Title 42

PART 10

Part 10 - 340b Drug Pricing Program

PART 10 - 340B DRUG PRICING PROGRAM Authority:Sec. 340B of the Public Health Service Act (42 U.S.C. 256b) (PHSA), as amended. Source:82 FR 1229, Jan. 5, 2017, unless otherwise noted.

• Authority: Sec. 340B of the Public Health Service Act (42 U.S.C. 256b) (PHSA), as amended.
• Source: 82 FR 1229, Jan. 5, 2017, unless otherwise noted.

42:1.0.1.1.11.1	SUBPART A	Subpart A - General Provisions
42:1.0.1.1.11.1.1.1	SECTION 10.1	10.1 Purpose.
42:1.0.1.1.11.1.1.2	SECTION 10.2	10.2 Summary of 340B Drug Pricing Program.
42:1.0.1.1.11.1.1.3	SECTION 10.3	10.3 Definitions. \
42:1.0.1.1.11.2	SUBPART B	Subpart B - 340B Ceiling Price
42:1.0.1.1.11.2.1.1	SECTION 10.10	10.10 Ceiling price for a covered outpatient drug.
42:1.0.1.1.11.2.1.2	SECTION 10.11	10.11 Manufacturer civil monetary penalties.
42:1.0.1.1.11.3	SUBPART C	Subpart C - Administrative Dispute Resolution
42:1.0.1.1.11.3.1.1	SECTION 10.20	10.20 Administrative Dispute Resolution Panel.
42:1.0.1.1.11.3.1.2	SECTION 10.21	10.21 Claims.
42:1.0.1.1.11.3.1.3	SECTION 10.22	10.22 Information requests.
42:1.0.1.1.11.3.1.4	SECTION 10.23	10.23 Conduct of the ADR proceeding.
42:1.0.1.1.11.3.1.5	SECTION 10.24	10.24 Final agency decision.

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