21 U.S.C.
United States Code, 2010 Edition
Title 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VIII - IMPORTS AND EXPORTS
From the U.S. Government Printing Office, www.gpo.gov

SUBCHAPTER VIII—IMPORTS AND EXPORTS

§381. Imports and exports

(a) Imports; list of registered foreign establishments; samples from unregistered foreign establishments; examination and refusal of admission

The Secretary of the Treasury shall deliver to the Secretary of Health and Human Services, upon his request, samples of food, drugs, devices, tobacco products, and cosmetics which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. The Secretary of Health and Human Services shall furnish to the Secretary of the Treasury a list of establishments registered pursuant to subsection (i) of section 360 or section 387e(h) of this title and shall request that if any drugs, devices, or tobacco products manufactured, prepared, propagated, compounded, or processed in an establishment not so registered are imported or offered for import into the United States, samples of such drugs, devices, or tobacco products be delivered to the Secretary of Health and Human Services, with notice of such delivery to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. If it appears from the examination of such samples or otherwise that (1) such article has been manufactured, processed, or packed under insanitary conditions or, in the case of a device, the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of section 360j(f) of this title, or (2) such article is forbidden or restricted in sale in the country in which it was produced or from which it was exported, or (3) such article is adulterated, misbranded, or in violation of section 355 of this title, or prohibited from introduction or delivery for introduction into interstate commerce under section 331(ll) of this title, or (4) the recordkeeping requirements under section 2223 of this title (other than the requirements under subsection (f) of such section) have not been complied with regarding such article, then such article shall be refused admission, except as provided in subsection (b) of this section. With respect to an article of food, if importation of such food is subject to, but not compliant with, the requirement under subsection (q) that such food be accompanied by a certification or other assurance that the food meets applicable requirements of this chapter, then such article shall be refused admission. If such article is subject to a requirement under section 379aa or 379aa–1 of this title and if the Secretary has credible evidence or information indicating that the responsible person (as defined in such section 379aa or 379aa–1 of this title) has not complied with a requirement of such section 379aa or 379aa–1 of this title with respect to any such article, or has not allowed access to records described in such section 379aa or 379aa–1 of this title, then such article shall be refused admission, except as provided in subsection (b) of this section. The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within ninety days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations. Clause (2) of the third sentence of this paragraph 1 shall not be construed to prohibit the admission of narcotic drugs the importation of which is permitted under the Controlled Substances Import and Export Act [21 U.S.C. 951 et seq.].

(b) Disposition of refused articles

Pending decision as to the admission of an article being imported or offered for import, the Secretary of the Treasury may authorize delivery of such article to the owner or consignee upon the execution by him of a good and sufficient bond providing for the payment of such liquidated damages in the event of default as may be required pursuant to regulations of the Secretary of the Treasury. If it appears to the Secretary of Health and Human Services that (1) an article included within the provisions of clause (3) of subsection (a) of this section can, by relabeling or other action, be brought into compliance with this chapter or rendered other than a food, drug, device, or cosmetic, or (2) with respect to an article described in subsection (a) relating to the requirements of sections 2 379aa or 379aa–1 of this title,,3 the responsible person (as defined in section 379aa or 379aa–1 of this title) can take action that would assure that the responsible person is in compliance with section 379aa or 379aa–1 of this title, as the case may be, final determination as to admission of such article may be deferred and, upon filing of timely written application by the owner or consignee and the execution by him of a bond as provided in the preceding provisions of this subsection, the Secretary may, in accordance with regulations, authorize the applicant, or, with respect to clause (2), the responsible person, to perform such relabeling or other action specified in such authorization (including destruction or export of rejected articles or portions thereof, as may be specified in the Secretary's authorization). All such relabeling or other action pursuant to such authorization shall in accordance with regulations be under the supervision of an officer or employee of the Department of Health and Human Services designated by the Secretary, or an officer or employee of the Department of the Treasury designated by the Secretary of the Treasury.

(c) Charges concerning refused articles

All expenses (including travel, per diem or subsistence, and salaries of officers or employees of the United States) in connection with the destruction provided for in subsection (a) of this section and the supervision of the relabeling or other action authorized under the provisions of subsection (b) of this section, the amount of such expenses to be determined in accordance with regulations, and all expenses in connection with the storage, cartage, or labor with respect to any article refused admission under subsection (a) of this section, shall be paid by the owner or consignee and, in default of such payment, shall constitute a lien against any future importations made by such owner or consignee.

(d) Reimportation

(1) Except as provided in paragraph (2) and section 384 of this title, no drug subject to section 353(b) of this title or composed wholly or partly of insulin which is manufactured in a State and exported may be imported into the United States unless the drug is imported by the manufacturer of the drug.

(2) The Secretary may authorize the importation of a drug the importation of which is prohibited by paragraph (1) if the drug is required for emergency medical care.

(3)(A) Subject to subparagraph (B), no component of a drug, no component part or accessory of a device, or other article of device requiring further processing, which is ready or suitable for use for health-related purposes, and no article of a food additive, color additive, or dietary supplement, including a product in bulk form, shall be excluded from importation into the United States under subsection (a) of this section if each of the following conditions is met:

(i) The importer of such article of a drug or device or importer of such article of a food additive, color additive, or dietary supplement submits to the Secretary, at the time of initial importation, a statement in accordance with the following:

(I) Such statement provides that such article is intended to be further processed by the initial owner or consignee, or incorporated by the initial owner or consignee, into a drug, biological product, device, food, food additive, color additive, or dietary supplement that will be exported by the initial owner or consignee from the United States in accordance with subsection (e) of this section or section 382 of this title, or with section 262(h) of title 42.

(II) The statement identifies the manufacturer of such article and each processor, packer, distributor, or other entity that had possession of the article in the chain of possession of the article from the manufacturer to such importer of the article.

(III) The statement is accompanied by such certificates of analysis as are necessary to identify such article, unless the article is a device or is an article described in paragraph (4).


(ii) At the time of initial importation and before the delivery of such article to the importer or the initial owner or consignee, such owner or consignee executes a good and sufficient bond providing for the payment of such liquidated damages in the event of default as may be required pursuant to regulations of the Secretary of the Treasury.

(iii) Such article is used and exported by the initial owner or consignee in accordance with the intent described under clause (i)(I), except for any portions of the article that are destroyed.

(iv) The initial owner or consignee maintains records on the use or destruction of such article or portions thereof, as the case may be, and submits to the Secretary any such records requested by the Secretary.

(v) Upon request of the Secretary, the initial owner or consignee submits a report that provides an accounting of the exportation or destruction of such article or portions thereof, and the manner in which such owner or consignee complied with the requirements of this subparagraph.


(B) Notwithstanding subparagraph (A), the Secretary may refuse admission to an article that otherwise would be imported into the United States under such subparagraph if the Secretary determines that there is credible evidence or information indicating that such article is not intended to be further processed by the initial owner or consignee, or incorporated by the initial owner or consignee, into a drug, biological product, device, food, food additive, color additive, or dietary supplement that will be exported by the initial owner or consignee from the United States in accordance with subsection (e) of this section or section 382 of this title, or with section 262(h) of title 42.

(C) This section may not be construed as affecting the responsibility of the Secretary to ensure that articles imported into the United States under authority of subparagraph (A) meet each of the conditions established in such subparagraph for importation.

(4) The importation into the United States of blood, blood components, source plasma, or source leukocytes or of a component, accessory, or part thereof is not permitted pursuant to paragraph (3) unless the importation complies with section 262(a) of title 42 or the Secretary permits the importation under appropriate circumstances and conditions, as determined by the Secretary. The importation of tissue or a component or part of tissue is not permitted pursuant to paragraph (3) unless the importation complies with section 264 of title 42.

(e) Exports

(1) A food, drug, device, tobacco product or cosmetic intended for export shall not be deemed to be adulterated or misbranded under this chapter, and a tobacco product intended for export shall not be deemed to be in violation of section 387f(e), 387g, 387k, or 387t(a) of this title, if it—

(A) accords to the specifications of the foreign purchaser,

(B) is not in conflict with the laws of the country to which it is intended for export,

(C) is labeled on the outside of the shipping package that it is intended for export, and

(D) is not sold or offered for sale in domestic commerce.


(2) Paragraph (1) does not apply to any device—

(A) which does not comply with an applicable requirement of section 360d or 360e of this title,

(B) which under section 360j(g) of this title is exempt from either such section, or

(C) which is a banned device under section 360f of this title,


unless, in addition to the requirements of paragraph (1), either (i) the Secretary has determined that the exportation of the device is not contrary to public health and safety and has the approval of the country to which it is intended for export or (ii) the device is eligible for export under section 382 of this title.

(3) A new animal drug that requires approval under section 360b of this title shall not be exported pursuant to paragraph (1) if such drug has been banned in the United States.

(4)(A) Any person who exports a food, drug, animal drug, or device may request that the Secretary—

(i) certify in writing that the exported food, drug, animal drug, or device meets the requirements of paragraph (1) or section 382 of this title; or

(ii) certify in writing that the food, drug, animal drug, or device being exported meets the applicable requirements of this chapter upon a showing that the food, drug or device meets the applicable requirements of this chapter.


The Secretary shall issue such a certification within 20 days of the receipt of a request for such certification.

(B) If the Secretary issues a written export certification within the 20 days prescribed by subparagraph (A), a fee for such certification may be charged but shall not exceed $175 for each certification. Fees collected for a fiscal year pursuant to this subparagraph shall be credited to the appropriation account for salaries and expenses of the Food and Drug Administration and shall be available in accordance with appropriations Acts until expended without fiscal year limitation. Such fees shall be collected in each fiscal year in an amount equal to the amount specified in appropriations Acts for such fiscal year and shall only be collected and available for the costs of the Food and Drug Administration.

(C) For purposes of this paragraph, a certification by the Secretary shall be made on such basis, and in such form (including a publicly available listing) as the Secretary determines appropriate.

(D) With regard to fees pursuant to subparagraph (B) in connection with written export certifications for food:

(i) Such fees shall be collected and available solely for the costs of the Food and Drug Administration associated with issuing such certifications.

(ii) Such fees may not be retained in an amount that exceeds such costs for the respective fiscal year.

(f) Labeling of exported drugs

(1) If a drug (other than insulin, an antibiotic drug, an animal drug, or a drug exported under section 382 of this title) being exported in accordance with subsection (e) of this section is being exported to a country that has different or additional labeling requirements or conditions for use and such country requires the drug to be labeled in accordance with those requirements or uses, such drug may be labeled in accordance with such requirements and conditions for use in the country to which such drug is being exported if it also is labeled in accordance with the requirements of this chapter.

(2) If, pursuant to paragraph (1), the labeling of an exported drug includes conditions for use that have not been approved under this chapter, the labeling must state that such conditions for use have not been approved under this chapter. A drug exported under section 382 of this title is exempt from this section.

(g) Warning notice of importation in violation of chapter

(1) With respect to a prescription drug being imported or offered for import into the United States, the Secretary, in the case of an individual who is not in the business of such importations, may not send a warning notice to the individual unless the following conditions are met:

(A) The notice specifies, as applicable to the importation of the drug, that the Secretary has made a determination that—

(i) importation is in violation of subsection (a) of this section because the drug is or appears to be adulterated, misbranded, or in violation of section 355 of this title;

(ii) importation is in violation of subsection (a) of this section because the drug is or appears to be forbidden or restricted in sale in the country in which it was produced or from which it was exported;

(iii) importation is or appears to be in violation of subsection (d)(1) of this section; or

(iv) importation otherwise is or appears to be in violation of Federal law.


