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Regulatory Focus™ > News Articles > 2022 > 3 > DSCSA: FDA gives firms more leeway on verification requests

DSCSA: FDA gives firms more leeway on verification requests

Posted 09 March 2022 | By Joanne S. Eglovitch 

DSCSA: FDA gives firms more leeway on verification requests

The US Food and Drug Administration (FDA) on Wednesday issued a revised draft guidance that gives manufacturers and repackagers some flexibility, and more time, in responding to requests for verification from trading partners for suspect or illegitimate products.  Other changes from a previous version include clarifying the terms taking “possession or control” of a drug as well as “electronic quarantine.”
 
The guidance addresses the verification system that manufacturers, repackagers, wholesale distributors and dispensers must have in place in responding to requests for products that may be suspect or illegitimate. The 2013 Drug Supply Security Act (DSCSA) mandated that trading partners have such systems in place to determine that a product is suspect, as well as systems for quarantining and investigating suspect product and systems for processing saleable returns.
 
The previous version of the draft guidance was issued in October 2018. (RELATED:  Verification systems: FDA drafts guidance on what to include, Regulatory Focus 24 October 2018)
 
Pharmaceutical and generic drug industry groups took issue with several provisions of the draft guidance in comments, including one that would give manufacturers and repackagers 24 hours to respond to requests for verification from trading partners. (RELATED: PhRMA, AAM seek tweaks to FDA’s verification guidance, Regulatory Focus 5 February 2019)
 
The revision gives manufacturers flexibility in responding to these requests. It states that manufacturers and repackagers must have systems in place to respond to requests “not later than 24 hours after receiving such request or in ‘other reasonable time’ as determined by FDA, based on the circumstances of the request.”
 
The guidance also accommodates stakeholder comments by providing other changes.
 
It adds FDA’s interpretation of what “possession or control” means defining these terms “to include physical custody of the product, or ownership of the product.”
 
It also clarifies situations where trading partners may not be able to determine, with other trading partners, that a product is illegitimate. There is new language that “FDA recognizes that a situation may arise where a trading partner is not able to physically quarantine, disposition, or collect a sample of illegitimate product that the trading partner owns because that product has been stolen and is no longer in the trading partner’s physical custody.”
 
Additionally, it more firmly sets FDA’s expectations for an “electronic quarantine.” The draft was vague regarding what was meant by their term. The revision states “FDA encourages trading partners to use both physical and electronic quarantine when possible to ensure accurate record keeping. FDA understands quarantine by electronic means (or electronic quarantine) to be an electronic system or process that designates specific products as being quarantined to prevent the sale and further distribution of the product.”
 
The deadline to comment is 9 May 2022.
 
Guidance

 

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