---
kind: "section"
citation: "21 U.S.C. § 379j–62"
title: "21"
title_heading: "Food and Drugs"
number: "379j–62"
heading: "Authority to assess and use outsourcing facility fees"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/379j-62"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter VII — General Authority"
  - "Part C — Fees"
  - "Subpart 9 — fees relating to outsourcing facilities"
---

# §379j–62. Authority to assess and use outsourcing facility fees

- (a) **Establishment and reinspection fees—**
  - (1) **In general—** For fiscal year 2015 and each subsequent fiscal year, the [Secretary](/usc/21/321.md?p=d) shall, in accordance with this subsection, assess and collect—
    - (A) an annual establishment fee from each [outsourcing facility](/usc/21/379j–61.md?p=3); and
    - (B) a [reinspection](/usc/21/379j–61.md?p=4) fee from each [outsourcing facility](/usc/21/379j–61.md?p=3) subject to a [reinspection](/usc/21/379j–61.md?p=4) in such fiscal year.
  - (2) **Multiple reinspections—** An [outsourcing facility](/usc/21/379j–61.md?p=3) subject to multiple [reinspections](/usc/21/379j–61.md?p=4) in a fiscal year shall be subject to a [reinspection](/usc/21/379j–61.md?p=4) fee for each [reinspection](/usc/21/379j–61.md?p=4).
- (b) **Establishment and reinspection fee setting—** The [Secretary](/usc/21/321.md?p=d) shall—
  - (1) establish the amount of the establishment fee and [reinspection](/usc/21/379j–61.md?p=4) fee to be collected under this section for each fiscal year based on the methodology described in [subsection (c)](#c); and
  - (2) publish such fee amounts in a Federal Register notice not later than 60 calendar days before the start of each such year.
- (c) **Amount of establishment fee and reinspection fee—**
  - (1) **In general—** For each [outsourcing facility](/usc/21/379j–61.md?p=3) in a fiscal year—
    - (A) except as provided in [paragraph (4)](#c-4), the amount of the annual establishment fee under [subsection (b)](#b) shall be equal to the sum of—
      - (i) $15,000, multiplied by the inflation adjustment factor described in [paragraph (2)](#c-2); plus
      - (ii) the small business adjustment factor described in [paragraph (3)](#c-3); and
    - (B) the amount of any [reinspection](/usc/21/379j–61.md?p=4) fee (if applicable) under [subsection (b)](#b) shall be equal to $15,000, multiplied by the inflation adjustment factor described in [paragraph (2)](#c-2).
  - (2) **Inflation adjustment factor—**
    - (A) **In general—** For fiscal year 2015 and subsequent fiscal years, the fee amounts established in [paragraph (1)](#c-1) shall be adjusted by the [Secretary](/usc/21/321.md?p=d) by notice, published in the Federal Register, for a fiscal year by the amount equal to the sum of—
      - (i) 1;
      - (ii) the average annual percent change in the cost, per full-time equivalent position of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of an average full-time equivalent position of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration for the first 3 years of the preceding 4 fiscal years; plus
      - (iii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (U.S. City Average; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of an average full-time equivalent position of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration for the first 3 years of the preceding 4 fiscal years.
    - (B) **Compounded basis—** The adjustment made each fiscal year under [subparagraph (A)](#c-2-A) shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2014 under [subparagraph (A)](#c-2-A).
  - (3) **Small business adjustment factor—** The small business adjustment factor described in this paragraph shall be an amount established by the [Secretary](/usc/21/321.md?p=d) for each fiscal year based on the [Secretary](/usc/21/321.md?p=d)’s estimate of—
    - (A) the number of small businesses that will pay a reduced establishment fee for such fiscal year; and
    - (B) the adjustment to the establishment fee necessary to achieve total fees equaling the total fees that the [Secretary](/usc/21/321.md?p=d) would have collected if no entity qualified for the small business exception in [paragraph (4)](#c-4).
  - (4) **Exception for small businesses—**
    - (A) **In general—** In the case of an [outsourcing facility](/usc/21/379j–61.md?p=3) with [gross annual sales](/usc/21/379j–61.md?p=2) of $1,000,000 or less in the 12 months ending April 1 of the fiscal year immediately preceding the fiscal year in which the fees under this section are assessed, the amount of the establishment fee under [subsection (b)](#b) for a fiscal year shall be equal to \1/3\ of the amount calculated under [paragraph (1)(A)(i)](#c-1-A-i) for such fiscal year.
