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HHS/HRSA RIN: 0906-AB11 Publication ID: Fall 2017 
Title: ●340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation – Further Delay of Effective Date 

This proposed rule would delay until July 1, 2018, the effective date of the January 5, 2017, final rule (82 FR 1210; RIN 0906-AA89) that sets forth the calculation of the 340B ceiling price and application of civil monetary penalties to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. The final rule is required under the Affordable Care Act and amends section 340B of the Public Health Service Act to impose monetary sanctions (not to exceed $5,000 per instance) on drug manufacturers who intentionally charge a covered entity a price above the ceiling price established under the procedures of the 340B Program and also define standards and methodology for the calculation of ceiling prices for purposes of the 340B Program.


Agency: Department of Health and Human Services(HHS)  Priority: Info./Admin./Other 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Fully or Partially Exempt 
CFR Citation: 42 CFR 10   
Legal Authority: Pub.L.102-585: Veterans Health Care Act of 1992   
Legal Deadline:  None
Action Date FR Cite
NPRM  08/21/2017  82 FR 39553   
NPRM Comment Period End  09/20/2017 
Final Action  11/00/2017 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Related RINs: Related to 0906-AA89 
Agency Contact:
Krista Pedley
Director, Office of Pharmacy Affairs
Department of Health and Human Services
Health Resources and Services Administration
Healthcare Systems Bureau, 5600 Fishers Lane,
Rockville, MD 20857
Phone:301 443-5294