21 U.S.C. § 381 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VIII: IMPORTS AND EXPORTS / Section 381: Imports and exports
Imports and exports
Status: in_force

(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 the importer (as defined in section 384a of this title) is in violation of such section 384a of this title, or prohibited from introduction or delivery for introduction into interstate commerce under section 331(ll) of this title, or is a controlled substance subject to an order under section 360bbb–8d 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 or 1 (5) such article is being imported or offered for import in violation of section 331(cc) of this title, then any such article described in any of clauses (1) through (5) shall be refused admission, except as provided in subsection (b) of this section. If it appears from the examination of such samples or otherwise that the article is a counterfeit drug or counterfeit device, such article shall be refused admission. 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 364a, 379aa, or 379aa–1 of this title and if the Secretary has credible evidence or information indicating that the responsible person (as defined in section 364, 379aa, or 379aa–1 of this title) has not complied with a requirement of such section 364a, 379aa, or 379aa–1 of this title with respect to any such article, or has not allowed access to records described in such section 364a, 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 90 days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug or device refused admission under this section, if such drug or device is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 1498(a)(1) of title 19) and was not brought into compliance as described under subsection (b). The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug or device under the seventh sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug or device. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug or device, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug or device after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c). Such process may be combined with the notice and opportunity to appear before the Secretary and introduce testimony, as described in the first sentence of this subsection, as long as appropriate notice is provided to the owner or consignee. Neither clause (2) nor clause (5) of the third sentence of this subsection shall 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 section 364a, 379aa, or 379aa–1 of this title, the responsible person (as defined in section 364, 379aa, or 379aa–1 of this title) can take action that would assure that the responsible person is in compliance with section 364a, 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)(A) 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.

(B) Except as authorized by the Secretary in the case of a drug that appears on the drug shortage list under section 356e of this title or in the case of importation pursuant to section 384 of this title, no drug that is subject to section 353(b)(1) of this title may be imported into the United States for commercial use if such drug is manufactured outside the United States, unless the manufacturer has authorized the drug to be marketed in the United States and has caused the drug to be labeled to be marketed in the United States.

(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) 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) or section 382 of this title, or with section 351(h) of the Public Health Service Act [42 U.S.C. 262(h)].

(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) or section 382 of this title, or with section 351(h) of the Public Health Service Act [42 U.S.C. 262(h)].

(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 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] 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 361 of the Public Health Service Act [42 U.S.C. 264].

(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.

(E)(i)(I) If the Secretary denies a request for certification under subparagraph (A)(ii) with respect to a device manufactured in an establishment (foreign or domestic) registered under section 360 of this title, the Secretary shall provide in writing to the person seeking such certification the basis for such denial, and specifically identify the finding upon which such denial is based.

(II) If the denial of a request as described in subclause (I) is based on grounds other than an injunction proceeding pursuant to section 332 of this title, seizure action pursuant to section 334 of this title, or a recall designated Class I or Class II pursuant to part 7, title 21, Code of Federal Regulations, and is based on the facility being out of compliance with part 820 of title 21, Code of Federal Regulations, the Secretary shall provide a substantive summary of the specific grounds for noncompliance identified by the Secretary.

(III) With respect to a device manufactured in an establishment that has received a report under section 374(b) of this title, the Secretary shall not deny a request for certification as described in subclause (I) with respect to a device based solely on the issuance of that report if the owner, operator, or agent in charge of such establishment has agreed to a plan of correction in response to such report.

(ii)(I) The Secretary shall provide a process for a person who is denied a certification as described in clause (i)(I) to request a review that conforms to the standards of section 360g–1(b) of this title.

(II) Notwithstanding any previous review conducted pursuant to subclause (I), a person who has been denied a certification as described in clause (i)(I) may at any time request a review in order to present new information relating to actions taken by such person to address the reasons identified by the Secretary for the denial of certification, including evidence that corrective actions are being or have been implemented to address grounds for noncompliance identified by the Secretary.

(III) Not later than 1 year after August 18, 2017, the Secretary shall issue guidance providing for a process to carry out this subparagraph. Not later than 1 year after the close of the comment period for such guidance, the Secretary shall issue final guidance.

(F)(i) This paragraph applies to requests for certification under this subparagraph of a device manufactured by a device establishment located outside of the United States that is registered under section 360 of this title, if the device is listed pursuant to section 360(j) of this title, the device has been cleared, approved, or is not required to submit a premarket report pursuant to subsection (l) or (m) of section 360 of this title, and the device is imported or offered for import into the United States.

(ii) The Secretary shall issue the certification as described in clause (iii) if the device or devices for which certification is requested under this subparagraph meet the applicable requirements of this chapter.

(iii)(I) A certification for a device described in clause (i) shall be subject to the fee described in subparagraph (B).

(II) Notwithstanding subparagraph (C), a certification for a device described in clause (i) shall address and include the same material information as a "Certificate to Foreign Government" and shall have a document title including the words "Certificate to Foreign Government".

(iv) The requirements and procedures of subparagraph (E) shall apply to a denial of a certification under this subparagraph.

(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) 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) 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) 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); 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 5304(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) 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) 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) 2 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) 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) 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), 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 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) 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.

(r) Standards for admission of imported drugs

(1) The Secretary may require, pursuant to the regulations promulgated under paragraph (4)(A), as a condition of granting admission to a drug imported or offered for import into the United States, that the importer electronically submit information demonstrating that the drug complies with applicable requirements of this chapter.

(2) The information described under paragraph (1) may include—

(A) information demonstrating the regulatory status of the drug, such as the new drug application, abbreviated new drug application, or investigational new drug or drug master file number;

(B) facility information, such as proof of registration and the unique facility identifier;

(C) indication of compliance with current good manufacturing practice, testing results, certifications relating to satisfactory inspections, and compliance with the country of export regulations; and

(D) any other information deemed necessary and appropriate by the Secretary to assess compliance of the article being offered for import.

(3) Information requirements referred to in paragraph (2)(C) may, at the discretion of the Secretary, be satisfied—

(A) through representation by a foreign government, if an inspection is conducted by a foreign government using standards and practices as determined appropriate by the Secretary;

(B) through representation by a foreign government or an agency of a foreign government recognized under section 384e of this title; or

(C) other appropriate documentation or evidence as described by the Secretary.

(4)(A) Not later than 18 months after July 9, 2012, the Secretary shall adopt final regulations implementing this subsection. Such requirements shall be appropriate for the type of import, such as whether the drug is for import into the United States for use in preclinical research or in a clinical investigation under an investigational new drug exemption under 355(i) 3 of this title.

(B) In promulgating the regulations under subparagraph (A), the Secretary—

(i) may, as appropriate, take into account differences among importers and types of imports, and, based on the level of risk posed by the imported drug, provide for expedited clearance for those importers that volunteer to participate in partnership programs for highly compliant companies and pass a review of internal controls, including sourcing of foreign manufacturing inputs, and plant inspections; and

(ii) shall—

(I) issue a notice of proposed rulemaking that includes the proposed regulation;

(II) provide a period of not less than 60 days for comments on the proposed regulation; and

(III) publish the final regulation not less than 30 days before the effective date of the regulation.

(C) Notwithstanding any other provision of law, the Secretary shall promulgate regulations implementing this subsection only as described in subparagraph (B).

(s) Registration of commercial importers

(1) Registration

The Secretary shall require a commercial importer of drugs—

(A) to be registered with the Secretary in a form and manner specified by the Secretary; and

(B) subject to paragraph (4), to submit, at the time of registration, a unique identifier for the principal place of business for which the importer is required to register under this subsection.

(2) Regulations

(A) In general

The Secretary, in consultation with the Secretary of Homeland Security acting through U.S. Customs and Border Protection, shall promulgate regulations to establish good importer practices that specify the measures an importer shall take to ensure imported drugs are in compliance with the requirements of this chapter and the Public Health Service Act [42 U.S.C. 201 et seq.].

(B) Procedure

In promulgating a regulation under subparagraph (A), the Secretary shall—

(i) issue a notice of proposed rulemaking that includes the proposed regulation;

(ii) provide a period of not less than 60 days for comments on the proposed regulation; and

(iii) publish the final regulation not less than 30 days before the regulation's effective date.

(C) Restrictions

Notwithstanding any other provision of Federal law, in implementing this subsection, the Secretary shall only promulgate regulations as described in subparagraph (B).

