21 U.S.C. § 381 — Imports and exports

(a) Imports. The Secretary of the Treasury must give the Secretary of Health and Human Services (HHS) samples of any food, drug, device, tobacco product, or cosmetic being imported, if HHS asks. Treasury must notify the owner or consignee, who can appear before HHS and give testimony. HHS gives Treasury a list of manufacturing establishments registered under section 360(i) or 387e(h). If a drug, device, or tobacco product comes from an unregistered establishment, HHS can ask for samples of it too, with the same notice and right to testify. HHS must refuse admission if the samples or other evidence show any of these: (1) the article was made or packed in unsanitary conditions, or, for a device, the manufacturing, packing, storage, or installation methods don't meet the safety controls required by section 360j(f); (2) the article is banned or restricted for sale in the country that made or shipped it; (3) it is adulterated or misbranded, violates section 355, or its importer violates section 384a, or it is barred from interstate commerce under section 331(ll), or it is a controlled substance subject to an order under section 360bbb–8d; (4) required recordkeeping under section 2223 (other than the subsection (f) part) was not followed; or (5) it is imported in violation of section 331(cc). Any article that fails one of those five tests must be refused, unless subsection (b) lets it in anyway. A counterfeit drug or counterfeit device must always be refused. Food that needs a certification under subsection (q) but doesn't have one must be refused. If an article is subject to the recordkeeping and access rules in section 364a, 379aa, or 379aa–1, and HHS has credible evidence the responsible person didn't follow those rules or blocked access to records, the article must be refused, unless subsection (b) applies. Treasury must destroy any refused article unless it is exported within 90 days of the refusal notice (or a longer time allowed by regulation). HHS can destroy a refused drug, device, or tobacco product right away, with no chance to export it, if it's worth $2,500 or less (or a higher amount Treasury sets by regulation) and it wasn't fixed under subsection (b). Before destroying a drug, device, or tobacco product that way, HHS must issue regulations giving the owner notice, a chance to appear and testify, and a fair chance to challenge the destruction decision. While that process runs, HHS stores and, if needed, disposes of the product, but the owner still owes the costs under subsection (c). This notice can be combined with the earlier notice-and-testify step, as long as the owner gets proper notice. Nothing in clause (2) or (5) blocks the admission of narcotic drugs allowed under the Controlled Substances Import and Export Act. (b) Disposition of refused articles. While a decision on an imported article is pending, Treasury may let the owner take delivery of it if the owner posts a bond that would pay damages if the article turns out not to qualify. If HHS decides that an article refused under clause (3) of subsection (a) could be fixed — for example, by relabeling — so it complies with the law, or could stop being treated as a food, drug, device, or cosmetic; or if, for an article covered by section 364a, 379aa, or 379aa–1, the responsible person could take action to come into compliance — HHS may postpone the final admission decision. The owner (or, for the second situation, the responsible person) must file a written application and post a bond. HHS can then authorize relabeling or other fixes, including destroying or exporting the rejected parts. All of this must be supervised by an HHS or Treasury officer chosen by the relevant Secretary. (c) Charges concerning refused articles. The owner or consignee must pay all costs connected to destroying a refused article and supervising its relabeling or other fix — including officers' travel, per diem, and salaries — plus storage, cartage, and labor costs for any refused article. If the owner doesn't pay, the unpaid amount becomes a lien against anything that owner imports in the future. (d) Reimportation. (1)(A) A drug that needs approval under section 353(b), or that contains insulin, and that was made in the U.S. and then exported, generally cannot be brought back into the U.S. unless the same manufacturer imports it. (B) A drug covered by section 353(b)(1) that was made outside the U.S. cannot be imported for commercial use unless its manufacturer authorized it to be sold in the U.S. and labeled it for the U.S. market — except when HHS allows it because the drug is on the drug-shortage list, or under section 384. (2) HHS can still allow a reimportation that (1) would otherwise block, if the drug is needed for emergency medical care. (3)(A) A component or part of a drug, a component or accessory of a device, another article awaiting more processing that is ready for health-related use, or a food additive, color additive, or dietary supplement (even in bulk form) can still be imported despite subsection (a) if all of these are true: (i) the importer files a statement at the time of import saying — (I) the article will be further processed or built into a finished product that the same importer will export, under subsection (e), section 382, or section 351(h) of the Public Health Service Act; (II) the statement names the manufacturer and everyone else who has handled the article on its way to the importer; and (III) the statement includes certificates of