cluded within the classifications stated in section 3220 of Title 26, or to marihuana as defined in section 3238 (b) of Title 26. (June 25, 1938, ch. 675, § 503, 52 Stat. 1051; 1940 Reorg. Plan No. IV, § 12, eff. June 30, 1940, 5 F. R. 2422, 54 Stat. 1237; Oct. 26, 1951, ch. 578, § 1, 65 Stat. 648.)

AMENDMENTS

1951-Subsec. (b) amended generally by act Oct. 26, 1951, to protect the public from abuses in the sale of potent prescription drugs, and to relieve retail pharmacists and the public from unnecessary restrictions on the dispensation of drugs that are safe to use without supervision of a doctor.

EFFECTIVE DATE OF 1951 AMENDMENT

Section 3 of act Oct. 26, 1951, provided that the amendment of this section should take effect six months after Oct. 26, 1951.

EFFECTIVE DATE

Section 902 (a) of act June 25, 1938, provided that this section should take effect twelve months after June 25, 1938.

TRANSFER OF FUNCTIONS

See note under section 321 of this title.

§ 354. Certification of coal-tar colors for drugs.

The Administrator shall promulgate regulations providing for the listing of coal-tar colors which are harmless and suitable for use in drugs for purposes of coloring only and for the certification of batches of such colors, with or without harmless diluents. (June 25, 1938, ch. 675, § 504, 52 Stat. 1052; 1940 Reorg. Plan No. IV, § 12, eff. June 30, 1940, 5 F. R. 2422, 54 Stat. 1237.)

EFFECTIVE DATE

Section 902 (a) of act June 25, 1938, provided that this section should take effect twelve months after June 25, 1938.

TRANSFER OF FUNCTIONS

See note under section 321 of this title.

§ 355. New drugs—(a) Necessity of effective application.

No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an application filed pursuant to subsection (b) of this section is effective with respect to such drug. (b) Filing application; contents.

Any person may file with the Administrator an application with respect to any drug subject to the provisions of subsection (a) of this section. Such person shall submit to the Administrator as a part of the application (1) full reports of investigations which have been made to show whether or not such lrug is safe for use; (2) a full list of the articles used s components of such drug; (3) a full statement of he composition of such drug; (4) a full description f the methods used in, and the facilities and controls sed for, the manufacture, processing, and packing such drug; (5) such samples of such drug and of e articles used as components thereof as the Adinistrator may require; and (6) specimens of the beling proposed to be used for such drug.

Effective date of application.

An application provided for in subsection (b) of s section shall become effective on the sixtieth day er the filing thereof unless prior to such day the ninistrator by notice to the applicant in writing

postpones the effective date of the application to such time (not more than one hundred and eighty days after the filing thereof) as the Administrator deems necessary to enable him to study and investigate the application.

(d) Grounds for refusing application to become effective.

If the Administrator finds, after due notice to the applicant and giving him an opportunity for a hearing, that (1) the investigations, reports of which are required to be submitted to the Administrator pursuant to subsection (b) of this section, do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; (2) the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions; (3) the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to preserve its identity, strength, quality, and purity; or (4) upon the basis of the information submitted to him as part of the application, or upon the basis of any other information before him with respect to such drug, he has insufficient information to determine whether such drug is safe for use under such conditions, he shall, prior to the effective date of the application, issue an order refusing to permit the application to become effective.

(e) Suspension of effectiveness of application.

The effectiveness of an application with respect to any drug shall, after due notice and opportunity for hearing to the applicant, by order of the Administrator be suspended if the Administrator finds (1) that clinical experience, tests by new methods, or tests by methods not deemed reasonably applicable when such application became effective show that such drug is unsafe for use under the conditions of use upon the basis of which the application became effective, or (2) that the application contains any untrue statement of a material fact. The order shall state the findings upon which it is based. (f) Revocation of order refusing effectiveness.

An order refusing to permit an application with respect to any drug to become effective shall be revoked whenever the Administrator finds that the facts so require.

