Prescribing Approved Drugs for Nonapproved Uses: The Pharmacist’s Potential for Liability

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Drugs are frequently used for purposes not included in the manufacturers’ package inserts which are approved by the Federal Food and Drug Administration (FDA). A current example involves the industrial solvent dimethyl sulfoxide (DMSO), which is approved for human use only for the treatment of chronic interstitial cystitis, but is reportedly widely sold for the nonapproved purpose of arthritis treatment. The placing of this product in the pharmacy for sale to consumers could constitute the basis for an action by FDA against the pharmacy. This article will discuss the potential legal ramifications when a pharmacist dispenses an approved drug for a nonapproved use.

The question of a pharmacist’s liability for dispensing approved drugs for nonapproved uses has not yet been litigated. Courts have, however, held physicians liable for improperly prescribing drugs for nonapproved uses, as discussed by Professor Kapp in the preceding article. The premise of this article is that the pharmacist is potentially liable, and that the basis of this liability may be analogized to that of the physician’s liability.