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(a) Each licensee and permittee shall maintain a list of all approved labels currently being used. Each label shall be identified as to:
(1) Name and product code number as it appears on the product license or permit for the product;
(2) Where applicable, the size of the package (doses, ml, cc, or units) on which the label shall be used;
(3) Label number and date assigned; and
(4) Name of licensee or subsidiary appearing on the label as the producer.
(b) All labels printed shall be accounted for and an inventory maintained.
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.
§ 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
Title 9 published on 06-Jun-2018 03:51
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 9 CFR Part 116 after this date.
We are amending the Virus-Serum-Toxin Act regulations concerning records and reports. This change requires veterinary biologics licensees and permittees to record and submit reports concerning adverse events associated with the use of biological products they produce or distribute. The information that must be included in the adverse event reports submitted to the Animal and Plant Health Inspection Service (APHIS) will be provided in separate guidance documents. These records and reports will help ensure that APHIS can provide complete and accurate information to consumers regarding adverse reactions or other problems associated with the use of licensed biological products.
We are proposing to amend the Virus-Serum-Toxin Act regulations concerning records and reports. This change would require veterinary biologics licensees and permittees to record and submit reports concerning adverse events associated with the use of biological products they produce or distribute. The information that must be included in the adverse event reports submitted to the Animal and Plant Health Inspection Service would be provided in separate guidance documents. This proposed rule replaces a previously published proposed rule, which we are withdrawing as part of this document.