other · Food and Drug Administration · Rule · Published 2020-02-21 · Effective 2020-03-23 · 85 FR 10057
Document
Document number
2020-03505
Federal Register citation
85 FR 10057
CFR reference
21 CFR 600
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
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.