42 C.F.R. § 10.24 : Public Health — PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES — GENERAL PROVISIONS — 340B DRUG PRICING PROGRAM — ADMINISTRATIVE DISPUTE RESOLUTION — Final agency decision

(a) The 340B ADR Panel will review the evidence submitted by the parties and determine if the preponderance of the evidence supports the conclusion that a violation as described in § 10.21(c)(1) or (2) has occurred.
(b) The 340B ADR Panel will prepare an agency decision based on its review and evaluation of the evidence submitted by the parties, including documents provided as required in § 10.21(d), information requests in support of a claim, and responses to a claim.
(c) The agency decision will represent the decision of a majority of the 340B ADR Panel's findings regarding the claim and discuss the findings supporting the decision.
(d) The agency decision constitutes a final agency decision that is precedential and binding on the parties involved unless invalidated by an order of a court of competent jurisdiction.
(e) The 340B ADR Panel will submit the final agency decision to all parties, and to HRSA for appropriate action regarding refunds, penalties, removal, or referral to appropriate Federal authorities.

42 C.F.R. §10.24

85 FR 80644, 1/13/2021