Source: https://www.law.cornell.edu/cfr/text/9/112.3
Timestamp: 2016-02-06 01:05:30
Document Index: 19537457

Matched Legal Cases: ['art 112', '§ 112', '§ 112', '§ 112', '§ 151', '§ 152', '§ 153', '§ 154', '§ 154', '§ 155', '§ 156', '§ 157', '§ 158', '§ 159']

9 CFR 112.3 - Diluent labels. | US Law | LII / Legal Information Institute
CFR › Title 9 › Chapter I › Subchapter E › Part 112 › Section 112.3 9 CFR 112.3 - Diluent labels.
The name—Sterile Diluent.
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.
The recoverable quantity of contents in cubic centimeters (cc) or milliliters (ml).
A serial number by which the diluent can be identified with the manufacturer's records of preparation;
Name and address of the licensee or the permittee;
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,
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
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.
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]
§ 112.3 Diluent labels.
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] 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.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.United States CodeU.S. Code: Title 21 - FOOD AND DRUGS§ 151 - Preparation and sale of worthless or harmful products for domestic animals prohibited; preparation to be in compliance with rules at licensed establishments§ 152 - Importation regulated and prohibited§ 153 - Inspection of imports; denial of entry and destruction§ 154 - Regulations for preparation and sale; licenses§ 154a - Special licenses for special circumstances; expedited procedure; conditions; exemptions; criteria§ 155 - Permits for importation§ 156 - Licenses conditioned on permitting inspection; suspension of licenses§ 157 - Inspection§ 158 - Offenses; punishment§ 159 - Enforcement; penalties applicable; Congressional findings