analysis identifying the article, unless it's a device or falls under paragraph (4); (ii) before delivery, the importer posts a bond; (iii) the article is actually used and exported as promised, except for any part that is destroyed; (iv) the importer keeps records on how the article was used or destroyed and gives them to HHS on request; and (v) the importer reports to HHS, on request, on how the article was exported or destroyed and how the importer met all these rules. (B) Even so, HHS can refuse an article under this exception if it has credible evidence the article isn't really meant for that further-processing-and-export use. (C) This paragraph doesn't reduce HHS's duty to make sure imported articles actually satisfy these conditions. (4) Blood, blood components, source plasma, source leukocytes, or their parts can't come in under paragraph (3) unless they comply with section 351(a) of the Public Health Service Act, or HHS permits it under conditions HHS sets. Tissue or parts of tissue can't come in under paragraph (3) unless they comply with section 361 of the Public Health Service Act. (e) Exports. (1) A food, drug, device, tobacco product, or cosmetic meant for export isn't treated as adulterated or misbranded — and an exported tobacco product isn't treated as violating sections 387f(e), 387g, 387k, or 387t(a) — if it (A) matches what the foreign buyer ordered, (B) doesn't break the destination country's laws, (C) is labeled on the outside of the shipping package as meant for export, and (D) isn't sold in the U.S. (2) That protection doesn't cover a device that (A) fails to meet section 360d or 360e requirements, (B) is exempt from those sections under section 360j(g), or (C) is a banned device under section 360f — unless HHS also finds the export won't hurt public health and the destination country approves it, or the device qualifies for export under section 382. (3) A new animal drug needing approval under section 360b can't be exported this way if it's banned in the U.S. (4)(A) Anyone exporting a food, drug, animal drug, or device can ask HHS to certify in writing either that the export meets paragraph (1) or section 382, or that it meets the chapter's applicable requirements. HHS must issue the certification within 20 days of the request. (B) If HHS meets that 20-day deadline, it may charge a fee, capped at $175 per certificate; the money goes to FDA's salaries-and-expenses account and stays available under appropriations law. (C) HHS decides the form of certification, which can be a public list. (D) For food-export fees: (i) they can be used only for FDA's costs of issuing the certificates, and (ii) FDA can't keep more than those costs each year. (E)(i)(I) If HHS turns down a device certification request under (A)(ii), it must explain the specific finding behind the denial in writing. (II) If the denial isn't based on an injunction, a seizure, or a Class I or II recall, but on the facility failing part 820 of title 21 of the Code of Federal Regulations, HHS must give a substantive summary of the noncompliance. (III) HHS can't deny a certificate just because of an inspection report under section 374(b) if the facility already agreed to a correction plan. (ii)(I) HHS must offer a review process meeting the standards of section 360g–1(b). (II) A person denied certification can request a new review anytime by presenting new evidence of corrective action. (III) Within a year of August 18, 2017, HHS must propose guidance for this review process, and finalize it within a year after the comment period closes. (F)(i) This part covers certification requests for devices made in a foreign, section-360-registered establishment that is listed, cleared or approved (or exempt from that premarket step), and that is imported or offered for import. (ii) HHS must issue the certificate described in (iii) if the device meets the chapter's requirements. (iii)(I) The fee in (B) applies. (II) The certificate must include the same information as, and be titled, a "Certificate to Foreign Government." (iv) The review and denial rules in (E) apply here too. (f) Labeling of exported drugs. (1) If a drug (other than insulin, an antibiotic, an animal drug, or a section-382 export) is exported under subsection (e) to a country with different labeling rules, it can carry that country's labeling — as long as it also carries the labeling this chapter requires. (2) If that foreign labeling describes a use not approved under this chapter, the label must say so. Drugs exported under section 382 don't need to follow this subsection. (g) Warning notice of importation in violation of chapter. (1) For a prescription drug imported by someone who isn't in the importing business, HHS can send a warning notice only if the notice (A) states which specific determination applies — that the import breaks subsection (a) because the drug is or appears adulterated, misbranded, or in violation of section 355; or is forbidden or restricted for sale where it came from; or breaks subsection (d)(1); or otherwise appears to break federal law — (B) leaves out any of those grounds that don't apply, and (C) explains the reasons and key facts behind the determination. (2) A "warning notice" here means any communication from HHS telling, or clearly suggesting to, a person that importing the drug for personal use is or appears to be against this chapter. (h) Protection against adulteration of food. (1) HHS must prioritize doing more import inspections, especially to catch intentional