Regulatory Focus™ > News Articles > Report: Compounding Regulatory Issues Come to Light After 'Urgent' Recall

Report: Compounding Regulatory Issues Come to Light After 'Urgent' Recall

Posted 04 June 2012 | By Alexander Gaffney, RAC 

Common are the concerns about good manufacturing practices at pharmaceutical manufacturing facilities. The US Food and Drug Administration sends out dozens, if not hundreds, of warning letters each year to pharmaceutical companies found to be violating basic standards of cleanliness, sterility or quality.

Less common are concerns registered by FDA towards pharmaceutical compounding companies, which make medications to unique specifications from scratch using raw materials.

That may be changing, reports the Ocala Star-Banner, after Ocala, Florida-based Franck's Pharmacy was subject to an extensive recall.

As Regulatory Focus reported on 24 May, Franck's issued what it called an "urgent" recall of all sterile human and veterinary products compounded by Franck's after finding fungal growth and microorganisms in compounds which were purportedly sterile.

"In light of the FDA's findings and the resulting possible risk of infection, we have decided that it is imperative that we recall all human and veterinary sterile preparations that have left our control," wrote Franck's in a letter posted to both its website and FDA's website. The recall affected all products compounded by the company after 21 November 2011.

FDA's oversight of this area is typically sparse, notes The Star-Banner, because it has limited statutory oversight authority over compounders. While the practice started to fade from view once mass production techniques became commonplace, improvements in logistical networks and internet ordering has launched a resurgence in the popularity of compounded products.

And that's causing problems for a quality-focused FDA, notes The Star-Banner.

"Not all pharmacists have the same level of skills and equipment," said Rear Admiral Steven Galson, deputy director of the Center for Drug Evaluation and Research at FDA and the US's acting surgeon general. "In some cases, compounders may lack sufficient controls-equipment, training, testing, or facilities-to ensure product quality or to compound complex products such as sterile or modified release drugs."

Because the majority compounds are made-to-order and exist in small quantities, many current good manufacturing practices such as lot and batch testing are impossible. "The quality of the drugs that these pharmacists compound is uncertain and these drugs pose potential risks to the patients who take them," concluded Galson.

However, large-volume suppliers such as Franck's are frequently making batches of products in amounts suitable for quality testing, creating tensions between FDA and the compounders, report The Star-Banner.

In response, FDA is starting to leverage its oversight authority towards companies "whose activities raise the kinds of concerns normally associated with a drug manufacturer and whose compounding practices result in significant violations of" The Federal Food, Drug and Cosmetic Act, said Galston in previous testimony before Congress.

Read more:

Ocala - Mistakes by Franck's Pharmacy put spotlight on FDA's limited oversight of compounding

[Editor's Note: An excellent article and well worth your time]

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