(D) Effective date

In establishing the effective date of the regulations under subparagraph (A), the Secretary shall, in consultation with the Secretary of Homeland Security acting through U.S. Customs and Border Protection, as determined appropriate by the Secretary of Health and Human Services, provide a reasonable period of time for an importer of a drug to comply with good importer practices, taking into account differences among importers and types of imports, including based on the level of risk posed by the imported product.

(3) Discontinuance of registration

The Secretary shall discontinue the registration of any commercial importer of drugs that fails to comply with the regulations promulgated under this subsection.

(4) Unique facility identifier

The Secretary shall specify the unique facility identifier system that shall be used by registrants under paragraph (1). The requirement to include a unique facility identifier in a registration under paragraph (1) shall not apply until the date that the identifier system is specified by the Secretary under the preceding sentence.

(5) Exemptions

The Secretary, by notice in the Federal Register, may establish exemptions from the requirements of this subsection.

(t) Single source pattern of imported illegal drugs

If the Secretary determines that a person subject to debarment as a result of engaging in a pattern of importing or offering for import controlled substances or drugs as described in section 335a(b)(3)(D) of this title, and such pattern is identified by the Secretary as being offered for import from the same manufacturer, distributor, or importer, the Secretary may by order determine all drugs being offered for import from such person as adulterated or misbranded, unless such person can provide evidence otherwise.

(u) Illicit articles containing active pharmaceutical ingredients

(1) In general

For purposes of this section, an article that is being imported or offered for import into the United States may be treated by the Secretary as a drug if the article—

(A) is not—

(i) accompanied by an electronic import entry for such article submitted using an authorized electronic data interchange system; and

(ii) designated in such a system as an article regulated by the Secretary (which may include regulation as a drug, a device, a dietary supplement, or other product that is regulated under this chapter); and

(B) is an ingredient that presents significant public health concern and is, or contains—

(i) an active ingredient in a drug—

(I) that is approved under section 355 of this title or licensed under section 351 of the Public Health Service Act [42 U.S.C. 262]; or

(II) for which—

(aa) an investigational use exemption has been authorized under section 355(i) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)]; and

(bb) a substantial clinical investigation has been instituted, and such investigation has been made public; or

(ii) a substance that has a chemical structure that is substantially similar to the chemical structure of an active ingredient in a drug or biological product described in subclause (I) or (II) of clause (i).

(2) Effect

This subsection shall not be construed to bear upon any determination of whether an article is a drug within the meaning of section 321(g) of this title, other than for the purposes described in paragraph (1).

(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; Pub. L. 112–144, title VII, §§708(a), (b), 713, 714(b), July 9, 2012, 126 Stat. 1068, 1072, 1073; Pub. L. 114–255, div. A, title III, §3101(a)(2)(W)(i), Dec. 13, 2016, 130 Stat. 1155; Pub. L. 115–52, title VI, §604(a), title VII, §704, Aug. 18, 2017, 131 Stat. 1048, 1056; Pub. L. 115–271, title III, §§3012(c), 3013, 3022(c), (d), Oct. 24, 2018, 132 Stat. 3936, 3939, 3940; Pub. L. 116–136, div. A, title III, §3856(a), Mar. 27, 2020, 134 Stat. 458; Pub. L. 116–304, §2(a), Jan. 5, 2021, 134 Stat. 4915; Pub. L. 117–328, div. FF, title III, §§3304, 3503(a)(4)(C), (D), Dec. 29, 2022, 136 Stat. 5832, 5858.)

Editorial Notes

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 V of act Mar. 4, 1907, ch. 2907, as added Pub. L. 90–201, Dec. 15, 1967, 81 Stat. 584, and Pub. L. 110–246, title XI, §11015(a), June 18, 2008, 122 Stat. 2124, which are classified generally to subchapters I to IV–A (§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.

The Public Health Service Act, referred to in subsec. (s)(2)(A), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Amendments

2022—Subsec. (a). Pub. L. 117–328, §3503(a)(4)(C), substituted "under section 364a, 379aa, or 379aa–1 of this title" for "under section 379aa or 379aa–1 of this title", "defined in section 364, 379aa, or 379aa–1 of this title" for "defined in such section 379aa or 379aa–1 of this title", "of such section 364a, 379aa, or 379aa–1 of this title" for "of such section 379aa or 379aa–1 of this title", and "described in such section 364a, 379aa, or 379aa–1 of this title" for "described in such section 379aa or 379aa–1 of this title".

Subsec. (b). Pub. L. 117–328, §3503(a)(4)(D), substituted "requirements of section 364a, 379aa, or 379aa–1 of this title" for "requirements of sections 379aa or 379aa–1 of this title,", "as defined in section 364, 379aa, or 379aa–1 of this title" for "defined in section 379aa or 379aa–1 of this title", and "with section 364a, 379aa, or 379aa–1 of this title" for "with section 379aa or 379aa–1 of this title".

Subsec. (e)(4)(E)(iii). Pub. L. 117–328, §3304(1), struck out cl. (iii) which applied to requests for certification on behalf of any device establishment registered under section 360 of this title, whether the establishment is located inside or outside of the United States, and regardless of whether such devices are to be exported from the United States.

Subsec. (e)(4)(F). Pub. L. 117–328, §3304(2), added subpar. (F).

2021—Subsec. (a). Pub. L. 116–304 inserted "or counterfeit device" after "counterfeit drug" in fourth sentence, and substituted "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 90 days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug or device refused admission under this section, if such drug or device is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 1498(a)(1) of title 19) and was not brought into compliance as described under subsection (b). The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug or device under the seventh sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug or device. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug or device, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug or device after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c)." for "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, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug refused admission under this section, if such drug is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 1498(a)(1) of title 19) and was not brought into compliance as described under subsection (b).. The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug under the sixth sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c)."

2020—Subsec. (e)(4)(E)(iii). Pub. L. 116–136 substituted "paragraph" for "subparagraph" in subcls. (I) and (II).

2018—Subsec. (a). Pub. L. 115–271, §3022(c)(2), (3), inserted "If it appears from the examination of such samples or otherwise that the article is a counterfeit drug, such article shall be refused admission." after third sentence, and substituted "Neither clause (2) nor clause (5) of the third sentence of this subsection shall be construed to prohibit the admission of narcotic drugs, the importation of which is permitted under the Controlled Substances Import and Export Act." for "Clause (2) of the third sentence of this paragraph 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."

Pub. L. 115–271, §3022(c)(1), which directed substitution of "or (5) such article is being imported or offered for import in violation of section 331(cc) of this title, then any such article described in any of clauses (1) through (5) shall be refused admission" for ", then such article shall be refused admission", was executed by making the substitution only in the third sentence, to reflect the probable intent of Congress.

Pub. L. 115–271, §3012(c), inserted ", or is a controlled substance subject to an order under section 360bbb–8d of this title" before "or (4)" in third sentence.

Subsec. (t). Pub. L. 115–271, §3013, added subsec. (t).

Subsec. (u). Pub. L. 115–271, §3022(d), added subsec. (u).

2017—Subsec. (d)(1). Pub. L. 115–52, §604(a), designated existing provisions as subpar. (A) and added subpar. (B).

Subsec. (e)(4)(C), (D). Pub. L. 115–52, §704(2), realigned margins.

Subsec. (e)(4)(E). Pub. L. 115–52, §704(1), added subpar. (E).

2016—Subsec. (s)(2)(D). Pub. L. 114–255 added subpar. (D).

2012—Subsec. (a). Pub. L. 112–144, §708(b), inserted "The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug under the sixth sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c). Such process may be combined with the notice and opportunity to appear before the Secretary and introduce testimony, as described in the first sentence of this subsection, as long as appropriate notice is provided to the owner or consignee." after "described under subsection (b).."

Pub. L. 112–144, §708(a), inserted ", except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug refused admission under this section, if such drug is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 1498(a)(1) of title 19 and was not brought into compliance as described under subsection (b)." after "pursuant to such regulations".

Subsec. (o). Pub. L. 112–144, §713(1), struck out "drug or" after "If an article that is a".

Subsec. (r). Pub. L. 112–144, §713(2), added subsec. (r).

Subsec. (s). Pub. L. 112–144, §714(b), added subsec. (s).

2011—Subsec. (a). Pub. L. 111–353, §301(c), inserted "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".

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.

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Amendment by section 3503(a)(4)(C), (D) of Pub. L. 117–328 effective on the date that is 1 year after Dec. 29, 2022, see section 3503(b)(1) of Pub. L. 117–328, set out as a note under section 331 of this title.

