FDA Removes Biennial Inspection Requirement for Biologics Establishments

Posted 25 January 2018 | By Zachary Brennan 

FDA Removes Biennial Inspection Requirement for Biologics Establishments

Kicking off an agency-wide push to remove outdated requirements, the US Food and Drug Administration (FDA) on Thursday issued a direct final rule to remove the biennial inspection requirement for biological product establishments that are registered as drug establishments and for those that are registered as device establishments.

FDA called the biennial inspection schedule “outdated and unnecessary” because since July 2012, when  the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law, the biennial requirement was replaced with a requirement that FDA inspect drug establishments in accordance with a risk-based schedule.

In addition, FDA noted that another section of the regulations requires specific duties of an FDA inspector.

“These existing codified requirements are unnecessary because they are duplicative of statutory requirements that apply to biological product inspections under section 704 of the FD&C Act [Food, Drugs & Cosmetics Act]. Specifically, the inspection requirements in section 704 of the FD&C Act encompass all of the requirements outlined in § 600.22. Thus, we are removing § 600.22(a) through (h).

“These changes are designed to remove the existing codified requirements that are outdated and to accommodate new approaches, such as a risk-based inspection frequency for biological product establishments, thereby providing flexibility without diminishing public health protections,” FDA said in the Federal Register. “FDA is issuing these revisions directly as a final rule because the Agency believes they include only noncontroversial amendments and FDA anticipates no significant adverse comments.”

The decision to remove and amend these regulations was prompted by executive orders from President Donald Trump, under which FDA is reviewing its regulations to identify opportunities to repeal, replace or modify regulations that will result in meaningful burden reduction while allowing the agency to achieve its public health mission and fulfill statutory obligations.

In addition to the direct final rule, FDA on Thursday also released a companion proposed rule, which it said “provides a procedural framework within which the rule may be finalized in the event that the direct final rule is withdrawn because of any significant adverse comments. The comment period for the direct final rule runs concurrently with the companion proposed rule.”

FDA said any comments received within 75 days in response to the companion proposed rule will be considered as comments regarding the direct final rule.

Direct Final Rule: Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological

Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products; Companion to Direct Final Rule

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