# Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review
> **Food and Drug Administration** · Final rule and final order. · Published 2004-01-05 · Effective 2003-01-04 · 69 FR 255
## Document
- **Document number:** 03-32255
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 69 FR 255
- **CFR reference:** 21 CFR 201
- **Publication date:** 2004-01-05
- **Effective date:** 2003-01-04
- **HHS docket:** Docket No. 1980N-0208
## Abstract

The Food and Drug Administration (FDA) is amending the biologics regulations in response to the report and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids with Standards of Potency (the Panel). The Panel reviewed the safety, efficacy, and labeling of bacterial vaccines and toxoids that have standards of potency, bacterial antitoxins, and immune globulins. On the basis of the Panel's findings and recommendations, FDA is classifying these products as Category I (safe, effective, and not misbranded), Category II (unsafe, ineffective, or misbranded), or Category IIIB (off the market pending completion of studies permitting a determination of effectiveness).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2004/01/05/03-32255/biological-products-bacterial-vaccines-and-toxoids-implementation-of-efficacy-review)
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