Effective Date of 2012 Amendment; Applicability

Pub. L. 112–144, title VII, §708(c), July 9, 2012, 126 Stat. 1069, provided that: "The amendment made by subsection (a) [amending this section] shall apply beginning on the effective date of the regulations promulgated pursuant to the amendment made by subsection (b) [amending this section]."

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. 112–144, title VII, §708(d), July 9, 2012, 126 Stat. 1069, provided that:

"(1) In general.—Not later than 2 years after the date of enactment of this Act [July 9, 2012], the Secretary of Health and Human Services shall adopt final regulations implementing the amendments made this section [amending this section].

"(2) Procedure.—In promulgating a regulation implementing the amendments made by this section, the Secretary of Health and Human Services shall—

"(A) issue a notice of proposed rulemaking that includes a copy of the proposed regulation;

"(B) provide a period of not less than 60 days for comments on the proposed regulation; and

"(C) publish the final regulation not less than 30 days before the effective date of the regulation.

"(3) Restrictions.—Notwithstanding any other provision of law, the Secretary of Health and Human Services shall promulgate regulations implementing the amendments made by this section only as described in paragraph (2)."

Pub. L. 112–144, title VII, §714(d), July 9, 2012, 126 Stat. 1074, provided that, within 36 months after July 9, 2012, the Secretary of Homeland Security acting through U.S. Customs and Border Protection, was to promulgate regulations required to carry out subsection (s) of this section relating to registration of commercial importers and specified procedures for promulgating regulations and their effective date, prior to repeal by Pub. L. 114–255, div. A, title III, §3101(a)(2)(W)(ii), Dec. 13, 2016, 130 Stat. 1156.

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; Confidentiality

Nothing in amendment made by section 3503(a)(4)(C), (D) of Pub. L. 117–328 to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 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.

Port Shopping

Pub. L. 111–353, title I, §115, Jan. 4, 2011, 124 Stat. 3922, as amended by Pub. L. 114–125, title VIII, §802(d)(2), Feb. 24, 2016, 130 Stat. 210, 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 U.S. 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."

["Commissioner of U.S. Customs and Border Protection" substituted for "Commissioner of Customs and Border Protection" in section 115 of Pub. L. 111–353, set out above, to reflect the probable intent of section 802(d)(2) of Pub. L. 114–125, set out as a note under section 211 of Title 6, Domestic Security, which provided that on or after Feb. 24, 2016, any reference to the "Commissioner of Customs" or the "Commissioner of the Customs Service" would be deemed to be a reference to the Commissioner of U.S. Customs and Border Protection.]

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."

Executive Documents

Transfer of Functions

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.

1 So in original. Probably should be preceded by a comma.

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

3 So in original. Probably should be preceded by "section".
21 U.S.C. § 360pp (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360pp: Enforcement
Enforcement
Status: in_force

(a) Jurisdiction of courts

The district courts of the United States shall have jurisdiction, for cause shown, to restrain violations of section 360oo of this title and to restrain dealers and distributors of electronic products from selling or otherwise disposing of electronic products which do not conform to an applicable standard prescribed pursuant to section 360kk of this title except when such products are disposed of by returning them to the distributor or manufacturer from whom they were obtained. The district courts of the United States shall also have jurisdiction in accordance with section 1355 of title 28 to enforce the provisions of subsection (b) of this section.

(b) Penalties

(1) Any person who violates section 360oo of this title shall be subject to a civil penalty of not more than $1,000. For purposes of this subsection, any such violation shall with respect to each electronic product involved, or with respect to each act or omission made unlawful by section 360oo of this title, constitute a separate violation, except that the maximum civil penalty imposed on any person under this subsection for any related series of violations shall not exceed $300,000.

(2) Any such civil penalty may on application be remitted or mitigated by the Secretary. In determining the amount of such penalty, or whether it should be remitted or mitigated and in what amount, the appropriateness of such penalty to the size of the business of the person charged and the gravity of the violation shall be considered. The amount of such penalty, when finally determined, may be deducted from any sums owing by the United States to the person charged.

(c) Venue; process

Actions under subsections (a) and (b) of this section may be brought in the district court of the United States for the district wherein any act or omission or transaction constituting the violation occurred, or in such court for the district where the defendant is found or transacts business, and process in such cases may be served in any other district of which the defendant is an inhabitant or wherever the defendant may be found.

(d) Warnings

Nothing in this part shall be construed as requiring the Secretary to report for the institution of proceedings minor violations of this part whenever he believes that the public interest will be adequately served by a suitable written notice or warning.

(e) Compliance with regulations

Except as provided in the first sentence of section 360ss of this title, compliance with this part or any regulations issued thereunder shall not relieve any person from liability at common law or under statutory law.

(f) Additional remedies

The remedies provided for in this part shall be in addition to and not in substitution for any other remedies provided by law.

(June 25, 1938, ch. 675, §539, formerly act July 1, 1944, ch. 373, title III, §539, formerly §360C, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1184; renumbered §539 and amended Pub. L. 101–629, §19(a)(1)(B), (2)(G), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, §4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

Editorial Notes

Codification

Section was classified to section 263k of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629.

Amendments

1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, §19(a)(4), which renumbered section 263k of Title 42, The Public Health and Welfare, as this section.

1990—Subsec. (a). Pub. L. 101–629, §19(a)(2)(G)(i), (ii), substituted "section 360oo" for "section 263j" and "section 360kk" for "section 263f".

Subsec. (b)(1). Pub. L. 101–629, §19(a)(2)(G)(ii), substituted "section 360oo" for "section 263j" in two places.

Subsec. (d). Pub. L. 101–629, §19(a)(1)(B), substituted "this part" for "this subpart" in two places.

Subsec. (e). Pub. L. 101–629, §19(a)(1)(B), (2)(G)(iii), substituted "section 360ss" for "section 263n" and "this part" for "this subpart".

Subsec. (f). Pub. L. 101–629, §19(a)(1)(B), substituted "this part" for "this subpart".

Statutory Notes and Related Subsidiaries

Noninterference With Other Federal Agencies

Enactment of this section not to be construed to supersede or limit the functions under any other provision of law of any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title.
21 U.S.C. § 619 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter I: INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING / Section 619: Marking, labeling, or other identification to show kinds of animals from which derived; separate establishments for preparation and slaughtering activities
Marking, labeling, or other identification to show kinds of animals from which derived; separate establishments for preparation and slaughtering activities
Status: in_force

No person, firm, or corporation shall sell, transport, offer for sale or transportation, or receive for transportation, in commerce, any carcasses of species designated by regulations in effect on the day before November 10, 2005, or parts of such carcasses, or the meat or meat food products thereof, unless they are plainly and conspicuously marked or labeled or otherwise identified as required by regulations prescribed by the Secretary to show the kinds of animals from which they were derived. When required by the Secretary, with respect to establishments at which inspection is maintained under this subchapter, such animals and their carcasses, parts thereof, meat and meat food products shall be prepared in establishments separate from those in which other amenable species are slaughtered or their carcasses, parts thereof, meat or meat food products are prepared.

(Mar. 4, 1907, ch. 2907, title I, §19, formerly 17th par., 34 Stat. 1264; renumbered §19 and amended Pub. L. 90–201, §§1, 9, Dec. 15, 1967, 81 Stat. 584, 590; Pub. L. 109–97, title VII, §798[(a)](3), Nov. 10, 2005, 119 Stat. 2166.)

Editorial Notes

Codification

Section was formerly classified to section 87 of this title.

Amendments

2005—Pub. L. 109–97 substituted "species designated by regulations in effect on the day before November 10, 2005," for "horses, mules, or other equines" and "other amenable species" for "cattle, sheep, swine, or goats".

1967—Pub. L. 90–201, §9, substituted provisions for marking, labeling, or other identification of kinds of animals whence the articles are derived and for separate establishments for preparation and slaughtering activities for prohibition against transportation or sale of meat or meat food products without complying with inspection provisions. See section 610(b) of this title.

Statutory Notes and Related Subsidiaries

Effective Date of 2005 Amendment

Amendment by Pub. L. 109–97 effective the day after 120 days after Nov. 10, 2005, see section 798(b) of Pub. L. 109–97, set out as a note under section 601 of this title.

Effective Date of 1967 Amendment

Amendment by Pub. L, 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expiration, of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.
21 U.S.C. § 822 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 822: Persons required to register
Persons required to register
Status: in_force

(a) Period of registration

(1) Every person who manufactures or distributes any controlled substance or list I chemical, or who proposes to engage in the manufacture or distribution of any controlled substance or list I chemical, shall obtain annually a registration issued by the Attorney General in accordance with the rules and regulations promulgated by him.

