The USDA’s Animal and Plant Health Inspection Service (APHIS) is amending its regulations for veterinary biologics labeling and packaging to make the requirements more consistent with current science and veterinary practices. These changes are necessary to update and clarify labeling requirements and to ensure the required labeling is accurate with regard to the expected performance of the product.
The rule will become effective 60 days after publication in the Federal Register, but there will be a 4-year phase-in of the packaging and labeling requirements in this rule, with additional extensions of up to 2 years allowed under certain conditions.
In addition to the changes described in this new rule, when manufacturers implement these changes, they will also need to implement a simpler, uniform label format for veterinary biologics. The simpler format will allow biologics companies to more clearly communicate performance information to the end user. APHIS published that final rule in July 2015, but delayed its implementation until now so that the companies only need to change label formats once.
The changes included in this new rule will increase the information readily available to consumers, including veterinarians, livestock and dairy producers, pet stores, and animal health technicians. It will benefit these consumers and, ultimately, the animals they treat with those products.
Specific changes include:
- Allowing the use of an abbreviated name on small final container labeling;
- Requiring a consumer contact telephone number to be listed on the label;
- Changing the format used to show the establishment or permit number on labeling and requiring such labeling to show the product code number;
- Changing the recommended storage temperature for veterinary biologics;
- Requiring vaccination and revaccination recommendations in labeling to be consistent with licensing data;
- Requiring labeling information placed on carton tray covers to appear on the outside face;
- Removing the restriction requiring multiple-dose final containers of veterinary biologics to be packaged in individual cartons;
- Requiring labeling for bovine virus diarrhea vaccines containing modified live virus to bear a statement warning against use in pregnant animals;
- Reducing the number of copies of each finished final container label, carton label, or enclosure required to be submitted for review and approval;
- Requiring labels for autogenous biologics to specify the organism(s) and/or antigen(s) they contain; and
- Requiring labeling for conditionally licensed veterinary biologics to bear a statement concerning efficacy and potency expectations.
Under the Virus-Serum-Toxin Act, APHIS has the authority to grant licenses or permits for biological products that are pure, safe, potent, and efficacious when used according to label instructions. The regulations list out requirements for the packaging and labeling of veterinary biological products to ensure that labeling provides adequate instructions for the proper use of the product, including vaccination schedules, warnings, and cautions. Complete labeling (either on the product or accompanying the product) must be reviewed and approved by APHIS.
APHIS reviewed the comments received on the proposed rule, and incorporated a number the changes into the final rule. The final rule is available for public inspection on the Federal Register page.