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FDA Finalizes Rule on Biologic Inspections a Year After Pulling the Rule

Posted 01 April 2019 | By Zachary Brennan 

FDA Finalizes Rule on Biologic Inspections a Year After Pulling the Rule

As part of President Donald Trump’s “two out, one in” executive order on new regulations, the US Food and Drug Administration (FDA) on Monday finalized a rule to amend biologics regulations related to time of inspection requirements and to remove certain inspector requirements.

The finalization of the rule comes a little less than a year after FDA withdrew the same rule due to “significant adverse comment.”

As the agency said when it previously proposed the rule, the revision and removal of these biologic regulations are designed to eliminate outdated inspection requirements and accommodate a risk-based inspection approach.

But FDA does address the five comments it received on the proposed rule, explaining why a risk-based inspection approach will not have negative health consequences. And while some biologic establishments may be inspected less frequently than every two years, FDA says “these establishments will have been determined to be at a lower risk based on the Agency's evaluation.”

The known safety risks that FDA must consider in establishing such a risk-based schedule are outlined in section 510(h)(4) of the FD&C Act, FDA says.

“In addition, the resources saved by performing less frequent inspections at lower risk establishments will allow FDA to inspect those establishments deemed higher risk more frequently when needed. We reiterate that the removal of these regulations will not change the establishment inspection requirements and duties of an investigator requirements specified in sections 704 and 510(h) of the FD&C Act and section 351(c) of the PHS Act,” FDA said.

Specifically, this final rule revises the biennial inspection requirement in § 600.21 to make way for a risk-based schedule, and removes § 600.22(a) through (h), which FDA said “are duplicative of statutory requirements that apply to biological product inspections under section 704 of the FD&C Act.”

From 2016 to today, FDA’s Center for Biologics Evaluation and Research has issued just eight warning letters. By comparison, FDA’s Center for Drug Evaluation and Research’s Office of Manufacturing Quality has already issued six warning letters in the first three months of 2019.

Final Rule

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