C.F.R. » Title 42 » CHAPTER I—PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER A—GENERAL PROVISIONS › PART 10—340B DRUG PRICING PROGRAM › Subpart B—340B Ceiling Price

42 C.F.R. § 10.10

Ceiling price for a covered outpatient drug

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A manufacturer is required to calculate the 340B ceiling price for each covered outpatient drug, by National Drug Code (NDC) on a quarterly basis.

(a) Calculation of 340B ceiling price. The 340B ceiling price for a covered outpatient drug is equal to the Average Manufacturer Price (AMP) from the preceding calendar quarter for the smallest unit of measure minus the Unit Rebate Amount (URA) and will be calculated using six decimal places. HRSA will publish the 340B ceiling price rounded to two decimal places.

(b) Exception. When the ceiling price calculation in paragraph (a) of this section results in an amount less than $0.01 the ceiling price will be $0.01.

(c) New drug price estimation. A manufacturer must estimate the 340B ceiling price for a new covered outpatient drug as of the date the drug is first available for sale. That estimation should be calculated as wholesale acquisition cost minus the appropriate rebate percentage until an AMP is available, which should occur no later than the 4th quarter that the drug is available for sale. Manufacturers are required to calculate the actual 340B ceiling price as described in paragraph (a) of this section and offer to refund or credit the covered entity the difference between the estimated 340B ceiling price and the actual 340B ceiling price within 120 days of the determination by the manufacturer that an overcharge occurred.

Notes of Decisions
Cited in 4 cases (4 in the last 5 years), 2024–2025 · leading case: AstraZeneca Pharm. L P v. Jeff Landry (W.D. La. 2024).
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AstraZeneca Pharm. L P v. Jeff Landry (W.D. La. 2024). “§ 256b(d); 42 C.F.R. §§ 10.10 , 10.20 - 10.25. 55 These requirements are sometimes referred to as the “purchase by” or “shall offer” requirements.”
Pharm. Rsch. & Mfrs. of Am. v. Landry (W.D. La. 2024). “§ 256b(d); 42 C.F.R. §§ 10.10 , 10.20 - 10.25. 55 These requirements are sometimes referred to as the “purchase by” or “shall offer” requirements.”
AbbVie Inc v. Landry (W.D. La. 2024). “§ 256b(d); 42 C.F.R. §§ 10.10 , 10.20 - 10.25. 55 These requirements are sometimes referred to as the “purchase by” or “shall offer” requirements.”
Sanofi-Aventis U.S. LLC v. United States Dep't of Health & Human Servs. (D.D.C. 2025). “See 42 C.F.R. § 10.10 (c). Likewise, when the Medicaid rebate percentage exceeds the up-front price of the drug, manufacturers would face negative prices and be obligated to pay the purchasers of their drugs under the 340B formula.”
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