FDA-CVM compliance + UDI for animal drugs, what does Magento need to handle?

FDA Center for Veterinary Medicine (CVM) regulates animal drugs in the US. Two flavors:

• Approved animal drugs (NADA / ANADA numbers), full FDA approval. Catalog should display the NADA number, manufacturer, species + indication, and any boxed warnings. Common for branded products like Bravecto, Apoquel, Heartgard.
• Compounded drugs, pharmacy-compounded for individual patients. Different regulatory regime (505 vs 503A vs 503B). Magento needs to differentiate compounded from approved in the catalog; the Rx validation flow needs to capture the compounding pharmacy + patient-specific dosing.

UDI (Unique Device Identifier) applies to medical devices, not drugs, relevant for surgical instruments, lab equipment, and some diagnostic kits. UDI is captured as a product attribute in Magento; on B2B orders the UDI is included on the packing slip + invoice for the clinic’s own compliance trail.

Adverse-event reporting: FDA Form FDA 1932a for serious adverse events. The clinic files this, but as a distributor you keep the lot-traceability data so the clinic can complete the form. Magento captures lot/batch number on every order line item; if a recall happens, you can pull every clinic that received that lot in under 30 seconds.

Quarterly mock-audit is the cheapest insurance: pretend FDA-CVM is auditing, pull a random sample of orders, verify lot traceability + Rx validation + DEA workflow + cold-chain temperature curves are all intact. Fix the gaps before they bite.