(2) Every person who dispenses, or who proposes to dispense, any controlled substance, shall obtain from the Attorney General a registration issued in accordance with the rules and regulations promulgated by him. The Attorney General shall, by regulation, determine the period of such registrations. In no event, however, shall such registrations be issued for less than one year nor for more than three years.

(3)(A) Except as provided in subparagraph (C), the registration of any registrant under this subchapter to manufacture, distribute, or dispense controlled substances or list I chemicals terminates if and when such registrant—

(i) dies;

(ii) ceases legal existence;

(iii) discontinues business or professional practice; or

(iv) surrenders such registration.

(B) In the case of such a registrant who ceases legal existence or discontinues business or professional practice, such registrant shall promptly notify the Attorney General in writing of such fact.

(C) No registration under this subchapter to manufacture, distribute, or dispense controlled substances or list I chemicals, and no authority conferred thereby, may be assigned or otherwise transferred except upon such conditions as the Attorney General may specify and then only pursuant to written consent. A registrant to whom a registration is assigned or transferred pursuant to the preceding sentence may not manufacture, distribute, or dispense controlled substances or list I chemicals pursuant to such registration until the Attorney General receives such written consent.

(D) In the case of a registrant under this subchapter to manufacture, distribute, or dispense controlled substances or list I chemicals desiring to discontinue business or professional practice altogether or with respect to controlled substances and list I chemicals (without assigning or transferring such business or professional practice to another entity), such registrant shall return to the Attorney General for cancellation—

(i) the registrant's certificate of registration;

(ii) any unexecuted order forms in the registrant's possession; and

(iii) any other documentation that the Attorney General may require.

(b) Authorized activities

Persons registered by the Attorney General under this subchapter to manufacture, distribute, or dispense controlled substances or list I chemicals are authorized to possess, manufacture, distribute, or dispense such substances or chemicals (including any such activity in the conduct of research) to the extent authorized by their registration and in conformity with the other provisions of this subchapter.

(c) Exceptions

The following persons shall not be required to register and may lawfully possess any controlled substance or list I chemical under this subchapter:

(1) An agent or employee of any registered manufacturer, distributor, or dispenser of any controlled substance or list I chemical if such agent or employee is acting in the usual course of his business or employment.

(2) A common or contract carrier or warehouseman, or an employee thereof, whose possession of the controlled substance or list I chemical is in the usual course of his business or employment.

(3) An ultimate user who possesses such substance for a purpose specified in section 802(25) 1 of this title.

(d) Waiver

The Attorney General may, by regulation, waive the requirement for registration of certain manufacturers, distributors, or dispensers if he finds it consistent with the public health and safety.

(e) Separate registration

(1) A separate registration shall be required at each principal place of business or professional practice where the applicant manufactures, distributes, or dispenses controlled substances or list I chemicals.

(2) Notwithstanding paragraph (1), a registrant who is a veterinarian shall not be required to have a separate registration in order to transport and dispense controlled substances in the usual course of veterinary practice at a site other than the registrant's registered principal place of business or professional practice, so long as the site of transporting and dispensing is located in a State where the veterinarian is licensed to practice veterinary medicine and is not a principal place of business or professional practice.

(3) Notwithstanding paragraph (1), a registrant that is dispensing pursuant to section 823(g) 1 of this title narcotic drugs to individuals for maintenance treatment or detoxification treatment shall not be required to have a separate registration to incorporate one or more mobile medication units into the registrant's practice to dispense such narcotics at locations other than the registrant's principal place of business or professional practice described in paragraph (1), so long as the registrant meets such standards for operation of a mobile medication unit as the Attorney General may establish.

(f) Inspection

The Attorney General is authorized to inspect the establishment of a registrant or applicant for registration in accordance with the rules and regulations promulgated by him.

(g) Delivery of controlled substances by ultimate users for disposal

(1) An ultimate user who has lawfully obtained a controlled substance in accordance with this subchapter may, without being registered, deliver the controlled substance to another person for the purpose of disposal of the controlled substance if—

(A) the person receiving the controlled substance is authorized under this subchapter to engage in such activity; and

(B) the disposal takes place in accordance with regulations issued by the Attorney General to prevent diversion of controlled substances.

(2) In developing regulations under this subsection, the Attorney General shall take into consideration the public health and safety, as well as the ease and cost of program implementation and participation by various communities. Such regulations may not require any entity to establish or operate a delivery or disposal program.

(3) The Attorney General may, by regulation, authorize long-term care facilities, as defined by the Attorney General by regulation, to dispose of controlled substances on behalf of ultimate users who reside, or have resided, at such long-term care facilities in a manner that the Attorney General determines will provide effective controls against diversion and be consistent with the public health and safety.

(4) If a person dies while lawfully in possession of a controlled substance for personal use, any person lawfully entitled to dispose of the decedent's property may deliver the controlled substance to another person for the purpose of disposal under the same conditions as provided in paragraph (1) for an ultimate user.

(5)(A) In the case of a person receiving hospice care, an employee of a qualified hospice program, acting within the scope of employment, may handle, without being registered under this section, any controlled substance that was lawfully dispensed to the person receiving hospice care, for the purpose of disposal of the controlled substance so long as such disposal occurs onsite in accordance with all applicable Federal, State, Tribal, and local law and—

(i) the disposal occurs after the death of a person receiving hospice care;

(ii) the controlled substance is expired; or

(iii)(I) the employee is—

(aa) the physician of the person receiving hospice care; and

(bb) registered under section 823(g) of this title; and

(II) the hospice patient no longer requires the controlled substance because the plan of care of the hospice patient has been modified.

(B) For the purposes of this paragraph:

(i) The terms "hospice care" and "hospice program" have the meanings given to those terms in section 1395x(dd) of title 42.

(ii) The term "employee of a qualified hospice program" means a physician, physician assistant, nurse, or other person who—

(I) is employed by, or pursuant to arrangements made by, a qualified hospice program;

(II)(aa) is licensed to perform medical or nursing services by the jurisdiction in which the person receiving hospice care was located; and

(bb) is acting within the scope of such employment in accordance with applicable State law; and

(III) has completed training through the qualified hospice program regarding the disposal of controlled substances in a secure and responsible manner so as to discourage abuse, misuse, or diversion.

(iii) The term "qualified hospice program" means a hospice program that—

(I) has written policies and procedures for assisting in the disposal of the controlled substances of a person receiving hospice care after the person's death;

(II) at the time when the controlled substances are first ordered—

(aa) provides a copy of the written policies and procedures to the patient or patient representative and family;

(bb) discusses the policies and procedures with the patient or representative and the family in a language and manner that they understand to ensure that these parties are educated regarding the safe disposal of controlled substances; and

(cc) documents in the patient's clinical record that the written policies and procedures were provided and discussed; and

(III) at the time following the disposal of the controlled substances—

(aa) documents in the patient's clinical record the type of controlled substance, dosage, route of administration, and quantity so disposed; and

(bb) the time, date, and manner in which that disposal occurred.

(Pub. L. 91–513, title II, §302, Oct. 27, 1970, 84 Stat. 1253; Pub. L. 98–473, title II, §510, Oct. 12, 1984, 98 Stat. 2072; Pub. L. 103–200, §3(b), Dec. 17, 1993, 107 Stat. 2336; Pub. L. 111–273, §3(a), Oct. 12, 2010, 124 Stat. 2859; Pub. L. 113–143, §2, Aug. 1, 2014, 128 Stat. 1750; Pub. L. 115–271, title III, §3222(a), Oct. 24, 2018, 132 Stat. 3948; Pub. L. 117–53, §2, Nov. 10, 2021, 135 Stat. 411; Pub. L. 117–215, title I, §103(b)(1)(B), Dec. 2, 2022, 136 Stat. 2263; Pub. L. 117–328, div. FF, title I, §1252(a), Dec. 29, 2022, 136 Stat. 5681.)

Editorial Notes

References in Text

This subchapter, referred to in subsecs. (a)(3), (b), (c), and (g)(1), was in the original "this title", meaning title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, and is popularly known as the "Controlled Substances Act". For complete classification of title II to the Code, see second paragraph of Short Title note set out under section 801 of this title and Tables.