adulteration. (2) HHS must prioritize upgrading FDA's information systems on imported food, to better target resources, catch intentional adulteration, and speed compliant food through. (3) HHS must strengthen ties with other federal food-safety agencies, and, on safety matters, with states and Indian tribes. (i) Testing for rapid detection of adulteration of food. (1) HHS must fund research on tests and sampling methods that (A) quickly detect food adulteration, especially intentional adulteration, and (B) beat current technology on accuracy, speed, or cost. (2) That research should prioritize tests usable at ports of entry. (3) HHS should coordinate, as appropriate, with the CDC, NIH, EPA, and the Secretary of Agriculture. (4) Each year, HHS must report to the House Energy and Commerce Committee and the Senate HELP Committee on the research's progress. (j) Temporary holds at ports of entry. (1) If an FDA officer or qualified employee has credible evidence that a food poses a threat of serious illness or death, and can't inspect it at the port right away, that person can ask Treasury to hold the food for up to 24 hours so FDA can look at it. (2) HHS can ask Treasury to move the held food to a secure facility; while it's held, no one may move it from the port or that facility, and subsection (b)'s bond-release option doesn't apply. (3) An officer can only make this request if the Secretary, or an official the Secretary designates (who must be a district director or higher), approves it. (4) HHS must promptly tell the state where the port sits that the hold request was made and, if true, that the food is being held. (k) Importation by debarred persons. (1) If a food's importer, owner, or consignee has been debarred under section 335a(b)(3), the food must be held at the port and can't be delivered to that person; subsection (b)'s bond option doesn't apply; the food is moved to a secure facility and can't be transferred while held. (2) The food can still be delivered to someone who isn't debarred, if that person proves, at their own expense, that the food meets this chapter's requirements. (l) Failure to register. If imported food comes from a foreign facility that hasn't registered under section 350d (or whose registration was suspended), the food must be held at the port and can't be delivered until the facility registers. Subsection (b)'s bond option doesn't apply; the food goes to a secure facility and can't be moved while held. (m) Prior notice of imported food shipments. (1) HHS, after talking with Treasury, must require by regulation that importers submit advance notice identifying the food, its manufacturer and shipper, its grower (if known in time), the country it comes from, the country shipping it, any country that refused it, and the expected port of entry — so FDA can inspect it. Food imported without this notice must be refused. This doesn't limit which port an importer may use. (2)(A) The regulations must set how far in advance notice is due — no shorter than HHS truly needs to review and respond, but never more than five days. HHS can weigh commerce impacts, port locations, shipping methods, food types, and other factors, but this doesn't excuse HHS from reviewing and responding to every notice. (B)(i) If food arrives without the required advance notice, it must be held at the port and can't be delivered until the notice is filed and HHS confirms it's adequate; the bond option in (b) doesn't apply, the food moves to a secure facility, and no one may move it while held. (ii) In deciding this, HHS must check whether it has credible evidence the food threatens serious illness or death. (3)(A) This subsection doesn't limit HHS's power to get information under other parts of the chapter. (B) It also doesn't let HHS impose requirements on food that falls exclusively under the Department of Agriculture's authority under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act. (n) Labeling of food refused admission. (1) If food is refused under subsection (a) and doesn't have to be destroyed, HHS may make the owner label its container "UNITED STATES: REFUSED ENTRY." (2) The owner pays for the labeling; unpaid costs become a lien on future imports. (3) This labeling requirement lasts until HHS decides the food now complies with the chapter. (o) Registration statement. If an imported device's importer, owner, or consignee doesn't give HHS, at the time of import, a statement identifying the section 360(i) registration of every establishment required to register for that device, the device may be refused admission. If it's refused for that reason, it's held at the port — not delivered until the statement is filed — the bond option in (b) doesn't apply, it goes to a secure facility, and it can't be moved while held. (p) Report. (1) No later than 36 months after June 22, 2009, and every year after that, HHS must report to the Senate HELP Committee and House Energy and Commerce Committee on (A) how much and where noncompliant U.S. tobacco exports go, (B) the public-health effects of those exports, including any evidence of harm, and (C) policy options for Congress and the executive branch to reduce that harm. (2) HHS may set up information-disclosure rules to support this reporting. (q) Certifications concerning imported foods. (1) HHS may require, as a condition for letting food in, that a qualified entity certify — or otherwise assure — that the food meets the chapter's requirements. This can be a shipment-specific certificate, a list of certified facilities, or another form HHS specifies. (2) HHS must base the certification requirement on the food's risk, considering (A) known safety risks of the food itself, (B) known food-safety risks tied to its country or region of origin, (C) a science-based finding that (i) that place's food-safety programs aren't adequate to make the food as safe as U.S.