(B) The notice does not specify any provision described in subparagraph (A) that is not applicable to the importation of the drug.

(C) The notice states the reasons underlying such determination by the Secretary, including a brief application to the principal facts involved of the provision of law described in subparagraph (A) that is the basis of the determination by the Secretary.


(2) For purposes of this section, the term “warning notice”, with respect to the importation of a drug, means a communication from the Secretary (written or otherwise) notifying a person, or clearly suggesting to the person, that importing the drug for personal use is, or appears to be, a violation of this chapter.

(h) Protection against adulteration of food

(1) The Secretary shall give high priority to increasing the number of inspections under this section for the purpose of enabling the Secretary to inspect food offered for import at ports of entry into the United States, with the greatest priority given to inspections to detect the intentional adulteration of food.

(2) The Secretary shall give high priority to making necessary improvements to the information management systems of the Food and Drug Administration that contain information related to foods imported or offered for import into the United States for purposes of improving the ability of the Secretary to allocate resources, detect the intentional adulteration of food, and facilitate the importation of food that is in compliance with this chapter.

(3) The Secretary shall improve linkages with other regulatory agencies of the Federal Government that share responsibility for food safety, and shall with respect to such safety improve linkages with the States and Indian tribes (as defined in section 450b(e) of title 25).

(i) Testing for rapid detection of adulteration of food

(1) For use in inspections of food under this section, the Secretary shall provide for research on the development of tests and sampling methodologies—

(A) whose purpose is to test food in order to rapidly detect the adulteration of the food, with the greatest priority given to detect the intentional adulteration of food; and

(B) whose results offer significant improvements over the available technology in terms of accuracy, timing, or costs.


(2) In providing for research under paragraph (1), the Secretary shall give priority to conducting research on the development of tests that are suitable for inspections of food at ports of entry into the United States.

(3) In providing for research under paragraph (1), the Secretary shall as appropriate coordinate with the Director of the Centers for Disease Control and Prevention, the Director of the National Institutes of Health, the Administrator of the Environmental Protection Agency, and the Secretary of Agriculture.

(4) The Secretary shall annually submit to the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report describing the progress made in research under paragraph (1), including progress regarding paragraph (2).

(j) Temporary holds at ports of entry

(1) If an officer or qualified employee of the Food and Drug Administration has credible evidence or information indicating that an article of food presents a threat of serious adverse health consequences or death to humans or animals, and such officer or qualified employee is unable to inspect, examine, or investigate such article upon the article being offered for import at a port of entry into the United States, the officer or qualified employee shall request the Secretary of Treasury to hold the food at the port of entry for a reasonable period of time, not to exceed 24 hours, for the purpose of enabling the Secretary to inspect, examine, or investigate the article as appropriate.

(2) The Secretary shall request the Secretary of Treasury to remove an article held pursuant to paragraph (1) to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be. Subsection (b) of this section does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held.

(3) An officer or qualified employee of the Food and Drug Administration may make a request under paragraph (1) only if the Secretary or an official designated by the Secretary approves the request. An official may not be so designated unless the official is the director of the district under this chapter in which the article involved is located, or is an official senior to such director.

(4) With respect to an article of food for which a request under paragraph (1) is made, the Secretary, promptly after the request is made, shall notify the State in which the port of entry involved is located that the request has been made, and as applicable, that such article is being held under this subsection.

(k) Importation by debarred persons

(1) If an article of food is being imported or offered for import into the United States, and the importer, owner, or consignee of the article is a person who has been debarred under section 335a(b)(3) of this title, such article shall be held at the port of entry for the article, and may not be delivered to such person. Subsection (b) of this section does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be.

(2) An article of food held under paragraph (1) may be delivered to a person who is not a debarred person under section 335a(b)(3) of this title if such person affirmatively establishes, at the expense of the person, that the article complies with the requirements of this chapter, as determined by the Secretary.

(l) Failure to register

(1) 4 If an article of food is being imported or offered for import into the United States, and such article is from a foreign facility for which a registration has not been submitted to the Secretary under section 350d of this title (or for which a registration has been suspended under such section), such article shall be held at the port of entry for the article, and may not be delivered to the importer, owner, or consignee of the article, until the foreign facility is so registered. Subsection (b) of this section does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be.

(m) Prior notice of imported food shipments

(1) In the case of an article of food that is being imported or offered for import into the United States, the Secretary, after consultation with the Secretary of the Treasury, shall by regulation require, for the purpose of enabling such article to be inspected at ports of entry into the United States, the submission to the Secretary of a notice providing the identity of each of the following: The article; the manufacturer and shipper of the article; if known within the specified period of time that notice is required to be provided, the grower of the article; the country from which the article originates; the country from which the article is shipped; any country to which the article has been refused entry; and the anticipated port of entry for the article. An article of food imported or offered for import without submission of such notice in accordance with the requirements under this paragraph shall be refused admission into the United States. Nothing in this section may be construed as a limitation on the port of entry for an article of food.

(2)(A) Regulations under paragraph (1) shall require that a notice under such paragraph be provided by a specified period of time in advance of the time of the importation of the article of food involved or the offering of the food for import, which period shall be no less than the minimum amount of time necessary for the Secretary to receive, review, and appropriately respond to such notification, but may not exceed five days. In determining the specified period of time required under this subparagraph, the Secretary may consider, but is not limited to consideration of, the effect on commerce of such period of time, the locations of the various ports of entry into the United States, the various modes of transportation, the types of food imported into the United States, and any other such consideration. Nothing in the preceding sentence may be construed as a limitation on the obligation of the Secretary to receive, review, and appropriately respond to any notice under paragraph (1).

(B)(i) If an article of food is being imported or offered for import into the United States and a notice under paragraph (1) is not provided in advance in accordance with the requirements under paragraph (1), such article shall be held at the port of entry for the article, and may not be delivered to the importer, owner, or consignee of the article, until such notice is submitted to the Secretary, and the Secretary examines the notice and determines that the notice is in accordance with the requirements under paragraph (1). Subsection (b) of this section does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be.

(ii) In carrying out clause (i) with respect to an article of food, the Secretary shall determine whether there is in the possession of the Secretary any credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals.

(3)(A) This subsection may not be construed as limiting the authority of the Secretary to obtain information under any other provision of this chapter.

(B) This subsection may not be construed as authorizing the Secretary to impose any requirements with respect to a food to the extent that it is within the exclusive jurisdiction of the Secretary of Agriculture pursuant to the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).

(n) Labeling of food refused admission

(1) If a food has been refused admission under subsection (a) of this section, other than such a food that is required to be destroyed, the Secretary may require the owner or consignee of the food to affix to the container of the food a label that clearly and conspicuously bears the statement: “UNITED STATES: REFUSED ENTRY”.

(2) All expenses in connection with affixing a label under paragraph (1) shall be paid by the owner or consignee of the food involved, and in default of such payment, shall constitute a lien against future importations made by such owner or consignee.

(3) A requirement under paragraph (1) remains in effect until the Secretary determines that the food involved has been brought into compliance with this chapter.

(o) Registration statement

If an article that is a drug or device is being imported or offered for import into the United States, and the importer, owner, or consignee of such article does not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 360(i) of this title of each establishment that with respect to such article is required under such section to register with the Secretary, the article may be refused admission. If the article is refused admission for failure to submit such a statement, the article shall be held at the port of entry for the article, and may not be delivered to the importer, owner, or consignee of the article, until such a statement is submitted to the Secretary. Subsection (b) of this section does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be.

(p) Report

(1) Not later than 36 months after June 22, 2009, and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report regarding—

(A) the nature, extent, and destination of United States tobacco product exports that do not conform to tobacco product standards established pursuant to this chapter;

(B) the public health implications of such exports, including any evidence of a negative public health impact; and

(C) recommendations or assessments of policy alternatives available to Congress and the executive branch to reduce any negative public health impact caused by such exports.


(2) The Secretary is authorized to establish appropriate information disclosure requirements to carry out this subsection.

(q) Certifications concerning imported foods

(1) In general

The Secretary may require, as a condition of granting admission to an article of food imported or offered for import into the United States, that an entity described in paragraph (3) provide a certification, or such other assurances as the Secretary determines appropriate, that the article of food complies with applicable requirements of this chapter. Such certification or assurances may be provided in the form of shipment-specific certificates, a listing of certified facilities that manufacture, process, pack, or hold such food, or in such other form as the Secretary may specify.

(2) Factors to be considered in requiring certification

The Secretary shall base the determination that an article of food is required to have a certification described in paragraph (1) on the risk of the food, including—

(A) known safety risks associated with the food;

(B) known food safety risks associated with the country, territory, or region of origin of the food;

(C) a finding by the Secretary, supported by scientific, risk-based evidence, that—

(i) the food safety programs, systems, and standards in the country, territory, or region of origin of the food are inadequate to ensure that the article of food is as safe as a similar article of food that is manufactured, processed, packed, or held in the United States in accordance with the requirements of this chapter; and

(ii) the certification would assist the Secretary in determining whether to refuse or admit the article of food under subsection (a); and


(D) information submitted to the Secretary in accordance with the process established in paragraph (7).

(3) Certifying entities

For purposes of paragraph (1), entities that shall provide the certification or assurances described in such paragraph are—

(A) an agency or a representative of the government of the country from which the article of food at issue originated, as designated by the Secretary; or

(B) such other persons or entities accredited pursuant to section 384d of this title to provide such certification or assurance.

(4) Renewal and refusal of certifications

The Secretary may—

(A) require that any certification or other assurance provided by an entity specified in paragraph (2) be renewed by such entity at such times as the Secretary determines appropriate; and

(B) refuse to accept any certification or assurance if the Secretary determines that such certification or assurance is not valid or reliable.

(5) Electronic submission

The Secretary shall provide for the electronic submission of certifications under this subsection.

(6) False statements

Any statement or representation made by an entity described in paragraph (2) to the Secretary shall be subject to section 1001 of title 18.

(7) Assessment of food safety programs, systems, and standards

If the Secretary determines that the food safety programs, systems, and standards in a foreign region, country, or territory are inadequate to ensure that an article of food is as safe as a similar article of food that is manufactured, processed, packed, or held in the United States in accordance with the requirements of this chapter, the Secretary shall, to the extent practicable, identify such inadequacies and establish a process by which the foreign region, country, or territory may inform the Secretary of improvements made to such food safety program, system, or standard and demonstrate that those controls are adequate to ensure that an article of food is as safe as a similar article of food that is manufactured, processed, packed, or held in the United States in accordance with the requirements of this chapter.

