Mistakes by Franck's Pharmacy put spotlight on FDA's limited oversight of compounding

By Carlos E. Medina Correspondent

The Federal Drug Administration, which is tasked with ensuring the safety of drugs in the nation, has limited oversight over compounding pharmacies like Franck's because of a 74-year-old law that allows pharmacists to compound, or create unique variations of existing drugs for patients.

But that law, and the FDA's lack of authority over the practice of compounding, may draw new scrutiny in the wake of a well-publicized mistake at Franck's that killed two dozen prized polo ponies in 2009 and the production of contaminated solutions that reportedly damaged the vision of 33 eye surgery patients in recent months.

Compounding pharmacies make medications and other medical preparations from scratch. They cannot make straight copies of commercially available medications and can only make medications when they are ordered by a doctor.

These pharmacies fine tune drugs to a patient's need, whether that means creating a specific dosage not offered by a manufacturer or a liquid form of a drug only available in pill form.

Historically, compounding was the way most people got their prescription medicines. As recently as the 1960s pharmacists routinely ground and mixed compounds in their stores to make the medicines prescribed by local doctors.

The age of mass-produced drugs is a phenomenon of the last fifty years. The availability of those mass-produced drugs eventually led most pharmacies only to dispense ready-made medicines.

But compounding is in the midst of a national comeback. It's resurgence has come in the age of the Internet and overnight shipping, while the 1938 rules exempting compounding pharmacies from most FDA scrutiny have stayed largely the same.

Critics of compounding labs say the rules were written for the pharmacist grinding away at chemicals with a mortar and pestle, not for labs making hundreds and sometimes thousands of doses using machines similar to the drug manufacturers under FDA authority.

The safety and effectiveness of those drugs produced by the compounders is at the heart of the debate.

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Mistakes by Franck's Pharmacy put spotlight on FDA's limited oversight of compounding