# Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products
> **Food and Drug Administration** · Direct final rule. · Published 2016-05-04 · Effective 2016-09-16 · 81 FR 26687
## Document
- **Document number:** 2016-10385
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 81 FR 26687
- **CFR reference:** 21 CFR 610
- **Publication date:** 2016-05-04
- **Effective date:** 2016-09-16
- **HHS docket:** Docket No. FDA-2016-N-1170
## Abstract

The Food and Drug Administration (FDA or Agency or we) is amending the general biological products standards relating to dating periods and also removing 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 FDA is taking this action to update outdated requirements, and accommodate new and evolving technology and testing capabilities, without diminishing public health protections. This action is part of FDA's retrospective review of its regulations in response to an Executive order. FDA is issuing these amendments directly as a final rule because the Agency believes they are noncontroversial and FDA anticipates no significant adverse comments.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2016/05/04/2016-10385/standard-preparations-limits-of-potency-and-dating-period-limitations-for-biological-products)
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