Title 42 — The Public Health and WelfareRelease 119-73

§1320a–7i Reporting of information relating to drug samples

Title 42 › Chapter CHAPTER 7— - SOCIAL SECURITY › Subchapter SUBCHAPTER XI— - GENERAL PROVISIONS, PEER REVIEW, AND ADMINISTRATIVE SIMPLIFICATION › Part Part A— - General Provisions › § 1320a–7i

Last updated Apr 6, 2026|Official source

Summary

By April 1 each year, starting in 2012, manufacturers and authorized distributors of record must send the Secretary a yearly report, in the form and way the Secretary requires, covering the previous year. The report must say which sample drugs were asked for and which were sent, and how many. It covers samples sent by mail or common carrier and samples sent by other means. The information must be grouped by the requesting practitioner’s name, address, job title, and signature (or the signature of anyone who signed for them), plus any other categories the Secretary asks for. Applicable drug — a drug that meets the rule in 21 U.S.C. 353(b) and for which payment is available under subchapter XVIII or a State plan under subchapter XIX or XXI (or a waiver). Authorized distributor of record — defined in 21 U.S.C. 353(e)(3)(A). Manufacturer — defined for subsection (d) of 21 U.S.C. 353.

Full Legal Text

Title 42, §1320a–7i

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

(a)Not later than April 1 of each year (beginning with 2012), each manufacturer and authorized distributor of record of an applicable drug shall submit to the Secretary (in a form and manner specified by the Secretary) the following information with respect to the preceding year:

(1)In the case of a manufacturer or authorized distributor of record which makes distributions by mail or common carrier under subsection (d)(2) of section 353 of title 21, the identity and quantity of drug samples requested and the identity and quantity of drug samples distributed under such subsection during that year, aggregated by—

(A)the name, address, professional designation, and signature of the practitioner making the request under subparagraph (A)(i) of such subsection, or of any individual who makes or signs for the request on behalf of the practitioner; and

(B)any other category of information determined appropriate by the Secretary.

(2)In the case of a manufacturer or authorized distributor of record which makes distributions by means other than mail or common carrier under subsection (d)(3) of such section 353 of title 21, the identity and quantity of drug samples requested and the identity and quantity of drug samples distributed under such subsection during that year, aggregated by—

(B)any other category of information determined appropriate by the Secretary.

(b)In this section:

(1)The term “applicable drug” means a drug—

(A)which is subject to subsection (b) of such section 353 of title 21; and

(B)for which payment is available under subchapter XVIII or a State plan under subchapter XIX or XXI (or a waiver of such a plan).

(2)The term “authorized distributor of record” has the meaning given that term in subsection (e)(3)(A) of such section.

(3)The term “manufacturer” has the meaning given that term for purposes of subsection (d) of such section.

Reference

Citations & Metadata

Citation

42 U.S.C. § 1320a–7i

Title 42 — The Public Health and Welfare

Last Updated

Apr 6, 2026

Release point: 119-73