FDA Warns Three Pharmacies to Stop Mass-Producing Compounded Drugs

The US Food and Drug Administration (Rockville, MD, www.fda.gov) has sent warning letters to RoTech Healthcare, Inc. (Orlando, FL, www.rotech.com), CCS Medical (Clearwater, FL, www.ccsmed.com), and Reliant Pharmacy Services (Clearwater, FL), demanding that they stop manufacturing and distributing compounded, unapproved respiratory drugs.

FDA says that because the three companies compounded and distributed the inhalable drugs in large amounts, they have gone “well beyond traditional compounding,” according to an official FDA announcement. Traditional compounding is only intended for preparing a unique drug for a patient who is allergic to an ingredient in an FDA-approved drug. Compounded preparations should not be mass-produced because the changes made from the FDA-approved drugs may not relate to every patient’s specific medical needs.

Rotech has already said it will no longer accept prescriptions for some of its compounded drugs and will dispense only FDA-approved formulations to some 30,000 of its patients, though it disagreed with FDA’s position.

Compounding pharmacies have recently drawn increased attention from FDA. In May 2006, a federal district court in Texas ruled that compounded formulations are not new, unapproved drugs and are out of FDA’s jurisdiction. The International Academy of Compounding Pharmacists (Sugar Land, TX, www.iacprx.org) has stated that compounded pharmacies are regulated by state boards of pharmacy and do not need any additional expensive oversight from FDA.

Meanwhile, pharmaceutical companies have petitioned FDA to take action against the pharmacies that make copies of their products for patients. Wyeth (Madison, NJ, www.wyeth.com) filed a 36-page citizen petition in October 2005, saying that there is no proof that bioidentical versions of its hormone therapies are safe and effective. The petition has drawn nearly 30,000 comments from physicians, patients, and pharmacists during the standard 180-day comment period.