The Health Resources and Services Administration (HRSA) has delayed until Oct. 1 the effective date of the final rule on drug ceiling prices and manufacturer civil monetary penalties under the 340B Drug Pricing Program. HRSA will begin enforcing the final rule on Oct. 1.
The rule — originally slated to go into effect on March 6 — previously was delayed in accordance with a White House memorandum that placed a temporary freeze on pending regulations until incoming department or agency heads had the opportunity to review and approve the regulations. Another delay subsequently was issued through an interim final rule in March, in which HRSA sought comments on delaying the rule until Oct. 1.
Contact Director of Policy Erin O’Malley at email@example.com or 202.585.0127 with questions.