Each final container of diluent, other than a liquid biological product, packaged with desiccated biological products shall bear a label that includes the following:
(a) The name—Sterile Diluent.
(b) True name of the biological product with which the diluent is packaged, except that when the firm packages all desiccated biological products with the same diluent, or two or more types of diluent are used, and the licensees' methods of identification and storage insure that all products are packaged with the correct type of diluent, labels affixed to the containers of diluent are exempt from this provision.
(c) The recoverable quantity of contents in cubic centimeters (cc) or milliliters (ml).
(d) A serial number by which the diluent can be identified with the manufacturer's records of preparation;
(e) Name and address of the licensee or the permittee;
(f) In the case of a diluent with which a desiccated biological product is to come in contact while the diluent is in its original container; and,
(1) Is in a multiple-dose container, a positive warning that all of the biological product shall be used at the time the container is first opened; and/or
(2) The biological product is composed of viable or dangerous organisms or viruses, the notice, “Burn this container and all unused contents,” except that, in the case of a small one-dose container, the statement “Burn this container” or “Burn this vial” may be used.
(g) The establishment license number or the permit number, as the case may be, in one of the forms provided in § 112.2(a)(3).
[38 FR 12094, May 9, 1973; 38 FR 13476, May 22, 1973, and amended at 39 FR 16856, May 10, 1974]
Title 9 published on 2013-01-01
no entries appear in the Federal Register after this date.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.