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

§1320a–7i Reporting of Information Relating to Drug Samples

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

Last updated Apr 5, 2026|Official source

Summary

Each year, by April 1 (starting in 2012), every drug manufacturer and every authorized distributor of record for certain drugs must send the Secretary a report about the previous year. The report must follow the Secretary’s form and rules. It must show, separately for samples sent by mail or common carrier and for samples sent by other methods, what kinds and how many samples were requested and how many were actually given out. The information must be grouped by the requesting practitioner’s name, address, job title, and signature (or whoever signed for the practitioner), and include any other categories the Secretary requires. applicable drug: a drug that is subject to the sample rules and that has payment available under subchapter XVIII or a State plan under subchapter XIX or XXI (or a waiver); authorized distributor of record: the distributor recognized under the law; manufacturer: the company defined under the law for these sample rules.

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 5, 2026

Release point: 119-73not60