Site Feedback

Title 42

Displaying title 42, up to date as of 9/23/2021. Title 42 was last amended 9/15/2021.

Title 42

eCFR Content

The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. It is not an official legal edition of the CFR.

Learn more about the eCFR, its status, and the editorial process.

§ 403.1201 Definitions.

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.