States within any district wherein such applicant resides or has his principal place of business, or in the District Court of the United States for the District of Columbia, within sixty days after the entry of such order, a written petition praying that the order of the Administrator be set aside. A copy of such petition shall be forthwith served upon the Administrator, or upon any officer designated by him for that purpose, and thereupon the Administrator shall certify and file in the court a transcript of the record upon which the order complained of was entered. Upon the filing of such transcript such court shall have exclusive jurisdiction to affirm or set aside such order. No objection to the order of the Administrator shall be considered by the court unless such objection shall have been urged before the Administrator or unless there were reasonable grounds for failure so to do. The finding of the Administrator as to the facts, if supported by substantial evidence, shall be conclusive. If any person shall apply to the court for leave to adduce additional evidence, and shall show to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for failure to adduce such evidence in the proceeding before the Administrator, the court may order such additional evidence to be taken before the Administrator and to be adduced upon the hearing in such manner and upon such terms and conditions as to the court may seem proper. The Administrator may modify his findings as to the facts by reason of the additional evidence so taken, and he shall file with the court such modified findings which, if supported by substantial evidence, shall be conclusive, and his recommendation, if any, for the setting aside of the original order. The judgment and decree of the court affirming or setting aside any such order of the Administrator shall be final, subject to review as provided in sections 225, 346, and 347 of Title 28, and in section 7, as amended, of the Act entitled "An Act to establish a Court of Appeals for the District of Columbia", approved February 9, 1893 [ch. 74, 27 Stat. 435] (D. C. Code, sec. 17-101). The commencement of proceedings under this subsection shall not, unless specifically ordered by the court to the contrary, operate as a stay of the Administrator's order.

(i) Exemption of drugs for research.

The Administrator shall promulgate regulations for exempting from the operation of this section drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety of drugs. (June 25, 1938, ch. 675, § 505, 52 Stat. 1052; 1940 Reorg. Plan No. IV, § 12, eff. June 30, 1940, 5 F. R. 2422, 54 Stat. 1237.) REFERENCES IN TEXT

Sections 225, 346, and 347 of Title 28, as amended, referred to in subsection (h), were repealed by act June 25, 1948, ch. 646, § 39, 62 Stat. 992, eff. Sept. 1, 1948, and are now covered by sections 1254 and 1291-1294 of Title 28, Judiciary and Judicial Procedure,

EFFECTIVE DATE

Section 902 (a) of act June 25, 1938, provided that this section should take effect June 25, 1938.

TRANSFER OF FUNCTIONS See note under section 321 of this title.

§ 356. Certification of drugs containing insulin. (a) The Federal Security Administrator, pursuant to regulations promulgated by him, shall provide for the certification of batches of drugs composed wholly or partly of insulin. A batch of any such drug shall be certified if such drug has such characteristics of identity and such batch has such characteristics of strength, quality, and purity, as the Administrator prescribes in such regulations as necessary to adequately insure safety and efficacy of use, but shall not otherwise be certified. Prior to the effective date of such regulations the Administrator, in lieu of certification, shall issue a release for any batch which, in his judgment, may be released without risk as to the safety and efficacy of its use. Such release shall prescribe the date of its expiration and other conditions under which it shall cease to be effective as to such batch and as to portions thereof.

(b) Regulations providing for such certification shall contain such provisions as are necessary to carry out the purposes of this section, including provisions prescribing (1) standards of identity and of strength, quality, and purity; (2) tests and methods of assay to determine compliance with such standards; (3) effective periods for certificates, and other conditions under which they shall cease to be effective as to certified batches and as to portions thereof; (4) administration and procedure; and (5) such fees, specified in such regulations, as are necessary to provide, equip, and maintain an adequate certification service. Such regulations shall prescribe no standard of identity or of strength, quality, or purity for any drug different from the standard of identity, strength, quality, or purity set forth for such drug in an official compendium.

(c) Such regulations, insofar as they prescribe tests or methods of assay to determine strength, quality, or purity of any drug, different from the tests or methods of assay set forth for such drug in an official compendium, shall be prescribed, after notice and opportunity for revision of such compendium, in the manner provided in the second sentence of section 351 (b) of this title. The provisions of subsections (e)-(g) of section 371 of this title shall be applicable to such portion of any regulation as prescribes any such different test or method, but shall not be applicable to any other portion of any such regulation. (June 25, 1938, ch. 675, § 506, as added Dec. 22, 1941, ch. 613, § 3, 55 Stat. 851.)

REGULATIONS

Section 4 of act Dec. 22, 1941, provided as follows: (Title "Regulations initially prescribed under * * * 21, § 356) shall be promulgated and made effective within forty-five days after the date of enactment of this Act." § 357. Certification of drugs containing penicillin, streptomycin, aureomycin, chloramphenicol, or bacitracin (a) Regulations prescribed by Administrator; release prior to certification.

