21 U.S.C. § 360ss — State standards

Page 413 TITLE 21—FOOD AND DRUGS § 360ss sums owing by the United States to the person charged. (c) Venue; process Actions under subsections (a) and (b) of this section may be brought in the district court of the United States for the district wherein any act or omission or transaction constituting the violation occurred, or in such court for the dis- trict where the defendant is found or transacts business, and process in such cases may be served in any other district of which the defend- ant is an inhabitant or wherever the defendant may be found. (d) Warnings Nothing in this part shall be construed as re- quiring the Secretary to report for the institu- tion of proceedings minor violations of this part whenever he believes that the public interest will be adequately served by a suitable written notice or warning. (e) Compliance with regulations Except as provided in the first sentence of sec- tion 360ss of this title, compliance with this part or any regulations issued thereunder shall not relieve any person from liability at common law or under statutory law. (f) Additional remedies The remedies provided for in this part shall be in addition to and not in substitution for any other remedies provided by law. (June 25, 1938, ch. 675, § 539, formerly act July 1, 1944, ch. 373, title III, § 539, formerly § 360C, as added Pub. L. 90–602, § 2(3), Oct. 18, 1968, 82 Stat. 1184; renumbered § 539 and amended Pub. L. 101–629, § 19(a)(1)(B), (2)(G), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, § 4(a)(2), Aug. 13, 1993, 107 Stat. 779.) Editorial Notes CODIFICATION Section was classified to section 263k of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629. AMENDMENTS 1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, § 19(a)(4), which renumbered section 263k of Title 42, The Public Health and Welfare, as this section. 1990—Subsec. (a). Pub. L. 101–629, § 19(a)(2)(G)(i), (ii), substituted ‘‘section 360oo’’ for ‘‘section 263j’’ and ‘‘sec- tion 360kk’’ for ‘‘section 263f’’. Subsec. (b)(1). Pub. L. 101–629, § 19(a)(2)(G)(ii), sub- stituted ‘‘section 360oo’’ for ‘‘section 263j’’ in two places. Subsec. (d). Pub. L. 101–629, § 19(a)(1)(B), substituted ‘‘this part’’ for ‘‘this subpart’’ in two places. Subsec. (e). Pub. L. 101–629, § 19(a)(1)(B), (2)(G)(iii), substituted ‘‘section 360ss’’ for ‘‘section 263n’’ and ‘‘this part’’ for ‘‘this subpart’’. Subsec. (f). Pub. L. 101–629, § 19(a)(1)(B), substituted ‘‘this part’’ for ‘‘this subpart’’. Statutory Notes and Related Subsidiaries NONINTERFERENCE WITH OTHER FEDERAL AGENCIES Enactment of this section not to be construed to su- persede or limit the functions under any other provi- sion of law of any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title. § 360qq. Repealed. Pub. L. 105–362, title VI, § 601(a)(2)(A), Nov. 10, 1998, 112 Stat. 3285 Section, act June 25, 1938, ch. 675, § 540, formerly act July 1, 1944, ch. 373, title III, § 540, formerly § 360D, as added Pub. L. 90–602, § 2(3), Oct. 18, 1968, 82 Stat. 1185; re- numbered § 540 and amended Pub. L. 101–629, § 19(a)(1)(B), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, § 4(a)(2), Aug. 13, 1993, 107 Stat. 779, re- lated to annual report on administration of electronic product radiation control program. § 360rr. Federal-State cooperation The Secretary is authorized (1) to accept from State and local authorities engaged in activities related to health or safety or consumer protec- tion, on a reimbursable basis or otherwise, any assistance in the administration and enforce- ment of this part which he may request and which they may be able and willing to provide and, if so agreed, may pay in advance or other- wise for the reasonable cost of such assistance, and (2) he may, for the purpose of conducting ex- aminations, investigations, and inspections, commission any officer or employee of any such authority as an officer of the Department. (June 25, 1938, ch. 675, § 541, formerly act July 1, 1944, ch. 373, title III, § 541, formerly § 360E, as added Pub. L. 90–602, § 2(3), Oct. 18, 1968, 82 Stat. 1186; renumbered § 541 and amended Pub. L. 101–629, § 19(a)(1)(B), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, § 4(a)(2), Aug. 13, 1993, 107 Stat. 779.) Editorial Notes CODIFICATION Section was classified to section 263m of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629. AMENDMENTS 1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, § 19(a)(4), which renumbered section 263m of Title 42, The Public Health and Welfare, as this section. 1990—Pub. L. 101–629, § 19(a)(1)(B), substituted ‘‘this part’’ for ‘‘this subpart’’. Statutory Notes and Related Subsidiaries NONINTERFERENCE WITH OTHER FEDERAL AGENCIES Enactment of this section not to be construed to su- persede or limit the functions under any other provi- sion of law of any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title. § 360ss. State standards Whenever any standard prescribed pursuant to section 360kk of this title with respect to an as- pect of performance of an electronic product is in effect, no State or political subdivision of a State shall have any authority either to estab- lish, or to continue in effect, any standard which is applicable to the same aspect of performance of such product and which is not identical to the Federal standard. Nothing in this part shall be construed to prevent the Federal Government or the government of any State or political sub- Page 414 TITLE 21—FOOD AND DRUGS §§ 360aaa to 360aaa–6 division thereof from establishing a requirement with respect to emission of radiation from elec- tronic products procured for its own use if such requirement imposes a more restrictive stand- ard than that required to comply with the other- wise applicable Federal standard. (June 25, 1938, ch. 675, § 542, formerly act July 1, 1944, ch. 373, title III, § 542, formerly § 360F, as added Pub. L. 90–602, § 2(3), Oct. 18, 1968, 82 Stat. 1186; renumbered § 542 and amended Pub. L. 101–629, § 19(a)(1)(B), (2)(H), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, § 4(a)(2), Aug. 13, 1993, 107 Stat. 779.) Editorial Notes CODIFICATION Section was classified to section 263n of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629. AMENDMENTS 1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, § 19(a)(4), which renumbered section 263n of Title 42, The Public Health and Welfare, as this section. 