    - (B) **Application—** To qualify for the exception under this paragraph, a small business shall submit to the [Secretary](/usc/21/321.md?p=d) a written request for such exception, in a format specified by the [Secretary](/usc/21/321.md?p=d) in guidance, certifying its [gross annual sales](/usc/21/379j–61.md?p=2) for the 12 months ending April 1 of the fiscal year immediately preceding the fiscal year in which fees under this subsection are assessed. Any such application shall be submitted to the [Secretary](/usc/21/321.md?p=d) not later than April 30 of such immediately preceding fiscal year.
  - (5) **Crediting of fees—** In establishing the small business adjustment factor under [paragraph (3)](#c-3) for a fiscal year, the [Secretary](/usc/21/321.md?p=d) shall—
    - (A) provide for the crediting of fees from the previous year to the next year if the [Secretary](/usc/21/321.md?p=d) overestimated the amount of the small business adjustment factor for such previous fiscal year; and
    - (B) consider the need to account for any adjustment of fees and such other factors as the [Secretary](/usc/21/321.md?p=d) determines appropriate.
- (d) **Use of fees—** The [Secretary](/usc/21/321.md?p=d) shall make all of the fees collected pursuant to subparagraphs [(A)](#a-1-A) and [(B)](#a-1-B) of subsection (a)(1) available solely to pay for the costs of oversight of [outsourcing facilities](/usc/21/379j–61.md?p=3).
- (e) **Supplement not supplant—** Funds received by the [Secretary](/usc/21/321.md?p=d) pursuant to this section shall be used to supplement and not supplant any other Federal funds available to carry out the activities described in this section.
- (f) **Crediting and availability of fees—** Fees [authorized](/usc/21/360eee.md?p=2) under this section shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are [authorized](/usc/21/360eee.md?p=2) to remain available until expended. Such sums as may be necessary may be transferred from the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the purpose of paying the costs of oversight of [outsourcing facilities](/usc/21/379j–61.md?p=3).
- (g) **Collection of fees—**
  - (1) **Establishment fee—** An [outsourcing facility](/usc/21/379j–61.md?p=3) shall remit the establishment fee due under this section in a fiscal year when submitting a registration pursuant to [section 353b(b) of this title](/usc/21/353b.md?p=b) for such fiscal year.
  - (2) **Reinspection fee—** The [Secretary](/usc/21/321.md?p=d) shall specify in the Federal Register notice described in [subsection (b)(2)](#b-2) the manner in which [reinspection](/usc/21/379j–61.md?p=4) fees assessed under this section shall be collected and the timeline for payment of such fees. Such a fee shall be collected after the [Secretary](/usc/21/321.md?p=d) has conducted a [reinspection](/usc/21/379j–61.md?p=4) of the [outsourcing facility](/usc/21/379j–61.md?p=3) involved.
  - (3) **Effect of failure to pay fees—**
    - (A) **Registration—** An [outsourcing facility](/usc/21/379j–61.md?p=3) shall not be considered registered under [section 353b(b) of this title](/usc/21/353b.md?p=b) in a fiscal year until the date that the [outsourcing facility](/usc/21/379j–61.md?p=3) remits the establishment fee under this subsection for such fiscal year.
    - (B) **Misbranding—** All [drugs](/usc/21/321.md?p=g-1) manufactured, prepared, propagated, compounded, or processed by an [outsourcing facility](/usc/21/379j–61.md?p=3) for which any establishment fee or [reinspection](/usc/21/379j–61.md?p=4) fee has not been paid, as required by this section, shall be deemed misbranded under [section 352 of this title](/usc/21/352.md) until the fees owed for such [outsourcing facility](/usc/21/379j–61.md?p=3) under this section have been paid.
  - (4) **Collection of unpaid fees—** In any case where the [Secretary](/usc/21/321.md?p=d) does not receive payment of a fee assessed under this section within 30 calendar days after it is due, such fee shall be treated as a claim of the United States Government subject to provisions of subchapter II of chapter 37 of title 31.
- (h) **Annual report to Congress—** Not later than 120 calendar days after each fiscal year in which fees are assessed and collected under this section, the [Secretary](/usc/21/321.md?p=d) shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and [Commerce](/usc/21/360hh.md?p=4) of the House of Representatives, to include a description of fees assessed and collected for such year, a summary description of entities paying the fees, a description of the hiring and placement of new staff, a description of the use of fee resources to support inspecting [outsourcing facilities](/usc/21/379j–61.md?p=3), and the number of inspections and [reinspections](/usc/21/379j–61.md?p=4) of such [facilities](/usc/21/364.md?p=3-A) performed each year.
- (i) **Authorization of appropriations—** For fiscal year 2014 and each subsequent fiscal year, there is [authorized](/usc/21/360eee.md?p=2) to be appropriated for fees under this section an amount equivalent to the total amount of fees assessed for such fiscal year under this section.

## Source credit

(June 25, 1938, ch. 675, § 744K, as added Pub. L. 113–54, title I, § 102(b), Nov. 27, 2013, 127 Stat. 594.)