U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 08, 2022

§ 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) and (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) 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:

Amphotericin B2.5 mcg.
Nystatin (Mycostatin)30.0 units
Tetracyclines30.0 mcg.
Penicillin30.0 units
Streptomycin30.0 mcg.
Polymyxin B30.0 mcg.
Neomycin30.0 mcg.
Gentamicin30.0 mcg.

(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) 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) 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.

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