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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 f a doctor.

EFFECTIVE DATE OF 1951 AMENDMENT Section 3 of act Oct. 26, 1951, provided that the amendient of this section should take effect six months after ict. 26, 1951.

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

38.

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

54. Certification of coal-tar colors for drugs. The Administrator shall promulgate regulations viding for the listing of coal-tar colors which are mless and suitable for use in drugs for purposes :oloring only and for the certification of batches such colors, with or without harmless diluents. ne 25, 1938, ch. 675, § 504, 52 Stat. 1052; 1940 rg. Plan No. IV, § 12, eff. June 30, 1940, 5 F. R. 1,54 Stat. 1237.)

EFFECTIVE DATE ction 902 (a) of act June 25, 1938, provided that this on should take effect twelve months after June 25,

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 effec

tive. 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 insuficient 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. (g). Service of orders.

Orders of the Administrator issued under this section shall be served (1) in person by any officer or employee of the Agency designated by the Administrator or (2) by mailing the order by registered mail addressed to the applicant or respondent at his last-known address in the records of the Administrator. (h) Appeal from order.

An appeal may be taken by the applicant from an order of the Administrator refusing to permit the application to become effective, or suspending the effectiveness of the application. Such appeal shall be taken by filling in the district court of the United

TRANSFER OF FUNCTIONS note under section 321 of this title.

New drugs—(a) Necessity of effective applicaion. person shall introduce or deliver for introon into interstate commerce any new drug,

an application filed pursuant to subsection (b) ; section is effective with respect to such drug. ling application; contents.

person may file with the Administrator an ition with respect to any drug subject to the ons of subsection (a) of this section. Such shall submit to the Administrator as a part of plication (1) full reports of investigations have been made to show whether or not such safe for use; (2) a full list of the articles used ponents of such drug; (3) a full statement of iposition of such drug; (4) a full description rethods used in, and the facilities and controls :, the manufacture, processing, and packing drug; (5) such samples of such drug and of ples used as components thereof as the Adtor may require; and (6) specimens of the proposed to be used for such drug. tive date of application. plication provided for in subsection (b) of on shall become effective on the sixtieth day

filing thereof unless prior to such day the rator by notice to the applicant in writing

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

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 afirming 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.

8 356. 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 cer. tification, 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 oficial 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: "Regulations initially prescribed under

(Title 21, $ 356) shall be promulgated and made effective within forty-five days after the date of enactment of this Act." 8 357. 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 expiraion and other conditions under which it shall cease o be effective as to such batch and as to portions hereof. 1) Provisions of regulations. Regulations providing for such certifications shall ntain such provisions as are necessary to carry out e purposes of this section, including provisions escribing (1) standards of identity and of ength, quality, and purity; (2) tests and methods assay to determine compliance with such standIs; (3) effective periods for certificates, and other ditions under which they shall cease to be effecas to certified batches and as to portions thereof; administration and procedure; and (5) such , specified in such regulations, as are necessary to ride, equip, and maintain an adequate certificaservice. Such regulations shall prescribe only tests and methods of assay as will provide for fication or rejection within the shortest time stent with the purposes of this section. xemption of drugs not involving safety and fficacy of use. enever in the judgment of the Administrator, quirements of this section and of section 352 this title with respect to any drug or class of are not necessary to insure safety and efficacy , the Administrator shall promulgate regula2xempting such drug or class of drugs from equirements. emption of drugs stored, processed, and labeled plants other than manufacturer, used in manuure of other drugs or used for investigational poses. Administrator shall promulgate regulations ing from any requirement of this section and on 352 (1) of this title, (1) drugs which are red, processed, labeled, or repacked at estabts other than those where manufactured, on n that such drugs comply with all such lents upon removal from such establish(2) drugs which conform to applicable s of identity, strength, quality, and purity d by these regulations and are intended in manufacturing other drugs; and (3) ich are intended solely for investigational (perts qualified by scientific training and e to investigate the safety and efficacy of

(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.

SUBCHAPTER VI.-COSMETICS 8 361. Adulterated cosmetics.

A cosmetic shall be deemed to be adulterated

(a) If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual: Provided, That this pro

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.

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. (June 25, 1938, ch. 675, $ 601, 52 Stat. 1054.)

EFFECTIVE DATE 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.

8 363. 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.

§ 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.)

SUBCHAPTER VII.-GENERAL ADMINISTRATIVE

PROVISIONS 8 371. 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 iden

tity. The definitions and standards of identity promulgated in accordance with the provisions of this chapter shall be effective for the purposes of the inforcement of this chapter, notwithstanding such lefinitions and standards as may be contained in ther laws of the United States and regulations pronulgated thereunder. :) Hearings of proposed changes in regulations;

orders. The Administrator, on his own initiative or upon 1 application of any interested industry or substanil portion thereof stating reasonable grounds therer, shall hold a public hearing upon a proposal to ue, amend, or repeal any regulation contemplated sections 341, 343 (j), 344 (a), 346 (a) and (b),

(b), 352 (d), 352 (h), 354, and 364 of this title. ? Administrator shall give appropriate notice of hearing, and the notice shall set forth the proal in general terms and specify the time and e for a public hearing to be held thereon not than thirty days after the date of the notice, pt that the public hearing on regulations under on 344 (a) of this title may be held within a onable time, to be fixed by the Administrator,

notice thereof. At the hearing any interested in may be heard in person or by his representa

As soon as practicable after completion of the ng, the Administrator shall by order make public ition in issuing, amending, or repealing the regn or determining not to take such action. The aistrator shall base his order only on substantial ice of record at the hearing and shall set forth rt of the order detailed findings of fact on the order is based. No such order shall take prior to the ninetieth day after it is issued, exlat if the Administrator finds that emergency ons exist necessitating an earlier effective date, e Administrator shall specify in the order his s as to such conditions and the order shall 'ect at such earlier date as the Administrator ecify therein to meet the emergency. ew of order. la case of actual controversy as to the validy order under subsection (e) of this section, son who will be adversely affected by such placed in effect may at any time prior to tieth day after such order is issued file a with the United States court of appeals ircuit wherein such person resides or has ipal place of business, for a judicial review rder. The summons and petition may be any place in the United States. The Ador, promptly upon service of the summons on, shall certify and file in the court the

of the proceedings and the record on ✓ Administrator based his order. le petitioner applies to the court for leave

additional evidence, and shows to the 2 of the court that such additional evilaterial and that there were reasonable r 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 modifcation 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 afirming 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, Jud ary 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.

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