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. § 403.1200

Scope

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(a) Covered pharmaceuticals. Except as specified in paragraph (b) of this section, this subpart applies to advertisements for a prescription drug or biological product distributed in the United States for which payment is available, directly or indirectly, under titles XVIII or XIX of the Social Security Act.

(b) Excepted pharmaceuticals. An advertisement for any prescription drug or biological product that has a list price, as defined in § 403.1201, less than $35 per month for a 30-day supply or typical course of treatment shall be exempt from the requirements of this subpart.

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 2× “at 20,732, 20,758 (codified at 42 C.F.R. § 403.1200 (2019)); see id. at 20,735 .”
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