Waltham health care company pleads guilty to purchasing, using Botox not approved for use in U.S.

A Massachusetts health care company has pleaded guilty and agreed to pay millions after officials said it purposefully bought and used Botox that was only labeled for sale in foreign countries. 

The Waltham-based Greater Boston Behavioral Health must now pay more than $2.5 million in fines and forfeiture. 

“Greater Boston Behavioral Health disregarded laws designed to protect patient safety,” U.S. Attorney Rachael Rollins said in a statement. “The U.S. Attorney’s Office is committed to protecting patients and the integrity of federal health care programs, and we will continue to use our criminal authority to ensure that health care providers play by the rules that protect the public and ensure quality of care.” 

Officials said the company sought out sources from which it could buy Botox that was packaged and labeled only for sale in the United Kingdom and other foreign countries. 

The labels of the Botox and Botox Cosmetic products purchased by Greater Boston Behavioral Health did not have the designation “Rx Only,” as required by the FDA. The labels also, for the most part, did not have the FDA-required “black-box warning” that informs customers about the side-effects of Botox, Rollins’s office said. 

Greater Boston Behavioral Health was able to purchase this foreign Botox at prices “significantly below” the price that authorized distributors charge for the same products that were manufactured and labeled for sale in the U.S. 

Doctors working at Greater Boston Behavioral Health used the foreign Botox to treat patients suffering from migraine headaches, officials said. They did not disclose to these patients that the Botox was purchased from foreign sources or that it was not labeled for distribution in the United States.

The company was charged with violations of the Food, Drug and Cosmetic Act. Greater Boston Behavioral Health has agreed to plead guilty to a misdemeanor offense, to pay a criminal fine of $657,678 and to forfeit $1,929,464. 

Correction: An initial version of this article incorrectly stated the Greater Boston Behavioral Health facing fines is based in Needham. The company was based in Waltham.

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