(1) is intended to be held and not used; and
(2) is held and not used, unless and until that product—(A) is approved, cleared, or licensed under section 355, 360(k), 360b, or 360e of this title or section 351 of the Public Health Service Act [42 U.S.C. 262] or conditionally approved under section 360ccc of this title;
(B) is authorized for investigational use under section 355, 360b, or 360j of this title or section 351 of the Public Health Service Act [42 U.S.C. 262]; or
(C) is authorized for use under section 360bbb–3 of this title or section 360bbb–3a of this title.
Structure US Code
CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V— DRUGS AND DEVICES
Part E— General Provisions Relating to Drugs and Devices
§ 360bbb. Expanded access to unapproved therapies and diagnostics
§ 360bbb–0. Expanded access policy required for investigational drugs
§ 360bbb–0a. Investigational drugs for use by eligible patients
§ 360bbb–1. Dispute resolution
§ 360bbb–2. Classification of products
§ 360bbb–3. Authorization for medical products for use in emergencies
§ 360bbb–3a. Emergency use of medical products
§ 360bbb–3b. Products held for emergency use
§ 360bbb–3c. Expedited development and review of medical products for emergency uses
§ 360bbb–4. Countermeasure development, review, and technical assistance
§ 360bbb–4b. Medical countermeasure master files
§ 360bbb–5. Critical Path Public-Private Partnerships
§ 360bbb–5a. Emerging technology program
§ 360bbb–6. Risk communication
§ 360bbb–8a. Optimizing global clinical trials
§ 360bbb–8b. Use of clinical investigation data from outside the United States
§ 360bbb–8c. Patient participation in medical product discussion
§ 360bbb–8d. Notification, nondistribution, and recall of controlled substances