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HHS/HRSA RIN: 0906-AB12 Publication ID: Fall 2017 
Title: ●340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation 

This proposed rule would amend the definition of 'knowingly and intentionally' at section 10.3 and amend section 10.10(b) regarding 340B ceiling price.  The sections being amended were included in a final rule that published on January 5, 2017 (82 FR 1210; RIN 0906-AA89).  The January 5, 2017, final rule set forth the calculation of the ceiling price and application of civil monetary penalties.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Fully or Partially Exempt 
CFR Citation: 42 CFR 10   
Legal Authority: Pub. L. 102-585: Veterans HealthCare Act of 1992   
Legal Deadline:  None

Statement of Need:

This statutorily required rule defines the standards and methodology for the calculation of ceiling prices within the 340B Program and imposes civil monetary penalties on drug manufacturers who knowingly and intentionally charge a covered entity a price above the 340B ceiling price.

Summary of the Legal Basis:

This rule would implement provisions of section 340B of the Public Health Service Act (PHSA), referred to as the 340B Drug Pricing Program or the 340B Program.


None. This rule implements statutory requirements.

Anticipated Costs and Benefits:

This proposed rule will not have economic impacts of $100 million or more in any 1 year, and, therefore, has not been designated an economically significant rule under section 3(f)(1) of Executive Order 12866. This proposed rule proposes to modify current policy regarding calculation of the 340B ceiling price.



Action Date FR Cite
NPRM  12/00/2017 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Undetermined 
Federalism: Undetermined 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Related RINs: Related to 0906-AA89 
Agency Contact:
CAPT Krista Pedley
Director, Office of Pharmacy Affairs
Department of Health and Human Services
Health Resources and Services Administration
Healthcare Systems Bureau, 5600 Fishers Lane, 10C-03,
Rockville, MD 20857
Phone:301 443-5294