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July 01, 2020

FDA guide helps drug companies report shortages

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Food and Drug Administration officials are asking that drug companies help them watch for pandemic-related delays in animal drug production.

In May, agency officials published guidance on why those companies should share information about the animal drug supply chain and what details companies should share. FDA officials published similar guidance in March for product supply chains in human medicine.

“Given that animal drug sponsors are most familiar with the supply chain affecting the manufacture, distribution, and sale of their animal drug products, FDA believes that animal drug sponsors are in the best position to analyze shortage situations related to their specific products,” the document states. “Information that is submitted to FDA will not be disclosed except in accordance with applicable disclosure law, which includes restrictions on the release of confidential commercial information and trade secrets.”

Sources of delays could include shortages of drug ingredients or problems within drug manufacturing facilities, the document states.

“Although some supply disruptions and shortages cannot be predicted or prevented, FDA recognizes that early communication and detailed notifications from sponsors to the agency play a significant role in decreasing their incidence, impact, and duration,” agency officials said in a related announcement.

The guidance applies to all animal drugs, regardless of whether the agency classifies them as medically necessary veterinary products.

When the guidance was published, the FDA was tracking 13 shortages of animal drugs with that classification. One of those shortages began in April 2020, with delays in manufacturing clindamycin oral liquid, whereas another eight started in 2019, and four started prior to 2019.