[Code of Federal Regulations]

[Title 19, Volume 1]

[Revised as of April 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 19CFR12.23]



[Page 268-269]

 

                        TITLE 19--CUSTOMS DUTIES

 

   CHAPTER I--BUREAU OF CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF 

              HOMELAND SECURITY; DEPARTMENT OF THE TREASURY

 

PART 12_SPECIAL CLASSES OF MERCHANDISE--Table of Contents

 

Sec.  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



[[Page 269]]



Drug,'' pursuant to Sec.  312.1 of the Food, Drug, and Cosmetic Act 

Regulations (21 CFR 312.1), or are being imported under the short supply 

provisions of Sec.  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]



     Domestic Animals, Animal Products, and Animal Feeding Materials