340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
other · US Department of Health and Human Services · Rule · Published 2017-03-20 · Effective 2017-05-22 · 82 FR 14332
Document
Document number
2017-05491
Federal Register citation
82 FR 14332
CFR reference
42 CFR 10
Type
Rule
Action
Interim final rule; further delay of effective date with comment.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
2017-03-20
Effective date
2017-05-22
Abstract
The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the "340B Drug Pricing Program" or the "340B Program." The January 5, 2017 final rule sets forth the calculation of the ceiling price and application of civil monetary penalties, and applies to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. This interim final rule delays the effective date of the final rule published in the Federal Register (82 FR 1210, (January 5, 2017)) to May 22, 2017. Commenters are also invited to provide their views on whether a longer delay of the effective date to October 1, 2017, would be more appropriate.