Similar provisions were contained in the following prior appropriation acts:

Oct. 18, 1986, Pub. L. 99-500, § 101(a) [title I, § 101], 100 Stat. 1783, 1783-8, and Oct. 30, 1986, Pub. L. 99-591, § 101(a) [title I, § 101], 100 Stat. 3341, 3341-8. Dec. 19, 1985, Pub. L. 99-190, § 101(a) [H.R. 3037, title I, § 101], 99 Stat. 1185.

Oct. 12, 1984, Pub. L. 98-473, title I, § 101(a) [H.R. 5743, title I, § 1011, 98 Stat. 1837.

Nov. 14, 1983, Pub. L. 98-151, § 101(d) [H.R. 3223, title I, § 1011, 97 Stat. 972.

or any place under the jurisdiction of the United States, any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product intended for use in the treatment of domestic animals, and no person, firm, or corporation shall prepare, sell, barter, exchange, or ship as aforesaid any virus, serum, toxin, or analogous product manufactured within the United States and intended for use in the treatment of domestic animals, unless and until the said virus, serum, toxin, or analogous product shall have been prepared, under and in compliance with regulations prescribed by the Secretary of Agriculture, at an establishment holding an unsuspended and unrevoked license issued by the Secretary of Agriculture as hereinafter authorized.

(As amended Dec. 23, 1985, Pub. L. 99-198, title XVII, § 1768(a), 99 Stat. 1654.)

CODIFICATION

The sections of this chapter are comprised of the sentences of the eighth paragraph under the heading "Bureau of Animal Industry," in the Department of Agriculture Appropriation Act, 1914, as amended.

Another section 1768 of Pub. L. 99-198, cited as a credit to this section, amended section 136y of Title 7, Agriculture.

AMENDMENTS

1985-Pub. L. 99-198 substituted "in or from the United States, the District of Columbia, any territory of the United States, or any place under the jurisdiction of the United States" for "from one State or Territory or the District of Columbia to any other State or Territory or the District of Columbia".

EFFECTIVE DATE OF 1985 AMENDMENT

Section 1768(f) of Pub. L. 99-198 provided that: "(1) Except as provided in paragraph (2), the amendments made by this section [enacting sections 154a and 159 of this title and amending sections 151, 154, and 157 of this Title] shall become effective on the date of enactment of this Act [Dec. 23, 1985].

“(2)(A) Subject to subparagraphs (B) through (D), in the case of a person, firm, or corporation preparing, selling, bartering, exchanging, or shipping a virus, serum, toxin, or analogous product during the 12month period ending on the date of enactment of this Act [Dec. 23, 1985] solely for intrastate commerce or for exportation, such product shall not after such date of enactment, as a result of its not having been licensed or produced in a licensed establishment, be considered in violation of the eighth paragraph of the matter under the heading 'BUREAU OF ANIMAL INDUSTRY' of the Act entitled 'An Act making appropriations for the Department of Agriculture for the fiscal year ending June thirtieth, nineteen hundred and fourteen', approved March 14, 1913 (as amended by this section) [this chapter], until the first day of

the 49th month following the date of enactment of this Act.

"(B) The exemption granted by subparagraph (A) may be extended by the Secretary of Agriculture for a period up to 12 months in an individual case on a showing by a person, firm, or corporation of good cause and a good faith effort to comply with such eighth paragraph with due diligence.

"(C) The exemption granted by subparagraph (A) must be claimed by the person, firm, or corporation preparing such product by the first day of the 13th month following the date of enactment of this Act [Dec. 23, 1985], in the form and manner prescribed by the Secretary, unless the Secretary grants an extension of the time to claim such exemption in an individual case for good cause shown.

"(D) On the issuance by the Secretary of a license to such person, firm, or corporation for such product prior to the first day of the 49th month following the date of enactment of this Act [Dec. 23, 1985], or the end of an extension of the exemption granted by the Secretary, the exemption granted by subparagraph (A) shall terminate with respect to such product."

§ 154. Regulations for preparation and sale; licenses

The Secretary of Agriculture is authorized to make and promulgate from time to time such rules and regulations as may be necessary to prevent the preparation, sale, barter, exchange, or shipment as aforesaid of any worthless, contaminated, dangerous, or harmful virus, sei um, toxin, or analogous product for use in the treatment of domestic animals, or otherwise to carry out this chapter, and to issue, suspend, and revoke licenses for the maintenance of establishments for the preparation of viruses, serums, toxins, and analogous products, for use in the treatment of domestic animals, intended for sale, barter, exchange, or shipment as aforesaid.

