Suzanne Sechen, Ph.D. Leader, Ruminant Drugs Team Division of Production Drugs Office of New Animal Drug Evaluation, CVM Labeling Issues

2 August 7, 2012 Key Way We Communicate to Users:  What we learned about the drug during the pre-approval (investigational) phase  What we continue to learn after approval  How to use the drug safely, effectively, and in an approved manner Labeling of Approved New Animal Drugs :

3 August 7, 2012 Comprehensive, but succinct Accurate Clear Appropriate for the user Ideally, labeling will be:

4 August 7, 2012 Consider appropriate labeling information as complete review of each “technical section.” For example:  Effectiveness: indications and target animal dosage route of administration treatment period recommendations for successful use Labeling: “Built” during review process, approved with application

5 August 7, 2012 Target Animal Safety  Warnings and other risks to the treated animal Human Food Safety (food animals)  Withdrawal periods for meat and milk  Residue statements Building labeling with technical sections, cont.

6 August 7, 2012 User Safety  “Not for use in humans”  “Keep out of reach of children”  Safe handling of the product Building labeling with technical sections, cont.

7 August 7, 2012 Environmental Considerations  Proper disposal Manufacturing Chemistry  Storage conditions  Expiration period Building labeling with technical sections, cont.

8 August 7, 2012 Prescription (Rx) vs. Over-The-Counter (OTC) status For OTC: Pet Owner vs. Livestock Producer/Caretaker Who is the “audience” – the intended user of the animal drug

9 August 7, 2012 Properly administer the drug Provide adequate instructions for post- treatment care Monitor safe use of the drug Treat any adverse reactions Rx animal drug – Professional veterinary expertise required to:

10 August 7, 2012 Therefore, Rx labeling is typically detailed to help the veterinarian address these issues. May include:  Summarized study results  Pharmacological information  Detailed descriptions of adverse reactions Also, labeling states that drug is only for use by veterinarian. Rx animal drug, cont.

11 August 7, 2012 Labeling should be clear and in language understandable and informative to layperson Target language to be appropriate for intended user, for example:  Pet owner  Livestock producer/caretaker OTC animal drug – Professional veterinary expertise NOT required

12 August 7, 2012 Package insert Label on vial, syringe, bottle, etc. Carton labeling Shipping labeling Client information sheet Display carton labeling Bags for medicated feeds Labeling – Consider all “pieces”

13 August 7, 2012 Often the package insert; feed bag for medicated feeds Provides the “complete” labeling information Subsets of this information typically used for other pieces of labeling for the drug For small pieces of labeling, consider what is most critical information Start with most comprehensive piece of labeling

14 August 7, 2012 What’s in a name? Proprietary name  Overly or inaccurately promotional?  Confusion with another product? Established name  Name of drug active ingredient typically provided in a recognized compendium Other labeling considerations

15 August 7, 2012 Other useful information:  Cautions against extralabel use  Contact information for user to report adverse reactions  Lot or batch numbers  Storage information, expiration date  Drug application number  Revision date of the labeling piece Other labeling considerations, cont.

16 August 7, 2012 Changes due to:  Post-approval information  Supplemental approvals for the drug Labeling can be dynamic

17 August 7, 2012 U.S. Federal Food Drug and Cosmetic Act: – Sections 201(k) and (m) define “label” and “labeling”, respectively  Section 502(a): a drug shall be deemed misbranded if its labeling is false or misleading  Section 502(f)(1): requires that drugs bear adequate directions for use and warnings on labeling U.S. laws and regulations pertaining to labeling of animal drugs

18 August 7, 2012 Title 21 of the Code of Federal Regulations (CFR)  Part 201 (i.e., 21 CFR 201) addresses labeling of drugs in general  21 CFR addresses in general the labeling of prescription animal drugs U.S. laws and regulations pertaining to labeling of animal drugs, cont.