Antibiotics regulations

FDA issues direct final rule eliminating citations and references to section 507 of the FDC Act. It will remove references to the certification of antibiotics, to antibiotics certification regulations, and to specific antibiotics monographs as well as references to all types of antibiotic drug applications. The rule will become effective May 19 and written comments will be accepted until March 20. Section 507, which set policy for antibiotics certification, was repealed by a direct final rule published May 12, 1998. Certification procedures and standards for antibiotics (21 CFR parts 430 through 460) were struck as well. FDA is considering a third phase to resolve issues arising from the change in regulatory coverage from section 507 to 505