(June 25, 1938, ch. 675, §801, 52 Stat. 1058; Oct. 18, 1949, ch. 696, §§1–3, 63 Stat. 882; Pub. L. 87–781, title III, §306, Oct. 10, 1962, 76 Stat. 796; Pub. L. 90–399, §106, July 13, 1968, 82 Stat. 353; Pub. L. 91–513, title II, §701(h), Oct. 27, 1970, 84 Stat. 1282; Pub. L. 94–295, §§3(f), 4(b)(3), May 28, 1976, 90 Stat. 578, 580; Pub. L. 100–293, §3, Apr. 22, 1988, 102 Stat. 96; Pub. L. 102–300, §6(b)(1), June 16, 1992, 106 Stat. 240; Pub. L. 102–353, §5, Aug. 26, 1992, 106 Stat. 943; Pub. L. 103–80, §3(cc), (dd)(1), Aug. 13, 1993, 107 Stat. 778, 779; Pub. L. 104–134, title II, §2102(a)–(c), Apr. 26, 1996, 110 Stat. 1321–313, 1321–314; Pub. L. 104–180, title VI, §603(a), (b), Aug. 6, 1996, 110 Stat. 1594, 1595; Pub. L. 105–115, title I, §125(a)(2)(D), Nov. 21, 1997, 111 Stat. 2325; Pub. L. 106–387, §1(a) [title VII, §§745(c)(1), 746(c)], Oct. 28, 2000, 114 Stat. 1549, 1549A–36, 1549A–40; Pub. L. 107–188, title III, §§302(a)–(d), 303(c), 304(e), 305(c), 307(a), 308(a), 321(b)(1), 322(a), June 12, 2002, 116 Stat. 662, 663, 665, 667, 668, 670, 672, 676; Pub. L. 109–462, §5(a), Dec. 22, 2006, 120 Stat. 3475; Pub. L. 110–85, title IX, §912(b)(2), Sept. 27, 2007, 121 Stat. 952; Pub. L. 111–31, div. A, title I, §103(l), June 22, 2009, 123 Stat. 1837; Pub. L. 111–353, title I, §§102(b)(3), 107(b), title II, §204(j)(2), title III, §§301(c), 303(a)–(c), 304(a), Jan. 4, 2011, 124 Stat. 3889, 3910, 3937, 3955–3957.)

Amendment of Subsection (a)

Pub. L. 111–353, title III, §301(c), (d), Jan. 4, 2011, 124 Stat. 3955, provided that, effective 2 years after Jan. 4, 2011, subsection (a) of this section is amended by inserting “or the importer (as defined in section 384a of this title) is in violation of such section 384a of this title” after “or in violation of section 355 of this title”.

References in Text

The Controlled Substances Import and Export Act, referred to in subsec. (a), is title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285, which is classified principally to subchapter II (§951 et seq.) of chapter 13 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 951 of this title and Tables.

The Federal Meat Inspection Act, referred to in subsec. (m)(3)(B), is titles I to IV of act Mar. 4, 1907, ch. 2907, as added Pub. L. 90–201, Dec. 15, 1967, 81 Stat. 584, which are classified generally to subchapters I to IV (§601 et seq.) of chapter 12 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 601 of this title and Tables.

The Poultry Products Inspection Act, referred to in subsec. (m)(3)(B), is Pub. L. 85–172, Aug. 28, 1957, 71 Stat. 441, which is classified generally to chapter 10 (§451 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 451 of this title and Tables.

The Egg Products Inspection Act, referred to in subsec. (m)(3)(B), is Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to chapter 15 (§1031 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Amendments

2011—Subsec. (a). Pub. L. 111–353, §§204(j)(2), 303(a), inserted “or (4) the recordkeeping requirements under section 2223 of this title (other than the requirements under subsection (f) of such section) have not been complied with regarding such article,” in the third sentence before “then such article shall be refused admission” and inserted after the third sentence “With respect to an article of food, if importation of such food is subject to, but not compliant with, the requirement under subsection (q) that such food be accompanied by a certification or other assurance that the food meets applicable requirements of this chapter, then such article shall be refused admission.”

Subsec. (b). Pub. L. 111–353, §303(c), substituted “with respect to an article described in subsection (a) relating to the requirements of sections 379aa or 379aa–1 of this title,” for “with respect to an article included within the provision of the fourth sentence of subsection (a)” in second sentence.

Subsec. (e)(4)(A). Pub. L. 111–353, §107(b)(1)(A), substituted “a food, drug” for “a drug” in introductory provisions.

Subsec. (e)(4)(A)(i). Pub. L. 111–353, §107(b)(1)(B), substituted “exported food, drug” for “exported drug”.

Subsec. (e)(4)(A)(ii). Pub. L. 111–353, §107(b)(1)(C), substituted “the food, drug” for “the drug” in two places.

Subsec. (e)(4)(C). Pub. L. 111–353, §107(b)(2), added subpar. (C).

Subsec. (e)(4)(D). Pub. L. 111–353, §107(b)(3), added subpar. (D).

Subsec. (l). Pub. L. 111–353, §102(b)(3), inserted “(or for which a registration has been suspended under such section)” after “section 350d of this title”.

Subsec. (m)(1). Pub. L. 111–353, §304(a), inserted “any country to which the article has been refused entry;” after “the country from which the article is shipped;”.

Subsec. (q). Pub. L. 111–353, §303(b), added subsec. (q).

2009—Subsec. (a). Pub. L. 111–31, §103(l)(1)(C), which directed substitution of “drugs, devices, or tobacco products” for “drugs or devices” wherever appearing, was executed by making the substitution for “drugs and devices” in two places in second sentence, to reflect the probable intent of Congress.

Pub. L. 111–31, §103(l)(1)(A), (B), inserted “tobacco products,” after “devices,” in first sentence and “or section 387e(h)” after “section 360” in second sentence.

Subsec. (e)(1). Pub. L. 111–31, §103(l)(2), in introductory provisions, inserted “tobacco product” after “drug, device,” and “, and a tobacco product intended for export shall not be deemed to be in violation of section 387f(e), 387g, 387k, or 387t(a) of this title,” after “chapter”.

Subsec. (p). Pub. L. 111–31, §103(l)(3), added subsec. (p).

2007—Subsec. (a). Pub. L. 110–85 substituted “is adulterated, misbranded, or in violation of section 355 of this title, or prohibited from introduction or delivery for introduction into interstate commerce under section 331(ll) of this title,” for “is adulterated, misbranded, or in violation of section 355 of this title,”.

2006—Subsec. (a). Pub. L. 109–462, §5(a)(1), inserted after third sentence “If such article is subject to a requirement under section 379aa or 379aa–1 of this title and if the Secretary has credible evidence or information indicating that the responsible person (as defined in such section 379aa or 379aa–1 of this title) has not complied with a requirement of such section 379aa or 379aa–1 of this title with respect to any such article, or has not allowed access to records described in such section 379aa or 379aa–1 of this title, then such article shall be refused admission, except as provided in subsection (b) of this section.”

Subsec. (b). Pub. L. 109–462, §5(a)(2), in second sentence, inserted “(1)” before “an article included”, “or (2) with respect to an article included within the provision of the fourth sentence of subsection (a), the responsible person (as defined in section 379aa or 379aa–1 of this title) can take action that would assure that the responsible person is in compliance with section 379aa or 379aa–1 of this title, as the case may be,” before “final determination”, and “, or, with respect to clause (2), the responsible person,” before “to perform”.

2002—Subsec. (d)(3). Pub. L. 107–188, §322(a), amended par. (3) generally. Prior to amendment, par. (3) read as follows: “No component of a drug, no component part or accessory of a device, or other article of device requiring further processing, which is ready or suitable for use for health-related purposes, and no food additive, color additive, or dietary supplement, including a product in bulk form, shall be excluded from importation into the United States under subsection (a) of this section if—

“(A) the importer of such article of a drug or device or importer of the food additive, color additive, or dietary supplement submits a statement to the Secretary, at the time of initial importation, that such article of a drug or device, food additive, color additive, or dietary supplement is intended to be further processed by the initial owner or consignee, or incorporated by the initial owner or consignee into a drug, biological product, device, food, food additive, color additive, or dietary supplement that will be exported by such owner or consignee from the United States in accordance with subsection (e) of this section or section 382 of this title or section 262(h) of title 42;

“(B) the initial owner or consignee responsible for such imported article maintains records that identify the use of such imported article and upon request of the Secretary submits a report that provides an accounting of the exportation or the disposition of the imported article, including portions that have been destroyed, and the manner in which such person complied with the requirements of this paragraph; and

“(C) any imported component, part, article, or accessory of a drug or device and any food additive, color additive, or dietary supplement not incorporated or further processed as described in subparagraph (A) is destroyed or exported by the owner or consignee.”

Subsec. (h). Pub. L. 107–188, §302(a)–(c), added subsec. (h).

Subsec. (i). Pub. L. 107–188, §302(d), added subsec. (i).

Subsec. (j). Pub. L. 107–188, §303(c), added subsec. (j).

Subsec. (k). Pub. L. 107–188, §304(e), added subsec. (k).

Subsec. (l). Pub. L. 107–188, §305(c), added subsec. (l).

Subsec. (m). Pub. L. 107–188, §307(a), added subsec. (m).

Subsec. (n). Pub. L. 107–188, §308(a), added subsec. (n).

Subsec. (o). Pub. L. 107–188, §321(b)(1), added subsec. (o).

2000—Subsec. (d)(1). Pub. L. 106–387, §1(a) [title VII, §745(c)(1)], inserted “and section 384 of this title” after “paragraph (2)”.

Subsec. (g). Pub. L. 106–387, §1(a) [title VII, §746(c)], added subsec. (g).

1997—Subsec. (d)(1). Pub. L. 105–115 inserted “or composed wholly or partly of insulin” after “353(b) of this title”.

1996—Subsec. (d)(3). Pub. L. 104–180, §603(a), substituted “accessory of a device, or other article of device requiring further processing, which is ready” for “accessory of a device which is ready” in introductory provisions, inserted “further processed by the initial owner or consignee, or” after “is intended to be” in subpar. (A), and inserted “article,” after “part,” and “or further processed” after “incorporated” in subpar. (C).

Pub. L. 104–134, §2102(a)(1), added par. (3)

Subsec. (d)(4). Pub. L. 104–134, §2102(a)(1), added par. (4).

Subsec. (e)(1). Pub. L. 104–134, §2102(b)(1), struck out concluding provisions which read as follows: “This paragraph does not authorize the exportation of any new animal drug, or an animal feed bearing or containing a new animal drug, which is unsafe within the meaning of section 360b of this title.”

Subsec. (e)(2). Pub. L. 104–134, §2102(b)(2), in concluding provisions, substituted “either (i) the Secretary” for “the Secretary” and added cl. (ii).

Subsec. (e)(3), (4). Pub. L. 104–134, §2102(b)(3), added pars. (3) and (4).

Subsec. (f). Pub. L. 104–180, §603(b), inserted “(other than insulin, an antibiotic drug, an animal drug, or a drug exported under section 382 of this title)” after “If a drug” in par. (1) and “A drug exported under section 382 of this title is exempt from this section.” at end of par. (2).

Pub. L. 104–134, §2102(c), added subsec. (f).

1993—Subsec. (a). Pub. L. 103–80, §3(dd)(1), substituted “Health and Human Services” for “Agriculture” after “Secretary of” in two places in first sentence.

Subsec. (b). Pub. L. 103–80, §3(cc), substituted “Secretary of Health and Human Services” for “Administrator” after “If it appears to the”, “Secretary” for “Administrator” after “provisions of this subsection, the”, “Secretary's” for “Administrator's” after “as may be specified in the”, “Department of Health and Human Services” for “Federal Security Agency”, and “Secretary” for “Administrator” after “designated by the”.

1992—Subsecs. (a), (b). Pub. L. 102–300, which directed the substitution of “Health and Human Services” for “Health, Education, and Welfare” wherever appearing, was executed in second sentence of subsec. (a), but could not be executed in first sentence of subsec. (a) or in subsec. (b) because such words did not appear. See 1993 Amendment note above and Transfer of Functions note below.

