United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2017_register executive 2018-02-01 article Rules and Regulations D09002ee1c7f300cc D09002ee1c7f30153 United States Department of Health and Human Services originator org United States Government Agency or Subagency The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), referred to as the "340B Drug Pricing Program" or the "340B Program." This final rule will apply to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. This final rule sets forth the calculation of the 340B ceiling price and application of civil monetary penalties (CMPs). 82 FR 1210 https://www.govinfo.gov/app/details/FR-2017-01-05/2016-31935 2016-31935 fr05ja17-15 RIN 0906-AA89 4165-15-P https://www.govinfo.gov/app/details/FR-2017-01-05/2016-31935 https://www.govinfo.gov/content/pkg/FR-2017-01-05/html/2016-31935.htm https://www.govinfo.gov/content/pkg/FR-2017-01-05/pdf/2016-31935.pdf Biologics Business and Industry Diseases Drugs Health Health Care Health Facilities Hospitals 340b Drug Pricing Program 21 p. 1210 1230 82 FR 1210 Title 42 Part 10 42 CFR Part 10 RIN 0906-AA89 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation; Federal Register Vol. 82, Issue RULE 2016-31935 DEPARTMENT OF HEALTH AND HUMAN SERVICES 2017-03-06 4165-15-P 2016-31935 Final rule.

The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), referred to as the "340B Drug Pricing Program" or the "340B Program." This final rule will apply to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. This final rule sets forth the calculation of the 340B ceiling price and application of civil monetary penalties (CMPs).

This rule is effective March 6, 2017. CAPT Krista Pedley, Director, Office of Pharmacy Affairs (OPA), Healthcare Systems Bureau (HSB), HRSA, 5600 Fishers Lane, Mail Stop 08W05A, Rockville, MD 20857, or by telephone at 301-594-4353. Biologics Business and Industry Diseases Drugs Health Health Care Health Facilities Hospitals 340b Drug Pricing Program 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties , Vol. 82, no. 3 Office of the Federal Register, National Archives and Records Administration 2017-01-05 continuing daily deposited born digital 461 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2017-01-05 P0b002ee1982b753e 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr05ja17 https://www.govinfo.gov/app/details/FR-2017-01-05 https://www.govinfo.gov/content/pkg/FR-2017-01-05/pdf/FR-2017-01-05.pdf https://www.govinfo.gov/content/pkg/FR-2017-01-05/xml/FR-2017-01-05.xml fdlp 1139 1591 DGPO 2018-02-01 2024-06-01 FR-2017-01-05 machine generated eng FR FR-2017-01-05 82 3