First Warning Letter Issued Under DSCSA

On Feb. 7, 2019, the FDA issued its first warning letter for verification requirements violations post-DSCSA enforcement date.

 

According to the letter to McKesson, “The verification requirements at issue include those that apply to wholesale distributors when they determine or are notified that a product is suspect or illegitimate.”

 

The letter comes after a Form 483 was issued to the company back in July 2018. The FDA notes that the firm failed to respond to illegitimate product notifications as required, quarantine and investigate suspect product and keep records of the investigation of suspect product (for no less than 6 years).

 

The letter cites three instances in which Rite Aid pharmacies had ordered oxycodone hydrochloride but found bottles with broken seals and the oxycodone removed, replaced with other drugs such as naproxen. Though McKesson conducted an investigation, “your firm was unable to demonstrate that you met key obligations under section 582(c)(4). For example, you did not demonstrate that you identified all illegitimate product subject to the notification, such as by searching for product with the same lot number or NDC, or that you quarantined any such product,” explains the warning letter. 

 

“Similarly, your firm failed to demonstrate that you notified your immediate trading partners who may have received product with the same lot number or NDC. This is particularly troubling because your firm’s investigation noted that the oxycodone hydrochloride was likely replaced with different product at a McKesson distribution center. Also troubling is that during the FDA inspection of your firm’s San Francisco headquarters, a McKesson representative stated that incidents involving stolen or diverted controlled substances are not treated as Drug Supply Chain Security Act (DSCSA) verification events within the firm. In fact, DSCSA explicitly defines illegitimate product to include ‘a product for which credible evidence shows that the product is counterfeit, diverted, or stolen.’ Finally, your firm provided no records to demonstrate the disposition of these illegitimate products.”

 

The letter highlights two other examples in which the firm did not demonstrate proper quarantining of suspect product or provide records to show that requirements were met in identifying illegitimate product or subsequent requirements.