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Notes

§12.22. Labels; samples.

19 C.F.R. § 12.22

Each package of such products imported for sale, barter, or exchange shall be labeled or plainly marked with the name, address, and license number of the manufacturer, and the date beyond which the contents cannot be expected to yield their specific results. From each lot of product the port director shall select at random at least two final containers. The random sample together with a copy of the associated documents which describe and identify the shipment shall be forwarded to the Director, Bureau of Biologics, Food and Drug Administration, 8800 Rockville Pike, Bethesda, Md. 20014. For shipments of 20 or less final containers, samples need not be forwarded, provided a copy of an official release from the Bureau of Biologics accompanies each shipment.
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]