The Federal Security Administrator, pursuant to regulations promulgated by him, shall provide for the certification of batches of drugs composed

wholly or partly of any kind of penicillin, streptomycin, aureomycin, chloramphenicol, or bacitracin, or any derivative thereof. A batch of any such drug shall be certified if such drug has such characteristics of identity and such batch has such characteristics of strength, quality, and purity, as the Administrator prescribes in such regulations as necessary to adequately insure safety and efficacy of use, but shall not otherwise be certified. Prior to the effective date of such regulations the Administrator, in lieu of certification, shall issue a release for any batch which, in his judgment, may be released without risk as to the safety and efficacy of its use. Such release shall prescribe the date of its expiration and other conditions under which it shall cease to be effective as to such batch and as to portions thereof.

(b) Provisions of regulations.

Regulations providing for such certifications shall contain such provisions as are necessary to carry out the purposes of this section, including provisions prescribing (1) standards of identity and of strength, quality, and purity; (2) tests and methods of assay to determine compliance with such standards; (3) effective periods for certificates, and other conditions under which they shall cease to be effective as to certified batches and as to portions thereof; (4) administration and procedure; and (5) such fees, specified in such regulations, as are necessary to provide, equip, and maintain an adequate certification service. Such regulations shall prescribe only such tests and methods of assay as will provide for certification or rejection within the shortest time consistent with the purposes of this section.

(c) Exemption of drugs not involving safety and efficacy of use.

Whenever in the judgment of the Administrator, the requirements of this section and of section 352 (1) of this title with respect to any drug or class of drugs are not necessary to insure safety and efficacy of use, the Administrator shall promulgate regulations exempting such drug or class of drugs from such requirements.

(d) Exemption of drugs stored, processed, and labeled at plants other than manufacturer, used in manufacture of other drugs or used for investigational purposes.

The Administrator shall promulgate regulations xempting from any requirement of this section and - section 352 (7) of this title, (1) drugs which are be stored, processed, labeled, or repacked at estabhments other than those where manufactured, on ndition that such drugs comply with all such quirements upon removal from such establishnts; (2) drugs which conform to applicable ndards of identity, strength, quality, and purity scribed by these regulations and are intended use in manufacturing other drugs; and (3) gs which are intended solely for investigational by experts qualified by scientific training and rience to investigate the safety and efficacy of

s.

§ 361

(e) Determination of compliance with sections 351 (b) and 352 (g) of this title.

No drug which is subject to this section shall be deemed to be subject to any provision of section 355 of this title. Compliance of any drug subject to section 352 (1) of this title or this section with sections 351 (b) and 352 (g) of this title shall be determined by the application of the standards of strength, quality, and purity, the tests and methods of assay, and the requirements of packaging and labeling, respectively, prescribed by regulations promulgated under this section.

(f) Filing of petitions; contents; notice; answer; public hearing; orders.

Any interested person may file with the Administrator a petition proposing the issuance, amendment, or repeal of any regulation contemplated by this section. The petition shall set forth the proposal in general terms and shall state reasonable grounds therefor. The Administrator shall give public notice of the proposal and an opportunity for all interested persons to present their views thereon, orally or in writing, and as soon as practicable thereafter shall make public his action upon such proposal. At any time prior to the thirtieth day after such action is made public any interested person may file objections to such action, specifying with particularity the changes desired, stating reasonable grounds therefor, and requesting a public hearing upon such objections. The Administrator shall thereupon, after due notice, hold such public hearing. As soon as practicable after completion of the hearing, the Administrator shall by order make public his action on such objections. The Administrator shall base his order only on substantial evidence of record at the hearing and shall set forth as part of the order detailed findings of fact on which the order is based. The order shall be subject to the provisions of section 371 (f) and (g) of this title. (June 25, 1938, ch. 675, § 507, as added July 6, 1945, ch. 281, § 3, 59 Stat. 463, and amended Mar. 10, 1947, ch. 16, § 3, 61 Stat. 12; July 13, 1949, ch. 305, § 2, 63 Stat. 409.)

CODIFICATION

Section added as part of the Federal Food, Drug, and Cosmetic Act of 1938.

AMENDMENTS 1949-Catchline amended by act July 13, 1949, § 2 (a), to add "aureomycin, chloramphenicol, or bacitracin". Subsec. (a) amended by act July 13, 1949, to insert ", aureomycin, chloramphenicol, or bacitracin" following "streptomycin".

