[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR610.15]

[Page 68-69]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS--Table of Contents
 
                      Subpart B--General Provisions
 
Sec. 610.15  Constituent materials.

    (a) Ingredients, preservatives, diluents, adjuvants. All ingredients 
used in a licensed product, and any diluent provided as an aid in the 
administration of the product, shall meet generally accepted standards 
of purity and quality. Any preservative used shall be sufficiently 
nontoxic so that the amount present in the recommended dose of the 
product will not be toxic to the recipient, and in the combination used 
it shall not denature the specific substances in the product to result 
in a decrease below the minimum acceptable potency within the dating 
period when stored at the recommended temperature. Products in multiple-
dose containers shall contain a preservative, except that a preservative 
need not be added to Yellow Fever Vaccine; Poliovirus Vaccine Live Oral; 
viral vaccines labeled for use with the jet injector; dried vaccines 
when the accompanying diluent contains a preservative; or to an 
Allergenic Product in 50 percent or

[[Page 69]]

more volume in volume (v/v) glycerin. An adjuvant shall not be 
introduced into a product unless there is satisfactory evidence that it 
does not affect adversely the safety or potency of the product. The 
amount of aluminum in the recommended individual dose of a biological 
product shall not exceed:
    (1) 0.85 milligrams if determined by assay;
    (2) 1.14 milligrams if determined by calculation on the basis of the 
amount of aluminum compound added; or
    (3) 1.25 milligrams determined by assay provided that data 
demonstrating that the amount of aluminum used is safe and necessary to 
produce the intended effect are submitted to and approved by the 
Director, Center for Biologics Evaluation and Research.
    (b) Extraneous protein; cell culture produced vaccines. Extraneous 
protein known to be capable of producing allergenic effects in human 
subjects shall not be added to a final virus medium of cell culture 
produced vaccines intended for injection. If serum is used at any stage, 
its calculated concentration in the final medium shall not exceed 
1:1,000,000.
    (c) Antibiotics. A minimum concentration of antibiotics, other than 
penicillin, may be added to the production substrate of viral vaccines.

[38 FR 32056, Nov. 20, 1973, as amended at 46 FR 51903, Oct. 23, 1981; 
48 FR 13025, Mar. 29, 1983; 48 FR 37023, Aug. 16, 1983; 49 FR 23834, 
June 8, 1984; 50 FR 4134, Jan. 29, 1985; 51 FR 15607, Apr. 25, 1986; 55 
FR 11013, Mar. 26, 1990]