Labeling Issues

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

2. Labeling of Approved New Animal Drugs: • 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

3. Ideally, labeling will be: • Comprehensive, but succinct • Accurate • Clear • Appropriate for the user

4. Labeling: “Built” during review process, approved with application • 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

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

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

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

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

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

10. Rx animal drug, cont. 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.

11. OTC animal drug – Professional veterinary expertise NOT required • 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

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

13. Start with most comprehensive piece of labeling • 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

14. Other labeling considerations 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

15. Other labeling considerations, cont. • 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

16. Labeling can be dynamic • Changes due to: • Post-approval information • Supplemental approvals for the drug

17. U.S. laws and regulations pertaining to labeling of animal drugs • 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

18. U.S. laws and regulations pertaining to labeling of animal drugs, cont. • Title 21 of the Code of Federal Regulations (CFR) • Part 201 (i.e., 21 CFR 201) addresses labeling of drugs in general • 21 CFR 201.105 addresses in general the labeling of prescription animal drugs