21 U.S.C. § 360bbb–3a — Emergency use of medical products

(a) Definitions (1) Eligible product. An "eligible product" is a product meeting three things. (A) It is already approved, cleared, conditionally approved, or licensed by the FDA. (B) It is either (i) meant to prevent, diagnose, or treat a disease involving a biological, chemical, radiological, or nuclear agent, or (ii) meant to prevent, diagnose, or treat a serious or life-threatening disease caused by a product described in (i). (C) It is meant to be used during the kind of emergency circumstances described in section 360bbb–3(b)(1) — a domestic, military, or public health emergency determination, or an identified material threat. (2) Product. "Product" means a drug, device, or biological product. (b) Expiration dating (1) In general. The Secretary can extend an eligible product's expiration date, and allow it to be shipped across state lines after that original date, if (A) doing so supports either public health or military preparedness, and (B) the extension is backed by an appropriate scientific evaluation that the Secretary did or accepted. (2) Requirements and conditions. Every such extension must specify: (A) exactly which lot, batch, or unit of the product it covers; (B) how long the extension lasts; and (C) any other conditions the Secretary thinks are needed to protect public health — for example, rules about sampling, storage, repackaging, transport, labeling, notifying recipients, recordkeeping, retesting, or what to do with the product afterward. (3) Effect. Extending the expiration date this way does not make the product an "unapproved product," as defined in section 360bbb–3(a)(2)(A), and it does not make the product legally "adulterated" or "misbranded." (4) Expiration date. Here, "expiration date" means the date set by the stability testing the FDA requires, showing the product still meets its quality standards. (c) Current good manufacturing practice (1) In general. During a qualifying emergency or material threat, the Secretary can let an eligible product's maker deviate from current good manufacturing practice rules that would otherwise apply — including rules under sections 351 and 360j(f)(1), and conditions from a 360j(f)(2) order. (2) Effect. Allowing such a deviation does not make the product "unapproved," "adulterated," or "misbranded" either. (d) Emergency dispensing Normally, dispensing a drug requires an individual prescription, under sections 353(b), 353(f), 354, and 360j(e). Those requirements don't apply — and the product isn't treated as unapproved, adulterated, or misbranded — if (1) the product is dispensed during the emergency circumstances described in (a)(1)(C), and (2) it's dispensed without an individual prescription either (A) because state law allows it, or (B) under an order the Secretary issues for that emergency. (e) Emergency use instructions (1) In general. An appropriate official within the Department of Health and Human Services can write and issue "emergency use instructions" telling health care providers or patients how to properly use an eligible product. (2) Effect. Issuing these instructions, or shipping the product along with them, does not make the product unapproved, adulterated, or misbranded, whether that happens (A) during an actual emergency response, or (B) by a government entity — or someone acting for one — preparing ahead of time for an emergency response.