Eleanor V. Eagly 
Senior Staff Veterinarian
Licensing and Policy 
Development

Center for Veterinary Biologics
USDA, APHIS, VS
Ames, Iowa

• Last labeling regulation
  Change June 26, 1996-
  re: minor label changes
• Proposed notice published
  March 1999 in Federal
  Register-withdrawn May 2000

• Labeling Issues are a Priority
  for the Center for Veterinary
  Biologics
• Input Valued

• 4 Expert Group Meetings
• Federal Register Notice
  3/99 withdrawn 5/00

• Addition of Contact#
• Addition of APHIS Product Code
  Unique Identifier, not yet defined, will replace
• Foreign labels-provision for foreign
  regulatory approval
• Minimum Age each species
• Revaccination

• Science  Based Information
• Potential Information source of 
  science based for each product
• Efficacy and Safety Data

Science Based

• Provide Summary Efficacy 
  and Safety Data Accepted
  for Licensing Product
• Provide Summary Data
  Accepted for Post-licensing
  added claims
  (i.e. new species, new route)

Insert--likely necessary for
each product
Additional text for efficacy&
safety summaries
Additional space needed

Summary of Efficacy Testing
Supporting Product License

• Species, Age, Number of Animals
• Time between vaccination, if multiple
• Period of Time Between Vaccination
  and Challenge
• Other appropriate data

Summary Safety testing
supporting the license
age, species, # animals
other appropriate data

• New Definitions

--Duration of Immunity
--Export label
--Shipping label
--Bulk label

Duration of Immunity
The period of time an
administered biological product
has documented efficacy as
supported by scientific data
accepted by the Animal and 
Plant Health Inspection Service.

• Export Label 101.4(3)(i)
  All labels, including written, 
  printed, or graphical material
  accompanying final
  container(s) for export
  distribution.

• Bulk Label 101.4(3)(k)
  A label intended for affixing or
  affixed to a bulk container of
  veterinary biological.

• Shipping Label 101.4(3)(j)
  
  --A label for affixing to the 
  outer shipping carton
  containing unlabeled final
  container product.

• Foreign labels--provision
  regarding foreign regulatory
  approval
  --variance to domestic
  regulations considered
  --must be documented as
  acceptable to foreign country
  --no false or misleading
  statements allowed

• Unique Identifier
  International Cooperation on
  Harmonization of Technical 
  Requirements for Registration of
  Veterinary Products
  --Registration number adopted
  VICH Adverse Event Reporting
  Guideline

Full Instructions 112.2(a)(5)

• no change in policy--revision
• state additional specifics-
  indications for use, species, route
  withdrawal time (food animals)
• change "and such" to "additional 
  pertinent information"
  

Storage temperature recommendations
for the biological product stated as not over 45 F or stated as not over 7 C , or stated as not over 45 F or 7 C
2° to 7° C or 35° to 45° F.

Indications for Use
VS Memorandum 800.90

• prevents infection (no colonization)
• for prevention of disease due to...
  95% confidence > 80% effective
• aids in the prevention disease due...
  significant effect--mild disease,
  multiagent disease "syndromes"
  
  

• Revise 112.2(d)(3) to clarify
  "For Veterinary Use Only" to
  "For Use in Animals Only"
  
• 112.7(a) Expand the warning for
  live Newcastle Disease Vaccines
  to Include "Consult a Physician if
  Accidental Exposure Occurs"

• Update Live Product Disposal Statement
  (Change Burn to Inactivate) 112.2(a)(7)
• Add Statement In Case of Accidental 
  Human Exposure (injection)--Contact
  Your Physician
• Add Content of Adjuvant - i.e. oil, AIOH,
  Saponin-- to assist physician treatment
  112.2(12)

112.7 (I) All labels for 
autogenous biologics shall must 
bear the following statement
"Potency and efficacy of 
autogenous biologics have not
been established."  No additional 
efficacy indications are to appear
on autogenous biological labels.

new
112.7(n) Labels for Avian
vaccines for In Ovo
administration are to state
"Not recommended to be 
combined with other
biological products."

112.2(a)(10) In the case of a product
which contains an antibiotic or other
preservative added during the 
production process, the statement
"Contains ______ as a preservative", or 
an equivalent statement indicating the
specific antibiotic or other
preservative added shall must appear
on the cartons and enclosures if
used.

• True Name- 112.2(c) no policy
  change--amendment--replace
  "overshadow" with "more"
  prominent than"
  consistent with 112.2(a)(1)
• Add--Contact #
• Add--Unique Identifier

• Permit the Packaging of More
  Than One Multiple Dose
  Container in a Carton
  (applies to both liquid & 
  lyophilized products with diluent)

Minor Label change addition
112.5(c)(2)(vii)
adding, deleting or revising
e-mail address or web site

• Small Label Minimum Information
  --True Name
  --Storage Temperature
  --Location of Full Instructions Use
  --Unique Identifier
  --Serial Number
  --Expiration Date

• Labeling Considerations for OTCs
  --Instructions for giving injection &
  sites
  --Care/Storage Directions
  --Descriptions of most common side
  effects/reaction
  --Sharps Disposal

• Standardize the Presentation
  
  --True Name
  --Storage Conditions
  --Target Species
  --Indications for Use
  --Full Instructions for Use

• Special Precautions for Use
  (risk to animal)
• Special Precautions in Using
  (risk to humans)
• Adjuvant

Labeling is a priority