FDA Releases DSCSA Suspect Product Guidance
The FDA released its suspect product guidance today to help the industry in its implementation of the Drug Supply Chain Security Act. The guidance entitled "Draft Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification" provides information for identifying suspect products and managing termination of illegitimate product investigations.
NOTE: This guidance does not address data exchange questions with respect to requests for information and verification queries from government officials or trading partners as required by DSCSA verification regulations. Register for this short webinar summarizing the guidance and 2015 DSCSA verification.
DSCSA Suspect Product Guidance has four goals:
- ID specific scenarios that could significantly increase the risk of a suspect product.
- Provide recommendations on how trading partners can identify the product and determine whether the product is a suspect product as soon as practicable.
- Process by which trading partners should notify the FDA of illegitimate product.
- How they must terminate the notifications in consultation with the FDA.
Suspect product covers several scenarios in DSCSA including potentially counterfeit, diverted, stolen, adulterated, subject of a fraudulent transaction or otherwise unfit for distribution.
The FDA makes it clear that this guidance doesn't address all DSCSA provisions related to suspect and illegitimate guidance. Furthermore, this document is meant to be viewed as a set of recommendations, not new regulatory rules, unless outlined as required by law. Most of the commentary is focused on laying out a set of standard operating procedures for these processes
- Specific suspect product scenarios
- Recommendations for identifying suspect product
- Notification of illegitimate product
- Termination of illegitimate product notification with FDA
The biggest new area relates to the FDA Form 3911 (Attachment A) which must be completed and submitted to the FDA when initiating an illegitimate product notification or when requesting a consultation with the FDA for terminating an illegitimate product notification.
See the Drug Notification page on the FDA website with more details on notification submission.