1990—Pub. L. 101–629, § 19(a)(1)(B), (2)(H), substituted ‘‘section 360kk’’ for ‘‘section 263f’’ and ‘‘this part’’ for ‘‘this subpart’’. Statutory Notes and Related Subsidiaries NONINTERFERENCE WITH OTHER FEDERAL AGENCIES Enactment of this section not to be construed to su- persede or limit the functions under any other provi- sion of law of any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title. PART D—DISSEMINATION OF TREATMENT INFORMATION §§ 360aaa to 360aaa–6. Omitted Editorial Notes CODIFICATION Sections 360aaa to 360aaa–6 ceased to be effective pur- suant to section 401(e) of Pub. L. 105–115, set out as an Effective and Termination Dates note below. Section 360aaa, act June 25, 1938, ch. 675, § 551, as added Pub. L. 105–115, title IV, § 401(a), Nov. 21, 1997, 111 Stat. 2356, related to requirements for dissemination of treatment information on drugs or devices. Section 360aaa–1, act June 25, 1938, ch. 675, § 552, as added Pub. L. 105–115, title IV, § 401(a), Nov. 21, 1997, 111 Stat. 2358, related to information authorized to be dis- seminated under section 360aaa. Section 360aaa–2, act June 25, 1938, ch. 675, § 553, as added Pub. L. 105–115, title IV, § 401(a), Nov. 21, 1997, 111 Stat. 2359, related to establishment of list of articles and publications disseminated and list of providers that received articles and reference publications. Section 360aaa–3, act June 25, 1938, ch. 675, § 554, as added Pub. L. 105–115, title IV, § 401(a), Nov. 21, 1997, 111 Stat. 2359, related to requirement regarding submission of supplemental application for new use and an exemp- tion from that requirement. Section 360aaa–4, act June 25, 1938, ch. 675, § 555, as added Pub. L. 105–115, title IV, § 401(a), Nov. 21, 1997, 111 Stat. 2361, related to corrective actions and cessation of dissemination. Section 360aaa–5, act June 25, 1938, ch. 675, § 556, as added Pub. L. 105–115, title IV, § 401(a), Nov. 21, 1997, 111 Stat. 2362, related to definitions. Section 360aaa–6, act June 25, 1938, ch. 675, § 557, as added Pub. L. 105–115, title IV, § 401(a), Nov. 21, 1997, 111 Stat. 2363, related to rules of construction. Statutory Notes and Related Subsidiaries EFFECTIVE AND TERMINATION DATES Pub. L. 105–115, title IV, § 401(d), Nov. 21, 1997, 111 Stat. 2364, provided that: ‘‘The amendments made by this section [enacting this part and amending section 331 of this title] shall take effect 1 year after the date of enactment of this Act [Nov. 21, 1997], or upon the Secretary’s issuance of final regulations pursuant to subsection (c) [section 401(c) of Pub. L. 105–115 set out below] [Such regulations were issued effective Nov. 20, 1998. See 63 F.R. 64556.], whichever is sooner.’’ Pub. L. 105–115, title IV, § 401(e), Nov. 21, 1997, 111 Stat. 2364, provided that: ‘‘The amendments made by this section [enacting this part and amending section 331 of this title] cease to be effective September 30, 2006, or 7 years after the date on which the Secretary pro- mulgates the regulations described in subsection (c) [section 401(c) of Pub. L. 105–115 set out below] [Such regulations were issued effective Nov. 20, 1998. See 63 F.R. 64556.], whichever is later.’’ REGULATIONS Pub. L. 105–115, title IV, § 401(c), Nov. 21, 1997, 111 Stat. 2364, provided that: ‘‘Not later than 1 year after the date of enactment of this Act [Nov. 21, 1997], the Secretary of Health and Human Services shall promul- gate regulations to implement the amendments made by this section [enacting this part and amending sec- tion 331 of this title].’’ PART E—GENERAL PROVISIONS RELATING TO DRUGS AND DEVICES § 360bbb. Expanded access to unapproved thera- pies and diagnostics (a) Emergency situations The Secretary may, under appropriate condi- tions determined by the Secretary, authorize the shipment of investigational drugs or inves- tigational devices for the diagnosis, monitoring, or treatment of a serious disease or condition in emergency situations. (b) Individual patient access to investigational products intended for serious diseases Any person, acting through a physician li- censed in accordance with State law, may re- quest from a manufacturer or distributor, and any manufacturer or distributor may, after complying with the provisions of this sub- section, provide to such physician an investiga- tional drug or investigational device for the di- agnosis, monitoring, or treatment of a serious disease or condition if— (1) the licensed physician determines that the person has no comparable or satisfactory alternative therapy available to diagnose, monitor, or treat the disease or condition in- volved, and that the probable risk to the per- son from the investigational drug or investiga- tional device is not greater than the probable risk from the disease or condition; (2) the Secretary determines that there is sufficient evidence of safety and effectiveness to support the use of the investigational drug or investigational device in the case described in paragraph (1); (3) the Secretary determines that provision of the investigational drug or investigational device will not interfere with the initiation, conduct, or completion of clinical investiga- tions to support marketing approval; and (4) the sponsor, or clinical investigator, of the investigational drug or investigational de-