# Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products
> **Food and Drug Administration** · Final rule. · Published 2015-07-08 · Effective 2015-09-08 · 80 FR 38915
## Document
- **Document number:** 2015-16659
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 80 FR 38915
- **CFR reference:** 21 CFR 20
- **Publication date:** 2015-07-08
- **Effective date:** 2015-09-08
- **HHS docket:** Docket No. FDA-2011-N-0898
## Abstract

The Food and Drug Administration (FDA or the Agency) is amending its regulations to implement certain drug shortages provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). The rule requires all applicants of covered approved drugs or biological products--including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application--to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2015/07/08/2015-16659/permanent-discontinuance-or-interruption-in-manufacturing-of-certain-drug-or-biological-products)
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