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Notes

§12.21. Licensed establishments.

19 C.F.R. § 12.21

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.
Notes, amendments, and revision history

Amendments

[T.D. 69-201, 34 FR 14328, Sept. 12, 1969, as amended by T.D. 82-145, 47 FR 35476, Aug. 16, 1982]

Authority

Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202 (General Note 3(i), Harmonized Tariff Schedule of the United States (HTSUS)), 1624. Section 12.1 also issued under 21 U.S.C. 371(b); Section 12.3 also issued under 7 U.S.C. 135h, 21 U.S.C. 381; Section 12.4 also issued under 21 U.S.C. 381(b); Section 12.6 also issued under 7 U.S.C. 1854; Section 12.10 also issued under 7 U.S.C. 151-162; Section 12.15 also issued under 19 U.S.C. 1558; Section 12.16 also issued under 7 U.S.C. 1592(b); Sections 12.21 through 12.23 also issued under 42 U.S.C. 262; Section 12.26 also issued under 18 U.S.C. 42; Section 12.28 also issued under 18 U.S.C. 42, 19 U.S.C. 1527; Section 12.34 also issued under 19 U.S.C. 1202 (additional U.S. Note to Chapter 36, HTSUS); Section 12.37 also issued under 27 U.S.C. 203; Section 12.39 also issued under 19 U.S.C. 1337, 1623; Sections 12.40 and 12.41 also issued under 19 U.S.C. 1305; Sections 12.42 through 12.44 also issued under 19 U.S.C. 1307, Pub. L. 105-61 (111 Stat. 1272), and Public L. 114-125 (130 Stat. 122); Sections 12.73 and 12.74 also issued under 19 U.S.C. 1484, 42 U.S.C. 7522, 7601; Section 12.50 also issued under 42 U.S.C. 6301; Section 12.85 also issued under 19 U.S.C. 1623, 46 U.S.C. 4302, 4306, 4310; Sections 12.95 through 12.103 also issued under 15 U.S.C. 1241-1245; Sections 12.104 through 12.104i also issued under 19 U.S.C. 2612; Section 12.104j also issued under Pub. L. 108-429, 118 Stat. 2600; 19 U.S.C. 2612; Section 12.104k also issued under Pub. L. 114-151, 130 Stat. 369; 19 U.S.C. 2612; Sections 12.105 through 12.109 also issued under 19 U.S.C. 2094; Sections 12.110 through 12.117 also issued under 7 U.S.C. 136 et seq.; Sections 12.118 through 12.127 also issued under 15 U.S.C. 2601 et seq.; Section 12.140 also issued under 19 U.S.C. 1484, 2416(a), 2171; Section 12.142 also issued under 19 U.S.C. 1484; section 3301 of Pub. L. 110-246. Section 12.150 also issued under 19 U.S.C. 1595a and 1618; 22 U.S.C. 401. Section 12.152 also issued under 19 U.S.C. 1484, 1498; the Clean Diamond Trade Act (Pub. L. 108-19, 117 Stat. 631 (19 U.S.C. 3901 et seq.)); Executive Order 13312 dated July 29, 2003.

Source

Source: 28 FR 14710, Dec. 31, 1963, unless otherwise noted.

Amendments

[T.D. 69-201, 34 FR 14328, Sept. 12, 1969, as amended by T.D. 82-145, 47 FR 35476, Aug. 16, 1982]