McKesson Corp Receives FDA Warning Letter For Failing To Stop Opioid Product Tampering

FDA Warning Letter
Used Narcan (naloxone hydrochloride) containers and syringes sit in a case (Photo: Reuters)

McKesson Corporation, a pharmaceutical and health care products distributor, has now received a warning letter from the Food the Drug Administration (FDA) for failing to properly keep track and handle its medical supplies. The letter warned the company that it has 15 days to outline its plan of action to correct its violations. If the company does not adhere to the terms within the letter, the FDA will take regulatory action that could include lawsuits and an injunction.

The FDA has included several examples of incidents where McKesson had failed to keep track of its drug shipments. Several pharmacies across Michigan have apparently received "illegitimate" or tampered opioid products. Three Rite Aid pharmacies in Michigan reportedly received products from the company that was either tampered during manufacturing or during transit. The FDA's warning letter is its first step before regulatory action under the 2013 Drug Supply Chain Security Act.

Pharmaceutical distributors such as McKesson and Cardinal Health have been accused of mismanaging their deliveries resulting in the increase of opioids being sold in the streets. According to reports, the increase of supply has led to the opioid epidemic that is currently being experienced in the United States. Numerous lawsuits have been filed against these companies, but this time the FDA has now stepped in to try and find a solution to the problem.

According to the FDA's commissioner, Scott Gottlieb, distributors should be held accountable for failing to have systems in place to prevent the tampering of their products. Failure to report and investigate these incidents are also a violation of the law. The commissioner also pointed out in his statement that the recent oversights are particularly concerning given the ongoing opioid crisis in the country.

In response to the warning letter, McKesson released a statement earlier in the week to clarify that it is fully willing to adhere to the FDA's requests and they are now in direct communication with them. The company is now reportedly providing the FDA with procedural details and documentation for review. The company also stated that they are taking steps to enhance the security of their supply chains.

The instances of product tampering that was outlined by the FDA in the warning letter included reports of Rite Aid pharmacies in Michigan receiving bottles of oxycodone hydrochloride with replaced contents. The bottles reportedly contained naproxen or ciprofloxacin hydrochloride instead. McKesson did launch an investigation into the matter, but the FDA found that the company's efforts were insufficient as they weren't able to identify the cause of the problem. The FDA also noted that McKesson wasn't able to notify its customers who may have received the wrong prescription medication. 

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