Federal government should take wise approach to compounding regulations

Congress is expected to pass the Drug Quality and Security Act, which would subject sterile compounding pharmacies to stronger federal regulations and has attracted support from an independent pharmacy trade group, compared with a previous effort at federal regulations of compounding, Senate Bill 959, which many pharmacists feared would threaten their businesses and patients' access to compounded drugs. The efforts to place compounding pharmacies under federal regulations stem from last year's scandal in which many patients died and more were sickened after taking injected steroids contaminated with fungus.

The bills' purpose is simple enough: protecting the safety of patients. But the older bill attracted opposition from independent pharmacies because, despite its good intentions, it forced them to make costly changes to their business models or force them out of compounding altogether.

Since the NECC scandal last year, the Food and Drug Administration has been inspecting sterile compounding pharmacies around the country, finding many problems with sterilization and lab cleanliness, and with numerous compounding pharmacies shipping their drugs across state lines, it's no secret that some kind of federal oversight is needed.

But as a recent survey of pharmacists conducted by compounding supply company PCCA regarding S. 959 showed, it's important that regulations be applied carefully. The survey found that more than 40% of compounding pharmacies would fit the bill's criteria as "manufacturers," forcing them to make "painful" adjustments or to give up their business altogether. The National Community Pharmacists Association likewise expressed opposition to the bill, saying it would "create unnecessary federal regulatory burdens, hamper independent community pharmacies from providing medications to patients with unique health needs, and far exceeds a targeted approach to prevent another tragedy like NECC."

By contrast, however, the NCPA is supporting the Drug Quality and Security Act, saying it would enhance safety while preserving patients' access to compounded drugs and also creating a uniform standard for security in the country's drug supply chain.

Another important aspect of the bill is that it would distinguish between sterile and traditional compounding — a distinction that was often lost in media reports about the NECC scandal. Traditional compounding would continue to be regulated by state boards of pharmacy.

Compounding is a highly important part of pharmacy practice. It's as old as the profession itself, historically being the norm before the rise of the modern drug industry. Today, many independent pharmacies have gotten into compounding because it provides a competitive niche. But while regulations of compounding, especially sterile compounding, are necessary, they also must be done wisely so that protecting patients' safety doesn't mean depriving them of access to needed drugs altogether.