2016 US Code
Title 42 - The Public Health and Welfare
Chapter 7 - Social Security
Subchapter XI - General Provisions, Peer Review, and Administrative Simplification
Part A - General Provisions
Sec. 1320a-7i - Reporting of information relating to drug samples

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Citation 42 U.S.C. § 1320a-7i (2016)
Section Name

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

Section 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.

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.)

Publication Title United States Code, 2012 Edition, Supplement 4, Title 42 - THE PUBLIC HEALTH AND WELFARE
Category Bills and Statutes
Collection United States Code
SuDoc Class Number Y 1.2/5:
Contained Within Title 42 - THE PUBLIC HEALTH AND WELFARE
CHAPTER 7 - SOCIAL SECURITY
SUBCHAPTER XI - GENERAL PROVISIONS, PEER REVIEW, AND ADMINISTRATIVE SIMPLIFICATION
Part A - General Provisions
Sec. 1320a-7i - Reporting of information relating to drug samples
Contains section 1320a-7i
Date 2016
Laws In Effect As Of Date January 6, 2017
Positive Law No
Disposition standard
Statutes at Large Reference 124 Stat. 697
Public Law References Public Law 111-148
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