Subsec. (d)(1). Pub. L. 102–353 substituted “manufacturer of” for “person who manufactured”.

1988—Subsecs. (d), (e). Pub. L. 100–293 added subsec. (d) and redesignated former subsec. (d) as (e).

1976—Subsec. (a). Pub. L. 94–295, §§3(f)(2), 4(b)(3), expanded provisions requiring the Secretary of Health, Education, and Welfare to request that the Secretary of the Treasury deliver to the Secretary of Health, Education, and Welfare items imported or offered for import into the United States that were manufactured, prepared, propagated, compounded, or processed in non-registered establishments by extending the provisions to include devices imported or offered for import, and, in cl. (1), inserted reference to devices which were manufactured, packed, stored, or installed using methods, facilities, or controls not conforming to the requirements of section 360j(f) of this title.

Subsec. (d). Pub. L. 94–295, §3(f)(1), designated existing provisions as par. (1) and added par. (2).

1970—Subsec. (a). Pub. L. 91–513 substituted “Clause (2) of the third sentence of this paragraph” for “This paragraph” and “the Controlled Substances Import and Export Act” for “section 173 of this title” in last sentence.

1968—Subsec. (d). Pub. L. 90–399 provided that nothing in subsec. (d) shall authorize the exportation of any new animal drug, or an animal feed bearing or containing a new animal drug, which is unsafe within the meaning of section 360b of this title.

1962—Subsec. (a). Pub. L. 87–781 inserted provisions requiring the Secretary of Health, Education, and Welfare to furnish the Secretary of the Treasury a list of establishments registered under section 360(i) of this title, and to request that samples of any drugs from any establishments not so registered be delivered to the Secretary of Health, Education, and Welfare, with notice of delivery to the consignee who may appear before the Secretary to testify.

1949—Subsec. (a). Act Oct. 18, 1949, §1, inserted before period at end of second sentence “, except as provided in subsection (b) of this section. The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury within ninety days of the notice of such refusal or within such additional time as may be permitted pursuant to such regulations”.

Subsec. (b). Act Oct. 18, 1949, §2, provided for express statutory authority for the long-standing administrative practice of releasing imported articles that do not comply with the requirements of the law so that they may be relabeled or given appropriate treatment to bring them into compliance.

Subsec. (c). Act Oct. 18, 1949, §3, charged all costs, including salaries and travel and subsistence expenses of officers and employees, against importers.

Effective Date of 2011 Amendment

Amendment by section 301(c) of Pub. L. 111–353 effective 2 years after Jan. 4, 2011, see section 301(d) of Pub. L. 111–353, set out as a note under section 331 of this title.

Pub. L. 111–353, title III, §304(c), Jan. 4, 2011, 124 Stat. 3958, provided that: “The amendment made by this section [amending this section] shall take effect 180 days after the date of enactment of this Act [Jan. 4, 2011].”

Effective Date of 2006 Amendment

Pub. L. 109–462, §5(b), Dec. 22, 2006, 120 Stat. 3476, provided that: “The amendments made by this section [amending this section] shall take effect 1 year after the date of enactment of this Act [Dec. 22, 2006].”

Effective Date of 2002 Amendment

Amendment by section 321(b)(1) of Pub. L. 107–188 effective upon the expiration of the 180-day period beginning June 12, 2002, see section 321(c) of Pub. L. 107–188, set out as a note under section 331 of this title.

Amendment by section 322(a) of Pub. L. 107–188 effective upon the expiration of the 90-day period beginning June 12, 2002, see section 322(c) of Pub. L. 107–188, set out as a note under section 331 of this title.

Effective Date of 1988 Amendment

Amendment by Pub. L. 100–293 effective upon expiration of 90 days after Apr. 22, 1988, see section 8(a) of Pub. L. 100–293, set out as a note under section 353 of this title.

Effective Date of 1970 Amendment

Amendment by Pub. L. 91–513 effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as an Effective Date note under section 801 of this title.

Effective Date of 1968 Amendment

Amendment of subsec. (d) by Pub. L. 90–399 effective on first day of thirteenth calendar month after July 13, 1968, see section 108(a) of Pub. L. 90–399, set out as an Effective Date and Transitional Provisions note under section 360b of this title.

Regulations

Pub. L. 111–353, title III, §304(b), Jan. 4, 2011, 124 Stat. 3958, provided that: “Not later than 120 days after the date of enactment of this Act [Jan. 4, 2011], the Secretary shall issue an interim final rule amending subpart I of part 1 of title 21, Code of Federal Regulations, to implement the amendment made by this section [amending this section].”

Pub. L. 107–188, title III, §307(c), June 12, 2002, 116 Stat. 672, provided that:

“(1) In general.—Not later than 18 months after the date of the enactment of this Act [June 12, 2002], the Secretary of Health and Human Services shall promulgate proposed and final regulations for the requirement of providing notice in accordance with section 801(m) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 381(m)] (as added by subsection (a) of this section). Such requirement of notification takes effect—

“(A) upon the effective date of such final regulations; or

“(B) upon the expiration of such 18-month period if the final regulations have not been made effective as of the expiration of such period, subject to compliance with the final regulations when the final regulations are made effective.

“(2) Default; minimum period of advance notice.—If under paragraph (1) the requirement for providing notice in accordance with section 801(m) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 381(m)] takes effect without final regulations having been made effective, then for purposes of such requirement, the specified period of time that the notice is required to be made in advance of the time of the importation of the article of food involved or the offering of the food for import shall be not fewer than eight hours and not more than five days, which shall remain in effect until the final regulations are made effective.”

Savings Provision

Amendment by Pub. L. 91–513 not to affect or abate any prosecutions for violation of law or any civil seizure or forfeitures and injunctive proceedings commenced prior to the effective date of such amendment, and all administrative proceedings pending before the Bureau of Narcotic and Dangerous Drugs [now Drug Enforcement Administration] on Oct. 27, 1970, to be continued and brought to final determination in accord with laws and regulations in effect prior to Oct. 27, 1970, see section 702 of Pub. L. 91–513, set out as a note under section 321 of this title.

Construction of 2011 Amendment

Pub. L. 111–353, title III, §303(d), Jan. 4, 2011, 124 Stat. 3957, provided that: “Nothing in the amendments made by this section [amending this section] shall limit the authority of the Secretary to conduct inspections of imported food or to take such other steps as the Secretary deems appropriate to determine the admissibility of imported food.”

Nothing in amendments by sections 107(b), 204(j)(2), 301(c), and 303(a)–(c) of Pub. L. 111–353 to be construed to apply to certain alcohol-related facilities, see section 2206 of this title.

Nothing in amendments by Pub. L. 111–353 to be construed to alter jurisdiction and authorities established under certain other Acts or in a manner inconsistent with international agreements to which the United States is a party, see sections 2251 and 2252 of this title.

Construction of Amendments by Pub. L. 107–188

Pub. L. 107–188, title III, §308(c), June 12, 2002, 116 Stat. 673, provided that: “With respect to articles of food that are imported or offered for import into the United States, nothing in this section [amending this section and section 343 of this title] shall be construed to limit the authority of the Secretary of Health and Human Services or the Secretary of the Treasury to require the marking of refused articles of food under any other provision of law.”

Transfer of Functions

Secretary and Department of Health, Education, and Welfare redesignated Secretary and Department of Health and Human Services by Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695, which is classified to section 3508(b) of Title 20, Education.

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

Port Shopping

Pub. L. 111–353, title I, §115, Jan. 4, 2011, 124 Stat. 3922, provided that: “Until the date on which the Secretary promulgates a final rule that implements the amendments made by section 308 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, (Public Law 107–188) [amending this section and section 343 of this title], the Secretary shall notify the Secretary of Homeland Security of all instances in which the Secretary refuses to admit a food into the United States under section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) so that the Secretary of Homeland Security, acting through the Commissioner of Customs and Border Protection, may prevent food refused admittance into the United States by a United States port of entry from being admitted by another United States port of entry, through the notification of other such United States ports of entry.”

Modification of Deadlines for Secretarial Action

With respect to any time periods specified in an amendment by div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title.

Study and Report on Trade in Pharmaceuticals

Pub. L. 108–173, title XI, §1123, Dec. 8, 2003, 117 Stat. 2469, provided that: “The President's designees shall conduct a study and report on issues related to trade and pharmaceuticals.”

Findings

Pub. L. 106–387, §1(a) [title VII, §746(b)], Oct. 28, 2000, 114 Stat. 1549, 1549A–40, provided that: “The Congress finds as follows:

“(1) Patients and their families sometimes have reason to import into the United States drugs that have been approved by the Food and Drug Administration (‘FDA’).

“(2) There have been circumstances in which—

“(A) an individual seeking to import such a drug has received a notice from FDA that importing the drug violates or may violate the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]; and

“(B) the notice failed to inform the individual of the reasons underlying the decision to send the notice.

“(3) FDA should not send a warning notice regarding the importation of a drug without providing to the individual involved a statement of the underlying reasons for the notice.”

1 So in original. Probably should be “subsection”.

2 So in original. Probably should be “section”.

3 So in original.

4 So in original. No par. (2) has been enacted.

§382. Exports of certain unapproved products

(a) Drugs or devices intended for human or animal use which require approval or licensing

A drug or device—

(1) which, in the case of a drug—

(A)(i) requires approval by the Secretary under section 355 of this title before such drug may be introduced or delivered for introduction into interstate commerce; or

(ii) requires licensing by the Secretary under section 262 of title 42 or by the Secretary of Agriculture under the Act of March 4, 1913 [21 U.S.C. 151 et seq.] (known as the Virus-Serum Toxin Act) before it may be introduced or delivered for introduction into interstate commerce;

(B) does not have such approval or license; and

(C) is not exempt from such sections or Act; and


(2) which, in the case of a device—

(A) does not comply with an applicable requirement under section 360d or 360e of this title;

(B) under section 360j(g) of this title is exempt from either such section; or

(C) is a banned device under section 360f of this title, is adulterated, misbranded, and in violation of such sections or Act unless the export of the drug or device is, except as provided in subsection (f) of this section, authorized under subsection (b), (c), (d), or (e) of this section or section 381(e)(2) of this title. If a drug or device described in paragraphs (1) and (2) may be exported under subsection (b) of this section and if an application for such drug or device under section 355 or 360e of this title or section 262 of title 42 was disapproved, the Secretary shall notify the appropriate public health official of the country to which such drug will be exported of such disapproval.

(b) List of eligible countries for export; criteria for addition to list; direct export; petition for exemption

(1)(A) A drug or device described in subsection (a) of this section may be exported to any country, if the drug or device complies with the laws of that country and has valid marketing authorization by the appropriate authority—

(i) in Australia, Canada, Israel, Japan, New Zealand, Switzerland, or South Africa; or

(ii) in the European Union or a country in the European Economic Area (the countries in the European Union and the European Free Trade Association) if the drug or device is marketed in that country or the drug or device is authorized for general marketing in the European Economic Area.


(B) The Secretary may designate an additional country to be included in the list of countries described in clauses (i) and (ii) of subparagraph (A) if all of the following requirements are met in such country:

(i) Statutory or regulatory requirements which require the review of drugs and devices for safety and effectiveness by an entity of the government of such country and which authorize the approval of only those drugs and devices which have been determined to be safe and effective by experts employed by or acting on behalf of such entity and qualified by scientific training and experience to evaluate the safety and effectiveness of drugs and devices on the basis of adequate and well-controlled investigations, including clinical investigations, conducted by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs and devices.

