• prohibited adulterated and misbranded foods and drugs from interstate commerce
• did not address false statements about drugs
• did not require labels to list all ingrediets
• did not extend to cosmetics
• had no authority to ban unsafe drugs

• controlled traffic of narcotics by making containers bear a tax stamp
• exceptions:
  • written and legal prescription
  • licensed prescriber

• passed as result of the diethylene glycol disaster (used in sulfanilamide)
• required that drugs be
  
  • tested for safety
  • labeled to inform consumers of contents
  • warn if the product was habit-forming
  • bear adequate directions for use

• drugs that were taken under medical supervision could be exempt from the FDCA
  • *** had to be labeled with a legend (aka "Rx only")
• mandated ordering and refilling by a licensed prescriber and dispensing by a licensed pharmacist

• reaction to the thalidomide tragedy in children
• require manufacturers to:
  • prove effectiveness and safety of drugs
  • follow Good Manufacturing Practices
  • obtain informed consent of study subjects and report adverse events
• FDA would control prescription drug advertising and review new drug applications

• consolidated all federal laws related to drugs of abuse
• consolidated the agencies involved in drug abuse control into the Drug Enforcement Administration (DEA)
• limited handling of certain drugs to individuals registered with the DEA

• financial incentives for developing drugs for diseases that affect fewer than 200,000 US citizens
• over 190 drugs have been approved through this program

• allowed for accelerated approval of generic versions of existing drugs as long as the drug product was bioequivalent
• clinical trials do not have to be repeated

• prevented retail sales of:
  • substandard or counterfeit drugs
  • samples
  • re-imported drugs
  • discounted drugs from charitable institutions

Anabolic Steroids Control Act

Omnibus Budget Reconciliation Act of 1990 (OBRA)

• anabolic steroids were considered controlled substances
• Medicare/Medicaid:
  • only drugs proved safe and effective would be reimbursed
  • off-label/unlabeled uses would not be reimbursed
  • pharmacists must offer counsel to patients
  • drug utilization reviews

Prescription Drug User Fee Act (1992)

"PFUDA"

• manufacturers can pay user fees for certain types of new drug applications to get FDA to decrease review time

Health Insurance Portability and Accountability Act of 1996

HIPAA

• protect privacy of personal health information

• inclusion of more women and minorities in clinical trials
• provide marketing incentives to manufacturers who conduct studies of drugs in children

• extended Medicare coverage to include prescription drugs
• "donut hole" provision

• regulates selling of List I chemicals (Scheduled Listed Chemical Products):
  • ephedrine
  • pseudoephrine
  • phenylpropanolamine
• precursors of methamphetamine for DIY ppl