§360cc Protection for drugs for rare diseases or conditions

section 355(c)(2) of this title, referred to in subsec. (a), was redesignated as section 355(c)(1)(B) of this title by Pub. L. 98–417, title I, § 102(a)(2), Sept. 24, 1984, 98 Stat. 1592. This section, as amended by such Act, referred to in subsec. (d), means this section as amended by the FDA Reauthorization Act of 2017, Pub. L. 115–52.

2026—Subsec. (a). Pub. L. 119–75, § 6605(a)(1), substituted “same approved use or indication within such rare disease or condition” for “same disease or condition” in concluding provisions. Subsec. (b). Pub. L. 119–75, § 6605(a)(2)(A), substituted “same approved use or indication for which such 7-year period applies to such already approved or licensed drug” for “same rare disease or condition” in introductory provisions. Subsec. (b)(1). Pub. L. 119–75, § 6605(a)(2)(B), inserted “, relating to the approved use or indication,” after “the needs”. Subsec. (c)(1). Pub. L. 119–75, § 6605(a)(3), substituted “same use or indication for which the already approved or licensed drug was approved or licensed” for “same rare disease or condition as the already approved drug”. Subsec. (f). Pub. L. 119–75, § 6605(a)(4), added subsec. (f). 2020—Subsec. (c)(3). Pub. L. 116–260 added par. (3). 2017—Subsec. (a). Pub. L. 115–52, § 607(a)(1), substituted “the same drug for the same disease or condition” for “such drug for such disease or condition” in concluding provisions. Subsec. (b). Pub. L. 115–52, § 607(a)(2)(A), in introductory provisions, substituted “During the 7-year period described in subsection (a) for an approved application under section 355 of this title or license under section 262 of title 42, the Secretary may approve an application or issue a license for a drug that is otherwise the same, as determined by the Secretary, as the already approved drug for the same rare disease or condition if” for “If an application filed pursuant to section 355 of this title is approved for a drug designated under section 360bb of this title for a rare disease or condition or if a license is issued under section 262 of title 42 for such a drug, the Secretary may, during the seven-year period beginning on the date of the application approval or of the issuance of the license, approve another application under section 355 of this title or issue a license under section 262 of title 42, for such drug for such disease or condition for a person who is not the holder of such approved application or of such license if”. Subsec. (b)(1). Pub. L. 115–52, § 607(a)(2)(B), substituted “of exclusive approval or licensure notice and opportunity for the submission of views, that during such period the holder of the exclusive approval or licensure cannot ensure” for “notice and opportunity for the submission of views, that in such period the holder of the approved application or of the license cannot assure”. Subsec. (b)(2). Pub. L. 115–52, § 607(a)(2)(C), substituted “the holder provides” for “such holder provides”. Subsecs. (c) to (e). Pub. L. 115–52, § 607(a)(3), added subsecs. (c) to (e). 2002—Subsec. (a). Pub. L. 107–281, in concluding provisions, struck out “, of such certification,” after “such approved application” and “, the issuance of the certification,” after “approval of the approved application”. 1997—Subsec. (a). Pub. L. 105–115, § 125(b)(2)(J), struck out “, issue another certification under section 357 of this title,” before “or issue another license” in closing provisions, inserted “or” at end of par. (1), redesignated par. (3) as (2), and struck out former par. (2) which read as follows: “issues a certification under section 357 of this title, or”. Subsec. (b). Pub. L. 105–115, § 125(b)(2)(K), in introductory provisions, struck out “, if a certification is issued under section 357 of this title for such a drug,” after “rare disease or condition”, “, of the issuance of the certification under section 357 of this title,” after “application approval”, “, issue another certification under section 357 of this title,” after “application under section 355 of this title”, and “, of such certification,” after “approved application”. Subsec. (b)(1). Pub. L. 105–115, § 125(b)(2)(K), struck out “, of the certification,” after “holder of the approved application”. Subsec. (b)(2). Pub. L. 105–115, § 125(b)(2)(K), struck out “, issuance of other certifications,” after “approval of other applications”. 1993—Subsec. (b). Pub. L. 103–80 struck out extraneous comma before “or issue a license under section 262” in introductory provisions and substituted “the” for “The” at beginning of par. (1). 1985—Pub. L. 99–91, § 2(3), struck out “unpatented” before “drugs” in section catchline. Subsec. (a). Pub. L. 99–91, §§ 2(1), 3(a)(3)(A)–(D), struck out “or” at end of par. (1), added par. (2), redesignated former par. (2) as (3), struck out “and for which a United States Letter of Patent may not be issued” after “rare disease or condition”, inserted in first sentence “, issue another certification under section 357 of this title,” after “section 355 of this title” the second time it appeared, inserted “, of such certification,” after “holder of such approved application”, and inserted “, the issuance of the certification,” after “approval of the approved application”. Subsec. (b). Pub. L. 99–91, §§ 2(2), 3(a)(3)(E)–(K), struck out “and if a United States Letter of Patent may not be issued for the drug” after “such a drug”, substituted “, if a certification is issued under section 357 of this title for such a drug, or if a license” for “or a license”, inserted “, of the issuance of the certification under section 357 of this title,” after “application approval”, struck out “, if the drug is a biological product,” before “issue a license”, inserted “, issue another certification under section 357 of this title,” after “section 355 of this title”, inserted “, of such certification,” after “holder of such approved application”, inserted “, of such certification,” after “application” in par. (1), and inserted “, issuance of other certifications,” after “other applications” in par. (2). 1984—Subsecs. (a), (b). Pub. L. 98–417 substituted “section 355” for “section 355(b)” wherever appearing.

of 1985 AmendmentAmendment by Pub. L. 99–91 effective Aug. 15, 1985, see section 8(b) of Pub. L. 99–91, set out as a note under section 360aa of this title.

Pub. L. 115–52, title VI, § 607(b), Aug. 18, 2017, 131 Stat. 1050, provided that: “Nothing in the

made by subsection (a) [amending this section] shall affect any determination under section 526 and 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb, 360cc) made prior to the date of enactment of the FDA Reauthorization Act of 2017 [Aug. 18, 2017].” Application of

by Pub. L. 119–75 Pub. L. 119–75, div. J, title VI, § 6605(b), Feb. 3, 2026, 140 Stat. 701, provided that: “The

made by subsection (a) [amending this section] shall apply with respect to any drug designated under section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), regardless of the date on which the drug was so designated, and regardless of the date on which the drug was approved under section 505 of such Act (21 U.S.C. 355) or licensed under section 351 of the Public Health Service Act (42 U.S.C. 262).”