U.S. Code » Title 21 » Chapter CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER V— DRUGS AND DEVICES › Part Part A— Drugs and Devices

21 U.S.C. § 356a

Manufacturing changes

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(a) In generalWith 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(2)(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 changesFor 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 generalFor 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 distributionIn 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.)Statutory Notes and Related SubsidiariesEffective Date

Pub. L. 105–115, title I, § 116(b), Nov. 21, 1997, 111 Stat. 2315, provided that: “The amendment made by subsection (a) [enacting this section] takes effect upon the effective date of regulations promulgated by the Secretary of Health and Human Services to implement such amendment, or upon the expiration of the 24-month period beginning on the date of the enactment of this Act [Nov. 21, 1997], whichever occurs first.”

Notes of Decisions
Cited in 13 cases (3 in the last 5 years), 2005–2023 · leading case: Bartlett v. Mut. Pharm. Co., Inc., 659 F. Supp. 2d 279 (D.N.H. 2009).
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Bartlett v. Mut. Pharm. Co., Inc., 659 F. Supp. 2d 279 (D.N.H. 2009). · cites it 9× “Because 21 U.S.C. § 356a expressly authorizes a manufacturer’s changes to an application approved under § 355 of the Act — whether under subsection (b), as in the case of an NDA, or under subsection (j), as in the case of an ANDA — the defendants are incorrect that nothing in…”
United States Ex Rel. Campie v. Gilead Sciences, Inc., 862 F.3d 890 (9th Cir. 2017). “21 U.S.C. § 356a(c)(2); 21 C.F.R. § 314.70 (b)(3).”
Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir. 2010). · cites it 2× “80 (e); see also 21 C.F.R. § 314.70(c)(6)(iii) (a CBE may be used “[t]o add or strengthen a contraindication, warning, precaution, or adverse reaction for which the evidence of a causal association satisfies the standard for inclusion in the labeling under [21 C.”
Ignacuinos v. Boehringer Ingelheim Pharms., 8 F.4th 98 (2d Cir. 2021). · cites it 3× “7 We would add to the First Circuit’s compelling analysis only that the 8 authorizing statutory language of 21 U.S.C. § 356a(c)(2) provides that “a 9 major manufacturing change is a manufacturing change that is determined by 10 the [FDA] to have substantial potential to…”
Teva Pharm. Indus. Ltd. v. Crawford, 410 F.3d 51 (D.C. Cir. 2005). “” Teva argued in the alternative that the FDA should “require Pfizer to submit a pre-approval supplemental new drug application (sNDA) [under 21 U.S.C. § 356a(d) ] before marketing or distributing any version of [a name-brand drug] changed in any way such that the product…”
Gustavesen v. Alcon Labs., Inc., 272 F. Supp. 3d 241 (D. Mass. 2017). “See 21 U.S.C. § 356a(c)(2)(C). FDA guidance is controlling “unless plainly erroneous or inconsistent” with the statute or a.”
Nat'l Corn Growers Ass'n v. Env't Prot. Agency, 613 F.3d 266 (D.C. Cir. 2010). “, and the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. § 356a. The FIFRA establishes a registration system under which the EPA controls the sale, distribution, and use of pesticides.”
Nostrum Pharm. LLC v. FDA, 35 F.4th 820 (D.C. Cir. 2022). “21 U.S.C. § 356a(c)(1); 21 C.F.R. §§ 314.”
Weilbrenner v. Teva Pharm. USA, Inc., 696 F. Supp. 2d 1329 (M.D. Ga. 2010). “21 U.S.C. § 356a(c)(1); 21 C.F.R. § 314.70 (b)(2)(v).”
United States v. 1500 90-Tablet Bottles, 384 F. Supp. 2d 1205 (N.D. Ill. 2005). “Nothing in the plain language of the exemption, or in the legislative history provided to the court by the parties, suggests any intent on the part of Congress to allow any drug importer to make changes to the FDA-approved NDA for a drug.”
Fmc Corp. v. United States Env't Prot. Agency, 279 F.R.D. 14 (D.D.C. 2011). “Statutory Framework The EPA regulates pesticides pursuant to two federal statutes: the Federal Food, Drug and Cosmetic Act (“FFDCA”), codified at 21 U.S.C. § 356a, and FIFRA. Nat’l Corn Growers Ass’n v.”
Bartlett v. Mut. Pharm., 2009 DNH 144 (D.N.H. 2009). · cites it 8× “2296 , 2313 (codified at 21 U.S.C. § 356a (1999)). 8 The rule was subsequently revised in ways not relevant here.”
Show all 13 citing cases →
— 21 U.S.C. § 356a(a) — 1 case
Bartlett v. Mut. Pharm. Co., Inc., 659 F. Supp. 2d 279 (D.N.H. 2009). “Because 21 U.S.C. § 356a expressly authorizes a manufacturer’s changes to an application approved under § 355 of the Act — whether under subsection (b), as in the case of an NDA, or under subsection (j), as in the case of an ANDA — the defendants are incorrect that nothing in…”
