---
kind: "section"
citation: "42 U.S.C. § 1320f–2"
title: "42"
title_heading: "The Public Health and Welfare"
number: "1320f–2"
heading: "Manufacturer agreements"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/1320f-2"
units:
  - "Chapter 7 — Social Security"
  - "Subchapter XI — General Provisions, Peer Review, and Administrative Simplification"
  - "Part E — Price Negotiation Program To Lower Prices for Certain High-Priced Single Source Drugs"
---

# §1320f–2. Manufacturer agreements

- (a) **In general—** For purposes of [section 1320f(a)(2) of this title](/usc/42/1320f.md?p=a-2), the [Secretary](/usc/42/1301.md?p=a-6) shall enter into agreements with manufacturers of selected [drugs](/usc/42/11851.md?p=4) with respect to a price applicability period, by not later than February 28 following the selected [drug](/usc/42/11851.md?p=4) publication date with respect to such selected [drug](/usc/42/11851.md?p=4), under which—
  - (1) during the negotiation period for the initial price applicability year for the selected [drug](/usc/42/11851.md?p=4), the [Secretary](/usc/42/1301.md?p=a-6) and the manufacturer, in accordance with [section 1320f–3 of this title](/usc/42/1320f–3.md), negotiate to determine (and, by not later than the last date of such period, agree to) a maximum fair price for such selected [drug](/usc/42/11851.md?p=4) of the manufacturer in order for the manufacturer to provide access to such price—
    - (A) to maximum fair price eligible individuals who with respect to such [drug](/usc/42/11851.md?p=4) are described in subparagraph (A) of [section 1320f(c)(2) of this title](/usc/42/1320f.md?p=c-2) and are dispensed such [drug](/usc/42/11851.md?p=4) (and to pharmacies, mail order services, and other dispensers, with respect to such maximum fair price eligible individuals who are dispensed such [drugs](/usc/42/11851.md?p=4)) during, subject to [paragraph (2)](#a-2), the price applicability period; and
    - (B) to [hospitals](/usc/42/300s–3.md?p=1), [physicians](/usc/42/1301.md?p=a-7), and other providers of services and suppliers with respect to maximum fair price eligible individuals who with respect to such [drug](/usc/42/11851.md?p=4) are described in subparagraph (B) of such section and are furnished or administered such [drug](/usc/42/11851.md?p=4) during, subject to [paragraph (2)](#a-2), the price applicability period;
  - (2) the [Secretary](/usc/42/1301.md?p=a-6) and the manufacturer shall, in accordance with [section 1320f–3 of this title](/usc/42/1320f–3.md), renegotiate (and, by not later than the last date of the period of renegotiation, agree to) the maximum fair price for such [drug](/usc/42/11851.md?p=4), in order for the manufacturer to provide access to such maximum fair price (as so renegotiated)—
    - (A) to maximum fair price eligible individuals who with respect to such [drug](/usc/42/11851.md?p=4) are described in subparagraph (A) of [section 1320f(c)(2) of this title](/usc/42/1320f.md?p=c-2) and are dispensed such [drug](/usc/42/11851.md?p=4) (and to pharmacies, mail order services, and other dispensers, with respect to such maximum fair price eligible individuals who are dispensed such [drugs](/usc/42/11851.md?p=4)) during any year during the price applicability period (beginning after such renegotiation) with respect to such selected [drug](/usc/42/11851.md?p=4); and
    - (B) to [hospitals](/usc/42/300s–3.md?p=1), [physicians](/usc/42/1301.md?p=a-7), and other providers of services and suppliers with respect to maximum fair price eligible individuals who with respect to such [drug](/usc/42/11851.md?p=4) are described in subparagraph (B) of such section and are furnished or administered such [drug](/usc/42/11851.md?p=4) during any year described in [subparagraph (A)](#a-2-A);
  - (3) subject to [subsection (d)](#d), access to the maximum fair price ([including](/usc/42/1301.md?p=b) as renegotiated pursuant to [paragraph (2)](#a-2)), with respect to such a selected [drug](/usc/42/11851.md?p=4), shall be provided by the manufacturer to—
    - (A) maximum fair price eligible individuals, who with respect to such [drug](/usc/42/11851.md?p=4) are described in subparagraph (A) of [section 1320f(c)(2) of this title](/usc/42/1320f.md?p=c-2), at the pharmacy, mail order service, or other dispenser at the point-of-sale of such [drug](/usc/42/11851.md?p=4) (and shall be provided by the manufacturer to the pharmacy, mail order service, or other dispenser, with respect to such maximum fair price eligible individuals who are dispensed such [drugs](/usc/42/11851.md?p=4)), as described in paragraph [(1)(A)](#a-1-A) or [(2)(A)](#a-2-A), as applicable; and
