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Notice 1: The US FDA issued a ‘Proposed Rule for Comment’ in the Federal Register on Friday, 8 September, 2017.

As Senior Editor of GMP Publications and GXP News, and the Senior Auditor for The Auditing Group, I had anticipated this Proposed Rule to surface with the new Administration.  http://www.gxpnews.com/170908-GXPNews.html.

As part of the implementation of Executive Order 13771 entitled, ``Reducing Regulation and Controlling Regulatory Costs,'' and Executive Order 13777 entitled, ``Enforcing the Regulatory Reform Agenda,'' the FDA is seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations.'

Relates to the products regulated by CDER, CBER, CDRH CFSAN, CVM, Tobacco and ORA.
Comments must be issued by December 7th, 2017.

As Editor of GXP News and GMP Publications, one of my daily responsibilities is to monitor all rule changes published by the FDA Centers. Only minor Title 21 CFR rule changes have been published within the last 8 months, inconsistent with the Executive Order to reduce regulations. So, we know this was coming.

In accordance with the FDC Act, all industries which are required to comply with the regulations outlined with the US Title 21 Code of Federal Regulations, must follow all of the requirements under Title 21 which are applicable based upon ‘Risk’ and ‘Applicability’.

We need to ensure is that all of the ‘Predicate Rules’ are maintained and not compromised, to protect the efficacy, safety, purity, validity and quality of all products which are subject to Title 21 requirements. 
Before rule changes are considered, to satisfy the Executive Orders, appropriate formal risk assessments must be conducted by qualified authorities and not just the Agency based upon just public comments.  Outside quality authorities, such as GMP Auditors, Quality SMEs, and Industry must have first review, and then, those proposed changes must be issued for public comment, prior to Final Rule execution.

Risk assessments must take into consideration the ‘direct’ and ‘in-direct’ applicability as well, in accordance with a formal risk based approach.  We should not ‘run’ to modified, repealed, or replaced the regulations without due-diligence approach to risk and applicability.

 

 

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