# Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972
> **Food and Drug Administration** · Final rule. · Published 2016-02-12 · Effective 2016-03-14 · 81 FR 7445
## Document
- **Document number:** 2016-02884
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 81 FR 7445
- **CFR reference:** 21 CFR 601
- **Publication date:** 2016-02-12
- **Effective date:** 2016-03-14
- **HHS docket:** Docket No. FDA-2015-N-2103
## Abstract

The Food and Drug Administration (FDA, the Agency, or we) is removing two regulations that prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972. FDA is taking this action because the two regulations are obsolete and no longer necessary in light of other statutory and regulatory authorities established since 1972, which allow FDA to evaluate and monitor the safety and effectiveness of all biological products. In addition, other statutory and regulatory authorities authorize FDA to revoke a license for biological products because they are not safe and effective, or are misbranded. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2016/02/12/2016-02884/removal-of-review-and-reclassification-procedures-for-biological-products-licensed-prior-to-july-1)
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