With Drug Quality and Security Act, federal government sticks its nose where it's needed

Law distinguishes between areas of pharmacy regulation where federal, state regulations are required

On Nov. 18, the Senate passed by voice vote the Drug Quality and Security Act, sending to president Barack Obama's desk legislation that implements federal tracking and tracing of drugs and strengthens federal regulations on pharmacy compounding.

The bipartisan bill, which has the support of such trade groups as the National Association of Chain Drug Stores, the National Community Pharmacists Association and the Generic Pharmaceutical Association, ties up a couple of problematic loose ends in the pharmaceutical supply chain, namely the so-called "downstream" supply chain, which refers to the path that drugs take from their manufacturers to providers and patients, as well as sterile compounding.

The federal government already regulates the "upstream" supply chain - between manufacturers and their suppliers - but the downstream supply chain has long been regulated through a patchwork of state regulations that allows criminals to sneak counterfeit and adulterated drugs into the national supply chain through states with the laxest regulations. Without such inconsistencies, criminals will no longer find it easy to exploit the system.

The regulations concerning compounding pharmacies are important because they allow regulation of compounding of medicines for individual patients - which takes place at many pharmacies, including retail pharmacies - to continue happening at the state level, distinguishing it from large-scale sterile compounding of more complex medicines like injectables. In this way, the bill codifies the clear distinction between common pharmacy services and the kinds of activities that transform pharmacies into drug manufacturers.

In other words, the federal government is sticking its nose exactly where it needs to - in areas where patients' safety has already been compromised on a large scale around the country and where risk has crossed state lines, sometimes with deadly consequences - and keeping it out of where state regulations are adequate.

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