HRSA further delays effective date of final rule on 340B drug ceiling prices

The Health Resources and Services Administration today delayed to May 22 the effective date of its final rule on 340B drug ceiling prices and civil monetary penalties for manufacturers, and invited comments on whether a delay to Oct. 1 would be more appropriate. The rule was set to take effect March 21 following an earlier two-week delay. “[The Department of Health and Human Services] believes that the delay of the effective date is necessary to consider questions of fact, law and policy raised in the rule, consistent with the ‘Regulatory Freeze Pending Review’ memorandum,” the notice states. “In addition, HHS believes that the delay of the effective date is necessary to provide regulated entities sufficient time to implement the requirements of the rule.” HRSA will accept comments through April 17.