FDA Issues Talk Paper

Nationwide Alert on Injectable Drugs Prepared by Urgent Care Pharmacy

On November 15, 2002, the US FDA prepared a Talk Paper advising of a nationwide alert on all injectable drugs prepared by the Urgent Care Pharmacy in Spartanburg, South Carolina, based on the possibility that the drugs are not sterile.

The pharmacy, responding to a shortage of injectable methylprednisolone from the manufacturer, mixed a batch of methylprednisolone and sent it to medical facilities in several states earlier in 2002. A Pinehurst, North Carolina woman died in August 2002, after receiving some of the contaminated injectable methylprednisolone from the South Carolina pharmacy, which was apparently infected with a mold. On September 16, 2002, Urgent Care recalled all lots of its injectible methylprednisolone.

It is not uncommon for pharmacists to prepare customized drugs when a specific dose or form of a commercially manufactured drug is unavailable. The process is called compounding.

Subsequent to the September 16, 2002 recall of injectible methylprednisolone, the South Carolina Board of Pharmacy issued a Cease and Desist order to prevent further sales of compounded drugs from the Urgent Care Pharmacy.

In the alert, the FDA advises that the Urgent Care pharmacy has distributed the following injectable drugs to health care facilities in several states:

• Baclofen
• Betamethasone
• Bimix
• Clonidine
• Estradiol
• Hydromorphone HCl
• Fentanyl
• Methylprednisolone acetate
• Morphine Sulfate/Bupivacaine
• Papaverine HCl
• Super Trimix
• Testosterone cypionate
• Testosterone/Estradiol