February 2021

NSF/ANSI 455-4: OTCs (Over-the-Counter Drugs)

To meet a growing concern over the quality of OTC drugs, NSF International facilitated the development of an NSF/ANSI 455 GMP audit standard specifically for OTC products.
GMP Certified NSF/ANSI 455-4 OTC Drugs

NSF International is transitioning clients from its current GMP registration (NSF/ANSI 173 Section 8 ) to NSF/ANSI 455 GMP certification to be able to certify facilities to a consensus-based national standard, and to allow manufacturers to reduce their annual audit burden.

We are currently accepting applications for audits for OTC drugs (NSF/ANSI 455-4), and the current GMP registration for OTCs will be phased out entirely by 2022.

To help you understand this new international Good Manufacturing Practice (GMP) standard, NSF has developed resources to simplify your certification process.

If you are a current NSF client, please check the Announcements section of your NSF Connect portal for additional tools.

Roadmap to Certification: We’ve broken down each section the standard to make the move to NSF/ANSI 455-4 more straightforward and to provide background information about the standard.

FAQ: Our team of experts have answered a list of frequently asked questions (FAQs) for your convenience.

NSF/ANSI 455 Process Overview: Offers a clear overview of the process in becoming 455-4 certified.

Information Guide: Contains facts about 455-4, key items from the new standard and information on preparing for upcoming audits.

On-Demand Webinar
Make the move to NSF/ANSI 455-4 more straightforward and learn background information about the standard. This session is no cost to you.

Other Resources in Development

Please check back periodically for additional tools to help you throughout the migration process.