The US Food and Drug Administration (FDA) on 7 December issued a final guidance describing procedures to help trading partners establish systems to identify, quarantine and investigate suspect or illegitimate products under the Drug Supply Chain Security Act (DSCSA). It also describes the process for handling saleable returns.
DSCSA mandated that trading partners have these verification systems in place to determine whether a product is suspect, as well as have systems in place for quarantining and investigating suspect products and processing saleable returns.
The law was supposed to go into effect on 27 November, yet the FDA announced that it would be giving manufacturers and trading partners a one-year reprieve to allow more time to “stabilize” their track and trace systems (RELATED: FDA gives firms one-year reprieve from DSCSA track and trace, Regulatory Focus, 25 August 2023).
FDA said the guidance “serves to inform trading partners regarding the information that should be reviewed and communicated with other trading partners when investigating whether a suspect product is illegitimate. This guidance also serves to inform trading partners of the information that should be included in responding to requests for verification of the product identifier from FDA and other trading partners, where applicable, and in verifying the product identifier of saleable returned product.”
The final guidance contains minor revisions from a draft guidance issued in March 2022 (RELATED: DSCSA: FDA gives firms more leeway on verification requests, Regulatory Focus 9 March 2022).
The final guidance removes language stating that if a trading partner does not receive a response from a manufacturer or repackager within 24 hours of making a request for a verification, the product will be considered suspect and is not to be distributed or dispensed.
Other changes include clarifying that dispensers do not need to provide transaction information for saleable returns; clarifying that “verification” involves confirming that the product identifier affixed or imprinted upon a package or homogeneous case corresponds to the Standardized Numerical Identifier (SNI) or lot number and expiration date assigned to the product; and clarifying that when a trading partner does not receive a timely response to a verification request, the product that is the subject of the request will not automatically be classified as suspect.
The guidance adds new text saying that “on a case-by-case basis, FDA may consider ‘other such reasonable time’ for responding to requests for verification of the product identifier under limited circumstances.” These circumstances include power outages, transportation infrastructure disruptions, local regional disruptions, and the scope of the request. In these situations, “FDA expects manufacturers and repackagers to make a good faith effort to provide a rapid response, but FDA understands that they may need to follow-up with their trading partner with additional information.”
Tags: DSCSA FDA Supply Chain
