[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR601.22]

[Page 29-30]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 601_LICENSING--Table of Contents
 
                      Subpart C_Biologics Licensing
 
Sec. 601.22  Products in short supply; initial manufacturing at other than 

licensed location.

    A biologics license issued to a manufacturer and covering all 
locations of manufacture shall authorize persons other than such 
manufacturer to conduct at places other than such locations the initial, 
and partial manufacturing of a product for shipment solely to such 
manufacturer only to the extent that the names of such persons and 
places are registered with the Commissioner of Food and Drugs and it is 
found upon application of such manufacturer, that the product is in 
short supply due either to the peculiar growth requirements of the 
organism involved or to the scarcity of the animal required for 
manufacturing purposes, and such manufacturer has established with 
respect to such persons and places such procedures, inspections, tests 
or other arrangements as will ensure full compliance with the

[[Page 30]]

applicable regulations of this subchapter related to continued safety, 
purity, and potency. Such persons and places shall be subject to all 
regulations of this subchapter except Sec. Sec. 601.2 to 601.6, 601.9, 
601.10, 601.20, 601.21 to 601.33, and 610.60 to 610.65 of this chapter. 
For persons and places authorized under this section to conduct the 
initial and partial manufacturing of a product for shipment solely to a 
manufacturer of a product subject to licensure under Sec. 601.2(c), the 
following additional regulations shall not be applicable: Sec. Sec. 
600.10(b) and (c), 600.11, 600.12, 600.13, 610.11, and 610.53 of this 
chapter. Failure of such manufacturer to maintain such procedures, 
inspections, tests, or other arrangements, or failure of any person 
conducting such partial manufacturing to comply with applicable 
regulations shall constitute a ground for suspension or revocation of 
the authority conferred pursuant to this section on the same basis as 
provided in Sec. Sec. 601.6 to 601.8 with respect to the suspension and 
the revocation of licenses.

[42 FR 4718, Jan. 25, 1977, as amended at 61 FR 24233, May 14, 1996; 64 
FR 56452, Oct. 20, 1999]