(As amended Dec. 23, 1985, Pub. L. 99-198, title XVII, § 1768(b), 99 Stat. 1654.)

CODIFICATION

See Codification note set out under section 151 of this title.

Another section 1768 of Pub. L. 99-198, cited as a credit to this section, amended section 136y of Title 7, Agriculture.

AMENDMENTS

1985-Pub. L. 99-198 inserted "or otherwise to carry out this chapter," after "domestic animals,”.

EFFECTIVE DATE OF 1985 AMENDMENT Amendment by Pub. L. 99-198 effective Dec. 23, 1985, except as otherwise provided, see section 1768(f) of Pub. L. 99-198, set out as a note under section 151 of this title.

§ 154a. Special licenses for special circumstances; expedited procedure; conditions; exemptions; criteria

In order to meet an emergency condition, limited market or local situation, or other special circumstance (including production solely for intrastate use under a State-operated program), the Secretary may issue a special license under an expedited procedure on such conditions as are necessary to assure purity, safety, and a reasonable expectation of efficacy. The Secretary shall exempt by regulation from the requirement of preparation pursuant to an unsuspended and unrevoked license any virus, serum,

toxin, or analogous product prepared by any person, firm, or corporation

(1) solely for administration to animals of such person, firm, or corporation;

(2) solely for administration to animals under a veterinarian-client-patient relationship in the course of the State licensed professional practice of veterinary medicine by such person, firm, or corporation; or

(3) solely for distribution within the State of production pursuant to a license granted by such State under a program determined by the Secretary to meet criteria under which the State

(A) may license virus, serum, toxin, and analogous products and establishments that produce such products;

(B) may review the purity, safety, potency, and efficacy of such products prior to licensure;

(C) may review product test results to assure compliance with applicable standards for purity, safety, and potency, prior to release to the market;

(D) may deal effectively with violations of State law regulating virus, serum, toxin, and analogous products; and

(E) exercises the authority referred to in subclauses (A) through (D) consistent with the intent of this chapter of prohibiting the preparation, sale, barter, exchange, or shipment of worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous products.

(Mar. 4, 1913, ch. 145, § 1 [part], as added Dec. 23, 1985, Pub. L. 99-198, title XVII, § 1768(c), 99 Stat. 1654.)

CODIFICATION

See Codification note set out under section 151 of this title.

Another section 1768 of Pub. L. 99-198, cited as a credit to this section, amended section 136y of Title 7, Agriculture.

EFFECTIVE DATE

Section effective Dec. 23, 1985, except as otherwise provdied, see section 1768(f) of Pub. L. 99-198, set out as an Effective Date of 1985 Amendment note under section 151 of this title.

§ 157. Inspection

Any officer, agent, or employee of the Department of Agriculture duly authorized by the Secretary of Agriculture for the purpose may, at any hour during the daytime or nighttime, enter and inspect any establishment where any virus, serum, toxin, or analogous product for use in the treatment of domestic animals is prepared for sale, barter, exchange, or shipment as aforesaid.

(As amended Dec. 23, 1985, Pub. L. 99-198, title XVII, § 1768(d), 99 Stat. 1655.)

CODIFICATION

See Codification note set out under section 151 of this title.

Another section 1768 of Pub. L. 99-198, cited as a credit to this section, amended section 136y of Title 7, Agriculture.

AMENDMENTS

1985-Pub. L. 99-198 struck out "licensed under this chapter" after "enter and inspect any establishment".

EFFECTIVE DATE OF 1985 AMENDMENT

Amendment by Pub. L. 99-198 effective Dec. 23, 1985, except as otherwise provided, see section 1768(f) of Pub. L. 99-198, set out as a note under section 151 of this title.

§ 159. Enforcement; penalties applicable; Congressional findings

The procedures of sections 672, 673, and 674 of this title (relating to detentions, seizures and condemnations, and injunctions, respectively) shall apply to the enforcement of this chapter with respect to any product prepared, sold, bartered, exchanged, or shipped in violation of this chapter or a regulation promulgated under this chapter. The provisions (including penalties) of section 675 of this title shall apply to the performance of official duties under this chapter. Congress finds that (i) the products and activities that are regulated under this chapter are either in interstate or foreign commerce or substantially affect such commerce or the free flow thereof, and (ii) regulation of the products and activities as provided in this chapter is necessary to prevent and eliminate burdens on such commerce and to effectively regulate such commerce.