Section 802(25) of this title, referred to in subsec. (c)(3), was redesignated section 802(26) of this title by Pub. L. 98–473, title II, §507(a), Oct. 12, 1984, 98 Stat. 2071, and was further redesignated section 802(27) of this title by Pub. L. 99–570, title I, §1003(b)(2), Oct. 27, 1986, 100 Stat. 3207–6.

Section 823(g) of this title, referred to in subsec. (e)(3), was redesignated section 823(h) of this title by Pub. L. 117–215, title I, §103(a)(1), Dec. 2, 2022, 136 Stat. 2261.

Amendments

2022—Subsec. (e)(3). Pub. L. 117–328, §1252(a), added par. (3).

Subsec. (g)(5)(A)(iii)(I)(bb). Pub. L. 117–215 substituted "823(g)" for "823(f)".

2021—Subsec. (a)(3). Pub. L. 117–53 added par. (3).

2018—Subsec. (g)(5). Pub. L. 115–271 added par. (5).

2014—Subsec. (e). Pub. L. 113–143 designated existing provisions as par. (1) and added par. (2).

2010—Subsec. (g). Pub. L. 111–273 added subsec. (g).

1993—Subsec. (a)(1). Pub. L. 103–200, §3(b)(1), inserted "or list I chemical" after "controlled substance" in two places.

Subsec. (b). Pub. L. 103–200, §3(b)(2), inserted "or list I chemicals" after "controlled substances" and "or chemicals" after "such substances".

Subsec. (c). Pub. L. 103–200, §3(b)(3), inserted "or list I chemical" after "controlled substance" wherever appearing.

Subsec. (e). Pub. L. 103–200, §3(b)(4), inserted "or list I chemicals" after "controlled substances".

1984—Subsec. (a). Pub. L. 98–473 designated existing provisions as par. (1), struck out provisions relating to dispensing controlled substances, and added par. (2).

Statutory Notes and Related Subsidiaries

Effective Date of 1993 Amendment

Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 of this title.

Effective Date

Section 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 a note under section 801 of this title.

Rule of Construction Relating to State and Local Law

Pub. L. 115–271, title III, §3222(c), Oct. 24, 2018, 132 Stat. 3949, provided that: "Nothing in this section [amending this section and enacting provisions set out as a note below] or the amendments made by this section shall be construed to prevent a State or local government from imposing additional controls or restrictions relating to the regulation of the disposal of controlled substances in hospice care or hospice programs."

Guidance

Pub. L. 115–271, title III, §3222(b), Oct. 24, 2018, 132 Stat. 3949, provided that: "The Attorney General may issue guidance to hospice programs (as defined in paragraph (5) of section 302(g) of the Controlled Substances Act (21 U.S.C. 822(g)), as added by subsection (a)) to assist the programs in satisfying the requirements under such paragraph (5)."

Findings

Pub. L. 111–273, §2, Oct. 12, 2010, 124 Stat. 2858, provided that: "Congress finds the following:

"(1) The nonmedical use of prescription drugs is a growing problem in the United States, particularly among teenagers.

"(2) According to the Department of Justice's 2009 National Prescription Drug Threat Assessment—

"(A) the number of deaths and treatment admissions for controlled prescription drugs (CPDs) has increased significantly in recent years;

"(B) unintentional overdose deaths involving prescription opioids, for example, increased 114 percent from 2001 to 2005, and the number of treatment admissions for prescription opioids increased 74 percent from 2002 to 2006; and

"(C) violent crime and property crime associated with abuse and diversion of CPDs has increased in all regions of the United States over the past 5 years.

"(3) According to the Office of National Drug Control Policy's 2008 Report 'Prescription for Danger', prescription drug abuse is especially on the rise for teens—

"(A) one-third of all new abusers of prescription drugs in 2006 were 12- to 17-year-olds;

"(B) teens abuse prescription drugs more than any illicit drug except marijuana—more than cocaine, heroin, and methamphetamine combined; and

"(C) responsible adults are in a unique position to reduce teen access to prescription drugs because the drugs often are found in the home.

"(4)(A) Many State and local law enforcement agencies have established drug disposal programs (often called 'take-back' programs) to facilitate the collection and destruction of unused, unwanted, or expired medications. These programs help get outdated or unused medications off household shelves and out of the reach of children and teenagers.

"(B) However, take-back programs often cannot dispose of the most dangerous pharmaceutical drugs—controlled substance medications—because Federal law does not permit take-back programs to accept controlled substances unless they get specific permission from the Drug Enforcement Administration and arrange for full-time law enforcement officers to receive the controlled substances directly from the member of the public who seeks to dispose of them.

"(C) Individuals seeking to reduce the amount of unwanted controlled substances in their household consequently have few disposal options beyond discarding or flushing the substances, which may not be appropriate means of disposing of the substances. Drug take-back programs are also a convenient and effective means for individuals in various communities to reduce the introduction of some potentially harmful substances into the environment, particularly into water.

"(D) Long-term care facilities face a distinct set of obstacles to the safe disposal of controlled substances due to the increased volume of controlled substances they handle.

"(5) This Act [see Short Title of 2010 Amendment note set out under section 801 of this title] gives the Attorney General authority to promulgate new regulations, within the framework of the Controlled Substances Act [21 U.S.C. 801 et seq.], that will allow patients to deliver unused pharmaceutical controlled substances to appropriate entities for disposal in a safe and effective manner consistent with effective controls against diversion.

"(6) The goal of this Act is to encourage the Attorney General to set controlled substance diversion prevention parameters that will allow public and private entities to develop a variety of methods of collection and disposal of controlled substances, including some pharmaceuticals, in a secure, convenient, and responsible manner. This will also serve to reduce instances of diversion and introduction of some potentially harmful substances into the environment."

Provisional Registration

Pub. L. 91–513, title II, §703, Oct. 27, 1970, 84 Stat. 1283, as amended by Pub. L. 99–514, §2, Oct. 22, 1986, 100 Stat. 2095, provided that:

"(a)(1) Any person who—

"(A) is engaged in manufacturing, distributing, or dispensing any controlled substance on the day before the effective date of section 302 [this section], and

"(B) is registered on such day under section 510 of the Federal Food, Drug, and Cosmetic Act [section 360 of this title] or under section 4722 of the Internal Revenue Code of 1986 [formerly I.R.C. 1954, section 4722 of Title 26],

shall, with respect to each establishment for which such registration is in effect under any such section, be deemed to have a provisional registration under section 303 [section 823 of this title] for the manufacture, distribution, or dispensing (as the case may be) of controlled substances.

"(2) During the period his provisional registration is in effect under this section, the registration number assigned such person under such section 510 [section 360 of this title] or under such section 4722 [section 4722 of Title 26] (as the case may be) shall be his registration number for purposes of section 303 of this title [section 823 of this title].

"(b) The provisions of section 304 [section 824 of this title], relating to suspension and revocation of registration, shall apply to a provisional registration under this section.

"(c) Unless sooner suspended or revoked under subsection (b), a provisional registration of a person under subsection (a)(1) of this section shall be in effect until—

"(1) the date on which such person has registered with the Attorney General under section 303 [section 823 of this title] or has had his registration denied under such section, or

"(2) such date as may be prescribed by the Attorney General for registration of manufacturers, distributors, or dispensers, as the case may be,

whichever occurs first."

1 See References in Text note below.
21 U.S.C. § 454 (2024) — Title 21: FOOD AND DRUGS / Chapter 10: POULTRY AND POULTRY PRODUCTS INSPECTION / Section 454: Federal and State cooperation in development and administration of State poultry product inspection programs
Federal and State cooperation in development and administration of State poultry product inspection programs
Status: in_force

(a) State laws; planning, technical and financial assistance; advisory committees

It is the policy of the Congress to protect the consuming public from poultry products that are adulterated or misbranded and to assist in efforts by State and other government agencies to accomplish this objective. In furtherance of this policy—

(1) The Secretary is authorized, whenever he determines that it would effectuate the purposes of this chapter, to cooperate with the appropriate State agency in developing and administering a State poultry product inspection program in any State which has enacted a mandatory State poultry product inspection law that imposes ante mortem and post mortem inspection, reinspection and sanitation requirements that are at least equal to those under this chapter, with respect to all or certain classes of persons engaged in the State in slaughtering poultry or processing poultry products for use as human food solely for distribution within such State.

