Bringing Your Animal Health Products to the U.S. Market

By Meredith Crabtree | September 6th, 2019

Introducing animal health products into the U.S. can be a huge step for manufacturers looking to expand their reach and break into a rapidly growing market.

There are a lot of product-development considerations that go into making that leap, from unit conversions and translations to sizing and branding for a new audience. But first, you’ll need to get comfortable with a new set of regulations and make sure you’re compliant to create a smooth transition to the U.S. market.

Here are the key questions you should address before exporting your animal health products to the United States.

What Does the FDA Look for When Importing Animal Health Products?

Meet the Center for Veterinary Medicine, a branch of the Food and Drug Administration (FDA) that regulates animal and veterinary products being offered for import. Before your products can be legally imported into and marketed in America, the FDA will look for three things:

1. Proper registration: You must register with the FDA if you plan to manufacture, repackage, or relabel your products in the U.S.

2. All applicable documents. These could include:

  • New Animal Drug Application (NADA)
  • Abbreviated New Animal Drug Application (ANADA)
  • Investigational New Animal Drug (INAD)
  • Conditional Approval (CNADA)
  • Index listing. (This applies to minor species only.)

The only exceptions to these requirements are when there is a drug shortage or when the drug is considered to be medically necessary and an approved version is not available in the U.S. The FDA’s Unapproved Animal Drugs page has more information on approvals, conditional approvals, and indexing.

3. Field examinations and sample analyzations: This is how the FDA ensures that your products follow set guidelines and labeling requirements before granting importation.

What Animal Health Products Will the FDA Not Import?

Innovation is a sought-after quality in the American marketplace. But there are limitations to what animal drugs are eligible for importation. New animal medications cannot legally be imported if they don’t have an approved NADA or INAD status. This stands even if the medications would be entrusted to veterinarians for private-practice use or consigned to manufacturers or distributors for sales purposes.

Are There Any Exceptions to These Restrictions?

Although the U.S. government’s rules are strict regarding new animal-drug substances, there are four exceptions to the previous rule. A foreign manufacturer can legally export animal drug substances to the U.S. if the consignee:

  • Holds an approved NADA or ANADA, or a conditional NADA, for the substance you’re wanting to import.
  • Is the named sponsor or investigator in an INAD exemption for the substance in question.
  • Is overseeing tests in vitro and in lab research animals with drugs that comply with federal regulations.
  • Has the requisite approvals or has an order from a consignee who has the approved NADA or INAD exemption.

Can I Market My Products to Sell in the U.S.?

Before you can legally market a new imported animal health product in the U.S., you must attain legal marketing status and an FDA review of safety and effectiveness.

If you’re importing a veterinary device, the FDA will check the labeling to make sure it says, “For Veterinary Use Only.” (If the device emits radiation, it should be registered according to radiological health regulations.) However, manufacturers who exclusively manufacture or distribute veterinary devices are not required to register their establishments and list veterinary devices.

How Can I Streamline My Importing Process?

Working with a knowledgeable, well-connected partner who understands the intricacies of the FDA’s importation process can help you get your products on the U.S. market faster.

Partnering with the right master distributor can streamline the process for your company. As the importer of record for your business, they will work with a broker and handle freight for you. Learn more ways a master distributor relationship could help streamline your supply chain here.

Contact EPiQ Animal Health about partnering to bring your animal health products to the American market.

About the Author

Meredith Crabtree is regulatory and quality affairs manager at EPiQ Animal Health. She brings more than 15 years of quality and regulatory expertise to her role, with major focus on the Food and Drug Administration, the Drug Enforcement Administration, the Bureau of Prisons, and the International Organization for Standardization, as well as standards in a variety of industries, including animal health distribution, medical laboratory, blood and tissue manufacturing, and consumer goods manufacturing and distribution. Meredith has an associate’s degree in medical lab technology and is working on her bachelor’s degree in health care administration through Southern New Hampshire University. In her spare time, she spends time with her husband, her four daughters, and her grandkids.
Meredith Crabtree
Regulatory and Quality Affairs Manager

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