(Mar. 4, 1913, ch. 145, § 1 [part], as added Dec. 23, 1985, Pub. L. 99-198, title XVII, § 1768(e), 99 Stat. 1655.)

CODIFICATION

See Codification note set out under section 151 of this title.

Another section 1768 of Pub. L. 99-198, cited as a credit to this section, amended section 136y of Title 7, Agriculture.

EFFECTIVE DATE

Section effective Dec. 23, 1985, except as otherwise provided, see section 1768(f) of Pub. L. 99-198, set out as an Effective Date of 1985 Amendment note under section 151 of this title.

CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VIII-IMPORTS AND EXPORTS

Sec.

382.

Exports of certain unapproved products. (a) Drugs intended for human or animal use which require approval or licensing.

(b) Conditions for export; active pursuit of drug approval or licensing; application for export, contents, approval or disapproval; list of eligible countries for export; criteria for list change.

(c) Report to Secretary by holder of approved application; events requir ing report; annual report to Secretary on pursuit of approval of drug. (d) Export of drug under approved application prohibited.

Sec.

(e) Determination by Secretary of noncompliance, failure of active pursuit of drug approval, imminent hazard of drug to public health, or exportation of drug to noneligible country; notices and hearings; prohibition on exportation of drug.

(f) Drugs used in prevention or treatment of tropical disease.

(g) Reference to Secretary and holder of application.

CHAPTER REFERRED TO IN OTHER SECTIONS

This chapter is referred to in sections 453, 457, 466, 467, 467f, 601, 607, 620, 679, 811, 829, 902, 1033, 1049, 1052 of this title; title 7 sections 136v, 1431c; title 15 sections 70j, 1261, 1263, 1457, 1459, 1460, 2079; title 18 section 42; title 26 sections 170, 4817; title 35 sections 155, 156, 271; title 42 sections 262, 300aa-22, 300aa-23, 1786, 3512.

SUBCHAPTER I-SHORT TITLE

§ 301. Short title

SHORT TITLE OF 1986 AMENDMENT

Pub. L. 99-660, title I, § 101(a), Nov. 14, 1986, 100 Stat. 3743, provided that: "This title [enacting section 382 of this title, amending sections 241 and 262 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under section 333 of this title and section 262 of Title 42] may be cited as the 'Drug Export Amendments Act of 1986'."

SHORT TITLE OF 1985 AMENDMENT

Pub. L. 99-91, § 1, Aug. 15, 1985, 99 Stat. 387, provided that: "This Act [amending sections 360aa to 360cc, and 360ee of this title, and sections 295g-1 and 6022 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under section 360aa of this title and section 236 of Title 42] may be cited as the 'Orphan Drug Amendments of 1985'."

SHORT TITLE OF 1984 AMENDMENT

Pub. L. 98-417, § 1, Sept. 24, 1984, 98 Stat. 1585, provided: "That this Act [enacting section 156 of Title 35, Patents, amending sections 355 and 360cc of this title, sections 68b, 68c, and 70b of Title 15, Commerce and Trade, section 2201 of Title 28, Judiciary and Judicial Procedure, and sections 271 and 282 of Title 35, and enacting provisions set out as notes under section 355 of this title and section 68b of Title 15] may be cited as the 'Drug Price Competition and Patent Term Restoration Act of 1984'."

SHORT TITLE OF 1983 AMENDMENTS

Pub. L. 98-22, § 1, Apr. 22, 1983, 97 Stat. 173, provided: "That this Act [amending provisions set out as a note under section 348 of this title] may be cited as the 'Saccharin Study and Labeling Act Amendment of 1983'."

SUBCHAPTER II-DEFINITIONS

§ 321. Definitions; generally

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 346b, 350, 352, 355, 376, 802, 825 of this title; title 7 section 136; title 15 sections 1454, 1456, 1471, 2052, 2602; title 18 sections 842, 922, 1365; title 35 section 156; title 42 section 274e.

SUBCHAPTER III-PROHIBITED ACTS

AND PENALTIES

§ 331. Prohibited acts

The following acts and the causing thereof are prohibited:

[See main edition for text of (a) to (r)] (s) The failure to provide the notice required by section 350a(c) or 350a(d) 2 of this title, the failure to make the reports required by section 350a(f)(1)(B) of this title, the failure to retain the records required by section 350a(b)(4) of this title, or the failure to meet the requirements prescribed under section 350a(f)(3) of this title.