-made food under this chapter, and (ii) the certification would help HHS decide whether to admit the food, and (D) information submitted under the process in paragraph (7). (3) The certifying entities can be (A) a foreign government or its designated representative, or (B) other people or entities accredited under section 384d. (4) HHS may (A) require these certifications to be renewed on a schedule HHS sets, and (B) refuse to accept a certification it finds unreliable or invalid. (5) HHS must let people submit certifications electronically. (6) A false statement by a certifying entity is punishable under 18 U.S.C. § 1001. (7) If HHS finds a foreign region's, country's, or territory's food-safety programs inadequate, HHS must, where practical, identify the gaps and set up a process for that place to report improvements and show its controls are now adequate. (r) Standards for admission of imported drugs. (1) Under regulations issued per paragraph (4)(A), HHS may require importers to electronically submit information proving a drug meets the chapter's requirements, as a condition of admission. (2) That information can include (A) proof of the drug's regulatory status, like its NDA, ANDA, or IND number, or drug master file number, (B) facility information, like proof of registration and its unique facility identifier, (C) proof of good-manufacturing-practice compliance, test results, satisfactory inspection certificates, and compliance with the exporting country's rules, and (D) any other information HHS decides it needs. (3) The good-manufacturing-practice information in (2)(C) can be shown through (A) a foreign government's representation, if that government's inspection meets HHS's standards, (B) a foreign government or agency recognized under section 384e, or (C) other documentation HHS accepts. (4)(A) Within 18 months of July 9, 2012, HHS must finalize regulations carrying out this subsection, tailored to the kind of import — for example, drugs imported for preclinical research or for a clinical trial under an investigational exemption. (B) In writing those regulations, HHS (i) may account for differences among importers and import types, offering faster clearance to importers who volunteer for a partnership program and pass a review of their internal controls, sourcing, and plant inspections, and (ii) must (I) publish a proposed rule, (II) allow at least 60 days for comments, and (III) publish the final rule at least 30 days before it takes effect. (C) HHS may only issue these regulations by following that process. (s) Registration of commercial importers. (1) HHS must require commercial drug importers to (A) register with HHS in a specified form, and (B) submit, subject to paragraph (4), a unique identifier for the main place of business they're registering. (2)(A) HHS, consulting with the Department of Homeland Security through Customs and Border Protection, must issue regulations setting "good importer practices" — steps importers must take to keep imported drugs compliant with this chapter and the Public Health Service Act. (B) That rulemaking must (i) publish a proposed rule, (ii) allow at least 60 days for comments, and (iii) publish the final rule at least 30 days before it takes effect. (C) HHS may only issue these regulations by following that process. (D) HHS, again consulting DHS/CBP, must set the regulations' effective date to give importers a reasonable time to comply, accounting for differences among importers and import risk levels. (3) HHS must cancel the registration of any commercial drug importer who doesn't follow these regulations. (4) HHS must specify the unique-facility-identifier system importers must use; the identifier requirement doesn't kick in until HHS specifies that system. (5) HHS may create exemptions from this subsection by Federal Register notice. (t) Single source pattern of imported illegal drugs. If HHS finds that someone is subject to debarment for a pattern of importing controlled substances or drugs, as described in section 335a(b)(3)(D), and that pattern involves the same manufacturer, distributor, or importer, HHS may order that all drugs offered for import from that person be treated as adulterated or misbranded — unless that person proves otherwise. (u) Illicit articles containing active pharmaceutical ingredients. (1) HHS may treat an imported article as a drug if (A) it isn't (i) accompanied by an electronic import entry filed through an authorized system, and (ii) marked in that system as an FDA-regulated product (which could mean a drug, device, dietary supplement, or other regulated product), and (B) it's an ingredient that raises a real public-health concern and is, or contains, (i) an active ingredient from a drug approved under section 355 or licensed under Public Health Service Act section 351, or from a drug with an authorized investigational exemption under section 355(i) or PHSA section 351(a) where a substantial, publicly known clinical trial is underway, or (ii) a substance chemically very similar to such an active ingredient. (2) This subsection doesn't change whether an article counts as a "drug" under section 321(g) for any other purpose.