October 29, 2018
Authored and Edited by Katherine T. Leonard; Thomas L. Irving
On October 24, 2018, FDA issued draft guidance on verification systems under the Drug Supply Chain Security Act (DSCSA) for prescription drugs. FDA intends the new draft guidance to assist industry in understanding the verification systems requirements and provide recommendations on what those systems should include.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Readers are encouraged to read the draft guidance, also available on FDA's website.
FDA Guidance, Food and Drug Administration (FDA), drugs, new drug application (NDA), Biologic License Application (BLA)
Copyright © 2018 Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.
DISCLAIMER: Although we wish to hear from you, information exchanged in this blog cannot and does not create an attorney-client relationship. Please do not post any information that you consider to be personal or confidential. If you wish for Finnegan, Henderson, Farabow, Garrett & Dunner, LLP to consider representing you, in order to establish an attorney-client relationship you must first enter a written representation agreement with Finnegan. Contact us for additional information. One of our lawyers will be happy to discuss the possibility of representation with you. Additional disclaimer information.
Lecture
Patent Protection for Software-Related Inventions in Europe and the USA Training Course
June 5, 2024
Hybrid
Workshop
Life Sciences Workshop: Updates and Key Trends in Pharmaceutical and Biotechnology IP Law
May 2, 2024
Cambridge
Due to international data regulations, we’ve updated our privacy policy. Click here to read our privacy policy in full.
We use cookies on this website to provide you with the best user experience. By accepting cookies, you agree to our use of cookies. Please note that if you opt not to accept or if you disable cookies, the “Your Finnegan” feature on this website will be disabled as well. For more information on how we use cookies, please see our Privacy Policy.
Finnegan is thrilled to announce the launch of our new blog, Ad Law Buzz, devoted solely to breaking news, developments, trends, and analysis in advertising law.