(As amended Oct. 27, 1986, Pub. L. 99-570, title IV, § 4014(b)(2), 100 Stat. 3207-120.)

REFERENCES IN TEXT

Section 355(j) of this title, referred to in subsec. (e), was redesignated section 355(k) of this title by Pub. L. 98-417, title I, § 101, Sept. 24, 1984, 98 Stat. 1585.

AMENDMENTS

1986-Subsec. (s). Pub. L. 99-570 amended subsec. (s) generally. Prior to amendment, subsec. (s) read as follows: "The failure to provide the notice required by section 350a(b) or 350a(c), the failure to make the reports required by section 350a(d)(1)(B), or the failure to meet the requirements prescribed under section 350a(d)(2)."

§ 333. Penalties

ENFORCEMENT

Pub. L. 99-660, title I, § 103, Nov. 14, 1986, 100 Stat. 3751, provided that: "For the fines authorized to be imposed under section 303 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 333], see section 3623 of title 18, United States Code, for the period ending October 31, 1986 [probably should be October 31, 19871, and sections 3559 and 3571 of such title for the period beginning November 1, 1986 [probably should be November 1, 1987]."

SUBCHAPTER IV-FOOD

§ 342. Adulterated food

A food shall be deemed to be adulterated

[See main edition for text of (a) to (c)] (d) Confectionery containing alcohol or nonnutritive substance

If it is confectionery, and—

[See main edition for text of (1)]

(2) bears or contains any alcohol other than alcohol not in excess of one-half of 1 per centum by volume derived solely from the use of flavoring extracts, except that this clause shall not apply to confectionery which is introduced or delivered for introduction into, or received or held for sale in, interstate commerce if the sale of such confectionery is permitted under the laws of the State in which such confectionery is intended to be offered for sale;

[See main edition for text of (3); (e)]

"So in original. Probably should be "350a(e)".

(As amended Feb. 27, 1986, Pub. L. 99-252, § 10, 100 Stat. 35.)

AMENDMENTS

1986-Subsec. (d)(2). Pub. L. 99-252 inserted provision that this clause not apply to confectionery introduced or delivered for introduction into or received or held for sale in, interstate commerce if the sale is permitted under the laws of the State in which the confectionery is intended to be offered for sale.

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 334, 346, 346a, 346b, 347b, 348, 350a, 360b, 376 of this title.

§ 346a. Tolerances for pesticide chemicals in or on raw agricultural commodities

[See main edition for text of (a) to (h)] (i) Judicial review

[See main edition for text of (1) to (4)] (5) The judgment of the court affirming or setting aside, in whole or in part, any order under this section shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28. The commencement of proceedings under this section shall not, unless specifically ordered by the court to the contrary, operate as a stay of an order.

[See main edition for text of (j) to (o)] (As amended Nov. 8, 1984, Pub. L. 98-620, title IV, § 402(25)(A), 98 Stat. 3359.)

AMENDMENTS

1984-Subsec. (i)(5). Pub. L. 98-620 struck cut provision that required the court to advance on the docket and expedite the disposition of all causes filed therein pursuant to this section.

EFFECTIVE Date of 1984 AMENDMENT

Amendment by Pub. L. 98-620 not applicable to cases pending on Nov. 8, 1984, see section 403 of Pub. L. 98-620, set out as an Effective Date note under section 1657 of Title 28, Judiciary and Judicial Procedure. § 348. Food additives

[See main edition for text of (a) to (†)] (g) Judicial review

[See main edition for text of (1)]

(2) A copy of such petition shall be forthwith transmitted by the clerk of the court to the Secretary, or any officer designated by him for that purpose, and thereupon the Secretary shall file in the court the record of the proceedings on which he based his order, as provided in section 2112 of title 28. Upon the filing of such petition the court shall have jurisdiction, which upon the filing of the record with it shall be exclusive, to affirm or set aside the order complained of in whole or in part. Until the filing of the record the Secretary may modify or set aside his order. The findings of the Secretary with respect to questions of fact shall be sustained if based upon a fair evaluation of the entire record at such hearing.

[See main edition for text of (3) to (5); (h) and (i)]

(As amended Nov. 8, 1984, Pub. L. 98-620, title IV, § 402(25)(B), 98 Stat. 3359.)

AMENDMENTS

1984-Subsec. (g)(2). Pub. L. 98-620 struck out provision that required the court to advance on the docket and expedite the disposition of all causes filed therein pursuant to this section.

