Walgreens Pays $80 Million for Controlled Substances Act Violations

Walgreens Pays $80 Million for Controlled Substances Act Violations

June 12th, 2013 // 12:44 pm @

Latest FDA and cGMP Compliance News

There is a nationwide effort underway to cut down on the abuse of prescription painkillers, and Walgreens has gotten caught up in it now. Walgreens is the biggest pharmacy chain in the US, and it agreed this week to pay $80 million in penalties for violations of its license, and also the rules that govern how prescribed painkillers are distributed, the DEA reported Tuesday.

This settlement is a result of an investigation that started at a Walgreens warehouse and also pharmacies in FL, that then extended to other Walgreen locations in the US. The retailer committed several recordkeeping and drug dispensing violations, the DEA stated. It added that Walgreen’s allowed drugs to be diverted both for abuse and for sale on the black market.

The US attorney on the case stated that prescription drug abuse is a huge problem in the US. People die from prescription drug overdoses each day. There are strict record keeping requirements for the Controlled Substances Act. DEA regulations are set up to stop prescription painkillers from being abused and ending up being sold on the street.

Walgreen’s president Kermit Crawford has said in response that the company has identified several compliance measures to boost the ordering process and inventory system to give employees the tools and support that is needed to ensure these controlled substances are dispensed properly.

A 2010 report from the CDC noted that there was a serious rise in drug overdose deaths that mirrored a 300% increase since 1999 of the sale of these prescription drugs. The drugs were related to 14,000 overdose deaths in 2009, which is more than heroin and cocaine together. Also, misuse/abuse of the drugs caused 475,000 ER visits in 2009, which means the visits doubled in only 5 years.

Recently a bill was introduced in the US Congress that would switch drugs that contain hyerocodone, including Vicodin, to a ranking that is more restrictive on the national drug law enforcement schedule. That was after a recent FDA advisory committee voted to put Vicodin and related prescription drugs that contain hydrocodone on more limited restrictions.


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