HISTORY OF THE FDA AND THE FDCA

1951 Durham Humpery Amendment

Clear distinction of RX and OTC drugs.

2013 The drug quality security act

Created the difference between compounding pharmacies and compounding outsourcing facilities and it established track and trace requirements for pharmaceuticals.

1997 Food and Drug Administration Modernization Act

Established the first safe harbor for compounding by pharmacist.

1976 Medical Device Amendment

Establishes quality control procedures for devices and require performance standards/ premarket approval for some devices.

What does FDCA stand for?

Federal Drug Cosmetic Administration

What does FDA stand for ?

Federal Food Drug Administration

1906 Pure Food & Drug Act

Prohibited interstate commerce in misbranded adulterated foods and drugs.

1938 The Food Drug Cosmetic Act

Require new drugs to be shown safe before marketing.

1962 Kefauver Harris

Required new drug sponsors to show efficacy of their product prior to marketing.

1984 Drug Price Competition and Patent Term Restoration Act

Rushes the availability of generic products after patent (a governmental authority or license conferring a right or title for a set period) expiration of the innovator product.

What does the FDA do?

They assure the safety and efficiency of nations drug supply.

2007 Risk Evaluation and Mitigation Strategies

To assure safe use of safe drugs