Regulatory Counsel

0910-AH11 201804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers

The rulemaking will establish standards for State licensing of prescription drug wholesale distributors and third-party logistics providers. The rulemaking will also establish a Federal system for wholesale drug distributor and third-party logistics provider licensing for use in the absence of a State licensure program.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined Undetermined Regulatory 21 CFR 204 and 205 Pub. L. 113-54 Statutory Final 11/27/2015 The Drug Supply Chain Security Act of 2013 requires FDA to issue licensure regulations no later than two years after the date of enactment No NPRM 11/00/2018 Undetermined Businesses Federal State Undetermined Undetermined No No Aaron Weisbuch Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-9362 aaron.weisbuch@fda.hhs.gov Center for Drug Evaluation and Research, Building 51, Room 4261, 10903 New Hampshire Avenue, Silver Spring MD 20993