[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR600.81]

[Page 18]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 600--BIOLOGICAL PRODUCTS: GENERAL--Table of Contents
 
               Subpart D--Reporting of Adverse Experiences
 
Sec. 600.81  Distribution reports.

    The licensed manufacturer shall submit information about the 
quantity of the product distributed under the biologics license, 
including the quantity distributed to distributors. The interval between 
distribution reports shall be 6 months. Upon written notice, FDA may 
require that the licensed manufacturer submit distribution reports under 
this section at times other than every 6 months. The distribution report 
shall consist of the bulk lot number (from which the final container was 
filled), the fill lot numbers for the total number of dosage units of 
each strength or potency distributed (e.g., fifty thousand per 10-
milliliter vials), the label lot number (if different from fill lot 
number), labeled date of expiration, number of doses in fill lot/label 
lot, date of release of fill lot/label lot for distribution at that 
time. If any significant amount of a fill lot/label lot is returned, 
include this information. Disclosure of financial or pricing data is not 
required. As needed, FDA may require submission of more detailed product 
distribution information. Upon written notice, FDA may require that the 
licensed manufacturer submit reports under this section at times other 
than those stated. Requests by a licensed manufacturer to submit reports 
at times other than those stated should be made as a request for a 
waiver under Sec. 600.90.

[59 FR 54042, Oct. 27, 1994, as amended at 64 FR 56449, Oct. 20, 1999]