV).
Assigns a unique and permanent drug code to each medication.
Promote research & marketing of drugs needed for the treatment of rare diseases.
Requires pharmacist to offer counseling; requires pharmacies to maintain patient profiles.
Privacy/ security of patient protected health information (PHI).
Main focus is safe compounding and the regulation of medical devices.
Limits the purchase of pseudoephedrine & ephedrine