1947-Catchline amended by act Mar. 10, 1947, text, which inserted "or streptomycin" after "penicillin". Subsec. (a) amended by act Mar. 10, 1947, which inserted "or streptomycin" following "penicillin" in first sentence.

vision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon: "Caution-This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.", and the labeling of which bears adequate directions for such preliminary testing. For the purposes of this paragraph and paragraph (e) the term "hair dye" shall not include eyelash dyes or eyebrow dyes.

(b) If it consists in whole or in part of any filthy, putrid, or decomposed substance.

(c) If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

(d) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.

(e) If it is not a hair dye and it bears or contains a coal-tar color other than one from a batch that has been certified in accordance with regulations as provided by section 364 of this title. 25, 1938, ch. 675, § 601, 52 Stat. 1054.)

(June

Section 902 (a) of act June 25, 1938, provided that subsections (b)-(e) should take effect twelve months after June 25, 1938, and that subsection (a) should take effect June 25, 1938, except that in the case of a cosmetic to which the proviso of subsection (a) relates, such cosmetic should not, prior to the ninetieth day after June 25, 1938, be deemed adulterated by reason of the failure of its label to bear the legend prescribed in such proviso. Act June 23, 1939, ch. 242, § 1, 53 Stat. 853, provided that the effective date of subsection (e) should be postponed until January 1, 1940.

§ 362. Misbranded cosmetics.

A cosmetic shall be deemed to be misbranded(a) If its labeling is false or misleading in any particular.

(b) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, That under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Administrator.

(c) If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

(d) If its container is so made, formed, or filled as to be misleading. (June 25, 1938, ch. 675, § 602, 52 Stat. 1054; 1940 Reorg. Plan No. IV, § 12, eff. June 30, 1940, 5 F. R. 2422, 54 Stat. 1237.)

EFFECTIVE DATE

Section 902 (a) of act June 25, 1938, provided that this section should take effect twelve months after June 25, 1938. Act June 23, 1939, ch. 242, 53 Stat. 853, provided that the effective date of subsection (b) should be postponed until January 1, 1940.

TRANSFER OF FUNCTIONS

See note under section 321 of this title.

§ 363. Regulations making exemptions.

The Administrator shall promulgate regulations exempting from any labeling requirement of this chapter cosmetics which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such cosmetics are not adulterated or misbranded under the provisions of this chapter upon removal from such processing, labeling, or repacking establishment. (June 25, 1938, ch. 675, § 603, 52 Stat. 1054; 1940 Reorg. Plan No. IV, § 12, eff. June 30, 1940, 5 F. R. 2422, 54 Stat. 1237.)

EFFECTIVE DATE

Section 902 (a) of act June 25, 1938, provided that this section should take effect twelve months after June 25, 1938.

TRANSFER OF FUNCTIONS

See note under section 321 of this title.

§ 364. Certification of coal-tar colors for cosmetics.

The Administrator shall promulgate regulations providing for the listing of coal-tar colors which are harmless and suitable for use in cosmetics and for the certification of batches of such colors, with or without harmless diluents. (June 25, 1938, ch. 675, § 604, 52 Stat. 1055; 1940 Reorg. Plan No. IV, § 12, eff. June 30, 1940, 5 F. R. 2422, 54 Stat. 1237.)

EFFECTIVE DATE

Section 902 (a) of act June 25, 1938, provided that this section should take effect twelve months after June 25, 1938.

TRANSFER OF FUNCTIONS

See note under section 321 of this title. SUBCHAPTER VII.-GENERAL ADMINISTRATIVE PROVISIONS

§ 371. Regulations and hearings-(a) Authority to promulgate regulations.

The authority to promulgate regulations for the efficient enforcement of this chapter, except as otherwise provided in this section, is vested in the Administrator.

(b) Regulations for imports and exports.

The Secretary of the Treasury and the Federal Security Administrator shall jointly prescribe regulations for the efficient enforcement of the provisions of section 381 of this title, except as otherwise provided therein. Such regulations shall be promulgated in such manner and take effect at such time, after due notice, as the Federal Security Administrator shall determine.

(c) Conduct of hearings.

Hearings authorized or required by this chapter shall be conducted by the Administrator or such officer or employee as he may designate for the purpose.

(d) Effectiveness of definitions and standards of identity.

The definitions and standards of identity promulgated in accordance with the provisions of this chapter shall be effective for the purposes of the enforcement of this chapter, notwithstanding such definitions and standards as may be contained in other laws of the United States and regulations promulgated thereunder.

