Articles and Blogs

In August 2023, the U.S. Food and Drug Administration (“FDA”) issued two compliance policies that outlined its strategy for enforcing the drug distribution security requirements established by the Drug Supply Chain Security Act (“DSCSA”), which were set to take effect on November 27, 2023. To support trading partners in meeting these requirements, FDA implemented... READ MORE

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