Another Article Suggest that the FDA May Start Inspecting More Compounding Pharmacies

Another article entitled Report: Compounding Regulatory Issues Come to Light After 'Urgent' Recall by Alexander Gaffney  suggest that the FDA may start inspecting more compounding pharmacies.  The article states:

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.

To read the entitle article, click here.