With many of the Drug Supply Chain Security Act (DSCSA) requirements coming upon the industry soon, the FDA’s issuance of the draft guidance document, Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs, discusses the verification process and expectations of the Agency relative to ensuring that products are legitimate under the DSCSA.
The guidance covers the following topics:
- System to determine whether a product is suspect
- System for suspect product quarantine and investigation
- System for cleared product notification regarding suspect products
- System for illegitimate/high risk of illegitimacy product notifications
- System for responding to requests for verification
- System for processing saleable returns
The document also discusses FDA notification requirements and the six-year record-keeping requirements. The Agency also notes that this guidance should be read in conjunction with the Suspect Product and Notification Guidance that includes processes by which notifications to the FDA and other trading partners of illegitimate product are made, as well as termination of those notifications as described in Section 582(h)(2)(A)(iii) of the FD&C Act.
It is very important for firms to carefully review this draft procedural guidance, which can be found here.