• Do Compounding Pharmacies "Live in Sin"? The FDA's Assertion of Enforcement Authority Over Pharmacy Compounding, and Two Courts' Efforts to Bless the Practice
  • November 7, 2011 | Authors: Jonathan Berman; Michael Sennett
  • Law Firms: Jones Day - Washington Office ; Jones Day - Chicago Office
  • Pharmacy compounding, as the Food and Drug Administration (“FDA”) explains, “is an age-old practice in which pharmacists combine ¿ ingredients to create unique medications that meet specific needs of individual patients.” The FDA has recognized that “pharmacy compounding is a vital service that helps many people.” Congress expressly recognized and regulated the practice by adding §503A to the Food, Drug, and Cosmetic Act. But the fundamental legal questions about compounding still have no definitive answer.