[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR310.509]

[Page 26]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 310--NEW DRUGS--Table of Contents
 
        Subpart E--Requirements for Specific New Drugs or Devices
 
Sec. 310.509  Parenteral drug products in plastic containers.

    (a) Any parenteral drug product packaged in a plastic immediate 
container is not generally recognized as safe and effective, is a new 
drug within the meaning of section 201(p) of the act, and requires an 
approved new drug application as a condition for marketing. An 
``Investigational New Drug Application'' set forth in part 312 of this 
chapter is required for clinical investigations designed to obtain 
evidence of safety and effectiveness.
    (b) As used in this section, the term ``large volume parenteral drug 
product'' means a terminally sterilized aqueous drug product packaged in 
a single-dose container with a capacity of 100 milliliters or more and 
intended to be administered or used intravenously in a human.
    (c) Until the results of compatibility studies are evaluated, a 
large volume parenteral drug product for intravenous use in humans that 
is packaged in a plastic immediate container on or after April 16, 1979, 
is misbranded unless its labeling contains a warning that includes the 
following information:
    (1) A statement that additives may be incompatible.
    (2) A statement that, if additive drugs are introduced into the 
parenteral system, aseptic techniques should be used and the solution 
should be thoroughly mixed.
    (3) A statement that a solution containing an additive drug should 
not be stored.
    (d) This section does not apply to a biological product licensed 
under the Public Health Service Act of July 1, 1944 (42 U.S.C. 201).

[62 FR 12084, Mar. 14, 1997]