(ii) Statutory or regulatory requirements that the methods used in, and the facilities and controls used for—

(I) the manufacture, processing, and packing of drugs in the country are adequate to preserve their identity, quality, purity, and strength; and

(II) the manufacture, preproduction design validation, packing, storage, and installation of a device are adequate to assure that the device will be safe and effective.


(iii) Statutory or regulatory requirements for the reporting of adverse reactions to drugs and devices and procedures to withdraw approval and remove drugs and devices found not to be safe or effective.

(iv) Statutory or regulatory requirements that the labeling and promotion of drugs and devices must be in accordance with the approval of the drug or device.

(v) The valid marketing authorization system in such country or countries is equivalent to the systems in the countries described in clauses (i) and (ii) of subparagraph (A).


The Secretary shall not delegate the authority granted under this subparagraph.

(C) An appropriate country official, manufacturer, or exporter may request the Secretary to take action under subparagraph (B) to designate an additional country or countries to be added to the list of countries described in clauses (i) and (ii) of subparagraph (A) by submitting documentation to the Secretary in support of such designation. Any person other than a country requesting such designation shall include, along with the request, a letter from the country indicating the desire of such country to be designated.

(2) A drug described in subsection (a) of this section may be directly exported to a country which is not listed in clause (i) or (ii) of paragraph (1)(A) if—

(A) the drug complies with the laws of that country and has valid marketing authorization by the responsible authority in that country; and

(B) the Secretary determines that all of the following requirements are met in that country:

(i) Statutory or regulatory requirements which require the review of drugs for safety and effectiveness by an entity of the government of such country and which authorize the approval of only those drugs which have been determined to be safe and effective by experts employed by or acting on behalf of such entity and qualified by scientific training and experience to evaluate the safety and effectiveness of drugs on the basis of adequate and well-controlled investigations, including clinical investigations, conducted by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs.

(ii) Statutory or regulatory requirements that the methods used in, and the facilities and controls used for the manufacture, processing, and packing of drugs in the country are adequate to preserve their identity, quality, purity, and strength.

(iii) Statutory or regulatory requirements for the reporting of adverse reactions to drugs and procedures to withdraw approval and remove drugs found not to be safe or effective.

(iv) Statutory or regulatory requirements that the labeling and promotion of drugs must be in accordance with the approval of the drug.


(3) The exporter of a drug described in subsection (a) of this section which would not meet the conditions for approval under this chapter or conditions for approval of a country described in clause (i) or (ii) of paragraph (1)(A) may petition the Secretary for authorization to export such drug to a country which is not described in clause (i) or (ii) of paragraph (1)(A) or which is not described in paragraph (2). The Secretary shall permit such export if—

(A) the person exporting the drug—

(i) certifies that the drug would not meet the conditions for approval under this chapter or the conditions for approval of a country described in clause (i) or (ii) of paragraph (1)(A); and

(ii) provides the Secretary with credible scientific evidence, acceptable to the Secretary, that the drug would be safe and effective under the conditions of use in the country to which it is being exported; and


(B) the appropriate health authority in the country to which the drug is being exported—

(i) requests approval of the export of the drug to such country;

(ii) certifies that the health authority understands that the drug is not approved under this chapter or in a country described in clause (i) or (ii) of paragraph (1)(A); and

(iii) concurs that the scientific evidence provided pursuant to subparagraph (A) is credible scientific evidence that the drug would be reasonably safe and effective in such country.


The Secretary shall take action on a request for export of a drug under this paragraph within 60 days of receiving such request.

(c) Investigational use exemption

A drug or device intended for investigational use in any country described in clause (i) or (ii) of subsection (b)(1)(A) of this section may be exported in accordance with the laws of that country and shall be exempt from regulation under section 355(i) or 360j(g) of this title.

(d) Anticipation of market authorization

A drug or device intended for formulation, filling, packaging, labeling, or further processing in anticipation of market authorization in any country described in clause (i) or (ii) of subsection (b)(1)(A) of this section may be exported for use in accordance with the laws of that country.

(e) Diagnosis, prevention, or treatment of tropical disease

(1) A drug or device which is used in the diagnosis, prevention, or treatment of a tropical disease or another disease not of significant prevalence in the United States and which does not otherwise qualify for export under this section shall, upon approval of an application, be permitted to be exported if the Secretary finds that the drug or device will not expose patients in such country to an unreasonable risk of illness or injury and the probable benefit to health from the use of the drug or device (under conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling of the drug or device) outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available drug or device treatment.

(2) The holder of an approved application for the export of a drug or device under this subsection shall report to the Secretary—

(A) the receipt of any credible information indicating that the drug or device is being or may have been exported from a country for which the Secretary made a finding under paragraph (1)(A) to a country for which the Secretary cannot make such a finding; and

(B) the receipt of any information indicating adverse reactions to such drug.


(3)(A) If the Secretary determines that—

(i) a drug or device for which an application is approved under paragraph (1) does not continue to meet the requirements of such paragraph; or

(ii) the holder of an approved application under paragraph (1) has not made the report required by paragraph (2),


the Secretary may, after providing the holder of the application an opportunity for an informal hearing, withdraw the approved application.

(B) If the Secretary determines that the holder of an approved application under paragraph (1) or an importer is exporting a drug or device from the United States to an importer and such importer is exporting the drug or device to a country for which the Secretary cannot make a finding under paragraph (1) and such export presents an imminent hazard, the Secretary shall immediately prohibit the export of the drug or device to such importer, provide the person exporting the drug or device from the United States prompt notice of the prohibition, and afford such person an opportunity for an expedited hearing.

(f) Prohibition of export of drug or device

A drug or device may not be exported under this section—

(1) if the drug or device is not manufactured, processed, packaged, and held in substantial conformity with current good manufacturing practice requirements or does not meet international standards as certified by an international standards organization recognized by the Secretary;

(2) if the drug or device is adulterated under clause (1), (2)(A), or (3) of section 351(a) or subsection (c) or (d) of section 351 of this title;

(3) if the requirements of subparagraphs (A) through (D) of section 381(e)(1) of this title have not been met;

(4)(A) if the drug or device is the subject of a notice by the Secretary or the Secretary of Agriculture of a determination that the probability of reimportation of the exported drug or device would present an imminent hazard to the public health and safety of the United States and the only means of limiting the hazard is to prohibit the export of the drug or device; or

(B) if the drug or device presents an imminent hazard to the public health of the country to which the drug or device would be exported;

(5) if the labeling of the drug or device is not—

(A) in accordance with the requirements and conditions for use in—

(i) the country in which the drug or device received valid marketing authorization under subsection (b) of this section; and

(ii) the country to which the drug or device would be exported; and


(B) in the language and units of measurement of the country to which the drug or device would be exported or in the language designated by such country; or


(6) if the drug or device is not promoted in accordance with the labeling requirements set forth in paragraph (5).


In making a finding under paragraph (4)(B), (5), or (6) the Secretary shall consult with the appropriate public health official in the affected country.

(g) Notification of Secretary

The exporter of a drug or device exported under subsection (b)(1) of this section shall provide a simple notification to the Secretary identifying the drug or device when the exporter first begins to export such drug or device to any country listed in clause (i) or (ii) of subsection (b)(1)(A) of this section. When an exporter of a drug or device first begins to export a drug or device to a country which is not listed in clause (i) or (ii) of subsection (b)(1)A) 1 of this section, the exporter shall provide a simple notification to the Secretary identifying the drug or device and the country to which such drug or device is being exported. Any exporter of a drug or device shall maintain records of all drugs or devices exported and the countries to which they were exported.

(h) References to Secretary and term “drug”

For purposes of this section—

(1) a reference to the Secretary shall in the case of a biological product which is required to be licensed under the Act of March 4, 1913 [21 U.S.C. 151 et seq.] (37 Stat. 832–833) (commonly known as the Virus-Serum Toxin Act) be considered to be a reference to the Secretary of Agriculture, and

(2) the term “drug” includes drugs for human use as well as biologicals under section 262 of title 42 or the Act of March 4, 1913 (37 Stat. 832–833) (commonly known as the Virus-Serum Toxin Act).

(i) Exportation

Insulin and antibiotic drugs may be exported without regard to the requirements in this section if the insulin and antibiotic drugs meet the requirements of section 381(e)(1) of this title.

(June 25, 1938, ch. 675, §802, as added Pub. L. 99–660, title I, §102(2), Nov. 14, 1986, 100 Stat. 3743; amended Pub. L. 104–134, title III, §2102(d)(1), Apr. 26, 1996, 110 Stat. 1321–315; Pub. L. 104–180, title VI, §603(c), Aug. 6, 1996, 110 Stat. 1595; Pub. L. 105–115, title I, §125(c), Nov. 21, 1997, 111 Stat. 2326.)

References in Text

Act of March 4, 1913 (known as the Virus-Serum Toxin Act), referred to in subsecs. (a)(1)(A)(ii), (C), (2)(C) and (h), is the eighth paragraph under the heading “Bureau of Animal Industry” of act Mar. 4, 1913, ch. 145, 37 Stat. 832, as amended, which is classified generally to chapter 5 (§151 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 151 of this title and Tables.

Amendments

1997—Subsec. (i). Pub. L. 105–115 added subsec. (i).

1996—Pub. L. 104–134 reenacted section catchline without change and amended text generally. Prior to amendment, text related to exports of certain unapproved products, including provisions relating to drugs intended for human or animal use which required approval or licensing, conditions for export, active pursuit of drug approval or licensing, application for export, contents, approval or disapproval, list of eligible countries for export, and criteria for list change, report to Secretary by holder of approved application, events requiring report, and annual report to Secretary on pursuit of approval of drug, export of drug under approved application prohibited under certain conditions, 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, hearings, and prohibition on exportation of drug under certain circumstances, drugs used in prevention or treatment of tropical disease, and reference to Secretary and holder of application.

Subsec. (f)(5). Pub. L. 104–180 substituted “if the labeling of the drug or device is not” for “if the drug or device is not labeled”.

1 So in original. Probably should be subsection “(b)(1)(A)”.

§383. Office of International Relations

(a) Establishment

There is established in the Department of Health and Human Services an Office of International Relations.

(b) Agreements with foreign countries

In carrying out the functions of the office under subsection (a) of this section, the Secretary may enter into agreements with foreign countries to facilitate commerce in devices between the United States and such countries consistent with the requirements of this chapter. In such agreements, the Secretary shall encourage the mutual recognition of—

(1) good manufacturing practice regulations promulgated under section 360j(f) of this title, and

(2) other regulations and testing protocols as the Secretary determines to be appropriate.

(c) Harmonizing regulatory requirements

(1) The Secretary shall support the Office of the United States Trade Representative, in consultation with the Secretary of Commerce, in meetings with representatives of other countries to discuss methods and approaches to reduce the burden of regulation and harmonize regulatory requirements if the Secretary determines that such harmonization continues consumer protections consistent with the purposes of this chapter.

(2) The Secretary shall support the Office of the United States Trade Representative, in consultation with the Secretary of Commerce, in efforts to move toward the acceptance of mutual recognition agreements relating to the regulation of drugs, biological products, devices, foods, food additives, and color additives, and the regulation of good manufacturing practices, between the European Union and the United States.

(3) The Secretary shall regularly participate in meetings with representatives of other foreign governments to discuss and reach agreement on methods and approaches to harmonize regulatory requirements.

