---
kind: "section"
citation: "9 C.F.R. § 114.10"
title: "9"
number: "114.10"
heading: "Antibiotics as preservatives."
url: "https://uscodex.org/cfr/9/114.10"
---

# §114.10. Antibiotics as preservatives.


Antibiotics are authorized for use as preservatives for biological products if used within the limitations as to kinds and amounts prescribed in this section.

- (a) When an antibiotic or combination of antibiotics, with or without a fungistat is to be used in the preparation of a biological product, the kind(s) and amount(s) of each shall be specified in the outline for such product in such a way that the concentration in the final product may be calculated. Except as may be approved by the Administrator, only those individual antibiotics or combinations of antibiotics listed in paragraphs [(b)](#b) and [(c)](#c) of this section shall be used.
- (b) **Permitted individual antibiotics—**
  - (1) **The antibiotic level of a specified individual antibiotic in one ml.** of a biological product, when prepared as recommended for use, shall not exceed the amounts listed in this paragraph: Provided, That in the case a desiccated biological product is to be used with an indefinite quantity of water or other menstruum, the determination shall be based on 30 ml. per 1,000 dose vial or equivalent.
  - (2) Except as prescribed in [paragraph (c)](#c) of this section, only one antibiotic shall be used as a preservative in a biological product. The kind and maximum amount per ml. of such antibiotic shall be restricted to:
- (c) **Permitted combinations—**
  - (1) **Penicillin and streptomycin.**
  - (2) Either amphotericin B or nystatin, but not both, may be used with one of the other antibiotics listed in [paragraph (b)](#b) of this section, or with a combination of penicillin and streptomycin, or with a combination of polymyxin B and neomycin.
  - (3) The maximum amount of each antibiotic in a combination shall be the amount prescribed for such antibiotic in [paragraph (b)](#b) of this section.
- (d) Antibiotics used in virus seed stock purification are not restricted as to kind or amounts provided carryover into the final product is controlled and specified in outlines of production.

## Notes

### Amendments

[39 FR 16869, May 10, 1974, as amended at 56 FR 66784, Dec. 26, 1991]

### Authority

Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

### Source

Source: 39 FR 16869, May 10, 1974, unless otherwise noted.

### Amendments

[39 FR 16869, May 10, 1974, as amended at 56 FR 66784, Dec. 26, 1991]