On October 24, 2018, FDA issued draft guidance on verification systems under the Drug Supply Chain Security Act (DSCSA) for prescription drugs. FDA intends the new draft guidance to assist industry in understanding the verification systems requirements and provide recommendations on what those systems should include.
The DSCSA, which was enacted on November 27, 2013 established requirements for verification systems relating to identification and handling of suspect and illegitimate products. The systems are related to the determination of suspect products, quarantine and investigation of suspect products, quarantine and disposition of illegitimate products, notifications for cleared suspect products and for illegitimate/high risk of illegitimacy products, responding to FDA verification requests, and processing saleable returns.
Systems to determine whether a product is suspect should ensure that trading partners make consistent, effective, and timely determinations. Trading partners should focus on drugs that fall into the following categories: counterfeit, fraudulent transaction, unfit for distribution, or diverted.
Upon determining that a product is suspect, a trading partner is required to quarantine and investigate the product to determine whether the product is illegitimate. The quarantine system should be robust enough to ensure that the suspect product is not inadvertently distributed. Investigations into the suspect product must include validation of applicable transaction histories, active communication and coordination with the manufacturer, and use of appropriate laboratory standards and controls where testing of the suspect product is necessary.
Illegitimate products should be physically separated from products intended for distribution. Trading partners must ensure that the illegitimate products are appropriately and effectively disposed of, while retaining a sample for further examination by the manufacturer or FDA. The trading partners must also maintain disposition records for not less than 6 years after the conclusion of the disposition.
Trading partners must notify manufacturers or FDA of illegitimate/high risk of illegitimacy products or of cleared suspect products. FDA provides detailed guidelines for the content of and protocol for these notification systems.
Readers are encouraged to read the draft guidance, also available on FDA's website.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
