[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR600.81]

[Page 20]
 
                        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 to the Center for Biologics 
Evaluation and Research or the Center for Drug Evaluation and Research 
(see mailing addresses in Sec.  600.2), 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; 
70 FR 14983, Mar. 24, 2005]