Articles and Blogs

Earlier this year, the Food and Drug Administration (“FDA”) announced a Proposed Rule regarding national standards for the licensing of prescription drug wholesale distributors (“Wholesale Distributors”) and third-party logistics providers (“3PLs”). The proposed regulation is issued pursuant to requirements for national regulatory standards under the Drug Supply Chain Security Act (“DSCSA”), which is part... READ MORE

Thursday, April 30 Recap Note – ​We believe this is the most up-to-date information available at this time, but it is subject to change ​as circumstances warrant. Also, all finalized resources can be found ​on the COVID-19 ​Resource ​Center page ​of Hall Render’s website.​ CMS Issues Additional COVID-19 Waivers and Rule Changes CMS announced additional regulatory... READ MORE

Pharmacies, distributors and third-party logistics providers (“3PLs”) that ship prescription drugs into Alaska should take careful note of the new Alaska Board of Pharmacy regulations that took effect on October 31, 2019.[1] Among other elements, the rules: 1) now require licensure of nonresident wholesale drug distributors (“WDDs”), 3PLs and outsourcing facilities (“OFs”) to ship, mail... READ MORE