---
kind: "section"
citation: "21 C.F.R. § 880.5440"
title: "21"
number: "880.5440"
heading: "Intravascular administration set."
url: "https://uscodex.org/cfr/21/880.5440"
---

# §880.5440. Intravascular administration set.

- (a) **Identification.** An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.
- (b) **Classification.** Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in [subpart E](/cfr/21/subpartE.md) of this part and subject to the limitations in [§ 880.9](/cfr/21/880.9.md).

## Notes

### Amendments

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 15798, Mar. 21, 2001]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.

### Amendments

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 15798, Mar. 21, 2001]