21 U.S.C. § 382 — Exports of certain unapproved products

(a) Drugs or devices intended for human or animal use which require approval or licensing. A drug or device that (1) for a drug, needs FDA approval under section 355, or licensing under section 262 of title 42 or the Virus-Serum Toxin Act, before it can be sold across state lines, and doesn't have that approval or license and isn't exempt from it; or (2) for a device, doesn't meet the requirements of section 360d or 360e, is exempted from them under section 360j(g), or is banned under section 360f — counts as adulterated and misbranded, and can't be exported, unless the export is authorized under subsection (b), (c), (d), or (e), or section 381(e)(2), or falls under the exception in subsection (f). If such a drug or device could be exported under subsection (b) but its application under section 355, 360e, or 42 U.S.C. § 262 was denied, HHS must tell the destination country's public health officials about that denial. (b) List of eligible countries for export; criteria for addition to list; direct export; petition for exemption. (1)(A) A drug or device covered by subsection (a) can be exported to any country if it follows that country's laws and has valid marketing authorization there, when that country is Australia, Canada, Israel, Japan, New Zealand, Switzerland, or South Africa, or is in the European Union or European Economic Area and the drug or device is marketed there or authorized for general EEA marketing. (B) HHS can add another country to this list if that country has: (i) laws requiring qualified government experts to review drugs and devices for safety and effectiveness before approval; (ii) laws ensuring manufacturing, packing, storage, and (for devices) design and installation methods keep drugs and devices safe, pure, and effective; (iii) laws requiring adverse-reaction reporting and a process to withdraw unsafe or ineffective products; (iv) laws requiring labeling and promotion to match the approval; and (v) a marketing-authorization system equivalent to the countries already listed. HHS can't delegate this designation decision to anyone else. (C) A country official, manufacturer, or exporter can ask HHS to add a country, by submitting supporting documents; if someone other than the country itself asks, they must include a letter showing the country wants to be added. (2) A drug can be directly exported to a country not on that list if (A) it follows that country's laws and has valid authorization there, and (B) HHS determines that country has the same kinds of safety-review, manufacturing-control, adverse-reaction-reporting, and labeling laws described in paragraph (1)(B)(i) through (iv), but focused on drugs only. (3) If a drug wouldn't meet U.S. approval standards or the standards of a listed country, the exporter can petition HHS for permission to export it anyway to a non-listed country. HHS must allow this if (A) the exporter certifies the drug doesn't meet those standards and gives HHS credible scientific evidence the drug would be safe and effective under the conditions of use in the destination country, and (B) that country's health authority requests the export, certifies it understands the drug isn't approved, and agrees the evidence is credible. HHS must act on such a request within 60 days. (c) Investigational use exemption. A drug or device meant for investigational use in a listed country can be exported under that country's laws, and is exempt from the investigational-use rules in section 355(i) or 360j(g). (d) Anticipation of market authorization. A drug or device meant to be formulated, filled, packaged, labeled, or otherwise processed in expectation of getting marketing authorization in a listed country can be exported for that purpose under that country's laws. (e) Diagnosis, prevention, or treatment of tropical disease. (1) A drug or device used for a tropical disease, or another disease not common in the U.S., that doesn't otherwise qualify for export can still be exported if HHS approves an application and finds it won't expose patients there to unreasonable risk, and that its likely health benefits — under its labeling's directions — outweigh its risks, compared with other available treatments. (2) The holder of that approval must report to HHS (A) any credible information that the drug or device is being, or may have been, re-exported from an approved country to a country HHS hasn't approved, and (B) any information about adverse reactions. (3)(A) If HHS finds the drug or device no longer meets paragraph (1)'s standard, or the holder failed to make the paragraph (2) reports, HHS can withdraw the approval after giving the holder an informal hearing. (B) If HHS finds the holder, or an importer, is re-exporting the drug or device from the U.S. to a country HHS hasn't approved, and this creates an imminent hazard, HHS must immediately block that export, promptly notify the exporter, and give them a chance for an expedited hearing. (f) Prohibition of export of drug or device. A drug or device can't be exported under this section if: (1) it wasn't made, processed, packaged, and held under current good manufacturing practice, or doesn't meet international standards certified by a recognized standards organization; (2) it's adulterated under section 351(a)(1), (2)(A), or (3), or under section 351(c) or (d); (3) the requirements of section 381(e)(1)(A) through (D) haven't been met; (4)(A) HHS or the Secretary of Agriculture has determined that it's likely to be re-imported and that this would create an imminent hazard the only way to stop is by blocking the export, or (B) it presents an imminent hazard to public health in the destination country; (5) its labeling doesn't (A) match the requirements and conditions for use of both the country that authorized it under subsection (b) and the destination country, and (B) use the destination country's language and units of measurement, or a language that country designates; or (6) it isn't promoted according to that labeling. Before making a finding under (4)(B), (5), or (6), HHS must consult the destination country's public health officials. (g) Notification of Secretary. An exporter using subsection (b)(1) must send HHS a simple notice naming the drug or device the first time it's exported to any listed country. When an exporter first exports to a country not on that list, the exporter must also notify HHS of the drug or device and the destination country. Exporters must keep records of everything exported and the countries it went to. (h) References to Secretary and term "drug." For this section: (1) for a biological product that must be licensed under the Virus-Serum Toxin Act, references to HHS mean the Secretary of Agriculture instead; and (2) "drug" includes both human drugs and biologicals licensed under 42 U.S.C. § 262 or the Virus-Serum Toxin Act. (i) Exportation. Insulin and antibiotic drugs can be exported without following this section's rules, as long as they meet the requirements of section 381(e)(1).