19 C.F.R. § 12.21

Licensed establishments

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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.

[T.D. 69-201, 34 FR 14328, Sept. 12, 1969, as amended by T.D. 82-145, 47 FR 35476, Aug. 16, 1982]
Notes of Decisions
Cited in 1 case, 1974–1974 · leading case: Certified Blood Donor Servs., Inc. v. United States, 377 F. Supp. 964 (Cust. Ct. 1974).
Certified Blood Donor Servs., Inc. v. United States, 377 F. Supp. 964 (Cust. Ct. 1974). “5 See also 19 CFR § 12.21 (1968). 6 Furthermore, in determining whether the imported antisera fall within the purview of item 437.”
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