(2) The Secretary is further authorized, whenever he determines that it would effectuate the purposes of this chapter, to cooperate with appropriate State agencies in developing and administering State programs under State laws containing authorities at least equal to those provided in section 460 of this title; and to cooperate with other agencies of the United States in carrying out any provisions of this chapter. In carrying out the provisions of this chapter, the Secretary may conduct such examinations, investigations, and inspections as he determines practicable through any officer or employee of any State or Territory or the District of Columbia commissioned by the Secretary for such purpose.

(3) Cooperation with State agencies under this section may include furnishing to the appropriate State agency (i) advisory assistance in planning and otherwise developing an adequate State program under the State law; and (ii) technical and laboratory assistance and training (including necessary curricular and instructional materials and equipment), and financial and other aid for administration of such a program. The amount to be contributed to any State by the Secretary under this section from Federal funds for any year shall not exceed 50 per centum of the estimated total cost of the cooperative program; and the Federal funds shall be allocated among the States desiring to cooperate on an equitable basis. Such cooperation and payment shall be contingent at all times upon the administration of the State program in a manner which the Secretary, in consultation with the appropriate advisory committee appointed under subparagraph (4), deems adequate to effectuate the purposes of this section.

(4) The Secretary may appoint advisory committees consisting of such representatives of appropriate State agencies as the Secretary and the State agencies may designate to consult with him concerning State and Federal programs with respect to poultry product inspection and other matters within the scope of this chapter, including evaluating State programs for purposes of this chapter, and obtaining better coordination and more uniformity among the State programs and between the Federal and State programs and adequate protection of consumers.

(b) Appropriate State agency; performance of functions by subordinate governmental unit

The appropriate State agency with which the Secretary may cooperate under this chapter shall be a single agency in the State which is primarily responsible for the coordination of the State programs having objectives similar to those under this chapter. When the State program includes performance of certain functions by a municipality or other subordinate governmental unit, such unit shall be deemed to be a part of the State agency for purposes of this section.

(c) Intrastate activities; designation of State for regulation; publication of designation; exempted operations; termination of designation; review of operations in nondesignated States; annual report

(1) If the Secretary has reason to believe, by thirty days prior to the expiration of two years after August 18, 1968, that a State has failed to develop or is not enforcing, with respect to all establishments within its jurisdiction (except those that would be exempted from Federal inspection under subparagraph (2) of this paragraph (c)) at which poultry are slaughtered, or poultry products are processed for use as human food, solely for distribution within such State, and the products of such establishments, requirements at least equal to those imposed under sections 451 to 453, 455 to 459, 461 to 467d of this title, he shall promptly notify the Governor of the State of this fact. If the Secretary determines, after consultation with the Governor of the State, or representative selected by him, that such requirements have not been developed and activated, he shall promptly after the expiration of such two-year period designate such State as one in which the provisions of said sections of this chapter shall apply to operations and transactions wholly within such State: Provided, That if the Secretary has reason to believe that the State will activate such requirements within one additional year, he may delay such designation for said period, and not designate the State, if he determines at the end of the year that the State then has such requirements in effective operation. The Secretary shall publish any such designation in the Federal Register and, upon the expiration of thirty days after such publication, the provisions of said sections of this chapter shall apply to operations and transactions and to persons engaged therein in the State to the same extent and in the same manner as if such operations and transactions were conducted in or for commerce. However, notwithstanding any other provision of this section, if the Secretary determines that any establishment within a State is producing adulterated poultry products for distribution within such State which would clearly endanger the public health he shall notify the Governor of the State and the appropriate advisory committee provided for by subparagraph (a)(4) of this section of such fact for effective action under State or local law. If the State does not take action to prevent such endangering of the public health within a reasonable time after such notice, as determined by the Secretary, in light of the risk to public health, the Secretary may forthwith designate any such establishment as subject to the provisions of said sections of this chapter, and thereupon the establishment and operator thereof shall be subject to such provisions as though engaged in commerce until such time as the Secretary determines that such State has developed and will enforce requirements at least equal to those imposed under said sections.

(2) The provisions of this chapter requiring inspection of the slaughter of poultry and the processing of poultry products shall not apply to operations of types traditionally and usually conducted at retail stores and restaurants, when conducted at any retail store or restaurant or similar retail-type establishment for sale in normal retail quantities or service of such articles to consumers at such establishments if such establishments are subject to such inspection provisions only under this paragraph (c). For the purposes of this subparagraph, operations conducted at a restaurant central kitchen facility shall be considered as being conducted at a restaurant if the restaurant central kitchen prepares poultry products that are ready to eat when they leave such facility and are served in meals or as entrees only to customers at restaurants owned or operated by the same person owning or operating such facility: Provided, That such facility shall be subject to the provisions of section 460(b) of this title: Provided further, That the facility may be subject to the inspection requirements of this chapter for as long as the Secretary deems necessary, if the Secretary determines that the sanitary conditions or practices of the facility or the processing procedures or methods at the facility are such that any of its poultry products are rendered adulterated.

(3) Whenever the Secretary determines that any State designated under this paragraph (c) has developed and will enforce State poultry products inspection requirements at least equal to those imposed under the aforesaid sections of this chapter, with respect to the operations and transactions within such State which are regulated under subparagraph (1) of this paragraph (c), he shall terminate the designation of such State under this paragraph (c), but this shall not preclude the subsequent redesignation of the State at any time upon thirty days' notice to the Governor and publication in the Federal Register in accordance with this paragraph, and any State may be designated upon such notice and publication, at any time after the period specified in this paragraph whether or not the State has theretofore been designated, upon the Secretary determining that it is not effectively enforcing requirements at least equal to those imposed under said sections.

(4) The Secretary shall promptly upon August 18, 1968, and periodically thereafter, but at least annually, review the requirements, including the enforcement thereof, of the several States not designated under this paragraph (c), with respect to the slaughter, and the processing, storage, handling, and distribution of poultry products, and inspection of such operations, and annually report thereon to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate in the report required in section 470 1 of this title.

(d) "State" defined

As used in this section, the term "State" means any State (including the Commonwealth of Puerto Rico) or organized territory.

(Pub. L. 85–172, §5, Aug. 28, 1957, 71 Stat. 443; Pub. L. 90–492, §5, Aug. 18, 1968, 82 Stat. 796; Pub. L. 98–487, §2, Oct. 17, 1984, 98 Stat. 2264; Pub. L. 103–437, §8(1), Nov. 2, 1994, 108 Stat. 4588.)

Editorial Notes

References in Text

Section 470 of this title, referred to in subsec. (c)(4), was omitted from the Code.

Codification

In par. (c)(1), (4), "August 18, 1968" substituted for "enactment of the Wholesome Poultry Products Act".

Amendments

1994—Subsec. (c)(4). Pub. L. 103–437 substituted "Agriculture, Nutrition, and Forestry" for "Agriculture and Forestry".

1984—Par. (c)(2). Pub. L. 98–487 inserted provisions relating to operations conducted at a restaurant central kitchen facility.

1968—Pub. L. 90–492 substituted provisions authorizing the Secretary to cooperate with the appropriate state agency in the development and administration of state poultry product inspection programs in those states having mandatory poultry product inspection laws and those states having laws at least equal to the provisions of section 460 of this title, provisions authorizing planning, technical and financial assistance and the appointment of advisory committees, provisions designating the appropriate state agency with which the Secretary may cooperate, provisions authorizing the Secretary to designate states as subject to the regulatory provisions of this chapter when the requirements of the specified section have not been complied with or when the specified intrastate activities are present, provisions exempting from the requirements of this chapter operations of the types traditionally and usually conducted at retail stores and restaurants, provisions authorizing the Secretary to terminate the aforementioned designation of states as subject to the regulatory provisions of this chapter, and provisions authorizing the Secretary to review the operations in nondesignated states and make an annual report thereon, for provisions authorizing the Secretary, upon application by any appropriate state or local official or agency or by any appropriate local poultry industry group and after public hearing, to designate major consuming areas as subject to the regulatory provisions of this chapter where the Secretary finds that poultry or poultry products are handled or consumed in such volume as to affect, burden or obstruct the movement of inspected poultry products in interstate commerce.

Statutory Notes and Related Subsidiaries

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–492 effective Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title.

