Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Antibiotics regulations

Executive Summary

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 Section 507, which set policy for antibiotics certification, was repealed by a direct final rule published May 12, 1998.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
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS033407

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel