Tap any paragraph to write a margin note. Your notes collect in the Desk below the text and file under cases with @. The side-by-side margin rail opens on a larger screen.

§
Marginalia
Code · U.S. Code · Title 21 - FOOD AND DRUGS · CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT · SUBCHAPTER V— DRUGS AND DEVICES · § 356a

§ 356a. Manufacturing changes

1,008 words·~5 min read·/usc/title-21/section-356a

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(a)In general With respect to a drug for which there is in effect an approved application under section 355 or 360b of this title or a license under section 262 of title 42, a change from the manufacturing process approved pursuant to such application or license may be made, and the drug as made with the change may be distributed, if—
(1)the holder of the approved application or license (referred to in this section as a “holder”) has validated the effects of the change in accordance with subsection (b); and
(A)in the case of a major manufacturing change, the holder has complied with the requirements of subsection (c); or
(B)in the case of a change that is not a major manufacturing change, the holder complies with the applicable requirements of subsection (d).
(b)Validation of effects of changes For purposes of subsection (a)(1), a drug made with a manufacturing change (whether a major manufacturing change or otherwise) may be distributed only if, before distribution of the drug as so made, the holder involved validates the effects of the change on the identity, strength, quality, purity, and potency of the drug as the identity, strength, quality, purity, and potency may relate to the safety or effectiveness of the drug.
(c)Major manufacturing changes
(1)Requirement of supplemental application For purposes of subsection (a)(2)(A), a drug made with a major manufacturing change may be distributed only if, before the distribution of the drug as so made, the holder involved submits to the Secretary a supplemental application for such change and the Secretary approves the application. The application shall contain such information as the Secretary determines to be appropriate, and shall include the information developed under subsection
(b)by the holder in validating the effects of the change.
(2)Changes qualifying as major changes For purposes of subsection (a)(2)(A), a major manufacturing change is a manufacturing change that is determined by the Secretary to have substantial potential to adversely affect the identity, strength, quality, purity, or potency of the drug as they may relate to the safety or effectiveness of a drug. Such a change includes a change that—
(A)is made in the qualitative or quantitative formulation of the drug involved or in the specifications in the approved application or license referred to in subsection
(a)for the drug (unless exempted by the Secretary by regulation or guidance from the requirements of this subsection);
(B)is determined by the Secretary by regulation or guidance to require completion of an appropriate clinical study demonstrating equivalence of the drug to the drug as manufactured without the change; or
(C)is another type of change determined by the Secretary by regulation or guidance to have a substantial potential to adversely affect the safety or effectiveness of the drug.
(d)Other manufacturing changes
(1)In general For purposes of subsection (a)(2)(B), the Secretary may regulate drugs made with manufacturing changes that are not major manufacturing changes as follows:
(A)The Secretary may in accordance with paragraph
(2)authorize holders to distribute such drugs without submitting a supplemental application for such changes.
(B)The Secretary may in accordance with paragraph
(3)require that, prior to the distribution of such drugs, holders submit to the Secretary supplemental applications for such changes.
(C)The Secretary may establish categories of such changes and designate categories to which subparagraph
(A)applies and categories to which subparagraph
(B)applies.
(2)Changes not requiring supplemental application
(A)Submission of report A holder making a manufacturing change to which paragraph (1)(A) applies shall submit to the Secretary a report on the change, which shall contain such information as the Secretary determines to be appropriate, and which shall include the information developed under subsection
(b)by the holder in validating the effects of the change. The report shall be submitted by such date as the Secretary may specify.
(B)Authority regarding annual reports In the case of a holder that during a single year makes more than one manufacturing change to which paragraph (1)(A) applies, the Secretary may in carrying out subparagraph
(A)authorize the holder to comply with such subparagraph by submitting a single report for the year that provides the information required in such subparagraph for all the changes made by the holder during the year.
(3)Changes requiring supplemental application
(A)Submission of supplemental application The supplemental application required under paragraph (1)(B) for a manufacturing change shall contain such information as the Secretary determines to be appropriate, which shall include the information developed under subsection
(b)by the holder in validating the effects of the change.
(B)Authority for distribution In the case of a manufacturing change to which paragraph (1)(B) applies:
(i)The holder involved may commence distribution of the drug involved 30 days after the Secretary receives the supplemental application under such paragraph, unless the Secretary notifies the holder within such 30-day period that prior approval of the application is required before distribution may be commenced.
(ii)The Secretary may designate a category of such changes for the purpose of providing that, in the case of a change that is in such category, the holder involved may commence distribution of the drug involved upon the receipt by the Secretary of a supplemental application for the change.
(iii)If the Secretary disapproves the supplemental application, the Secretary may order the manufacturer to cease the distribution of the drugs that have been made with the manufacturing change.
(June 25, 1938, ch. 675, § 506A, as added Pub. L. 105–115, title I, § 116(a), Nov. 21, 1997, 111 Stat. 2313.)
Connections30 cite this · traces to 1
Cited by 30 sections · top 29
Traces to 1 document
5 references not yet in our index
  • June 25, 1938, ch. 675, § 506A
  • Pub. L. 105–115, title I, § 116(a)
  • 111 Stat. 2313
  • Pub. L. 105–115, title I, § 116(b)
  • 111 Stat. 2315
Citation graph
cites case law
§ 356a
Manufacturing changes
Fed. Reg.×23
Stat.×3
Bills×2
Pub. L.×1
U.S.C.×1
U.S.C.§ 262
ActJune 25, 1938, ch. 675, § 506A
Pub. L.Pub. L. 105–115, title I, § 116(a)
Stat.111 Stat. 2313
Pub. L.Pub. L. 105–115, title I, § 116(b)
Stat.111 Stat. 2315
Cites 6Cited by 30 across 5 sources
★   the supreme law of the land   ★
Don't Tread on Me
E Pluribus Unum — out of many, one

"If you don't know your rights, you don't have any."

Marginalia · a citizen's law index
A research desk, not legal advice. Always read the cited source before relying on a summary.
Questions or an issue? support@self-law.org
disclaimerMarginalia is a research index, not a law firm. Nothing on this site is legal, tax, or financial advice and no attorney–client relationship is formed by using it. Statutes, regulations, and case law change; summaries, search results, AI output, and member posts may be incomplete, out of date, or wrong. Any interpretation drawn from material on this site should be validated by a licensed attorney in your jurisdiction before you act on it.