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Co-Authored-By: Claude Opus 4.8 <noreply@anthropic.com>
2026-07-06 10:51:44 -04:00

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LegalText 42 U.S.C. § 1320a7i Reporting of information relating to drug samples us united_states_code code_section 42 THE PUBLIC HEALTH AND WELFARE 7 SOCIAL SECURITY 1320a7i 42 U.S.C. § 1320a7i current 119-100 2026-06-26 official https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc42@119-100.zip /us/usc/t42/s1320a7i data/legal/raw/us/code/title-42/usc42.xml ae9ab0aa6c5df1aaad825a2535df9194449d9bf305177811e39c160392c0bb39 644321055a08eb1f260a6a3e31ac157fa024756abf612a9fd6857e7e400cf24e 59167584d236bfa13c362e4815b897726ab60fbca3d4037e7cc6e8b82f9b6874 2026-07-04 official
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42 U.S.C. § 1320a7i - Reporting of information relating to drug samples

Text

(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 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—

(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.

(b) Definitions In this section:

(1) Applicable drug 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) 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.

(Aug. 14, 1935, ch. 531, title XI, § 1128H, as added Pub. L. 111148, title VI, § 6004, Mar. 23, 2010, 124 Stat. 697.)