# Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products; Confirmation of Effective Date
> **Food and Drug Administration** · Direct final rule; confirmation of effective date. · Published 2016-08-08 · Effective 2016-05-04 · 81 FR 52329
## Document
- **Document number:** 2016-18584
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 81 FR 52329
- **CFR reference:** 21 CFR 610
- **Publication date:** 2016-08-08
- **Effective date:** 2016-05-04
- **HHS docket:** Docket No. FDA-2016-N-1170
## Abstract

The Food and Drug Administration (FDA) is confirming the effective date of September 16, 2016, for the final rule that appeared in the Federal Register of May 4, 2016. The direct final rule amends the general biological products standards relating to dating periods and removes certain standards relating to standard preparations and limits of potency. FDA is taking this action to update outdated requirements, and accommodate new and evolving technology and testing capabilities without diminishing public health concerns. This action is part of FDA's retrospective review of its regulations in response to an Executive order. This document confirms the effective date of the direct final rule.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2016/08/08/2016-18584/standard-preparations-limits-of-potency-and-dating-period-limitations-for-biological-products)
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