Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA Drafts Guidance To Dispel Confusion About DSCSA Trading Partners

Executive Summary

FDA draft guidance clarifies the roles of the different supply chain partners under the Drug Supply Chain Security Act. While much attention has focused on the serialization challenges in implementing DSCSA, less attention has been paid to which trading partners are authorized to transfer products.

You may also be interested in...



US FDA Backs EPCIS, Refines Advice As November 2023 DSCSA Deadline Approaches

Agency recommends the GS1 standard that stakeholders have been focusing on for working together to remove counterfeits from the US pharmaceutical distribution chain; adds its latest thinking on roles of additional types of trading partners.

FDA's Inaction On Issuing Licensing Rules For Wholesalers and 3PLs Creating Confusion

Highly anticipated proposed rulemaking from the FDA on licensing standards for wholesale distributors and third-party logistics providers has been repeatedly delayed, and the reasons for the delay are unclear. The rule is five years overdue under a DSCSA mandated timeline.

Track And Trace Deadline Could Slip Again After Worries Over Inferencing

Generic representative raises concerns about errors from bulk scanning, while distributors and pharmacies feel failure to include inferencing will hinder patient access to drugs.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS121422

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel