C.F.R. » Title 42 » CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER A—GENERAL PROVISIONS › PART 403—SPECIAL PROGRAMS AND PROJECTS › Subpart L—Requirements for Direct-to-Consumer Television Advertisements of Drugs and Biological Products To Include the List Price of That Advertised Product

42 C.F.R. § 403.1201

Definitions

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For the purposes of this subpart, the following definitions apply:

(a) Biological product. Biological product means any biological product, as that term is defined in Public Health Service Act (“PHS Act”) section 351(i), that is licensed by the Food and Drug Administration pursuant to section 351 and is subject to the requirements of Federal Food, Drug, and Cosmetic Act (FDCA) section 503(b)(1).

(b) Prescription drug. Prescription drug means any drug, as defined in the FDCA section 201(g), that has been approved by the Food and Drug Administration pursuant to FDCA section 505 and is subject to the requirements of FDCA section 503(b)(1).

(c) List price. List price means the wholesale acquisition cost, as defined in paragraph (d) of this section.

(d) Wholesale acquisition cost. Wholesale acquisition cost means, with respect to a prescription drug or biological product, the manufacturer's list price for the prescription drug or biological product to wholesalers or direct purchasers in the United States, not including prompt pay or other discounts, rebates or reductions in price, for the most recent month for which the information is available, as reported in wholesale price guides or other publications of drug or biological product pricing data.

Notes of Decisions
Cited in 2 cases (1 in the last 5 years), 2020–2025 · leading case: Merck & Co., Inc. v. HHS, 962 F.3d 531 (D.C. Cir. 2020).
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Merck & Co., Inc. v. HHS, 962 F.3d 531 (D.C. Cir. 2020). · cites it 2× “at 20,758 (codified at 42 C.F.R. § 403.1201 (c)). “Wholesale acquisition cost” is, in turn, defined as “the manufacturer’s list price for the prescription drug or biological product to wholesalers or direct purchasers[,] * * * not including prompt pay or other discounts, rebates…”
Fff Enter., Inc. v. Rising Pharma Holdings, Inc. (D.N.J. 2025). “42 C.F.R. § 403.1201 (d). Plaintiff alleges that the WAC is “widely recognized as the industry standard, [and] sets a benchmark price relied upon by distributors (i.”
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