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Temporary Importation of Hydromorphone Hydrochloride Injection, USP 2 mg/ml ampules from Canada to Address U.S. Opioid Drug Shortage - Veterinarians

December 2018

Dear Veterinarian:

In response to the current shortage of injectable opioid drug products experienced by the veterinary medical community, the FDA's Center for Veterinary Medicine has been working with Pfizer Inc. to make injectable hydromorphone available to veterinary distributors.

Most injectable opioid products are FDA-approved for use in humans but can be used legally in animals in accordance with the extralabel use provisions of the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA).

FDA is aware that the opioid shortage has been acutely felt in the veterinary community, just as it has in hospitals and health care settings providing critical care and pain management in human medicine.

FDA has already given permission for Hospira, Inc., a Pfizer company, to import Hydromorphone Hydrochloride Injection, USP, in 2 mg/ml strength, 1 ml volume ampules from Canada, to help alleviate the ongoing opioid shortage in human medicine. Hospira has initiated temporary importation of this product into the U.S. market. The product is manufactured in Canada by Sandoz Canada Inc. and is marketed in Canada. The Sandoz site is an FDA-registered and inspected facility and is in compliance with current good manufacturing practice requirements. Pfizer is now making this product available to the veterinary community in limited quantities.

FDA has not approved Sandoz’s Hydromorphone Hydrochloride Injection, USP in the United States. FDA is allowing this temporary importation in order to help address the ongoing opioid shortage.

Efforts to resolve the overall opioid drug shortage are ongoing. In the interim, veterinarians can purchase the Canada-approved Hydromorphone Hydrochloride Injection, USP through their veterinary distribution chains, which have been alerted that the product is now available in limited supply for the veterinary market. Pfizer also intends to make a limited supply of Morphine Sulfate Injection, USP in vials and ampules available to veterinary distributors. These products are currently in short supply but will continue to be available to veterinary practitioners when supply increases.

Pfizer reports that limited availability of injectable hydromorphone 2mg/ml will continue into early 2019, when many of the FDA-approved injectable opioid drug products that have been in shortage are expected to be back in normal supply.

For more information, please contact AskCVM@fda.hhs.gov.

Sincerely,

FDA Center for Veterinary Medicine

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