Automation Helps Pharmacies Meet Compliance Standards--What hosptials need to know about the DQSA and Compounding Pharmacies

July 30, 2014 Thomas Doherty | Intelligent Hospital Systems

 

The passage last year of federal legislation to regulate pharmacy compounding was not only necessary but long overdue. Compounding pharmacies had historically been regulated at the state level, even though some produced drugs that were being sold in other states. Meanwhile, the public remained largely unaware of the compounding industry, confident that their health care providers would never inject them with anything that was not safe.

All that changed in the fall of 2012 when people began falling ill – and dying – from steroid injections produced by the New England Compounding Center (NECC) in Farmingham, Massachusetts. The NECC tragedy not only reaffirmed the risks inherent in manual compounding, but the scale at which the pharmacy operated. The tainted injections it produced were linked to more than 750 cases of illness and 64 deaths across 20 U.S. states.

The federal government responded in two ways. First, FDA enforcement was stepped up substantially, evidenced by product recalls from compounding pharmacies in Georgia, Florida, Texas, Nevada and New Jersey, among others, all related to concerns about product sterility. Second, Congress passed legislation imposing new standards on pharmacy compounding and the interstate sale of compounded products.
Specifically, the Drug Quality and Security Act (DQSA) amends one section (503A) of the existing Food, Drug and Cosmetic Act to clarify compounding standards nationwide. It also adds a new section (503B) that describes how a compounding pharmacy can register with the FDA as an outsourcing facility. FDA’s draft guidance on Section 503A emphasizes compliance with current Good Manufacturing Practices (cGMP), as well as standards and documentation for the admixtures being used.
Although the law addresses weaknesses in the system, we should ask if it goes far enough in regulating an industry whose products continue to be manufactured manually – meaning dose safety depends on people following complex processes. Data documenting compliance with the law will only be as good as the humans that collect it, and as NECC and other recalls have shown, even the best-intentioned humans are prone to error.

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