[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: 21CFR610.50]

[Page 85-86]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 610_GENERAL BIOLOGICAL PRODUCTS STANDARDS--Table of Contents
 
                   Subpart F_Dating Period Limitations
 
Sec. 610.50  Date of manufacture.


    The date of manufacture shall be determined as follows:
    (a) For products for which an official standard of potency is 
prescribed in either Sec. 610.20 or Sec. 610.21, or which are subject 
to official potency tests, the date of initiation by the manufacturer of 
the last valid potency test.

[[Page 86]]

    (b) For products that are not subject to official potency tests, (1) 
the date of removal from animals, (2) the date of extraction, (3) the 
date of solution, (4) the date of cessation of growth, or (5) the date 
of final sterile filtration of a bulk solution, whichever is applicable.

[38 FR 32056, Nov. 20, 1973, as amended at 42 FR 27582, May 31, 1977]