Sec. 353. (g) Representations as recognized drug; packing and labeling; inconsistent requirements for designation of drug. (h) Deteriorative drugs; packing and labeling. (i) Drug; misleading container; imitation; offer for sale under another name. (j) Health-endangering when used as pre scribed. (k), (1) Repealed. (m) Color additives; packing and labeling. (n) Prescription drug advertisements: established name; quantitative formula; side effects, contraindications, and effectiveness; prior approval; false advertising; labeling; construction of the Convention on Psychotropic Substances. (0) Drugs or devices from nonregistered establishments. (p) Packaging or labeling of drugs in violation of regulations. (q) Restricted devices using false or misleading advertising or used in violation of regulations. (r) Restricted devices not carrying req- (s) Devices subject to performance stand- Exemptions and consideration for certain (b) Prescription by physician; exemption from labeling and prescription requirements; misbranded drugs; compliance with narcotic and marihuana laws. Sec. 355a. 356. 356a. 356b. (g) Service of orders. (i) Exemptions of drugs for research; dis- (1) Public disclosure of safety and effec- (m) "Patent" defined. (n) Scientific advisory panels. Pediatric studies of drugs. (a) Market exclusivity for new drugs. (c) Market exclusivity for already-mar- (d) Conduct of pediatric studies. (e) Delay of effective date for certain application. (f) Notice of determinations on studies requirement. (g) Definitions. (h) Limitations.. (i) Relationship to regulations. (j) Sunset. (k) Report. Fast track products. (a) Designation of drug as fast track product. (b) Approval of application for fast track (c) Review of incomplete applications for Manufacturing changes. (a) In general. (b) Validation of effects of changes. (c) Major manufacturing changes. (d) Other manufacturing changes. Reports of postmarketing studies. (a) Submission. (b) Consideration of information as pub lic information. (c) Status of studies and reports. Discontinuance of life saving product. (a) In general. (b) Reduction in notification period. (c) Distribution. Repealed. (a) In general. 358. (a) Necessity of effective approval of application. (b) Filing application; contents. (c) Period for approval of application; pe- 359. riod for, notice, and expedition of 360. hearing; period for issuance of order. (d) Grounds for refusing application; ap- (e) Withdrawal of approval; grounds; im- Authority to designate official names. (a) Necessity or desirability; use in official compendiums; infringement of trademarks. (b) Review of names in official compendiums. (c) Determinations of complexity, usefulness, multiplicity, or lack of name; designation by Secretary. (d) Revised official names; compilation, publication, and public distribution of listings. (e) Request by compiler of official compendium for designation of name. Nonapplicability of subchapter to cosmetics. Registration of producers of drugs or devices. (a) Definitions. (b) Annual registration. (c) New producers. (d) Additional establishments. (e) Registration number; uniform system for identification of devices intended for human use. (f) Availability of registrations for inspection. (g) Exclusions from application of sec tion. (a) Unsafe new animal drugs and animal feed containing such drugs; conditions of safety; exemption of drugs for research; import tolerances. (b) Filing application for uses of new animal drug; contents; patent information; abbreviated application; presubmission conference. (c) Period for submission and approval of application; period for notice and expedition of hearing; period for issuance of order; abbreviated applications; withdrawal periods; effective date of approval; relationship to other applications; withdrawal or suspension of approval; bioequivalence; filing of additional patent information. (d) Grounds for refusing application; approval of application; factors; "substantial evidence" defined; combination drugs. (e) Withdrawal of approval; grounds; immediate suspension upon finding imminent hazard to health of man or animals. (f) Revocation of order refusing, withdrawing or suspending approval of application. (g) Service of orders. (h) Appeal from order. (i) Publication in Federal Register; effective date and revocation or suspension of regulation. (j) Exemption of drugs for research; discretionary and mandatory conditions. (k) Food containing new animal drug considered unadulterated while approval of application for such drug is effective. (1) Records and reports; required information; regulations and orders; examination of data; access to records. (m) Feed mill licenses. (n) Abbreviated applications for new animal drugs; contents, filing, etc.; lists of approved drugs. (0) "Patent" defined. (p) Safety and effectiveness data. Classification of devices intended for human 360d. 360e. 360f. 360g. 360h. 360i. 360j. 360k. 360c. (a) General rule. (b) Exempt requirements. Postmarket surveillance. (a) In general. (b) Surveillance approval. Accredited persons. (a) In general. (b) Accreditation. (c) Duration. 360kk. 36077. Definitions. Program of control. (a) Establishment. (b) Powers of Secretary. Studies by the Secretary. (a) Report to Congress. (b) Participation of other Federal agen cies. (c) Organization of studies and participa tion. Performance standards for electronic products. (a) Promulgation of regulations. (b) Administrative procedure. (c) Publication in Federal Register. (d) Judicial review. (e) Availability of record. (f) Technical Electronic Product Radi- (g) Review and evaluation. Notification of defects in and repair or replacement of electronic products. (a) Notification; exemption. (b) Method of notification. (c) Requisite elements of notification. (f) Correction of defects. (g) Effective date. (a) In general. (b) Specific requirements. (c) Additional information. 360aaa-1. Information authorized to be disseminated. (a) Authorized information. (b) Reference publication. 360aaa-2. Establishment of list of articles and publications disseminated and list of providers that received articles and reference publications. (a) In general. (b) Records. 