21 C.F.R. § 610.11a Inactivated influenza vaccine, general safety test.
Title 21 - Food and Drugs
For inactivated influenza vaccine, the general safety test shall be conducted in the manner indicated in §610.11 of this chapter except that, with reference to guinea pigs, the test shall be satisfied if the product provides satisfactory results using either the subcutaneous or intraperitoneal injection of 5.0 milliliters of inactivated influenza vaccine into each guinea pig. The requirements for general safety for inactivated influenza vaccine shall not be considered to be satisfied unless each lot of influenza vaccine is assayed for endotoxin in comparison to a reference preparation provided by the Food and Drug Administration, and such lot is found to contain no more endotoxin than the reference preparation. [39 FR 40016, Nov. 13, 1974]
Title 21: Food and Drugs
PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS
Subpart B—General Provisions
§ 610.11a Inactivated influenza vaccine, general safety test.
