PhRMA sets off sparks on compounding

Many of the issues the Food and Drug Administration's Pharmacy Compounding Advisory Committee will look at are as incendiary as gasoline. And, though the committee's first meeting is months away, matches are already being lit.

The Pharmaceutical Research and Manufacturers of America, which was not overly active when the compounding provisions were debated in Congress, sent an unsolicited letter to FDA officials seeking to lay out what would appear to be new restrictions on a pharmacist's ability to compound. The PhRMA letter says the FDA should restrict the compounding of a commercially available product to "an emergency situation as a onetime event ..." A PhRMA official, who did not want to be identified, admitted that the FDA Modernization Act does not include any reference to emergency situations or onetime events. The official called the PhRMA language "a reasonable interpretation."

PhRMA would also allow a drug to be compounded for medical reasons, where the patient is allergic, for example,to one of the ingredients in the commercially available product.

The FDA Modernization Act says a pharmacist can compound a drug "which produces for that patient a significant difference, as determined by the prescribing practitioner ..." Obviously, avoiding an allergic reaction or some other adverse medical event qualifies as a significant difference.

But, what about a pharmacist who wants to compound simply to save a patient $100 on a prescription? Will that constitute a significant difference?

The PhRMA official said no. "That would be bad from the patient safety perspective since the pharmacist wouldn't have stability data or a potency measurement for the drug he compounded," she said. Compounding for reasons of thrift seems to be frowned upon by the FDAMA language, which says a drug cannot be compounded "regularly or in inordinate amounts (as defined by the secretary)" if it is essentially a copy of a commercially available drug product.

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