[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: 21CFR600.14]

[Page 12-13]
 
                        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 B--Establishment Standards
 
Sec. 600.14  Reporting of biological product deviations by licensed manufacturers.

    (a) Who must report under this section? (1) You, the manufacturer 
who holds the biological product license and who had control over the 
product when the deviation occurred, must report under this section. If 
you arrange for another person to perform a manufacturing, holding, or 
distribution step, while the product is in your control, that step is 
performed under your control. You must establish, maintain, and follow a 
procedure for receiving information from that person on all deviations, 
complaints, and adverse events concerning the affected product.
    (2) Exceptions:
    (i) Persons who manufacture only in vitro diagnostic products that 
are not subject to licensing under section 351 of the Public Health 
Service Act do not report biological product deviations for those 
products under this section but must report in accordance with part 803 
of this chapter;
    (ii) Persons who manufacture blood and blood components, including 
licensed manufacturers, unlicensed registered blood establishments, and 
transfusion services, do not report biological product deviations for 
those products under this section but must report under Sec. 606.171 of 
this chapter;
    (iii) Persons who manufacture Source Plasma or any other blood 
component and use that Source Plasma or any other blood component in the 
further manufacture of another licensed biological product must report:
    (A) Under Sec. 606.171 of this chapter, if a biological product 
deviation occurs during the manufacture of that Source Plasma or any 
other blood component; or
    (B) Under this section, if a biological product deviation occurs 
after the manufacture of that Source Plasma or any other blood 
component, and during manufacture of the licensed biological product.
    (b) What do I report under this section? You must report any event, 
and information relevant to the event, associated with the 
manufacturing, to include testing, processing, packing, labeling, or 
storage, or with the holding or distribution, of a licensed biological 
product, if that event meets all the following criteria:
    (1) Either:
    (i) Represents a deviation from current good manufacturing practice, 
applicable regulations, applicable standards, or established 
specifications that may affect the safety, purity, or potency of that 
product; or
    (ii) Represents an unexpected or unforeseeable event that may affect 
the safety, purity, or potency of that product; and
    (2) Occurs in your facility or another facility under contract with 
you; and
    (3) Involves a distributed biological product.
    (c) When do I report under this section? You should report a 
biological product deviation as soon as possible but you must report at 
a date not to exceed 45-calendar days from the date you, your agent, or 
another person who performs a manufacturing, holding, or distribution 
step under your control, acquire information reasonably suggesting that 
a reportable event has occurred.
    (d) How do I report under this section? You must report on Form FDA-
3486.
    (e) Where do I report under this section? You must send the 
completed

[[Page 13]]

Form FDA-3486 to the Director, Office of Compliance and Biologics 
Quality (HFM-600), Center for Biologics Evaluation and Research, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448, by either a paper 
or an electronic filing:
    (1) If you make a paper filing, you should identify on the envelope 
that a BPDR (biological product deviation report) is enclosed; or
    (2) If you make an electronic filing, you may submit the completed 
Form FDA-3486 electronically through CBER's website at www.fda.gov/cber.
    (f) How does this regulation affect other FDA regulations? This part 
supplements and does not supersede other provisions of the regulations 
in this chapter. All biological product deviations, whether or not they 
are required to be reported under this section, should be investigated 
in accordance with the applicable provisions of parts 211 and 820 of 
this chapter.

[65 FR 66634, Nov. 7, 2000]