Regulatory Affairs Syndicator

The 1941 sulfathiazole disaster and the birth of good manufacturing practices.

PDA J Pharm Sci Technol. 1999 May-Jun;53(3):148-53

Authors: Swann JP

The beginning of modern standards for good manufacturing practices can be traced to an incident that began in December 1940, when the Winthrop Chemical Company of New York put on the market sulfathiazole tablets contaminated with phenobarbital. Hundreds of deaths and injuries resulted. FDA’s investigation into Winthrop’s sulfathiazole production and the agency’s efforts to retrieve the Winthrop drug remaining on the market revealed numerous control deficiencies in the plant and serious irregularities in the firm’s attempt to recall the tainted tablets. The incident prompted FDA to require detailed controls in sulfathiazole production at Winthrop and throughout the industry, an approach that became the basis for production control standards for all pharmaceuticals.

PMID: 10754705 [PubMed - indexed for MEDLINE]