April 2026 Regulatory Roundup: FDA Compounding, New Approvals, and Stewardship
Erica Wassack, PharmD, DICVP, FACVP
Regulatory & Governmental Affairs Liaison
The following updates summarize recent FDA activity relevant to pharmacy and veterinary practice. Please review and share with your team as appropriate.
FDA Compounding Listening Session — February 27, 2026
The FDA hosted a formal compounding listening session on February 27, 2026. ACVP was invited to attend. Download the slides from the session below. These can be shared and disseminated within your networks.
↓ FDA Annual Listening Sessions Slides 2026
FDA Veterinary Drug Updates: Atinvicitinib and Generics
New Drug Approval: The FDA has approved Atinvicitinib (Numelvi), a new veterinary drug now available for clinical use.
- To see the full list of recent animal drug approvals: https://www.fda.gov/animal-veterinary/approved-animal-drug-products-green-book/recent-animal-drug-approvals
Generic Approvals: Generic approvals have been granted for robenacoxib injection and omeprazole paste.
- Read more here: https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-generic-omeprazole-oral-paste-gastric-ulcers-horses?utm_medium=email&utm_source=govdelivery
- Read more here: https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-generic-robenacoxib-injectable-postoperative-pain-and-inflammation-dogs-and-cats?utm_medium=email&utm_source=govdelivery
New Indexed Drug: Praziquantel powder for immersion has been added to the FDA Index of Legally Marketed Unapproved New Animal Drugs, indicated for use in ornamental fish.
FDA NDC Formatting Update
The FDA will require a standardized 12-digit National Drug Code (NDC) format beginning March 7, 2033. Pharmacies and veterinary practices should begin evaluating system, labeling, and workflow impacts in advance of this deadline.
Antimicrobial Stewardship — GFI #273 Finalized
The FDA has finalized Guidance for Industry (GFI) #273, which defines duration-of-use parameters for approved medically important antimicrobial drugs administered in feed to food-producing animals. This guidance carries significant implications for antimicrobial stewardship and regulatory compliance in food animal practice.
For full guidance documents and official announcements, please refer to the FDA website.
