Title 42, The Public Health and WelfareRelease 119-73not60

§263–1 Education on Biological Products

Title 42 › 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

Last updated Apr 5, 2026|Official source

Summary

The Secretary may run a website to give plain educational materials to health care providers, patients, and caregivers about biological products, including biosimilar and interchangeable biosimilar products. The site can explain key terms, how these products are studied and approved, how to report side effects, and how biosimilars and interchangeable products relate to the original reference products and their review standards. Materials can be webinars, training modules, videos, fact sheets, toolkits, or other formats and can be tailored for different audiences. The Secretary must keep posting the action package or a summary review for each licensed biological product. The site must not disclose trade secrets or other confidential business or financial information. The Secretary must also promote and improve continuing education for providers on prescribing and clinical issues for these products.

Full Legal Text

Title 42, §263–1

The Public Health and Welfare, Source: USLM XML via OLRC

(a)(1)The Secretary may maintain and operate an internet website to provide educational materials for health care providers, 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)Educational materials provided under paragraph (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 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 and reference products (as defined in section 262(i) of this title), including the standards for review and licensing of each such type of biological product.

(3)The educational materials provided under paragraph (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, patients, caregivers, and other audiences, as the Secretary determines appropriate.

(4)In addition to the information described in paragraph (2), the Secretary shall continue to publish—

(A)the action package of each biological product licensed under subsection (a) or (k) of section 262 of this title; or

(B)the summary review of each biological product licensed under subsection (a) or (k) of section 262 of this title.

(5)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.

(b)The Secretary shall advance education and awareness among health care providers regarding biological products, including biosimilar biological products and interchangeable biosimilar biological products, as appropriate, including by developing or improving continuing education programs that advance the education of such providers on the prescribing of, and relevant clinical considerations with respect to, biological products, including biosimilar biological products and interchangeable biosimilar biological products.

Reference

Citations & Metadata

Citation

42 U.S.C. § 263–1

Title 42, The Public Health and Welfare

Last Updated

Apr 5, 2026

Release point: 119-73not60