1 See References in Text note below.
21 U.S.C. § 113 (2024) — Title 21: FOOD AND DRUGS / Chapter 4: ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS / Subchapter III: PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION / Section 113: Repealed. Pub. L. 107-171, title X, §10418(a)(7), (8), May 13, 2002, 116 Stat. 507, 508
Repealed. Pub. L. 107-171, title X, §10418(a)(7), (8), May 13, 2002, 116 Stat. 507, 508
Status: repealed

Section, act May 29, 1884, ch. 60, §5, 23 Stat. 32; Feb. 2, 1903, ch. 349, §1, 32 Stat. 791; Feb. 7, 1928, ch. 30, 45 Stat. 59, related to measures to prevent exportation of diseased livestock and live poultry.
21 U.S.C. § 1401 (2024) — Title 21: FOOD AND DRUGS / Chapter 19: PESTICIDE MONITORING IMPROVEMENTS / Section 1401: Pesticide monitoring and enforcement information
Pesticide monitoring and enforcement information
Status: in_force

(a) Data management systems

(1) Not later than 480 days after August 23, 1988, the Secretary of Health and Human Services shall place in effect computerized data management systems for the Food and Drug Administration under which the Administration will—

(A) record, summarize, and evaluate the results of its program for monitoring food products for pesticide residues,

(B) identify gaps in its pesticide monitoring program in the monitoring of (i) pesticides, (ii) food products, and (iii) food from specific countries and from domestic sources,

(C) detect trends in the presence of pesticide residues in food products and identify public health problems emerging from the occurrence of pesticide residues in food products,

(D) focus its testing resources for monitoring pesticide residues in food on detecting those residues which pose a public health concern,

(E) prepare summaries of the information listed in subsection (b), and

(F) provide information to assist the Environmental Protection Agency in carrying out its responsibilities under the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.] and the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].

(2) As soon as practicable, the Secretary of Health and Human Services shall develop a means to enable the computerized data management systems placed into effect under paragraph (1) to make the summary described in subsection (c).

(3)(A) Paragraph (1) does not limit the authority of the Food and Drug Administration to—

(i) use the computerized data management systems placed in effect under paragraph (1), or

(ii) develop additional data management systems,

to facilitate the regulation of any substance or product covered under the requirements of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].

(B) In placing into effect the computerized data management systems under paragraph (1) and in carrying out paragraph (2), the Secretary shall comply with applicable regulations governing computer system design and procurement.

(b) Information

The Food and Drug Administration shall use the computerized data management systems placed into effect under subsection (a)(1) to prepare a summary of—

(1) information on—

(A) the types of imported and domestically produced food products analyzed for compliance with the requirements of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] regarding the presence of pesticide residues,

(B) the number of samples of each such food product analyzed for such compliance by country of origin,

(C) the pesticide residues which may be detected using the testing methods employed,

(D) the pesticide residues in such food detected and the levels detected,

(E) the compliance status of each sample of such food tested and the violation rate for each country-product combination, and

(F) the action taken with respect to each sample of such food found to be in violation of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and its ultimate disposition, and

(2) information on—

(A) the country of origin of each imported food product referred to in paragraph (1)(A), and

(B) the United States district of entry for each such imported food product.

(c) Volume data

The Food and Drug Administration shall use the computerized data management systems placed into effect under subsection (a)(1) to summarize the volume of each type of food product subject to the requirements of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] which is imported into the United States and which has an entry value which exceeds an amount established by the Secretary of Health and Human Services. The summary shall be made by country of origin and district of entry. Information with respect to volumes of food products to be included in the summary shall, to the extent feasible, be obtained from data bases of other Federal agencies.

(d) Compilation

Not later than 90 days after the expiration of 1 year after the data management systems are placed into effect under subsection (a) and annually thereafter, the Secretary of Health and Human Services shall compile a summary of the information described in subsection (b) with respect to the previous year. When the Food and Drug Administration is able to make summaries under subsection (c), the Secretary shall include in the compilation under the preceding sentence a compilation of the information described in subsection (c). Compilations under this subsection shall be made available to Federal and State agencies and other interested persons.

(Pub. L. 100–418, title IV, §4702, Aug. 23, 1988, 102 Stat. 1412.)

Editorial Notes

References in Text

The Federal Insecticide, Fungicide, and Rodenticide Act, referred to in subsec. (a)(1)(F), is act June 25, 1947, ch. 125, as amended generally by Pub. L. 92–516, Oct. 21, 1972, 86 Stat. 973, which is classified generally to subchapter II (§136 et seq.) of chapter 6 of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 136 of Title 7 and Tables.

The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (a) to (c), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Statutory Notes and Related Subsidiaries

Short Title

Pub. L. 100–418, title IV, §4701, Aug. 23, 1988, 102 Stat. 1411, provided that: "This subtitle [subtitle G (§§4701–4704) of title IV of Pub. L. 100–418, enacting this chapter] may be cited as the 'Pesticide Monitoring Improvements Act of 1988'."

Imported Meat, Poultry Products, Eggs, and Egg Products

Pub. L. 100–418, title IV, §4506, Aug. 23, 1988, 102 Stat. 1404, required the Secretary of Agriculture, not later than 90 days after Aug. 23, 1988, to submit a report to Congress concerning the planned distribution, in fiscal years 1988 and 1989, of the resources of the Department of Agriculture available for sampling imported covered products to ensure compliance with the requirements of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.) that govern the level of residues of pesticides, drugs, and other products permitted in or on such products.
21 U.S.C. § 350d (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IV: FOOD / Section 350d: Registration of food facilities
Registration of food facilities
Status: in_force

(a) Registration

(1) In general

The Secretary shall by regulation require that any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States be registered with the Secretary. To be registered—

(A) for a domestic facility, the owner, operator, or agent in charge of the facility shall submit a registration to the Secretary; and

(B) for a foreign facility, the owner, operator, or agent in charge of the facility shall submit a registration to the Secretary and shall include with the registration the name of the United States agent for the facility.

(2) Registration

An entity (referred to in this section as the "registrant") shall submit a registration under paragraph (1) to the Secretary containing information necessary to notify the Secretary of the name and address of each facility at which, and all trade names under which, the registrant conducts business, the e-mail address for the contact person of the facility or, in the case of a foreign facility, the United States agent for the facility, and, when determined necessary by the Secretary through guidance, the general food category (as identified under section 170.3 of title 21, Code of Federal Regulations, or any other food categories as determined appropriate by the Secretary, including by guidance) of any food manufactured, processed, packed, or held at such facility. The registration shall contain an assurance that the Secretary will be permitted to inspect such facility at the times and in the manner permitted by this chapter. The registrant shall notify the Secretary in a timely manner of changes to such information.

(3) Biennial registration renewal

During the period beginning on October 1 and ending on December 31 of each even-numbered year, a registrant that has submitted a registration under paragraph (1) shall submit to the Secretary a renewal registration containing the information described in paragraph (2). The Secretary shall provide for an abbreviated registration renewal process for any registrant that has not had any changes to such information since the registrant submitted the preceding registration or registration renewal for the facility involved.

(4) Procedure

Upon receipt of a completed registration described in paragraph (1), the Secretary shall notify the registrant of the receipt of such registration and assign a registration number to each registered facility.

(5) List

The Secretary shall compile and maintain an up-to-date list of facilities that are registered under this section. Such list and any registration documents submitted pursuant to this subsection shall not be subject to disclosure under section 552 of title 5. Information derived from such list or registration documents shall not be subject to disclosure under section 552 of title 5 to the extent that it discloses the identity or location of a specific registered person.

(b) Suspension of registration

(1) In general

If the Secretary determines that food manufactured, processed, packed, received, or held by a facility registered under this section has a reasonable probability of causing serious adverse health consequences or death to humans or animals, the Secretary may by order suspend the registration of a facility—

(A) that created, caused, or was otherwise responsible for such reasonable probability; or

(B)(i) that knew of, or had reason to know of, such reasonable probability; and

(ii) packed, received, or held such food.

(2) Hearing on suspension

The Secretary shall provide the registrant subject to an order under paragraph (1) with an opportunity for an informal hearing, to be held as soon as possible but not later than 2 business days after the issuance of the order or such other time period, as agreed upon by the Secretary and the registrant, on the actions required for reinstatement of registration and why the registration that is subject to suspension should be reinstated. The Secretary shall reinstate a registration if the Secretary determines, based on evidence presented, that adequate grounds do not exist to continue the suspension of the registration.

(3) Post-hearing corrective action plan; vacating of order

(A) Corrective action plan

If, after providing opportunity for an informal hearing under paragraph (2), the Secretary determines that the suspension of registration remains necessary, the Secretary shall require the registrant to submit a corrective action plan to demonstrate how the registrant plans to correct the conditions found by the Secretary. The Secretary shall review such plan not later than 14 days after the submission of the corrective action plan or such other time period as determined by the Secretary.

