Mutian GS for FIP, legal or not?

Can someone explain what the deal is?

So the big questions here are, what’s really in the Mutian pills? What is the active ingredient? Is it a triphosphorylated adenine C-nucleoside analog GS-441524? Is it a duplicate of it with some minor alterations? Or is it something completely different? And, whatever it is, is it legal? The answers to these interrogations are on the FDA site. All one has to do is search the database(s) for Mutian, and you can find out… everything.
And “everything” yields a few surprises and prompts intriguing questions. Once something becomes a matter of public record, there’s no room to hide or escape. And when you apply for anything with the FDA, it becomes public record.

A National Drug Code (NDC) does not mean FDA approved.

Mutian has applied and obtained several NDC (National Drug Code) for the product labels of Mutian Xraphconn (sold in various strengths).
The National Drug Code (NDC) is a 10-digit number that is required to be on all over-the-counter (OTC) and prescription medication packages or inserts. It’s a long and technical read, so I’ll highlight the important facts:
“What are the NDC Number and the National Drug Code Directory?
Section 510 of the Federal Food, Drug and Cosmetic Act (Act), 21 USC. §360 requires a registered drug establishment to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution.
THE INCLUSION OF A FIRM OR ITS PRODUCTS IN THE NDC DIRECTORY DOES NOT DENOTE APPROVAL BY THE FDA OF THE FIRM OR ANY OF ITS MARKETED PRODUCTS, NOR IS IT A DETERMINATION THAT A PRODUCT IS A DRUG AS DEFINED BY THE ACT (1).“
In plain English, the NDC is a registration number for the commercial distribution of a product. Under the condition that the product content matches the label submitted with the application, Mutian can import and sell it. That’s it.

Mutian NDC application content:

Mutian has registered several package labels for its different concentrations (50mg, 100mg, 200mg) and its single capsule and 20 capsules boxes, but each label is essentially the same, save for color and concentration. All registered labels are available on several sites including the NIH (National Institute of Health), the NDC list, and of course the FDA (enter Mutian in the search box).

Let’s look at the Mutian Xraphconn 100mg, 20 capsules pack, and its corresponding datasheet.

THE BASICS:
LABEL: MUTIAN XRAPHCONN – drug for treatment of FIP capsule
Packager: Nantong MUTIAN Biotechnology Co., Ltd
Category: OTC ANIMAL DRUG LABEL
Marketing Status: unapproved drug other

Check the product name.

The NDC is for a product labeled Mutian XRAPHCONN. Not Mutian, Not MutianX – if the package does not say Mutian XRAPHCONN, then it is not legal for commercial distribution as it does not match the NDC application.

Check the manufacturer.

The labeler/registrant/establishment is identified as Nantong MUTIAN Biotechnology Co. Ltd. If the package does not list the manufacturer’s name, or if it does not match, then the product is not legal for commercial distribution as it does not match the NDC application.

Read the disclaimer carefully.

Again, an NDC is NOT an FDA approval. So says the disclaimer on Mutian’s label:
“Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.”

Don’t confuse New Drug Code (NDC) with New Animal Drug, or New Drug Application. You can get an NDC for selling, for example, mineral oil as a laxative for large animals, such as this one: https://ndclist.com/ndc-animal/46066-044-98, labeled to Aspen Veterinary, as OTC Animal Drug, unapproved drug other just like Mutian XRaphconn. All it takes to get an NDC is an electronic filing and paying a fee.