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42 U.S.C. § 258a — Transferred

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42 U.S.C. § 258a — Transferred

Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 258a

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Stable record: federal_law:legal_authorities:usc2024-03685fff3dc734d664cc9348
Source file: Laws/federal/codes/united-states-code-2024/title-42/section-258a-transferred--612c8e5010.md
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Source location: USCODE-2024-title42-chap6A-subchapII-partE-sec258a.pdf

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Page 456 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 258a § 258a. Transferred Editorial Notes CODIFICATION Section, act July 8, 1947, ch. 210, title II, § 201, 61 Stat. 269, which related to transfer of balances in working capital fund, narcotic hospitals, to surplus fund, was transferred and is set out as a note under section 290aa of this title. §§ 259 to 261a. Repealed. Pub. L. 106–310, div. B, title XXXIV, § 3405(a), Oct. 17, 2000, 114 Stat. 1221, as amended by Pub. L. 114–198, title I, § 110(b), July 22, 2016, 130 Stat. 710 Section 259, acts July 1, 1944, ch. 373, title III, § 343, 58 Stat. 699; Pub. L. 91–513, title I, § 2(a)(2)(A), (3), (4), Oct. 27, 1970, 84 Stat. 1240; Pub. L. 92–293, § 3, May 11, 1972, 86 Stat. 136; Pub. L. 98–473, title II, § 232(b), Oct. 12, 1984, 98 Stat. 2031, related to convict addicts or other persons with drug abuse or drug dependence problems. Section 260, acts July 1, 1944, ch. 373, title III, § 344, 58 Stat. 701; June 25, 1948, ch. 654, § 5, 62 Stat. 1018; July 24, 1956, ch. 676, title III, § 302(b), 70 Stat. 622; Pub. L. 91–513, title I, § 2(a)(2)(A), (3), (4), Oct. 27, 1970, 84 Stat. 1240, re- lated to addicts and persons with drug abuse or drug dependence problems. Section 260a, act July 1, 1944, ch. 373, title III, § 345, as added May 8, 1954, ch. 195, § 2, 68 Stat. 79; amended July 24, 1956, ch. 676, title III, § 302(c), 70 Stat. 622; Pub. L. 91–358, title I, § 155(c)(32), July 29, 1970, 84 Stat. 572, re- lated to admission of addicts committed from District of Columbia. Section 261, acts July 1, 1944, ch. 373, title III, § 346, formerly § 345, 58 Stat. 701; renumbered § 346, May 8, 1954, ch. 195, § 2, 68 Stat. 79; amended Pub. L. 91–513, title I, § 2(a)(2)(A), (5), Oct. 27, 1970, 84 Stat. 1240, related to penalties for introducing prohibited articles and sub- stances into hospitals and escaping from, or aiding and abetting escape from hospitals. Section 261a, act July 1, 1944, ch. 373, title III, § 347, as added May 8, 1954, ch. 195, § 4, 68 Stat. 80; amended Pub. L. 91–513, title I, § 2(a)(4), Oct. 27, 1970, 84 Stat. 1240, re- lated to release of patients and determination by Sur- geon General. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2016 AMENDMENT Pub. L. 114–198, title I, § 110(b), July 22, 2016, 130 Stat. 710, provided that the amendment made by section 110(b) (amending directory language of section 3405(a) of Pub. L. 106–310, which repealed sections 259 to 261a of this title) is effective as if included in the enactment of Pub. L. 106–310. PART F—LICENSING OF BIOLOGICAL PRODUCTS AND CLINICAL LABORATORIES SUBPART 1—BIOLOGICAL PRODUCTS § 262. Regulation of biological products (a) Biologics license (1) No person shall introduce or deliver for in- troduction into interstate commerce any bio- logical product unless— (A) a biologics license under this subsection or subsection (k) is in effect for the biological product; and (B) each package of the biological product is plainly marked with— (i) the proper name of the biological prod- uct contained in the package; (ii) the name, address, and applicable li- cense number of the manufacturer of the bi- ological product; and (iii) the expiration date of the biological product. (2)(A) The Secretary shall establish, by regula- tion, requirements for the approval, suspension, and revocation of biologics licenses. (B) PEDIATRIC STUDIES.—A person that submits an application for a license under this paragraph shall submit to the Secretary as part of the ap- plication any assessments required under sec- tion 505B of the Federal Food, Drug, and Cos- metic Act [21 U.S.C. 355c]. (C) The Secretary shall approve a biologics li- cense application— (i) on the basis of a demonstration that— (I) the biological product that is the sub- ject of the application is safe, pure, and po- tent; and (II) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent; and (ii) if the applicant (or other appropriate person) consents to the inspection of the facil- ity that is the subject of the application, in accordance with subsection (c). (D) POSTMARKET STUDIES AND CLINICAL TRIALS; LABELING; RISK EVALUATION AND MITIGATION STRATEGY.—A person that submits an applica- tion for a license under this paragraph is subject to sections 505(o), 505(p), and 505–1 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(o), (p), 355–1]. (E)(i) The Secretary may rely upon qualified data summaries to support the approval of a supplemental application, with respect to a qualified indication for a drug, submitted under this subsection, if such supplemental applica- tion complies with the requirements of subpara- graph (B) of section 505(c)(5) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(c)(5)]. (ii) In this subparagraph, the terms ‘‘qualified indication’’ and ‘‘qualified data summary’’ have the meanings given such terms in section 505(c)(5) of the Federal Food, Drug, and Cos- metic Act. (3) The Secretary shall prescribe requirements under which a biological product undergoing in- vestigation shall be exempt from the require- ments of paragraph (1). (b) Falsely labeling or marking package or con- tainer; altering label or mark No person shall falsely label or mark any package or container of any biological product or alter any label or mark on the package or container of the biological product so as to fal- sify the label or mark. (c) Inspection of establishment for propagation and preparation Any officer, agent, or employee of the Depart- ment of Health and Human Services, authorized by the Secretary for the purpose, may during all reasonable hours enter and inspect any estab- lishment for the propagation or manufacture and preparation of any biological product. (d) Recall of product presenting imminent haz- ard; violations (1) Upon a determination that a batch, lot, or other quantity of a product licensed under this

