(a) In generalNot 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) DefinitionsIn this section:(1) Applicable drugThe 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 recordThe term “authorized distributor of record” has the meaning given that term in subsection (e)(3)(A) of such section.
(3) ManufacturerThe term “manufacturer” has the meaning given that term for purposes of subsection (d) of such section.
Structure US Code
Title 42— THE PUBLIC HEALTH AND WELFARE
SUBCHAPTER XI— GENERAL PROVISIONS, PEER REVIEW, AND ADMINISTRATIVE SIMPLIFICATION
§ 1304. Reservation of right to amend or repeal
§ 1305. Short title of chapter
§ 1306a. Public access to State disbursement records
§ 1306c. Restriction on access to the Death Master File
§ 1310. Cooperative research or demonstration projects
§ 1311. Public assistance payments to legal representatives
§ 1312. Medical care guides and reports for public assistance and medical assistance
§ 1313. Assistance for United States citizens returned from foreign countries
§ 1314. Public advisory groups
§ 1314a. Measurement and reporting of welfare receipt
§ 1315. Demonstration projects
§ 1315a. Center for Medicare and Medicaid Innovation
§ 1315b. Providing Federal coverage and payment coordination for dual eligible beneficiaries
§ 1316. Administrative and judicial review of public assistance determinations
§ 1318. Alternative Federal payment with respect to public assistance expenditures
§ 1320. Approval of certain projects
§ 1320a. Uniform reporting systems for health services facilities and organizations
§ 1320a–1. Limitation on use of Federal funds for capital expenditures
§ 1320a–2. Effect of failure to carry out State plan
§ 1320a–3a. Disclosure requirements for other providers under part B of Medicare
§ 1320a–4. Issuance of subpenas by Comptroller General
§ 1320a–6. Adjustments in SSI benefits on account of retroactive benefits under subchapter II
§ 1320a–6a. Interagency coordination to improve program administration
§ 1320a–7a. Civil monetary penalties
§ 1320a–7b. Criminal penalties for acts involving Federal health care programs
§ 1320a–7c. Fraud and abuse control program
§ 1320a–7d. Guidance regarding application of health care fraud and abuse sanctions
§ 1320a–7e. Health care fraud and abuse data collection program
§ 1320a–7f. Coordination of medicare and medicaid surety bond provisions
§ 1320a–7g. Funds to reduce medicaid fraud and abuse
§ 1320a–7h. Transparency reports and reporting of physician ownership or investment interests
§ 1320a–7i. Reporting of information relating to drug samples
§ 1320a–7j. Accountability requirements for facilities
§ 1320a–7k. Medicare and Medicaid program integrity provisions
§ 1320a–8. Civil monetary penalties and assessments for subchapters II, VIII and XVI
§ 1320a–8a. Administrative procedure for imposing penalties for false or misleading statements
§ 1320a–8b. Attempts to interfere with administration of this chapter
§ 1320a–9. Demonstration projects
§ 1320a–10. Effect of failure to carry out State plan
§ 1320b–1. Notification of Social Security claimant with respect to deferred vested benefits
§ 1320b–2. Period within which certain claims must be filed
§ 1320b–4. Nonprofit hospital or critical access hospital philanthropy
§ 1320b–5. Authority to waive requirements during national emergencies
§ 1320b–7. Income and eligibility verification system
§ 1320b–8. Hospital protocols for organ procurement and standards for organ procurement agencies
§ 1320b–9a. Child health quality measures
§ 1320b–9b. Adult health quality measures
§ 1320b–10. Prohibitions relating to references to Social Security or Medicare
§ 1320b–11. Blood donor locator service
§ 1320b–12. Research on outcomes of health care services and procedures
§ 1320b–13. Social security account statements
§ 1320b–15. Protection of social security and medicare trust funds
§ 1320b–17. Cross-program recovery of overpayments from benefits
§ 1320b–19. The Ticket to Work and Self-Sufficiency Program
§ 1320b–20. Work incentives outreach program
§ 1320b–21. State grants for work incentives assistance to disabled beneficiaries
§ 1320b–23. Pharmacy benefit managers transparency requirements
§ 1320b–24. Consultation with Tribal Technical Advisory Group