# Medical Device; Exemption From Premarket Notification; Class II Devices; Pharmacy Compounding Systems
> **Food and Drug Administration** · Final rule. · Published 2001-03-21 · Effective 2001-03-21 · 66 FR 15796
## Document
- **Document number:** 01-6938
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 66 FR 15796
- **CFR reference:** 21 CFR 880
- **Publication date:** 2001-03-21
- **Effective date:** 2001-03-21
- **HHS docket:** Docket No. 00P-1554
## Abstract

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for pharmacy compounding systems classified within the intravascular administration set, with certain limitations. This rule will exempt from premarket notification pharmacy compounding systems classified within the intravascular administration set and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2001/03/21/01-6938/medical-device-exemption-from-premarket-notification-class-ii-devices-pharmacy-compounding-systems)
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