---
kind: "section"
citation: "42 U.S.C. § 263–1"
title: "42"
title_heading: "The Public Health and Welfare"
number: "263–1"
heading: "Education on biological products"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/263-1"
units:
  - "Chapter 6A — Public Health Service"
  - "Subchapter II — General Powers and Duties"
  - "Part F — Licensing of Biological Products and Clinical Laboratories"
  - "Subpart 1 — biological products"
---

# §263–1. Education on biological products

- (a) **Internet website—**
  - (1) **In general—** The [Secretary](/usc/42/201.md?p=c) may maintain and operate an internet website to provide educational materials for [health care providers](/usc/42/300aa–33.md?p=1), patients, and caregivers, regarding the meaning of the terms, and the standards for review and licensing of, biological products, including biosimilar biological products and interchangeable biosimilar biological products.
  - (2) **Content—** Educational materials provided under [paragraph (1)](#a-1) may include—
    - (A) explanations of key statutory and regulatory terms, including “biosimilar” and “interchangeable”, and clarification regarding the use of interchangeable biosimilar biological products;
    - (B) information related to development [programs](/usc/42/274l–1.md?p=4) for biological products, including biosimilar biological products and interchangeable biosimilar biological products and relevant clinical considerations for prescribers, which may include, as appropriate and applicable, information related to the comparability of such biological products;
    - (C) an explanation of the process for reporting adverse events for biological products, including biosimilar biological products and interchangeable biosimilar biological products; and
    - (D) an explanation of the relationship between biosimilar biological products and interchangeable biosimilar biological products licensed under [section 262(k) of this title](/usc/42/262.md?p=k) and reference products (as defined in [section 262(i) of this title](/usc/42/262.md?p=i)), including the standards for review and licensing of each such type of biological product.
  - (3) **Format—** The educational materials provided under [paragraph (1)](#a-1) may be—
    - (A) in formats such as webinars, continuing education modules, videos, fact sheets, infographics, stakeholder toolkits, or other formats as appropriate and applicable; and
    - (B) tailored for the unique needs of [health care providers](/usc/42/300aa–33.md?p=1), patients, caregivers, and other audiences, as the [Secretary](/usc/42/201.md?p=c) determines appropriate.
  - (4) **Other information—** In addition to the information described in [paragraph (2)](#a-2), the [Secretary](/usc/42/201.md?p=c) shall continue to publish—
    - (A) the action package of each biological product licensed under subsection (a) or (k) of [section 262 of this title](/usc/42/262.md); or
    - (B) the summary review of each biological product licensed under subsection (a) or (k) of [section 262 of this title](/usc/42/262.md).
  - (5) **Confidential and trade secret information—** This subsection does not authorize the disclosure of any trade secret, confidential commercial or financial information, or other matter described in [section 552(b) of title 5](/usc/5/552.md?p=b).
- (b) **Continuing education—** The [Secretary](/usc/42/201.md?p=c) shall advance education and awareness among [health care providers](/usc/42/300aa–33.md?p=1) regarding biological products, including biosimilar biological products and interchangeable biosimilar biological products, as appropriate, including by developing or improving continuing education [programs](/usc/42/274l–1.md?p=4) that advance the education of such [providers](/usc/42/299b–21.md?p=8) on the prescribing of, and relevant clinical considerations with respect to, biological products, including biosimilar biological products and interchangeable biosimilar biological products.

## Source credit

(July 1, 1944, ch. 373, title III, § 352A, as added Pub. L. 117–8, § 2, Apr. 23, 2021, 135 Stat. 254.)