(e) Hearings of proposed changes in regulations; orders.

The Administrator, on his own initiative or upon an application of any interested industry or substantial portion thereof stating reasonable grounds therefor, shall hold a public hearing upon a proposal to issue, amend, or repeal any regulation contemplated by sections 341, 343 (j), 344 (a), 346 (a) and (b), 351 (b), 352 (d), 352 (h), 354, and 364 of this title. The Administrator shall give appropriate notice of the hearing, and the notice shall set forth the proposal in general terms and specify the time and place for a public hearing to be held thereon not less than thirty days after the date of the notice, except that the public hearing on regulations under section 344 (a) of this title may be held within a reasonable time, to be fixed by the Administrator, after notice thereof. At the hearing any interested person may be heard in person or by his representative. As soon as practicable after completion of the hearing, the Administrator shall by order make public his action in issuing, amending, or repealing the regulation or determining not to take such action. The Administrator shall base his order only on substantial evidence of record at the hearing and shall set forth as part of the order detailed findings of fact on which the order is based. No such order shall take effect prior to the ninetieth day after it is issued, except that if the Administrator finds that emergency conditions exist necessitating an earlier effective date, then the Administrator shall specify in the order his findings as to such conditions and the order shall take effect at such earlier date as the Administrator hall specify therein to meet the emergency.

) Review of order.

(1) In a case of actual controversy as to the validy of any order under subsection (e) of this section, y person who will be adversely affected by such der if placed in effect may at any time prior to › ninetieth day after such order is issued file a ition with the United States court of appeals the circuit wherein such person resides or has principal place of business, for a judicial review uch order. The summons and petition may be ed at any place in the United States. The Adistrator, promptly upon service of the summons petition, shall certify and file in the court the script of the proceedings and the record on h the Administrator based his order.

If the petitioner applies to the court for leave iduce additional evidence, and shows to the action of the court that such additional eviis material and that there were reasonable ds for the failure to adduce such evidence in

the proceeding before the Administrator, the court may order such additional evidence (and evidence in rebuttal thereof) to be taken before the Administrator, and to be adduced upon the hearing, in such manner and upon such terms and conditions as to the court may seem proper. The Administrator may modify his findings as to the facts, or make new findings, by reason of the additional evidence so taken, and he shall file such modified or new findings, and his recommendation, if any, for the modification or setting aside of his original order, with the return of such additional evidence.

(3) The court shall have jurisdiction to affirm the order, or to set it aside in whole or in part, temporarily or permanently. If the order of the Administrator refuses to issue, amend, or repeal a regulation and such order is not in accordance with law the court shall by its judgment order the Administrator to take action, with respect to such regulation, in accordance with law. The findings of the Administrator as to the facts, if supported by substantial evidence, shall be conclusive.

(4) The judgment of the court affirming or setting aside, in whole or in part, any such order of the Administrator shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in sections 346 and 347 of Title 28.

(5) Any action instituted under this subsection shall survive notwithstanding any change in the person occupying the office of Administrator or any vacancy in such office.

(6) The remedies provided for in this subsection shall be in addition to and not in substitution for any other remedies provided by law.

(g) Copies of records of hearings.

A certified copy of the transcript of the record and proceedings under subsection (e) of this section shall be furnished by the Administrator to any interested party at his request, and payment of the costs thereof, and shall be admissible in any criminal, libel for condemnation, exclusion of imports, or other proceeding arising under or in respect to this chapter, irrespective of whether proceedings with respect to the order have previously been instituted or become final under subsection (f) of this section. (June 25, 1938, ch. 675, § 701, 52 Stat. 1055; 1940 Reorg. Plan No. IV, § 12, eff. June 30, 1940, 5 F. R. 2422, 54 Stat. 1237; June 25, 1948, ch. 646, § 32, 62 Stat. 991.)

REFERENCES IN TEXT

Sections 346 and 347 of Title 28, referred to in subsection (f) (4) were repealed by act June 25, 1948, ch. 646, § 39, 62 Stat. 992, eff. Sept. 1, 1948, and are now covered by section 1254 of Title 28, Judiciary and Judicial Procedure.

CHANGE OF NAME

The Circuit Court of Appeals of the United States was changed to the United States court of appeals by act June 25, 1948.

EFFECTIVE DATE

Section 902 (a) of act June 25, 1938, provided that this section should take effect June 25, 1938. TRANSFER OF FUNCTIONS See note under section 321 of this title.