(B) Vacating of order

Upon a determination by the Secretary that adequate grounds do not exist to continue the suspension actions required by the order, or that such actions should be modified, the Secretary shall promptly vacate the order and reinstate the registration of the facility subject to the order or modify the order, as appropriate.

(4) Effect of suspension

If the registration of a facility is suspended under this subsection, no person shall import or export food into the United States from such facility, offer to import or export food into the United States from such facility, or otherwise introduce food from such facility into interstate or intrastate commerce in the United States.

(5) Regulations

(A) In general

The Secretary shall promulgate regulations to implement this subsection. The Secretary may promulgate such regulations on an interim final basis.

(B) Registration requirement

The Secretary may require that registration under this section be submitted in an electronic format. Such requirement may not take effect before the date that is 5 years after January 4, 2011.

(6) Application date

Facilities shall be subject to the requirements of this subsection beginning on the earlier of—

(A) the date on which the Secretary issues regulations under paragraph (5); or

(B) 180 days after January 4, 2011.

(7) No delegation

The authority conferred by this subsection to issue an order to suspend a registration or vacate an order of suspension shall not be delegated to any officer or employee other than the Commissioner.

(c) Facility

For purposes of this section:

(1) The term "facility" includes any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food. Such term does not include farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or fishing vessels (except such vessels engaged in processing as defined in section 123.3(k) of title 21, Code of Federal Regulations).

(2) The term "domestic facility" means a facility located in any of the States or Territories.

(3)(A) The term "foreign facility" means a facility that manufacturers,1 processes, packs, or holds food, but only if food from such facility is exported to the United States without further processing or packaging outside the United States.

(B) A food may not be considered to have undergone further processing or packaging for purposes of subparagraph (A) solely on the basis that labeling was added or that any similar activity of a de minimis nature was carried out with respect to the food.

(d) Rule of construction

Nothing in this section shall be construed to authorize the Secretary to require an application, review, or licensing process for a facility to be registered, except with respect to the reinstatement of a registration that is suspended under subsection (b).

(June 25, 1938, ch. 675, §415, as added Pub. L. 107–188, title III, §305(a), June 12, 2002, 116 Stat. 667; amended Pub. L. 111–353, title I, §102(a)–(b)(1), (d)(2), Jan. 4, 2011, 124 Stat. 3887, 3889.)

Editorial Notes

Amendments

2011—Subsec. (a)(2). Pub. L. 111–353, §102(a)(1), (b)(1)(A), substituted "conducts business, the e-mail address for the contact person of the facility or, in the case of a foreign facility, the United States agent for the facility, and" for "conducts business and", inserted ", or any other food categories as determined appropriate by the Secretary, including by guidance" after "Code of Federal Regulations", and inserted after first sentence "The registration shall contain an assurance that the Secretary will be permitted to inspect such facility at the times and in the manner permitted by this chapter."

Subsec. (a)(3) to (5). Pub. L. 111–353, §102(a)(2), (3), added par. (3) and redesignated former pars. (3) and (4) as (4) and (5), respectively.

Subsecs. (b), (c). Pub. L. 111–353, §102(b)(1)(B), (C), added subsec. (b) and redesignated former subsec. (b) as (c). Former subsec. (c) redesignated (d).

Subsec. (d). Pub. L. 111–353, §102(b)(1)(B), (d)(2), redesignated subsec. (c) as (d) and inserted "for a facility to be registered, except with respect to the reinstatement of a registration that is suspended under subsection (b)" before period at end.

Statutory Notes and Related Subsidiaries

Regulations

Pub. L. 111–353, title I, §102(c), Jan. 4, 2011, 124 Stat. 3889, provided that:

"(1) Retail food establishment.—The Secretary shall amend the definition of the term 'retail food establishment' in section in [sic] 1.227(b)(11) of title 21, Code of Federal Regulations[,] to clarify that, in determining the primary function of an establishment or a retail food establishment under such section, the sale of food products directly to consumers by such establishment and the sale of food directly to consumers by such retail food establishment include—

"(A) the sale of such food products or food directly to consumers by such establishment at a roadside stand or farmers' market where such stand or market is located other than where the food was manufactured or processed;

"(B) the sale and distribution of such food through a community supported agriculture program; and

"(C) the sale and distribution of such food at any other such direct sales platform as determined by the Secretary.

"(2) Definitions.—For purposes of paragraph (1)—

"(A) the term 'community supported agriculture program' has the same meaning given the term 'community supported agriculture (CSA) program' in section 249.2 of title 7, Code of Federal Regulations (or any successor regulation); and

"(B) the term 'consumer' does not include a business."

Pub. L. 111–353, title I, §103(c), Jan. 4, 2011, 124 Stat. 3896, provided that:

"(1) Proposed rulemaking.—

"(A) In general.—Not later than 9 months after the date of enactment of this Act [Jan. 4, 2011], the Secretary of Health and Human Services (referred to in this subsection as the 'Secretary') shall publish a notice of proposed rulemaking in the Federal Register to promulgate regulations with respect to—

"(i) activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership for purposes of section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as amended by this Act; and

"(ii) activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership for purposes of such section 415.

"(B) Clarification.—The rulemaking described under subparagraph (A) shall enhance the implementation of such section 415 and clarify the activities that are included as part of the definition of the term 'facility' under such section 415. Nothing in this Act [see Short Title note set out under section 2201 of this title] authorizes the Secretary to modify the definition of the term 'facility' under such section.

"(C) Science-based risk analysis.—In promulgating regulations under subparagraph (A), the Secretary shall conduct a science-based risk analysis of—

"(i) specific types of on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership, as such packing and holding relates to specific foods; and

"(ii) specific on-farm manufacturing and processing activities as such activities relate to specific foods that are not consumed on that farm or on another farm under common ownership.

"(D) Authority with respect to certain facilities.—

"(i) In general.—In promulgating the regulations under subparagraph (A), the Secretary shall consider the results of the science-based risk analysis conducted under subparagraph (C), and shall exempt certain facilities from the requirements in section 418 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350g] (as added by this section), including hazard analysis and preventive controls, and the mandatory inspection frequency in section 421 of such Act [21 U.S.C. 350j] (as added by section 201), or modify the requirements in such sections 418 or 421, as the Secretary determines appropriate, if such facilities are engaged only in specific types of on-farm manufacturing, processing, packing, or holding activities that the Secretary determines to be low risk involving specific foods the Secretary determines to be low risk.

"(ii) Limitation.—The exemptions or modifications under clause (i) shall not include an exemption from the requirement to register under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as amended by this Act, if applicable, and shall apply only to small businesses and very small businesses, as defined in the regulation promulgated under section 418(n) of the Federal Food, Drug, and Cosmetic Act (as added under subsection (a)).

"(2) Final regulations.—Not later than 9 months after the close of the comment period for the proposed rulemaking under paragraph (1), the Secretary shall adopt final rules with respect to—

"(A) activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership for purposes of section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as amended by this Act;

"(B) activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership for purposes of such section 415; and

"(C) the requirements under sections 418 and 421 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350g, 350j], as added by this Act, from which the Secretary may issue exemptions or modifications of the requirements for certain types of facilities."

Pub. L. 107–188, title III, §305(e), June 12, 2002, 116 Stat. 669, provided that: "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 registration under section 415 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350d] (as added by subsection (a) of this section). Such requirement of registration takes effect—

"(1) upon the effective date of such final regulations; or

"(2) 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."

Construction of 2011 Amendment

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.

Small Entity Compliance Policy Guide

Pub. L. 111–353, title I, §102(b)(2), Jan. 4, 2011, 124 Stat. 3888, provided that: "Not later than 180 days after the issuance of the regulations promulgated under section 415(b)(5) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350d(b)(5)] (as added by this section), the Secretary shall issue a small entity compliance policy guide setting forth in plain language the requirements of such regulations to assist small entities in complying with registration requirements and other activities required under such section."

Electronic Filing

Pub. L. 107–188, title III, §305(d), June 12, 2002, 116 Stat. 668, provided that: "For the purpose of reducing paperwork and reporting burdens, the Secretary of Health and Human Services may provide for, and encourage the use of, electronic methods of submitting to the Secretary registrations required pursuant to this section [enacting this section, amending sections 331 and 381 of this title, and enacting provisions set out as a note under this section]. In providing for the electronic submission of such registrations, the Secretary shall ensure adequate authentication protocols are used to enable identification of the registrant and validation of the data as appropriate."

1 So in original. Probably should be "manufactures,".