Proposed Rule Less Restrictive for Constituent Materials

Biologics manufacturers could gain some leeway on constituent materials under a rule the FDA has proposed in response to technological advances in development and manufacturing.

Current regulations on constituents such as preservatives, diluents, adjuvants, extraneous protein and antibiotics in biological products may be “unnecessarily restrictive,” according to the FDA notice published in the March 30 Federal Register.

For example, current preservative requirements do not allow the FDA to consider the use of preservative-free vaccines in multiple-dose containers, outside of listed exceptions.
Drug GMP Report