19 CFR 12.23 - Detention; examination; disposition.

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§ 12.23 Detention; examination; disposition.

(a) 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).

(b) 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.

(c) 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.

(d) 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.

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

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code
U.S. Code: Title 7 - AGRICULTURE
U.S. Code: Title 15 - COMMERCE AND TRADE
U.S. Code: Title 18 - CRIMES AND CRIMINAL PROCEDURE
U.S. Code: Title 19 - CUSTOMS DUTIES
U.S. Code: Title 21 - FOOD AND DRUGS
U.S. Code: Title 22 - FOREIGN RELATIONS AND INTERCOURSE
U.S. Code: Title 27 - INTOXICATING LIQUORS
U.S. Code: Title 42 - THE PUBLIC HEALTH AND WELFARE
U.S. Code: Title 46 - SHIPPING
Statutes at Large
Public Laws
Presidential Documents

Executive Order ... 13312

Proclamation ... 8294

Title 19 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 19 CFR Part 12 after this date.

  • 2015-10-26; vol. 80 # 206 - Monday, October 26, 2015
    1. 80 FR 65134 - Automated Commercial Environment (ACE) Filings for Electronic Entry/Entry Summary (Cargo Release and Related Entry); Correction
      GPO FDSys XML | Text
      DEPARTMENT OF THE TREASURY, DEPARTMENT OF HOMELAND SECURITY, U.S. Customs and Border Protection
      Interim final rule; correction.
      Effective November 1, 2015. The effective date for the interim final rule, published October 13, 2015 (80 FR 61278), remains November 1, 2015. Written comments must be submitted on or before November 12, 2015.
      19 CFR Parts 4, 7, 10, 12, 18, 19, 24, 54, 102, 113, 123, 125, 128, 132, 134, 141, 142, 143, 144, 145, 146, 148, 151, 152, 158, 163, 174, 181, and 191