The 1945 Penicillin Amendment required FDA testing and certification of the safety and effectiveness of all penicillin products.
Sources
- Milestones in US Food and Drug Law (fda.gov)
- https://biotech.law.lsu.edu/cases/fda/milestones.html (biotech.law.lsu.edu)
- https://stacks.cdc.gov/view/cdc/72583/cdc_72583_DS1.pdf (stacks.cdc.gov)
- https://www.usp.org/sites/default/files/fda-exhibit/topics/creation.html (usp.org)
- https://www.fdli.org/wp-content/uploads/2018/09/FDLI-Journal-73-3-Maliha.pdf (fdli.org)