19 CFR 12.21 : Customs Duties (§ 0.1 To Parts 400-599) — (§ 0.1 To Parts 135-140) — U.S. Customs And Border Protection, Department Of Homeland Security; Department Of The Treasury (§ 0.1 To Parts 135-140) — Special Classes Of Merchandise (§ 12.1 To § 12.152) — Viruses, Serums, Toxins, Antitoxins, And Analogous Products For The Treatment Of Man (§ 12.21 To § 12.23) — Licensed establishments.

The bringing into the United States for sale, barter, or exchange, of any virus, therapeutic serum, toxin, antitoxin, or analogous product, or arsphenamine or its derivatives (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of diseases or injuries of man is prohibited unless such virus, serum, toxin, antitoxin, or other product has been manufactured at an establishment holding an unsuspended and unrevoked license issued by the Secretary of Health and Human Services for such manufacture.