(4) The Secretary shall, not later than 180 days after November 21, 1997, make public a plan that establishes a framework for achieving mutual recognition of good manufacturing practices inspections.

(5) Paragraphs (1) through (4) shall not apply with respect to products defined in section 321(ff) of this title.

(June 25, 1938, ch. 675, §803, as added Pub. L. 101–629, §15(a), Nov. 28, 1990, 104 Stat. 4525; amended Pub. L. 105–115, title IV, §410(b), Nov. 21, 1997, 111 Stat. 2373.)

Amendments

1997—Subsec. (c). Pub. L. 105–115 added subsec. (c).

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Report on Activities of Office of International Relations

Section 15(b) of Pub. L. 101–629 directed Secretary of Health and Human Services, not later than 2 years after Nov. 28, 1990, to prepare and submit to the appropriate committees of Congress a report on the activities of the Office of International Relations under 21 U.S.C. 383.

§384. Importation of prescription drugs

(a) Definitions

In this section:

(1) Importer

The term “importer” means a pharmacist or wholesaler.

(2) Pharmacist

The term “pharmacist” means a person licensed by a State to practice pharmacy, including the dispensing and selling of prescription drugs.

(3) Prescription drug

The term “prescription drug” means a drug subject to section 353(b) of this title, other than—

(A) a controlled substance (as defined in section 802 of this title);

(B) a biological product (as defined in section 262 of title 42);

(C) an infused drug (including a peritoneal dialysis solution);

(D) an intravenously injected drug;

(E) a drug that is inhaled during surgery; or

(F) a drug which is a parenteral drug, the importation of which pursuant to subsection (b) of this section is determined by the Secretary to pose a threat to the public health, in which case section 381(d)(1) of this title shall continue to apply.

(4) Qualifying laboratory

The term “qualifying laboratory” means a laboratory in the United States that has been approved by the Secretary for the purposes of this section.

(5) Wholesaler

(A) In general

The term “wholesaler” means a person licensed as a wholesaler or distributor of prescription drugs in the United States under section 353(e)(2)(A) of this title.

(B) Exclusion

The term “wholesaler” does not include a person authorized to import drugs under section 381(d)(1) of this title.

(b) Regulations

The Secretary, after consultation with the United States Trade Representative and the Commissioner of Customs, shall promulgate regulations permitting pharmacists and wholesalers to import prescription drugs from Canada into the United States.

(c) Limitation

The regulations under subsection (b) of this section shall—

(1) require that safeguards be in place to ensure that each prescription drug imported under the regulations complies with section 355 of this title (including with respect to being safe and effective for the intended use of the prescription drug), with sections 351 and 352 of this title, and with other applicable requirements of this chapter;

(2) require that an importer of a prescription drug under the regulations comply with subsections (d)(1) and (e) of this section; and

(3) contain any additional provisions determined by the Secretary to be appropriate as a safeguard to protect the public health or as a means to facilitate the importation of prescription drugs.

(d) Information and records

(1) In general

The regulations under subsection (b) of this section shall require an importer of a prescription drug under subsection (b) of this section to submit to the Secretary the following information and documentation:

(A) The name and quantity of the active ingredient of the prescription drug.

(B) A description of the dosage form of the prescription drug.

(C) The date on which the prescription drug is shipped.

(D) The quantity of the prescription drug that is shipped.

(E) The point of origin and destination of the prescription drug.

(F) The price paid by the importer for the prescription drug.

(G) Documentation from the foreign seller specifying—

(i) the original source of the prescription drug; and

(ii) the quantity of each lot of the prescription drug originally received by the seller from that source.


(H) The lot or control number assigned to the prescription drug by the manufacturer of the prescription drug.

(I) The name, address, telephone number, and professional license number (if any) of the importer.

(J)(i) In the case of a prescription drug that is shipped directly from the first foreign recipient of the prescription drug from the manufacturer:

(I) Documentation demonstrating that the prescription drug was received by the recipient from the manufacturer and subsequently shipped by the first foreign recipient to the importer.

(II) Documentation of the quantity of each lot of the prescription drug received by the first foreign recipient demonstrating that the quantity being imported into the United States is not more than the quantity that was received by the first foreign recipient.

(III)(aa) In the case of an initial imported shipment, documentation demonstrating that each batch of the prescription drug in the shipment was statistically sampled and tested for authenticity and degradation.

(bb) In the case of any subsequent shipment, documentation demonstrating that a statistically valid sample of the shipment was tested for authenticity and degradation.


(ii) In the case of a prescription drug that is not shipped directly from the first foreign recipient of the prescription drug from the manufacturer, documentation demonstrating that each batch in each shipment offered for importation into the United States was statistically sampled and tested for authenticity and degradation.

(K) Certification from the importer or manufacturer of the prescription drug that the prescription drug—

(i) is approved for marketing in the United States and is not adulterated or misbranded; and

(ii) meets all labeling requirements under this chapter.


(L) Laboratory records, including complete data derived from all tests necessary to ensure that the prescription drug is in compliance with established specifications and standards.

(M) Documentation demonstrating that the testing required by subparagraphs (J) and (L) was conducted at a qualifying laboratory.

(N) Any other information that the Secretary determines is necessary to ensure the protection of the public health.

(2) Maintenance by the Secretary

The Secretary shall maintain information and documentation submitted under paragraph (1) for such period of time as the Secretary determines to be necessary.

(e) Testing

The regulations under subsection (b) of this section shall require—

(1) that testing described in subparagraphs (J) and (L) of subsection (d)(1) of this section be conducted by the importer or by the manufacturer of the prescription drug at a qualified laboratory;

(2) if the tests are conducted by the importer—

(A) that information needed to—

(i) authenticate the prescription drug being tested; and

(ii) confirm that the labeling of the prescription drug complies with labeling requirements under this chapter;


be supplied by the manufacturer of the prescription drug to the pharmacist or wholesaler; and

(B) that the information supplied under subparagraph (A) be kept in strict confidence and used only for purposes of testing or otherwise complying with this chapter; and


(3) may include such additional provisions as the Secretary determines to be appropriate to provide for the protection of trade secrets and commercial or financial information that is privileged or confidential.

(f) Registration of foreign sellers

Any establishment within Canada engaged in the distribution of a prescription drug that is imported or offered for importation into the United States shall register with the Secretary the name and place of business of the establishment and the name of the United States agent for the establishment.

(g) Suspension of importation

The Secretary shall require that importations of a specific prescription drug or importations by a specific importer under subsection (b) of this section be immediately suspended on discovery of a pattern of importation of that specific prescription drug or by that specific importer of drugs that are counterfeit or in violation of any requirement under this section, until an investigation is completed and the Secretary determines that the public is adequately protected from counterfeit and violative prescription drugs being imported under subsection (b) of this section.

(h) Approved labeling

The manufacturer of a prescription drug shall provide an importer written authorization for the importer to use, at no cost, the approved labeling for the prescription drug.

(i) Charitable contributions

Notwithstanding any other provision of this section, section 381(d)(1) of this title continues to apply to a prescription drug that is donated or otherwise supplied at no charge by the manufacturer of the drug to a charitable or humanitarian organization (including the United Nations and affiliates) or to a government of a foreign country.

(j) Waiver authority for importation by individuals

(1) Declarations

Congress declares that in the enforcement against individuals of the prohibition of importation of prescription drugs and devices, the Secretary should—

(A) focus enforcement on cases in which the importation by an individual poses a significant threat to public health; and

(B) exercise discretion to permit individuals to make such importations in circumstances in which—

(i) the importation is clearly for personal use; and

(ii) the prescription drug or device imported does not appear to present an unreasonable risk to the individual.

(2) Waiver authority

(A) In general

The Secretary may grant to individuals, by regulation or on a case-by-case basis, a waiver of the prohibition of importation of a prescription drug or device or class of prescription drugs or devices, under such conditions as the Secretary determines to be appropriate.

(B) Guidance on case-by-case waivers

The Secretary shall publish, and update as necessary, guidance that accurately describes circumstances in which the Secretary will consistently grant waivers on a case-by-case basis under subparagraph (A), so that individuals may know with the greatest practicable degree of certainty whether a particular importation for personal use will be permitted.

(3) Drugs imported from Canada

In particular, the Secretary shall by regulation grant individuals a waiver to permit individuals to import into the United States a prescription drug that—

(A) is imported from a licensed pharmacy for personal use by an individual, not for resale, in quantities that do not exceed a 90-day supply;

(B) is accompanied by a copy of a valid prescription;

(C) is imported from Canada, from a seller registered with the Secretary;

(D) is a prescription drug approved by the Secretary under subchapter V of this chapter;

(E) is in the form of a final finished dosage that was manufactured in an establishment registered under section 360 of this title; and

(F) is imported under such other conditions as the Secretary determines to be necessary to ensure public safety.

(k) Construction

Nothing in this section limits the authority of the Secretary relating to the importation of prescription drugs, other than with respect to section 381(d)(1) of this title as provided in this section.

(l) Effectiveness of section

(1) Commencement of program

This section shall become effective only if the Secretary certifies to the Congress that the implementation of this section will—

(A) pose no additional risk to the public's health and safety; and

(B) result in a significant reduction in the cost of covered products to the American consumer.

(2) Termination of program

(A) In general

If, after the date that is 1 year after the effective date of the regulations under subsection (b) of this section and before the date that is 18 months after the effective date, the Secretary submits to Congress a certification that, in the opinion of the Secretary, based on substantial evidence obtained after the effective date, the benefits of implementation of this section do not outweigh any detriment of implementation of this section, this section shall cease to be effective as of the date that is 30 days after the date on which the Secretary submits the certification.

(B) Procedure

The Secretary shall not submit a certification under subparagraph (A) unless, after a hearing on the record under sections 556 and 557 of title 5, the Secretary—

(i)(I) determines that it is more likely than not that implementation of this section would result in an increase in the risk to the public health and safety;

(II) identifies specifically, in qualitative and quantitative terms, the nature of the increased risk;

(III) identifies specifically the causes of the increased risk; and

(IV)(aa) considers whether any measures can be taken to avoid, reduce, or mitigate the increased risk; and

(bb) if the Secretary determines that any measures described in item (aa) would require additional statutory authority, submits to Congress a report describing the legislation that would be required;

(ii) identifies specifically, in qualitative and quantitative terms, the benefits that would result from implementation of this section (including the benefit of reductions in the cost of covered products to consumers in the United States, allowing consumers to procure needed medication that consumers might not otherwise be able to procure without foregoing other necessities of life); and

(iii)(I) compares in specific terms the detriment identified under clause (i) with the benefits identified under clause (ii); and

(II) determines that the benefits do not outweigh the detriment.

(m) Authorization of appropriations

There are authorized to be appropriated such sums as are necessary to carry out this section.

(June 25, 1938, ch. 675, §804, as added Pub. L. 108–173, title XI, §1121(a), Dec. 8, 2003, 117 Stat. 2464.)

Prior Provisions

A prior section 384, act June 25, 1938, ch. 675, §804, as added Pub. L. 106–387, §1(a) [title VII, §745(c)(2)], Oct. 28, 2000, 114 Stat. 1549, 1549A–36, related to importation of covered products, prior to repeal by Pub. L. 108–173, title XI, §1121(a), Dec. 8, 2003, 117 Stat. 2464.

Transfer of Functions

For transfer of functions, personnel, assets, and liabilities of the United States Customs Service of the Department of the Treasury, including functions of the Secretary of the Treasury relating thereto, to the Secretary of Homeland Security, and for treatment of related references, see sections 203(1), 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set out as a note under section 542 of Title 6.

