San Francisco Chronicle Examines Issue of Drug Compounding

The San Francisco Chronicle on Sunday examined the trend of prescription drug compounding, a practice in which pharmacists "tailor" treatments to a patient's "unique requirements." Although pharmacists compound only about 1% of prescription drugs sold in the United States, "pharmacy compounding today is becoming a multibillion-dollar business," the Chronicle reports. Compounders have begun "stepping in to take advantage" of shortages of some treatments that have resulted from the "rapid consolidation" of the pharmaceutical industry and the "wave of crackdowns" by the FDA on manufacturing operations at a number of companies. However, Larry Sasich of Public Citizen, a consumer advocacy group, said that the practice also has led to "two classes of prescription drugs in America." The FDA "closely" monitors medications manufactured by pharmaceutical companies, but the quality of compounded treatments "is a matter of trust among doctor, pharmacist and patient" and has become a "haven for the sale of unapproved, ineffective and potentially dangerous drugs," Sasich said. FDA officials lost most of their authority to regulate compounders after the Supreme Court ruled in April that a 1997 ban on the advertisement of compounded drugs violated pharmacies' right to free speech. In response, the FDA has asked state pharmacy boards, which have the authority to regulate compounders, to "crack down on volume production by compounders," but the Chronicle reports that the boards "lack the clout of a federal agency" (Hallissy/Russell, San Francisco Chronicle, 6/23).