21 U.S.C. § 360bbb–3b — Products held for emergency use

submitted 88 years ago by Pub. L. 113-5 to r/title-21-FOOD-AND-DRUGS · 180 words · no verdicts yet

in plain englishAI-generated · not legal advice

Governments — federal, state, local, or tribal — or people acting for them can legally ship an unapproved emergency product across state lines, as long as it's meant only to be stockpiled and not used. Once it's fully approved, authorized for research, or given emergency authorization, it can then be used.

This section protects stockpiling. It is not a violation of this chapter or the Public Health Service Act for a government entity — federal, state, local, or tribal — or someone acting on that government's behalf, to ship a product meant for emergency use across state lines, as long as two things are true. (1) The product is meant to be held in reserve, not used yet. (2) The product actually stays unused, unless and until it becomes one of three things: (A) approved, cleared, or licensed under sections 355, 360(k), 360b, or 360e of this title or section 351 of the Public Health Service Act, or conditionally approved under section 360ccc; (B) authorized for investigational use under section 355, 360b, or 360j of this title or section 351 of the Public Health Service Act; or (C) authorized for use under section 360bbb–3 or section 360bbb–3a of this title.

the actual law source: uscode.house.gov ↗public domain

It is not a violation of any section of this chapter or of the Public Health Service Act [42 U.S.C. 201 et seq.] for a government entity (including a Federal, State, local, or tribal government entity), or a person acting on behalf of such a government entity, to introduce into interstate commerce a product (as defined in section 360bbb–3(a)(4) of this title) intended for emergency use, if that product—

(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.

Source credit: (June 25, 1938, ch. 675, § 564B, as added Pub. L. 113–5, title III, § 302(d), Mar. 13, 2013, 127 Stat. 185; amended Pub. L. 114–255, div. A, title III, § 3088(d), Dec. 13, 2016, 130 Stat. 1149; Pub. L. 116–22, title VII, § 705(d), June 24, 2019, 133 Stat. 964.)

history & why it existsrecord from the source credit

1938Enacted · Pub. L. 113-5 · 127 Stat. 185
2016Amended · Pub. L. 114-255 · 130 Stat. 1149
2019Amended · Pub. L. 116-22 · 133 Stat. 964

A history note hasn’t been published yet. The record shows enactment by Pub. L. 113-5 on 1938-06-25.

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