# Definition of the Term “Biological Product”
> **Food and Drug Administration** · Final rule. · Published 2020-02-21 · Effective 2020-03-23 · 85 FR 10057
## Document
- **Document number:** 2020-03505
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 85 FR 10057
- **CFR reference:** 21 CFR 600
- **Publication date:** 2020-02-21
- **Effective date:** 2020-03-23
- **HHS docket:** Docket No. FDA-2018-N-2732
## Abstract

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulation that defines "biological product" to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and the Further Consolidated Appropriations Act, 2020 (FCA Act), and to provide its interpretation of the statutory term "protein." Under this final rule, the term protein means any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. This final rule is intended to clarify the statutory framework under which such products are regulated.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2020/02/21/2020-03505/definition-of-the-term-biological-product)
---
*AI Analytics · CC0 1.0*