112.7—Special additional requirements.
The label requirements in this section are additional to those prescribed elsewhere in this part.
(a)
In the case of biological products containing live Newcastle Disease virus, a caution statement indicating that Newcastle Disease can cause inflammation of the eyelids of humans, and a warning to the user to avoid infecting his eyes shall be included on the enclosure.
(b)
In the case of a biological product containing infectious bronchitis virus, all labels shall show the infectious bronchitis virus type or types used in the product. Abbreviation is permitted.
(c)
In the case of a biological product containing inactivated rabies virus, carton labels, enclosures, and all but very small final container labels shall include a warning against freezing and the recommendations provided in this paragraph.
(1)
That vaccine be administered to animals at 3 months of age or older, with a repeat dose 1 year later.
(2)
Subsequent revaccination as determined from the results of duration of immunity studies conducted as prescribed in § 113.209, paragraph (b) or (c), or both.
(d)
In the case of a biological product containing modified live rabies virus, the carton labels, enclosures, and all but very small final container labels shall include the recommendations provided in this paragraph.
(1)
For low egg-passage (below the 180th egg-passage level) the statement “For Use in Dogs Only! Not For Use in Any Other Animal!”
(2)
For other vaccines containing modified live rabies virus, the statement “For Use In (designate animal(s)) Only! Not For Use In Any Other Animal!”
(4)
The statement “In event of accidental exposure to the vaccine virus, the possible hazard to human health should be considered and State Public Health Officials should be consulted for specific recommendations” shall be prominently placed on all carton labels and on enclosures, if used.
(5)
That vaccine be administered to animals at 3 months of age or older, with a repeat dose 1 year later.
(6)
Subsequent revaccination as determined from the results of duration of immunity studies conducted as prescribed in § 113.312, paragraph (b) or (c), or both.
(e)
In the case of bovine rhinotracheitis vaccine containing modified live virus, all labeling except small final container labels shall bear the following statement: “Do not use in pregnant cows or in calves nursing pregnant cows.”: Provided, That such vaccines which have been shown to be safe for use in pregnant cows may be excepted from this label requirement by the Administrator.
(f)
Unless otherwise authorized in a filed Outline of Production, labels for inactivated bacterial products shall contain an unqualified recommendation for a repeat dose to accomplish primary immunization to be given at an appropriate time interval: Provided, That, repeat dose recommendations prescribed in paragraphs (f)(1) through (3) of this section are required for products containing the fractions listed.
(1) Clostridium haemolyticum.
“Repeat the dose every 5 or 6 months in animals subject to reexposure.”
(2) Erysipelothrix rhusiopathiae.
“Swine: For breeding animals, repeat after 21 days and annually. Turkeys: Repeat dose every 3 months.”
(g)
In the case of a liquid product authorized in a filed Outline of Production to be used as a diluent in a combination package, the carton labels and enclosures used for serials which are either not tested for bactericidal or viricidal activity or have been found unsatisfactory by such test shall contain the statement: “CAUTION: DO NOT USE AS DILUENT FOR LIVE VACCINES.”
(h)
In the case of wart vaccine, recommendations shall be limited to use in cattle. Indications for use shall be for prophylactic use only, as an aid in the control of viral papillomas (warts). All labels shall include a dosage recommendation of at least 10 ml to be given subcutaneously and the dose repeated in 3 to 5 weeks.
(i)
Unless otherwise authorized in an Outline of Production filed subsequent to the effective date of these amendments, all but very small final container labels for Feline Panleukopenia Vaccines shall contain the following recommendations for use:
(1) Killed virus vaccines.
Vaccinate healthy cats of any age with one dose except that if the animal is less than 12 weeks of age, a second dose should be given at 12 to 16 weeks of age. Annual revaccination with a single dose is recommended.
(2) Modified live virus vaccines.
Vaccinate healthy cats of any age with one dose except that if the animal is less than 12 weeks of age, a second dose should be given at 12 to 16 weeks of age. Annual revaccination with a single dose is recommended. Do not vaccinate pregnant cats.
(j)
In the case of normal serum, antiserum, or antiserum derivatives, the type of preservative used shall be indicated on all labels.
(k)
Unless acceptable data has been filed with Animal and Plant Health Inspection Service, to show that development of corneal opacity is not associated with the product, carton labels and enclosures used with biological products containing modified live canine hepatitis virus or modified live canine adenovirus Type 2 shall bear the following statement: “Occasionally, transient corneal opacity may occur following the administration of this product.”
(l)
All labels for autogenous biologics shall bear the following statement: “Potency and efficacy of autogenous biologics have not been established. This product is prepared for use only by or under the direction of a veterinarian or approved specialist.”
(m)
In the case of biological products containing Marek's disease virus, all labels shall specify the Marek's disease virus serotype(s) used in the product.
(Approved by the Office of Management and Budget under control number 0579-0013)