---
kind: "section"
citation: "21 C.F.R. § 310.509"
title: "21"
number: "310.509"
heading: "Parenteral drug products in plastic containers."
url: "https://uscodex.org/cfr/21/310.509"
---

# §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)](/cfr/21/201.md?p=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](/cfr/21/part312.md) 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](/usc/42/201.md)).

## Notes

### Amendments

[62 FR 12084, Mar. 14, 1997]

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f, 360j, 360hh-360ss, 361(a), 371, 374, 375, 379e, 379k-l; 42 U.S.C. 216, 241, 242(a), 262.

### Amendments

[62 FR 12084, Mar. 14, 1997]