Syncor Seeks to Stop Bid to Regulate PET Pharmacies

Syncor International Corp. has filed suit against the U. S. Food and Drug Administration to try to stop the agency’s plan to regulate pharmacies that prepare special diagnostic drugs.

The FDA wants to regulate pharmacies that mix so-called positron emission tomography (PET) drugs used to diagnose patients suffering from tumors, stroke, cancer and heart disease.

Syncor, based in Chatsworth, is a major supplier of various radiopharmaceutical drugs through 117 pharmacies it operates across the country. But the FDA proposal would require those pharmacies that prepare PET drugs, including Syncor’s, to become drug manufacturers and receive approval from the FDA.

Syncor contends that pharmacies preparing these drugs under state license already have enough experience to mix them safely without additional regulation.