FDA Releases Guidance to Help Animal Drug Sponsors with Antimicrobial Animal Drug Sales and Distribution Reporting Requirements
June 28, 2018
The U.S. Food and Drug Administration today is releasing Guidance for Industry #252, entitled “Antimicrobial Animal Drug Sales and Distribution Reporting Small Entity Compliance Guide.” This small entity compliance guide (SECG) is intended to help small businesses comply with the Antimicrobial Animal Drug Sales and Distribution final rule.
Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105) requires antimicrobial animal drug sponsors to annually report to the FDA the amount of all antimicrobial drugs they sell and distribute for use in food-producing animals, including those medically important antimicrobials that are used in human and veterinary medicine.
The FDA published a final rule in May 2016 to incorporate the annual reporting requirements for sponsors of antimicrobial drugs sold or distributed for use in food-producing animals that were established by ADUFA 105 into its existing records and reports regulations in 21 CFR part 514 and also added an additional reporting provision in order to obtain estimates of sales broken out by major food-producing species (i.e., cattle, swine, chickens, turkeys).
The additional data collected as a result of this rulemaking and supporting guidance issued today will improve our understanding of how antimicrobial drugs are sold and/or distributed for use in major food-producing species.
- Guidance for Industry #252: Antimicrobial Animal Drug Sales and Distribution Reporting, Small Entity Compliance Guide
- Notice of Availability: Antimicrobial Animal Drug Sales and Distribution Reporting; Small Entity Compliance Guide
- Final Rule to Collect Antimicrobial Sales and Distribution Information by Animal Species
- Questions and Answers: Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals
- ADUFA Reports
For questions, Contact CVM.