Study and Report on Importation of Drugs

Pub. L. 108–173, title XI, §1122, Dec. 8, 2003, 117 Stat. 2469, directed the Secretary of Health and Human Services to conduct a study on the importation of drugs into the United States pursuant to this section and to submit to Congress, not later than 12 months after Dec. 8, 2003, a report providing the findings of such study.

§384a. Foreign supplier verification program

(a) In general

(1) Verification requirement

Except as provided under subsections (e) and (f), each importer shall perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported by the importer or agent of an importer is—

(A) produced in compliance with the requirements of section 350g of this title or section 350h of this title, as appropriate; and

(B) is not adulterated under section 342 of this title or misbranded under section 343(w) of this title.

(2) Importer defined

For purposes of this section, the term “importer” means, with respect to an article of food—

(A) the United States owner or consignee of the article of food at the time of entry of such article into the United States; or

(B) in the case when there is no United States owner or consignee as described in subparagraph (A), the United States agent or representative of a foreign owner or consignee of the article of food at the time of entry of such article into the United States.

(b) Guidance

Not later than 1 year after January 4, 2011, the Secretary shall issue guidance to assist importers in developing foreign supplier verification programs.

(c) Regulations

(1) In general

Not later than 1 year after January 4, 2011, the Secretary shall promulgate regulations to provide for the content of the foreign supplier verification program established under subsection (a).

(2) Requirements

The regulations promulgated under paragraph (1)—

(A) shall require that the foreign supplier verification program of each importer be adequate to provide assurances that each foreign supplier to the importer produces the imported food in compliance with—

(i) processes and procedures, including reasonably appropriate risk-based preventive controls, that provide the same level of public health protection as those required under section 350g of this title or section 350h of this title (taking into consideration variances granted under section 350h of this title), as appropriate; and

(ii) section 342 of this title and section 343(w) of this title.1


(B) shall include such other requirements as the Secretary deems necessary and appropriate to verify that food imported into the United States is as safe as food produced and sold within the United States.

(3) Considerations

In promulgating regulations under this subsection, the Secretary shall, as appropriate, take into account differences among importers and types of imported foods, including based on the level of risk posed by the imported food.

(4) Activities

Verification activities under a foreign supplier verification program under this section may include monitoring records for shipments, lot-by-lot certification of compliance, annual on-site inspections, checking the hazard analysis and risk-based preventive control plan of the foreign supplier, and periodically testing and sampling shipments.

(d) Record maintenance and access

Records of an importer related to a foreign supplier verification program shall be maintained for a period of not less than 2 years and shall be made available promptly to a duly authorized representative of the Secretary upon request.

(e) Exemption of seafood, juice, and low-acid canned food facilities in compliance with HACCP

This section shall not apply to a facility if the owner, operator, or agent in charge of such facility is required to comply with, and is in compliance with, 1 of the following standards and regulations with respect to such facility:

(1) The Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration.

(2) The Juice Hazard Analysis Critical Control Points Program of the Food and Drug Administration.

(3) The Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards of the Food and Drug Administration (or any successor standards).


The exemption under paragraph (3) shall apply only with respect to microbiological hazards that are regulated under the standards for Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers under part 113 of chapter 2 21, Code of Federal Regulations (or any successor regulations).

(f) Additional exemptions

The Secretary, by notice published in the Federal Register, shall establish an exemption from the requirements of this section for articles of food imported in small quantities for research and evaluation purposes or for personal consumption, provided that such foods are not intended for retail sale and are not sold or distributed to the public.

(g) Publication of list of participants

The Secretary shall publish and maintain on the Internet Web site of the Food and Drug Administration a current list that includes the name of, location of, and other information deemed necessary by the Secretary about, importers participating under this section.

(June 25, 1938, ch. 675, §805, as added Pub. L. 111–353, title III, §301(a), Jan. 4, 2011, 124 Stat. 3953.)

Effective Date

Section effective 2 years after Jan. 4, 2011, see section 301(d) of Pub. L. 111–353, set out as an Effective Date of 2011 Amendment note under section 331 of this title.

Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

1 So in original.

2 So in original. Probably should be “title”.

§384b. Voluntary qualified importer program

(a) In general

Beginning not later than 18 months after January 4, 2011, the Secretary shall—

(1) establish a program, in consultation with the Secretary of Homeland Security—

(A) to provide for the expedited review and importation of food offered for importation by importers who have voluntarily agreed to participate in such program; and

(B) consistent with section 384d of this title, establish a process for the issuance of a facility certification to accompany food offered for importation by importers who have voluntarily agreed to participate in such program; and


(2) issue a guidance document related to participation in, revocation of such participation in, reinstatement in, and compliance with, such program.

(b) Voluntary participation

An importer may request the Secretary to provide for the expedited review and importation of designated foods in accordance with the program established by the Secretary under subsection (a).

(c) Notice of intent to participate

An importer that intends to participate in the program under this section in a fiscal year shall submit a notice and application to the Secretary of such intent at the time and in a manner established by the Secretary.

(d) Eligibility

Eligibility shall be limited to an importer offering food for importation from a facility that has a certification described in subsection (a). In reviewing the applications and making determinations on such applications, the Secretary shall consider the risk of the food to be imported based on factors, such as the following:

(1) The known safety risks of the food to be imported.

(2) The compliance history of foreign suppliers used by the importer, as appropriate.

(3) The capability of the regulatory system of the country of export to ensure compliance with United States food safety standards for a designated food.

(4) The compliance of the importer with the requirements of section 384a of this title.

(5) The recordkeeping, testing, inspections and audits of facilities, traceability of articles of food, temperature controls, and sourcing practices of the importer.

(6) The potential risk for intentional adulteration of the food.

(7) Any other factor that the Secretary determines appropriate.

(e) Review and revocation

Any importer qualified by the Secretary in accordance with the eligibility criteria set forth in this section shall be reevaluated not less often than once every 3 years and the Secretary shall promptly revoke the qualified importer status of any importer found not to be in compliance with such criteria.

(f) False statements

Any statement or representation made by an importer to the Secretary shall be subject to section 1001 of title 18.

(g) Definition

For purposes of this section, the term “importer” means the person that brings food, or causes food to be brought, from a foreign country into the customs territory of the United States.

(June 25, 1938, ch. 675, §806, as added Pub. L. 111–353, title III, §302, Jan. 4, 2011, 124 Stat. 3955.)

Construction

Nothing in this section to be construed to alter jurisdiction and authorities established under certain other Acts or in a manner inconsistent with international agreements to which the United States is a party, see sections 2251 and 2252 of this title.

§384c. Inspection of foreign food facilities

(a) Inspection

The Secretary—

(1) may enter into arrangements and agreements with foreign governments to facilitate the inspection of foreign facilities registered under section 350d of this title; and

(2) shall direct resources to inspections of foreign facilities, suppliers, and food types, especially such facilities, suppliers, and food types that present a high risk (as identified by the Secretary), to help ensure the safety and security of the food supply of the United States.

(b) Effect of inability to inspect

Notwithstanding any other provision of law, food shall be refused admission into the United States if it is from a foreign factory, warehouse, or other establishment of which the owner, operator, or agent in charge, or the government of the foreign country, refuses to permit entry of United States inspectors or other individuals duly designated by the Secretary, upon request, to inspect such factory, warehouse, or other establishment. For purposes of this subsection, such an owner, operator, or agent in charge shall be considered to have refused an inspection if such owner, operator, or agent in charge does not permit an inspection of a factory, warehouse, or other establishment during the 24-hour period after such request is submitted, or after such other time period, as agreed upon by the Secretary and the foreign factory, warehouse, or other establishment.

(June 25, 1938, ch. 675, §807, as added Pub. L. 111–353, title III, §306(a), Jan. 4, 2011, 124 Stat. 3958.)

Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

§384d. Accreditation of third-party auditors

(a) Definitions

In this section:

(1) Audit agent

The term “audit agent” means an individual who is an employee or agent of an accredited third-party auditor and, although not individually accredited, is qualified to conduct food safety audits on behalf of an accredited third-party auditor.

(2) Accreditation body

The term “accreditation body” means an authority that performs accreditation of third-party auditors.

(3) Third-party auditor

The term “third-party auditor” means a foreign government, agency of a foreign government, foreign cooperative, or any other third party, as the Secretary determines appropriate in accordance with the model standards described in subsection (b)(2), that is eligible to be considered for accreditation to conduct food safety audits to certify that eligible entities meet the applicable requirements of this section. A third-party auditor may be a single individual. A third-party auditor may employ or use audit agents to help conduct consultative and regulatory audits.

(4) Accredited third-party auditor

The term “accredited third-party auditor” means a third-party auditor accredited by an accreditation body to conduct audits of eligible entities to certify that such eligible entities meet the applicable requirements of this section. An accredited third-party auditor may be an individual who conducts food safety audits to certify that eligible entities meet the applicable requirements of this section.

(5) Consultative audit

The term “consultative audit” means an audit of an eligible entity—

(A) to determine whether such entity is in compliance with the provisions of this chapter and with applicable industry standards and practices; and

(B) the results of which are for internal purposes only.

(6) Eligible entity

The term “eligible entity” means a foreign entity, including a foreign facility registered under section 350d of this title, in the food import supply chain that chooses to be audited by an accredited third-party auditor or the audit agent of such accredited third-party auditor.

(7) Regulatory audit

The term “regulatory audit” means an audit of an eligible entity—

(A) to determine whether such entity is in compliance with the provisions of this chapter; and

(B) the results of which determine—

(i) whether an article of food manufactured, processed, packed, or held by such entity is eligible to receive a food certification under section 381(q) of this title; or

(ii) whether a facility is eligible to receive a facility certification under section 384b(a) of this title for purposes of participating in the program under section 384b of this title.

(b) Accreditation system

(1) Accreditation bodies

(A) Recognition of accreditation bodies

(i) In general

Not later than 2 years after January 4, 2011, the Secretary shall establish a system for the recognition of accreditation bodies that accredit third-party auditors to certify that eligible entities meet the applicable requirements of this section.

(ii) Direct accreditation

If, by the date that is 2 years after the date of establishment of the system described in clause (i), the Secretary has not identified and recognized an accreditation body to meet the requirements of this section, the Secretary may directly accredit third-party auditors.

(B) Notification

Each accreditation body recognized by the Secretary shall submit to the Secretary a list of all accredited third-party auditors accredited by such body and the audit agents of such auditors.

(C) Revocation of recognition as an accreditation body

The Secretary shall promptly revoke the recognition of any accreditation body found not to be in compliance with the requirements of this section.

(D) Reinstatement

The Secretary shall establish procedures to reinstate recognition of an accreditation body if the Secretary determines, based on evidence presented by such accreditation body, that revocation was inappropriate or that the body meets the requirements for recognition under this section.

(2) Model accreditation standards

Not later than 18 months after January 4, 2011, the Secretary shall develop model standards, including requirements for regulatory audit reports, and each recognized accreditation body shall ensure that third-party auditors and audit agents of such auditors meet such standards in order to qualify such third-party auditors as accredited third-party auditors under this section. In developing the model standards, the Secretary shall look to standards in place on January 4, 2011, for guidance, to avoid unnecessary duplication of efforts and costs.

