Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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


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

Agency May Be Forced To Issue Rule Through Litigation, Says Attorney

Executive Summary

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.

You may also be interested in...

Gottlieb: FDA May View State Drug Wholesaler Licensure As Fully Preempted Under DSCSA

US FDA Commissioner Scott Gottlieb says Congress intended to preempt all state licensure laws that were not identical to federal laws for licensing wholesalers and third-party logistics providers under the Drug Supply Chain Security Act.

FDA’s Delay Issuing DSCSA Grandfathering Guidance Creating Problems For Manufacturers

US agency's delay in issuing guidance for how it intends to handle un-serialized 'grandfathered' drug products is creating headaches for manufacturers and other parties in the pharmaceutical distribution chain.

FDA Drafts Guidance To Dispel Confusion About DSCSA Trading Partners

FDA draft guidance clarifies the roles of the different supply chain partners under the Drug Supply Chain Security Act.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.





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