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. § 403.1202

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Any advertisement for any prescription drug or biological product on television (including broadcast, cable, streaming, or satellite) must contain a textual statement indicating the current list price for a typical 30-day regimen or for a typical course of treatment, whichever is most appropriate, as determined on the first day of the quarter during which the advertisement is being aired or otherwise broadcast, as follows: “The list price for a [30-day supply of ] [typical course of treatment with] [name of prescription drug or biological product] is [insert list price]. If you have health insurance that covers drugs, your cost may be different.” Where the price is related to the typical course of treatment and that typical course of treatment varies depending on the indication for which a prescription drug or biological product is prescribed, the list price to be used is the one for the typical course of treatment associated with the primary indication addressed in the advertisement.

Notes of Decisions
Cited in 1 case, 2020–2020 · 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 3× “at 20,758 (codified at 42 C.F.R. § 403.1202 ). The only exception is for drugs with a list price of “less than $35 per month for a 30-day supply or typical course of treatment[.”
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