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 355 — New drugs

**(a) Necessity of effective approval of application** No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug. **(b) Filing application; contents** (1) (A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application— (i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use; (ii) a full list of the articles used as components of such drug; (iii) a full statement of the composition of such drug; (iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (v) such samples of such drug and of the articles used as components thereof as the Secretary may require; (vi) specimens of the labeling proposed to be used for such drug; (vii) any assessments required under [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim); and (viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that— (I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or (II) claims a method of using such drug for which approv

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 355 — New drugs

Page 186 TITLE 21—FOOD AND DRUGS § 355 § 355. New drugs (a) Necessity of effective approval of application No person shall introduce or deliver for intro- duction into interstate commerce any new drug, unless an approval of an application filed pursu- ant to subsection (b) or (j) is effective with re- spect to such drug. (b) Filing application; contents (1)(A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the ap- plication— (i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use; (ii) a full list of the articles used as compo- nents of such drug; (iii) a full statement of the composition of such drug; (iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (v) such samples of such drug and of the arti- cles used as components thereof as the Sec- retary may require; (vi) specimens of the labeling proposed to be used for such drug; (vii) any assessments required under section 355c of this title; and (viii) the patent number and expiration date of each patent for which a claim of patent in- fringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that— (I) claims the drug for which the applicant submitted the application and is a drug sub- stance (active ingredient) patent or a drug product (formulation or composition) pat- ent; or (II) claims a method of using such drug for which approval is sought or has been granted in the application. (B) If an a

Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 355

Stored review status: historical_2024_not_currentness_verified. The source passage cites 21 U.S.C. § 355. This identifies an authority to review, not proof of applicability.

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 355c — Research into pediatric uses for drugs and biological products

**(a) New drugs and biological products** (1) **In general** (A) *General requirements* — Except with respect to an application for which subparagraph (B) applies, a person that submits, on or after September 27, 2007, an application (or supplement to an application) for a drug— (i) under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration; or (ii) under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration, shall submit with the application the assessments described in paragraph (2). (B) *Certain molecularly targeted cancer indications* — A person that submits, on or after the date that is 3 years after August 18, 2017, an original application for a new active ingredient under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim), shall submit with the application reports on the investigation described in paragraph (3) if the drug or biological product that is the subject of the application is— (i) intended for the treatment of an adult cancer; and (ii) directed at a molecular target that the Secretary determines to be substantially relevant to the growth or progression of a pediatric cancer. (2) **Assessments** (A) *In general* — The assessments referred to in

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355c

Stored review status: release_metadata_unconfirmed. The source passage cites 21 U.S.C. § 355c. This identifies an authority to review, not proof of applicability.

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 355c — Research into pediatric uses for drugs

Page 248 TITLE 21—FOOD AND DRUGS § 355b 1 So in original. Probably should be preceded by ‘‘section’’. 2 So in original. Probably should be ‘‘Committee’’. STUDY BY GENERAL ACCOUNTING OFFICE Pub. L. 107–109, § 18(b), Jan. 4, 2002, 115 Stat. 1423, re- quired the Comptroller General, not later than Jan. 10, 2003, to conduct a study relating to the representation of children of ethnic and racial minorities in studies under section 355a of this title and to submit a report to Congress describing the findings of the study. § 355b. Adverse-event reporting (a) Toll-free number in labeling Not later than one year after January 4, 2002, the Secretary of Health and Human Services shall promulgate a final rule requiring that the labeling of each drug for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355] (regard- less of the date on which approved) include the toll-free number maintained by the Secretary for the purpose of receiving reports of adverse events regarding drugs and a statement that such number is to be used for reporting purposes only, not to receive medical advice. With re- spect to the final rule: (1) The rule shall provide for the implemen- tation of such labeling requirement in a man- ner that the Secretary considers to be most likely to reach the broadest consumer audi- ence. (2) In promulgating the rule, the Secretary shall seek to minimize the cost of the rule on the pharmacy profession. (3) The rule shall take effect not later than 60 days after the date on which the rule is pro- mulgated. (b) Drugs with pediatric market exclusivity (1) In general During the one year beginning on the date on which a drug receives a period of market exclusivity under 505A 1 of the Federal

Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 355c

Stored review status: historical_2024_not_currentness_verified. The source passage cites 21 U.S.C. § 355c. This identifies an authority to review, not proof of applicability.

Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 258a — Transferred

### Statutory Notes #### Codification Section, act July 8, 1947, ch. 210, title II, § 201, 61 Stat. 269, which related to transfer of balances in working capital fund, narcotic hospitals, to surplus fund, was transferred and is set out as a note under [section 290aa of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section290aa&num=0&edition=prelim).

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 258a

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