360aaa-3. Requirement regarding submission of supplemental application for new use; exemption from requirement. (a) In general. (b) Certification on supplemental application; condition in case of completed studies. (c) Certification on supplemental application; condition in case of planned studies. (d) Exemption from requirement of supplemental application. (e) Requirements regarding applications. 360aaa-4. Corrective actions; cessation of dissemination. (a) Postdissemination data regarding safety and effectiveness. (b) Cessation of dissemination. Expanded access to unapproved therapies and diagnostics. (a) Emergency situations. (b) Individual patient access to investigational products intended for serious diseases. (c) Treatment investigational new drug applications and treatment investigational device exemptions. (d) Termination. (e) Definitions. 360bbb-1. Dispute resolution. 360bbb-2. Classification of products. (a) Request. (b) Statement. (c) Inaction of Secretary. Sec. 383. 384. 391. 392. 393. 394. 395. 396. 397. (b) Applicability of certain provisions. (c) Authorization of appropriations. Practice of medicine. Contracts for expert review. (a) In general. (b) Review of expert review. CHAPTER REFERRED TO IN OTHER SECTIONS This chapter is referred to in sections 453, 457, 466, 467, 467f, 601, 607, 620, 679, 802, 811, 823, 829, 830, 902, 1033, 1049, 1052, 1401, 1402, 1403, 1601 of this title; title 7 sections 136a-1, 136v, 1381, 1431c, 5341, 6519, 7653; title 15 sections 70j, 1261, 1263, 1277, 1459, 1460, 2057a, 2057b, 2079; title 18 sections 42, 983; title 19 section 2578a; title 26 sections 170, 4817; title 35 sections 155, 156, 271, 287; title 42 sections 262, 300aa-22, 300aa-23, 1396r-8, 1786, 3512, 7671. SUBCHAPTER I-SHORT TITLE §301. Short title This chapter may be cited as the Federal Food, Drug, and Cosmetic Act. (June 25, 1938, ch. 675, §1, 52 Stat. 1040.) EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES Act June 23, 1939, ch. 242, §§ 1, 2, 53 Stat. 853, 854, provided that: "[SEC. 1] (a) The effective date of the following provisions of the Federal Food, Drug, and Cosmetic Act is hereby postponed until January 1, 1940: Sections 402(c) [342(c) of this title]; 403(e)(1) [343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g) to (k) of this title]; 501(a), (4) [351(a)(4) of this title]; 502(b), (d), (e), (f), (g), and (h) [352(b), (d) to (h) of this title]; 601(e) [361(e) of this title]; and 602(b) [362(b) of this title]. "(b) The Secretary of Agriculture shall promulgate regulations further postponing to July 1, 1940 the effective date of the provisions of sections 403(e)(1) [343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g) to (k)]; 502(b), (d), (e), (f), (g), and (h) [352(b), (d) to (h) of this title]; and 602(b) [362(b) of this title] of such Act with respect to lithographed labeling which was manufactured prior to February 1, 1939, and to containers bearing labeling which, prior to February 1, 1939, was lithographed, etched, stamped, pressed, printed, fused or blown on or in such containers, where compliance with such provisions would be unduly burdensome by reason of causing the loss of valuable stocks of such labeling or containers, and where such postponement would not prevent the public interest being adequately served: Provided, That in no case shall such regulations apply to labeling which would not have complied with the requirements of the Food and Drugs Act of June 30, 1906, as amended. "SEC. 2. (a) The provisions of section 8 [section 10 of this title], paragraph fifth, under the heading 'In the case of food:', of the Food and Drugs Act of June 30, 1906, as amended, and regulations promulgated thereunder, and all other provisions of such Act to the extent that they may relate to the enforcement of such section 8 [section 10 of this title] and of such regulations, shall remain in force until January 1, 1940. "(b) The provisions of such Act of June 30, 1906, as amended, [sections 1 to 5, 7 to 15, and 372a of this title] to the extent that they impose, or authorize the imposition of, any requirement imposed by section 403(k) of the Federal Food, Drug, and Cosmetic Act [section 343(k) of this title], shall remain in force until January 1, 1940. "(c) Notwithstanding the provisions of section 1 of this Act, such section shall not apply "(1) to the provisions of section 502(d) and (e) of the Federal Food, Drug, and Cosmetic Act [352(d), (e) of this title], insofar as such provisions relate to any substance named in section 8 [section 10 of this title], paragraph second, under the heading 'In the case of drugs:', of the Food and Drugs Act of June 30, 1906, as amended, or a derivative of any such substance; or "(2) to the provisions of section 502(b), (d), (e), (f), (g), and (h) of the Federal Food, Drug, and Cosmetic Act [352(b), (d) to (h) of this title], insofar as such provisions relate to drugs to which section 505 [355 of this title] of such Act applies." EFFECTIVE DATE Section 902(a) of act June 25, 1938, provided that: "This Act [enacting this chapter and repealing sections 1 to 5 and 7 to 15 of this title], shall take effect twelve months after the date of its enactment [June 25, 1938]. The Federal Food and Drugs Act of June 30, 1906, as amended (U.S.C., 1934 ed., title 21, secs. 1-15), shall remain in force until such effective date, and, except as otherwise provided in this subsection, is hereby repealed effective upon such date: Provided, That the provisions of section 701 [section 371 of this title] shall become effective on the enactment of this Act, and thereafter the Secretary is authorized hereby to (1) conduct hearings and to promulgate regulations which shall become effective on or after the effective date of this Act as the Secretary shall direct, and (2) designate prior to the effective date of this Act food having common or usual names and exempt such food from the requirements of clause (2) of section 403(i) [section 343(i) of this title] for a reasonable time to permit the formulation, promulgation, and effective application of definitions and standards of identity therefor as provided by section 401 [section 341 of this title]: Provided further, |