FDA product code NEP: System/Device, Pharmacy Compounding
NEP is the FDA product code for system/device, pharmacy compounding. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel. Devices under NEP reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 41 recalls for NEP devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System/Device, Pharmacy Compounding |
| Device class | Class II |
| Regulation | 21 CFR 880.5440 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Recalls for NEP devices
41 product recalls in 22 recall events; 4 initiated in the last five years and 3 still open. Most recent: 2026-04-22.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2020 | 3 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 1 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code NEP?
NEP is the FDA product code for system/device, pharmacy compounding. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel.
What device class is NEP?
Class II, regulation 21 CFR 880.5440. Typical premarket route: 510(k) exempt.
Have NEP devices been recalled?
Yes: 41 product recalls across 22 recall events; the most recent began 2026-04-22.
Next steps
- Run an FDA pathway report with predicate devices for product code NEP
- Run a recall and safety report across every NEP manufacturer
- Watch product code NEP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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