— 21 U.S.C. § 356a(a)(1) — 1 case
Bartlett v. Mut. Pharm., 2009 DNH 144 (D.N.H. 2009). “2296 , 2313 (codified at 21 U.S.C. § 356a (1999)). 8 The rule was subsequently revised in ways not relevant here.”
— 21 U.S.C. § 356a(a)(l) — 1 case
Bartlett v. Mut. Pharm. Co., Inc., 659 F. Supp. 2d 279 (D.N.H. 2009). “Because 21 U.S.C. § 356a expressly authorizes a manufacturer’s changes to an application approved under § 355 of the Act — whether under subsection (b), as in the case of an NDA, or under subsection (j), as in the case of an ANDA — the defendants are incorrect that nothing in…”
— 21 U.S.C. § 356a(c)(1) — 3 cases
Nostrum Pharm. LLC v. FDA, 35 F.4th 820 (D.C. Cir. 2022). “21 U.S.C. § 356a(c)(1); 21 C.F.R. §§ 314.”
Weilbrenner v. Teva Pharm. USA, Inc., 696 F. Supp. 2d 1329 (M.D. Ga. 2010). “21 U.S.C. § 356a(c)(1); 21 C.F.R. § 314.70 (b)(2)(v).”
Bartlett v. Mut. Pharm., 2009 DNH 144 (D.N.H. 2009). “2296 , 2313 (codified at 21 U.S.C. § 356a (1999)). 8 The rule was subsequently revised in ways not relevant here.”
— 21 U.S.C. § 356a(c)(2) — 2 cases
United States Ex Rel. Campie v. Gilead Sciences, Inc., 862 F.3d 890 (9th Cir. 2017). “21 U.S.C. § 356a(c)(2); 21 C.F.R. § 314.70 (b)(3).”
Ignacuinos v. Boehringer Ingelheim Pharms., 8 F.4th 98 (2d Cir. 2021). “7 We would add to the First Circuit’s compelling analysis only that the 8 authorizing statutory language of 21 U.S.C. § 356a(c)(2) provides that “a 9 major manufacturing change is a manufacturing change that is determined by 10 the [FDA] to have substantial potential to…”
— 21 U.S.C. § 356a(c)(2)(A) — 1 case
Ignacuinos v. Boehringer Ingelheim Pharms., 8 F.4th 98 (2d Cir. 2021). “7 We would add to the First Circuit’s compelling analysis only that the 8 authorizing statutory language of 21 U.S.C. § 356a(c)(2) provides that “a 9 major manufacturing change is a manufacturing change that is determined by 10 the [FDA] to have substantial potential to…”
— 21 U.S.C. § 356a(c)(2)(C) — 1 case
Gustavesen v. Alcon Labs., Inc., 272 F. Supp. 3d 241 (D. Mass. 2017). “See 21 U.S.C. § 356a(c)(2)(C). FDA guidance is controlling “unless plainly erroneous or inconsistent” with the statute or a.”
— 21 U.S.C. § 356a(c)(l) — 2 cases
Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir. 2010). “80 (e); see also 21 C.F.R. § 314.70(c)(6)(iii) (a CBE may be used “[t]o add or strengthen a contraindication, warning, precaution, or adverse reaction for which the evidence of a causal association satisfies the standard for inclusion in the labeling under [21 C.”
Bartlett v. Mut. Pharm. Co., Inc., 659 F. Supp. 2d 279 (D.N.H. 2009). “Because 21 U.S.C. § 356a expressly authorizes a manufacturer’s changes to an application approved under § 355 of the Act — whether under subsection (b), as in the case of an NDA, or under subsection (j), as in the case of an ANDA — the defendants are incorrect that nothing in…”
— 21 U.S.C. § 356a(d) — 1 case
Teva Pharm. Indus. Ltd. v. Crawford, 410 F.3d 51 (D.C. Cir. 2005). “” Teva argued in the alternative that the FDA should “require Pfizer to submit a pre-approval supplemental new drug application (sNDA) [under 21 U.S.C. § 356a(d) ] before marketing or distributing any version of [a name-brand drug] changed in any way such that the product…”
— 21 U.S.C. § 356a(d)(1) — 1 case
Bartlett v. Mut. Pharm., 2009 DNH 144 (D.N.H. 2009). “2296 , 2313 (codified at 21 U.S.C. § 356a (1999)). 8 The rule was subsequently revised in ways not relevant here.”
— 21 U.S.C. § 356a(d)(3)(A) — 2 cases
Bartlett v. Mut. Pharm. Co., Inc., 659 F. Supp. 2d 279 (D.N.H. 2009). “Because 21 U.S.C. § 356a expressly authorizes a manufacturer’s changes to an application approved under § 355 of the Act — whether under subsection (b), as in the case of an NDA, or under subsection (j), as in the case of an ANDA — the defendants are incorrect that nothing in…”
Bartlett v. Mut. Pharm., 2009 DNH 144 (D.N.H. 2009). “2296 , 2313 (codified at 21 U.S.C. § 356a (1999)). 8 The rule was subsequently revised in ways not relevant here.”
— 21 U.S.C. § 356a(d)(l) — 1 case
Bartlett v. Mut. Pharm. Co., Inc., 659 F. Supp. 2d 279 (D.N.H. 2009). “Because 21 U.S.C. § 356a expressly authorizes a manufacturer’s changes to an application approved under § 355 of the Act — whether under subsection (b), as in the case of an NDA, or under subsection (j), as in the case of an ANDA — the defendants are incorrect that nothing in…”
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