---
kind: "section"
citation: "21 U.S.C. § 356l"
title: "21"
title_heading: "Food and Drugs"
number: "356l"
heading: "Advanced manufacturing technologies designation program"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/356l"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §356l. Advanced manufacturing technologies designation program

- (a) **In general—** Not later than 1 year after December 29, 2022, the [Secretary](/usc/21/321.md?p=d) shall initiate a program under which [persons](/usc/21/321.md?p=e) may request designation of an advanced manufacturing technology as described in [subsection (b)](#b).
- (b) **Designation process—** The [Secretary](/usc/21/321.md?p=d) shall establish a process for the designation under this section of methods of manufacturing [drugs](/usc/21/321.md?p=g-1), including biological [products](/usc/21/360eee.md?p=13), and active pharmaceutical ingredients of such [drugs](/usc/21/321.md?p=g-1), as advanced manufacturing technologies. A method of manufacturing, or a combination of manufacturing methods, is eligible for designation as an advanced manufacturing technology if such method or combination of methods incorporates a novel technology, or uses an established technique or technology in a novel way, that will substantially improve the manufacturing process for a [drug](/usc/21/321.md?p=g-1) while maintaining equivalent, or providing superior, [drug](/usc/21/321.md?p=g-1) quality, including by—
  - (1) reducing development time for a [drug](/usc/21/321.md?p=g-1) using the designated manufacturing method; or
  - (2) increasing or maintaining the supply of—
    - (A) a [drug](/usc/21/321.md?p=g-1) that is life-supporting, life-sustaining, or of critical importance to providing health care; or
    - (B) a [drug](/usc/21/321.md?p=g-1) that is on the [drug](/usc/21/321.md?p=g-1) shortage list under [section 356e of this title](/usc/21/356e.md).
- (c) **Evaluation and designation of an advanced manufacturing technology—**
  - (1) **Submission—** A [person](/usc/21/321.md?p=e) who requests designation of a method of manufacturing as an advanced manufacturing technology under this section shall submit to the [Secretary](/usc/21/321.md?p=d) data or information demonstrating that the method of manufacturing meets the criteria described in [subsection (b)](#b) in a particular context of use. The [Secretary](/usc/21/321.md?p=d) may facilitate the development and review of such data or information by—
    - (A) providing timely advice to, and interactive communication with, such [person](/usc/21/321.md?p=e) regarding the development of the method of manufacturing; and
    - (B) involving senior managers and experienced staff of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, as appropriate, in a collaborative, cross-disciplinary review of the method of manufacturing, as applicable.
  - (2) **Evaluation and designation—** Not later than 180 calendar days after the receipt of a request under [paragraph (1)](#c-1), the [Secretary](/usc/21/321.md?p=d) shall determine whether to designate such method of manufacturing as an advanced manufacturing technology, in a particular context of use, based on the data and information submitted under [paragraph (1)](#c-1) and the criteria described in [subsection (b)](#b).
- (d) **Review of advanced manufacturing technologies—** If the [Secretary](/usc/21/321.md?p=d) designates a method of manufacturing as an advanced manufacturing technology, the [Secretary](/usc/21/321.md?p=d) shall—
  - (1) expedite the development and review of an application submitted under [section 355 of this title](/usc/21/355.md) or [section 262 of title 42](/usc/42/262.md), including supplemental applications, for [drugs](/usc/21/321.md?p=g-1) that are manufactured using a designated advanced manufacturing technology; and
  - (2) allow the holder of an advanced technology designation, or a [person](/usc/21/321.md?p=e) [authorized](/usc/21/360eee.md?p=2) by the advanced manufacturing technology designation holder, to reference or rely upon, in an application submitted under [section 355 of this title](/usc/21/355.md) or [section 262 of title 42](/usc/42/262.md), including a supplemental application, data and information about the designated advanced manufacturing technology for use in manufacturing [drugs](/usc/21/321.md?p=g-1) in the same context of use for which the designation was granted.
- (e) **Implementation and evaluation of advanced manufacturing technologies program—**
  - (1) **Public meeting—** The [Secretary](/usc/21/321.md?p=d) shall publish in the Federal Register a notice of a public meeting, to be held not later than 180 days after December 29, 2022, to discuss, and obtain input and recommendations from relevant stakeholders regarding—
    - (A) the goals and scope of the program under this section, and the framework, procedures, and requirements suitable for such program; and
    - (B) ways in which the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration will support the use of advanced manufacturing technologies and other innovative manufacturing approaches for [drugs](/usc/21/321.md?p=g-1).
  - (2) **Program guidance—**
    - (A) **In general—** The [Secretary](/usc/21/321.md?p=d) shall—
      - (i) not later than 180 days after the public meeting under [paragraph (1)](#e-1), issue draft guidance regarding the goals and implementation of the program under this section; and
      - (ii) not later than 2 years after December 29, 2022, issue final guidance regarding the implementation of such program.
    - (B) **Content—** The guidance described in [subparagraph (A)](#e-2-A) shall address—
      - (i) the process by which a [person](/usc/21/321.md?p=e) may request a designation under [subsection (b)](#b);
      - (ii) the data and information that a [person](/usc/21/321.md?p=e) requesting such a designation is required to submit under [subsection (c)](#c), and how the [Secretary](/usc/21/321.md?p=d) intends to evaluate such submissions;
      - (iii) the process to expedite the development and review of applications under [subsection (d)](#d); and
      - (iv) the criteria described in [subsection (b)](#b) for eligibility for such a designation.
  - (3) **Report—** Not later than 3 years after December 29, 2022, and annually thereafter, the [Secretary](/usc/21/321.md?p=d) shall publish on the website of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration and submit 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 a report containing a description and evaluation of the program being conducted under this section, including the types of innovative manufacturing approaches supported under the program. Such report shall include the following:
    - (A) The number of [persons](/usc/21/321.md?p=e) that have requested designations and that have been granted designations.
    - (B) The number of methods of manufacturing that have been the subject of designation requests and that have been granted designations.
    - (C) The average number of calendar days for completion of evaluations under [subsection (c)(2)](#c-2).
    - (D) An analysis of the factors in data submissions that result in determinations to designate and not to designate after evaluation under [subsection (c)(2)](#c-2).
    - (E) The number of applications received under [section 355 of this title](/usc/21/355.md) or [section 262 of title 42](/usc/42/262.md), including supplemental applications, that have included an advanced manufacturing technology designated under this section, and the number of such applications approved.
- (f) **Sunset—** The [Secretary](/usc/21/321.md?p=d)—
  - (1) may not consider any requests for designation submitted under [subsection (c)](#c) after October 1, 2032; and
  - (2) may continue all activities under this section with respect to advanced manufacturing technologies that were designated pursuant to [subsection (b)](#b) prior to such date, if the [Secretary](/usc/21/321.md?p=d) determines such activities are in the interest of the public health.

## Source credit

(June 25, 1938, ch. 675, § 506L, as added Pub. L. 117–328, div. FF, title III, § 3213, Dec. 29, 2022, 136 Stat. 5826.)