US Code

Public Law 119-102 (07/12/2026)

42 U.S.C. § 1320a–7i

Reporting of information relating to drug samples

Section text and notes

(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)
section 353 of title 21 In the case of a manufacturer or authorized distributor of record which makes distributions by mail or common carrier under subsection (d)(2) of , 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)
section 353 of title 21 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 , 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)
section 353 of title 21 which is subject to subsection (b) of such ; 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 Pub. L. 111–148, title VI, § 6004124 Stat. 697 (, title XI, § 1128H, as added , , .)