§12.23. Detention; examination; disposition.
19 C.F.R. § 12.23
Port directors shall detain all importations of unlicensed viruses, therapeutic serums, toxins, antitoxins, and analogous products, and arsphenamines or its derivatives (or any other trivalent organic arsenic compound) for the treatment or cure of diseases or injuries of man pending examination by the Director, Bureau of Biologics, unless satisfied from evidence furnished at the time of entry that the products are intended solely for purposes of controlled investigation and not for sale, barter, or exchange, as evidenced by a copy of a filed “Notice of Claimed Investigational Exemption for a New Drug,” pursuant to § 312.1 of the Food, Drug, and Cosmetic Act Regulations (21 CFR 312.1), or are being imported under the short supply provisions of § 601.22 of the Public Health Service Regulations (42 CFR 601.22).
If the shipment is imported for sale, barter, or exchange and is found by the Director, Division of Biologics Standards, to be admissible, the port director shall release it upon receipt of a report from him that the shipment is admissible.
If the Director, Division of Biologics Standards, reports that the shipment was found upon examination not to conform to the law and the regulations, the port director shall not release the shipment but shall permit the exportation or destruction thereof under Customs supervision at the option of the importer.
Shipments of such products for use in the treatment of man but made from or with material of animal origin other than human, shall, unless accompanied by a Department of Agriculture, Veterinary Services, Animal and Plant Health Inspection Service (APHIS) permit, be detained until proof is presented to the port director that their importation is not prohibited under 9 CFR part 94 or part 122.
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]