(c) Third-party auditors

(1) Requirements for accreditation as a third-party auditor

(A) Foreign governments

Prior to accrediting a foreign government or an agency of a foreign government as an accredited third-party auditor, the accreditation body (or, in the case of direct accreditation under subsection (b)(1)(A)(ii), the Secretary) shall perform such reviews and audits of food safety programs, systems, and standards of the government or agency of the government as the Secretary deems necessary, including requirements under the model standards developed under subsection (b)(2), to determine that the foreign government or agency of the foreign government is capable of adequately ensuring that eligible entities or foods certified by such government or agency meet the requirements of this chapter with respect to food manufactured, processed, packed, or held for import into the United States.

(B) Foreign cooperatives and other third parties

Prior to accrediting a foreign cooperative that aggregates the products of growers or processors, or any other third party to be an accredited third-party auditor, the accreditation body (or, in the case of direct accreditation under subsection (b)(1)(A)(ii), the Secretary) shall perform such reviews and audits of the training and qualifications of audit agents used by that cooperative or party and conduct such reviews of internal systems and such other investigation of the cooperative or party as the Secretary deems necessary, including requirements under the model standards developed under subsection (b)(2), to determine that each eligible entity certified by the cooperative or party has systems and standards in use to ensure that such entity or food meets the requirements of this chapter.

(2) Requirement to issue certification of eligible entities or foods

(A) In general

An accreditation body (or, in the case of direct accreditation under subsection (b)(1)(A)(ii), the Secretary) may not accredit a third-party auditor unless such third-party auditor agrees to issue a written and, as appropriate, electronic food certification, described in section 381(q) of this title, or facility certification under section 384b(a) of this title, as appropriate, to accompany each food shipment for import into the United States from an eligible entity, subject to requirements set forth by the Secretary. Such written or electronic certification may be included with other documentation regarding such food shipment. The Secretary shall consider certifications under section 381(q) of this title and participation in the voluntary qualified importer program described in section 384b of this title when targeting inspection resources under section 350j of this title.

(B) Purpose of certification

The Secretary shall use certification provided by accredited third-party auditors to—

(i) determine, in conjunction with any other assurances the Secretary may require under section 381(q) of this title, whether a food satisfies the requirements of such section; and

(ii) determine whether a facility is eligible to be a facility from which food may be offered for import under the voluntary qualified importer program under section 384b of this title.

(C) Requirements for issuing certification

(i) In general

An accredited third-party auditor shall issue a food certification under section 381(q) of this title or a facility certification described under subparagraph (B) only after conducting a regulatory audit and such other activities that may be necessary to establish compliance with the requirements of such sections.

(ii) Provision of certification

Only an accredited third-party auditor or the Secretary may provide a facility certification under section 384b(a) of this title. Only those parties described in 1 381(q)(3) of this title or the Secretary may provide a food certification under 1 381(q) 2 of this title.

(3) Audit report submission requirements

(A) Requirements in general

As a condition of accreditation, not later than 45 days after conducting an audit, an accredited third-party auditor or audit agent of such auditor shall prepare, and, in the case of a regulatory audit, submit, the audit report for each audit conducted, in a form and manner designated by the Secretary, which shall include—

(i) the identity of the persons at the audited eligible entity responsible for compliance with food safety requirements;

(ii) the dates of the audit;

(iii) the scope of the audit; and

(iv) any other information required by the Secretary that relates to or may influence an assessment of compliance with this chapter.

(B) Records

Following any accreditation of a third-party auditor, the Secretary may, at any time, require the accredited third-party auditor to submit to the Secretary an onsite audit report and such other reports or documents required as part of the audit process, for any eligible entity certified by the third-party auditor or audit agent of such auditor. Such report may include documentation that the eligible entity is in compliance with any applicable registration requirements.

(C) Limitation

The requirement under subparagraph (B) shall not include any report or other documents resulting from a consultative audit by the accredited third-party auditor, except that the Secretary may access the results of a consultative audit in accordance with section 350c of this title.

(4) Requirements of accredited third-party auditors and audit agents of such auditors

(A) Risks to public health

If, at any time during an audit, an accredited third-party auditor or audit agent of such auditor discovers a condition that could cause or contribute to a serious risk to the public health, such auditor shall immediately notify the Secretary of—

(i) the identification of the eligible entity subject to the audit; and

(ii) such condition.

(B) Types of audits

An accredited third-party auditor or audit agent of such auditor may perform consultative and regulatory audits of eligible entities.

(C) Limitations

(i) In general

An accredited third party auditor may not perform a regulatory audit of an eligible entity if such agent has performed a consultative audit or a regulatory audit of such eligible entity during the previous 13-month period.

(ii) Waiver

The Secretary may waive the application of clause (i) if the Secretary determines that there is insufficient access to accredited third-party auditors in a country or region.

(5) Conflicts of interest

(A) Third-party auditors

An accredited third-party auditor shall—

(i) not be owned, managed, or controlled by any person that owns or operates an eligible entity to be certified by such auditor;

(ii) in carrying out audits of eligible entities under this section, have procedures to ensure against the use of any officer or employee of such auditor that has a financial conflict of interest regarding an eligible entity to be certified by such auditor; and

(iii) annually make available to the Secretary disclosures of the extent to which such auditor and the officers and employees of such auditor have maintained compliance with clauses (i) and (ii) relating to financial conflicts of interest.

(B) Audit agents

An audit agent shall—

(i) not own or operate an eligible entity to be audited by such agent;

(ii) in carrying out audits of eligible entities under this section, have procedures to ensure that such agent does not have a financial conflict of interest regarding an eligible entity to be audited by such agent; and

(iii) annually make available to the Secretary disclosures of the extent to which such agent has maintained compliance with clauses (i) and (ii) relating to financial conflicts of interest.

(C) Regulations

The Secretary shall promulgate regulations not later than 18 months after January 4, 2011, to implement this section and to ensure that there are protections against conflicts of interest between an accredited third-party auditor and the eligible entity to be certified by such auditor or audited by such audit agent. Such regulations shall include—

(i) requiring that audits performed under this section be unannounced;

(ii) a structure to decrease the potential for conflicts of interest, including timing and public disclosure, for fees paid by eligible entities to accredited third-party auditors; and

(iii) appropriate limits on financial affiliations between an accredited third-party auditor or audit agents of such auditor and any person that owns or operates an eligible entity to be certified by such auditor, as described in subparagraphs (A) and (B).

(6) Withdrawal of accreditation

(A) In general

The Secretary shall withdraw accreditation from an accredited third-party auditor—

(i) if food certified under section 381(q) of this title or from a facility certified under paragraph (2)(B) by such third-party auditor is linked to an outbreak of foodborne illness that has a reasonable probability of causing serious adverse health consequences or death in humans or animals;

(ii) following an evaluation and finding by the Secretary that the third-party auditor no longer meets the requirements for accreditation; or

(iii) following a refusal to allow United States officials to conduct such audits and investigations as may be necessary to ensure continued compliance with the requirements set forth in this section.

(B) Additional basis for withdrawal of accreditation

The Secretary may withdraw accreditation from an accredited third-party auditor in the case that such third-party auditor is accredited by an accreditation body for which recognition as an accreditation body under subsection (b)(1)(C) is revoked, if the Secretary determines that there is good cause for the withdrawal.

(C) Exception

The Secretary may waive the application of subparagraph (A)(i) if the Secretary—

(i) conducts an investigation of the material facts related to the outbreak of human or animal illness; and

(ii) reviews the steps or actions taken by the third party auditor to justify the certification and determines that the accredited third-party auditor satisfied the requirements under section 381(q) of this title of certifying the food, or the requirements under paragraph (2)(B) of certifying the entity.

(7) Reaccreditation

The Secretary shall establish procedures to reinstate the accreditation of a third-party auditor for which accreditation has been withdrawn under paragraph (6)—

(A) if the Secretary determines, based on evidence presented, that the third-party auditor satisfies the requirements of this section and adequate grounds for revocation no longer exist; and

(B) in the case of a third-party auditor accredited by an accreditation body for which recognition as an accreditation body under subsection (b)(1)(C) is revoked—

(i) if the third-party auditor becomes accredited not later than 1 year after revocation of accreditation under paragraph (6)(A), through direct accreditation under subsection (b)(1)(A)(ii) or by an accreditation body in good standing; or

(ii) under such conditions as the Secretary may require for a third-party auditor under paragraph (6)(B).

(8) Neutralizing costs

The Secretary shall establish by regulation a reimbursement (user fee) program, similar to the method described in section 1622(h) of title 7,2 by which the Secretary assesses fees and requires accredited third-party auditors and audit agents to reimburse the Food and Drug Administration for the work performed to establish and administer the accreditation system under this section. The Secretary shall make operating this program revenue-neutral and shall not generate surplus revenue from such a reimbursement mechanism. Fees authorized under this paragraph shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriation Acts. Such fees are authorized to remain available until expended.

(d) Recertification of eligible entities

An eligible entity shall apply for annual recertification by an accredited third-party auditor if such entity—

(1) intends to participate in 3 voluntary qualified importer program under section 384b of this title; or

(2) is required to provide to the Secretary a certification under section 381(q) of this title for any food from such entity.

(e) False statements

Any statement or representation made—

(1) by an employee or agent of an eligible entity to an accredited third-party auditor or audit agent; or

(2) by an accredited third-party auditor to the Secretary,


shall be subject to section 1001 of title 18.

(f) Monitoring

To ensure compliance with the requirements of this section, the Secretary shall—

(1) periodically, or at least once every 4 years, reevaluate the accreditation bodies described in subsection (b)(1);

(2) periodically, or at least once every 4 years, evaluate the performance of each accredited third-party auditor, through the review of regulatory audit reports by such auditors, the compliance history as available of eligible entities certified by such auditors, and any other measures deemed necessary by the Secretary;

(3) at any time, conduct an onsite audit of any eligible entity certified by an accredited third-party auditor, with or without the auditor present; and

(4) take any other measures deemed necessary by the Secretary.

(g) Publicly available registry

The Secretary shall establish a publicly available registry of accreditation bodies and of accredited third-party auditors, including the name of, contact information for, and other information deemed necessary by the Secretary about such bodies and auditors.

(h) Limitations

(1) No effect on section 374 inspections

The audits performed under this section shall not be considered inspections under section 374 of this title.

(2) No effect on inspection authority

Nothing in this section affects the authority of the Secretary to inspect any eligible entity pursuant to this chapter.

(June 25, 1938, ch. 675, §808, as added Pub. L. 111–353, title III, §307, Jan. 4, 2011, 124 Stat. 3959.)

References in Text

Section 381(q) of this title, referred to in subsec. (c)(2)(C)(ii), was in the original “301(g)”, and was translated as reading “801(q)”, meaning section 801(q) of act June 25, 1938, ch. 675, which is classified to section 381(q) of this title, to reflect the probable intent of Congress, because section 381(q) of this title relates to food certification, whereas section 301(g) of act June 25, 1938, ch. 675, which is classified to section 331(g) of this title, does not relate to food certification.

Section 1622(h) of title 7, referred to in subsec. (c)(8), was in the original “section 203(h) of the Agriculture Marketing Act of 1946”, and was translated as reading “section 203(h) of the Agricultural Marketing Act of 1946”, meaning section 203(h) of act Aug. 14, 1946, ch. 966, which is classified to section 1622(h) of Title 7, Agriculture, to reflect the probable intent of Congress.

Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

1 So in original. Probably should be followed by “section”.

2 See References in Text note below.

3 So in original. Probably should be followed by “the”.