---
kind: "section"
citation: "42 U.S.C. § 1320a–7i"
title: "42"
title_heading: "The Public Health and Welfare"
number: "1320a–7i"
heading: "Reporting of information relating to drug samples"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/1320a-7i"
units:
  - "Chapter 7 — Social Security"
  - "Subchapter XI — General Provisions, Peer Review, and Administrative Simplification"
  - "Part A — General Provisions"
---

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

- (a) **In general—** Not later than April 1 of each year (beginning with 2012), each manufacturer and authorized distributor of record of an applicable [drug](/usc/42/11851.md?p=4) shall submit to the [Secretary](/usc/42/1301.md?p=a-6) (in a form and manner specified by the [Secretary](/usc/42/1301.md?p=a-6)) 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](/usc/21/353.md), the identity and quantity of [drug](/usc/42/11851.md?p=4) samples requested and the identity and quantity of [drug](/usc/42/11851.md?p=4) 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](/usc/42/1301.md?p=a-6).
  - (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](/usc/21/353.md), the identity and quantity of [drug](/usc/42/11851.md?p=4) samples requested and the identity and quantity of [drug](/usc/42/11851.md?p=4) 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](/usc/42/1301.md?p=a-6).
- (b) **Definitions—** In this section:
  - (1) **Applicable drug—** The term “applicable [drug](/usc/42/11851.md?p=4)” means a [drug](/usc/42/11851.md?p=4)—
    - (A) which is subject to subsection (b) of such [section 353 of title 21](/usc/21/353.md); and
    - (B) for which payment is available under subchapter XVIII or a [State](/usc/42/619.md?p=5) plan under subchapter XIX or XXI (or a waiver of such a plan).
  - (2) **Authorized distributor of record—** The term “authorized distributor of record” has the meaning given that term in subsection (e)(3)(A) of such section.
  - (3) **Manufacturer—** The term “manufacturer” has the meaning given that term for purposes of subsection (d) of such section.

## Source credit

(Aug. 14, 1935, ch. 531, title XI, § 1128H, as added Pub. L. 111–148, title VI, § 6004, Mar. 23, 2010, 124 Stat. 697.)