Current Good Manufacturing Practice Requirements for Combination Products
other · Food and Drug Administration · Rule · Published 2013-01-22 · Effective 2013-07-22 · 78 FR 4307
Document
Document number
2013-01068
Federal Register citation
78 FR 4307
CFR reference
21 CFR 4
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2013-01-22
Effective date
2013-07-22
HHS docket
Docket No. FDA-2009-N-0435
Abstract
The Food and Drug Administration (FDA or Agency) is issuing this regulation on the current good manufacturing practice (CGMP) requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for "single-entity" and "co-packaged" combination products.