    - (B) [hospitals](/usc/42/300s–3.md?p=1), [physicians](/usc/42/1301.md?p=a-7), and other providers of services and suppliers with respect to maximum fair price eligible individuals who with respect to such [drug](/usc/42/11851.md?p=4) are described in subparagraph (B) of such section and are furnished or administered such [drug](/usc/42/11851.md?p=4), as described in paragraph [(1)(B)](#a-1-B) or [(2)(B)](#a-2-B), as applicable;
  - (4) the manufacturer submits 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), for the negotiation period for the price applicability period (and, if applicable, before any period of renegotiation pursuant to [section 1320f–3(f) of this title](/usc/42/1320f–3.md?p=f)), and for [section 1320f–1(f) of this title](/usc/42/1320f–1.md?p=f), with respect to such [drug](/usc/42/11851.md?p=4)—
    - (A) information on the non-Federal average manufacturer price (as defined in [section 8126(h)(5) of title 38](/usc/38/8126.md?p=h-5)) for the [drug](/usc/42/11851.md?p=4) for the applicable year or period;
    - (B) information that the [Secretary](/usc/42/1301.md?p=a-6) requires to carry out the negotiation (or renegotiation process) under this part; and
    - (C) information that the [Secretary](/usc/42/1301.md?p=a-6) requires to carry out [section 1320f–1(f) of this title](/usc/42/1320f–1.md?p=f), [including](/usc/42/1301.md?p=b) rebates under [paragraph (4)](/usc/42/1320f–1.md?p=f-4) of such section; and
  - (5) the manufacturer complies with requirements determined by the [Secretary](/usc/42/1301.md?p=a-6) to be necessary for purposes of administering the program and monitoring compliance with the program.
- (b) **Agreement in effect until drug is no longer a selected drug—** An agreement entered into under this section shall be effective, with respect to a selected [drug](/usc/42/11851.md?p=4), until such [drug](/usc/42/11851.md?p=4) is no longer considered a selected [drug](/usc/42/11851.md?p=4) under [section 1320f–1(c) of this title](/usc/42/1320f–1.md?p=c).
- (c) **Confidentiality of information—** Information submitted to the [Secretary](/usc/42/1301.md?p=a-6) under this part by a manufacturer of a selected [drug](/usc/42/11851.md?p=4) that is proprietary information of such manufacturer (as determined by the [Secretary](/usc/42/1301.md?p=a-6)) shall be used only by the [Secretary](/usc/42/1301.md?p=a-6) or disclosed to and used by the Comptroller General of the [United States](/usc/42/1301.md?p=a-2) for purposes of carrying out this part.
- (d) **Nonduplication with 340B ceiling price—** Under an agreement entered into under this section, the manufacturer of a selected [drug](/usc/42/11851.md?p=4)—
  - (1) shall not be required to provide access to the maximum fair price under [subsection (a)(3)](#a-3), with respect to such selected [drug](/usc/42/11851.md?p=4) and maximum fair price eligible individuals who are eligible to be furnished, administered, or dispensed such selected [drug](/usc/42/11851.md?p=4) at a covered entity described in section 340B(a)(4) of the Public Health Service Act [[42 U.S.C. 256b(a)(4)](/usc/42/256b.md?p=a-4)], to such covered entity if such selected [drug](/usc/42/11851.md?p=4) is subject to an agreement described in section 340B(a)(1) of such Act [[42 U.S.C. 256b(a)(1)](/usc/42/256b.md?p=a-1)] and the ceiling price (defined in section 340B(a)(1) of such Act [[42 U.S.C. 256b(a)(1)](/usc/42/256b.md?p=a-1)]) is lower than the maximum fair price for such selected [drug](/usc/42/11851.md?p=4); and
  - (2) shall be required to provide access to the maximum fair price to such covered entity with respect to maximum fair price eligible individuals who are eligible to be furnished, administered, or dispensed such selected [drug](/usc/42/11851.md?p=4) at such entity at such ceiling price in a nonduplicated amount to the ceiling price if such maximum fair price is below the ceiling price for such selected [drug](/usc/42/11851.md?p=4).

## Source credit

(Aug. 14, 1935, ch. 531, title XI, § 1193, as added and amended Pub. L. 117–169, title I, §§ 11001(a), 11002(a)(2), Aug. 16, 2022, 136 Stat. 1841, 1861.)

## Notes

### Editorial Notes

### Amendments

2022—Subsec. (a)(4). Pub. L. 117–169, § 11002(a)(2)(A), inserted “, and for section 1320f–1(f) of this title,” after “section 1320f–3(f) of this title)” in introductory provisions.

Subsec. (a)(4)(C). Pub. L. 117–169, § 11002(a)(2)(B), (C), added subpar. (C).