EFFECTIVE DATE OF 1984 AMENDMENT Amendment by Pub. L. 98-620 not applicable to cases pending on Nov. 8, 1984, see section 403 of Pub. L. 98-620, set out as an Effective Date note under section 1657 of Title 28, Judiciary and Judicial Procedure. MORATORIUM ON AUTHORITY OF SECRETARY WITH RESPECT TO SACCHARIN

Pub. L. 95-203, § 3, Nov. 23, 1977, 91 Stat. 1452, as amended by Pub. L. 96-88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 96-273, June 17, 1980, 94 Stat. 536; Pub. L. 97-42, § 2, Aug. 14, 1981, 95 Stat. 946; Pub. L. 98-22, § 2, Apr. 22, 1983, 97 Stat. 173; Pub. L. 99-46, May 24, 1985, 99 Stat. 81; Pub. L. 100-71, title I, § 101, July 11, 1987, 101 Stat. 431, provided that: "During the period ending May 1, 1992, the Secretary

[See main edition for text of (1) and (2)] solely on the basis of the carcinogenic or other toxic effect of saccharin as determined by any study made available to the Secretary before the date of the enactment of this Act [Nov. 23, 1977] which involved human studies or animal testing, or both."

For definition of "saccharin" as used in this note, see section 2(d) of Pub. L. 95-203.

§ 350a. Infant formulas

(a) Adulteration

An infant formula, including an infant formula powder, shall be deemed to be adulterated if

(1) such infant formula does not provide nutrients as required by subsection (i) of this section,

(2) such infant formula does not meet the quality factor requirements prescribed by the Secretary under subsection (b)(1) of this section, or

(3) the processing of such infant formula is not in compliance with the good manufacturing practices and the quality control procedures prescribed by the Secretary under subsection (b)(2) of this section.

(b) Requirements for quality factors, good manufacturing practices, and retention of records

(1) The Secretary shall by regulation establish requirements for quality factors for infant formulas to the extent possible consistent with current scientific knowledge, including quality factor requirements for the nutrients required by subsection (i) of this section.

(2)(A) The Secretary shall by regulation establish good manufacturing practices for infant formulas, including quality control procedures that the Secretary determines are necessary to assure that an infant formula provides nutrients in accordance with this subsection and subsection (i) of this section and is manufactured in a manner designed to prevent adulteration of the infant formula.

(B) The good manufacturing practices and quality control procedures prescribed by the Secretary under subparagraph (A) shall include requirements for

(i) the testing, in accordance with paragraph (3) and by the manufacturer of an infant formula or an agent of such manufacturer, of each batch of infant formula for each nutrient required by subsection (i) of this section before the distribution of such batch,

(ii) regularly scheduled testing, by the manufacturer of an infant formula or an agent of such manufacturer, of samples of infant formulas during the shelf life of such formulas to ensure that such formulas are in compliance with this section,

(iii) in-process controls including, where necessary, testing required by good manufacturing practices designed to prevent adulteration of each batch of infant formula, and

(iv) the conduct by the manufacturer of an infant formula or an agent of such manufacturer of regularly scheduled audits to determine that such manufacturer has complied with the regulations prescribed under subparagraph (A).

In prescribing requirements for audits under clause (iv), the Secretary shall provide that such audits be conducted by appropriately trained individuals who do not have any direct responsibility for the manufacture or production of infant formula.

(3)(A) At the final product stage, each batch of infant formula shall be tested for vitamin A, vitamin B1, vitamin C, and vitamin E to ensure that such infant formula is in compliance with the requirements of this subsection and subsection (i) of this section relating to such vitamins.

(B) Each nutrient premix used in the manufacture of an infant formula shall be tested for each relied upon nutrient required by subsection (i) of this section which is contained in such premix to ensure that such premix is in compliance with its specifications or certifications by a premix supplier.

(C) During the manufacturing process or at the final product stage and before distribution of an infant formula, an infant formula shall be tested for all nutrients required to be included in such formula by subsection (i) of this section for which testing has not been conducted pursuant to subparagraph (A) or (B). Testing under this subparagraph shall be conducted to

(i) ensure that each batch of such infant formula is in compliance with the requirements of subsection (i) of this section relating to such nutrients, and

(ii) confirm that nutrients contained in any nutrient premix used in such infant formula are present in each batch of such infant formula in the proper concentration.

(D) If the Secretary adds a nutrient to the list of nutrients in the table in subsection (i) of this section, the Secretary shall by regulation require that the manufacturer of an infant formula test each batch of such formula for such