A community pharmacist with a small practice in a strip mall decided to re-invent himself as a "compounding pharmacist". He took out ads in a number of professional journals and even set up a web site on the internet to advertise his services. He became particularly fascinated with a product known as Sargenti paste or N2. Sargenti paste is a dental product that contains paraformaldehyde as the active ingredient and is sometimes used as a sealant in endodontic procedures. Its use is extremely controversial. Although some users (mostly general dentists who perform endodontic procedures) claim it is easier and faster to place in root canals than gutta-percha, its detractors (namely board-certified endodontists) have noted that if the active ingredient leaks out of the canal into surrounding tissue, damage to nerves and bone can be quite severe. Because of extreme opposition by endodontists, there are currently no commercial preparations of the product and although the FDA banned the interstate marketing of the product in 1991, a pharmacist can still legally compound it provided it does not contain heavy metals such as lead and it is not dispensed in quantities > 5 grams at any one time (the amount typically used to perform one procedure).
Because this pharmacist's compounding business was slow and it appeared there might be a market for Sargenti paste, he obtained the precise formula for it from his professional compounding society and actively advertised it to the American Endodontic Society (AES), an organization consisting of general dentists who use the product. It was there that his problems started. A group of general dentists in another state saw an advertisement in their professional newsletter and ordered a small supply of Sargenti paste. He dispensed 25 grams of the product, a quantity sufficient to perform 5 separate procedures. However, neither his recordkeeping nor product labeling listed the actual names of the patients who would be receiving the product. Rather, it was simply dispensed in a single bulk container.
One of the patients who received the product during her root canal experienced severe complications (leak into surrounding tissue) which necessitated extraction of the tooth as well as surrounding tissue. Her pain became chronic and intractable despite surgery, a very tragic case indeed. Subsequently she sued the dental group for malpractice (they immediately made an undisclosed settlement and signed a consent decree stating that they had been grossly negligent) and the pharmacist for both negligence and strict liability.
Normally, compounded prescriptions are not considered "manufactured" products per se, hence they are exempt from claims of strict liability. However in this particular case, there were some interesting twists. First, the pharmacist mailed out 25 grams of the product in a bulk container, a practice not consistent with FDA guidelines which require patient-specific dispensing. Second, the pharmacy did not possess a non-resident pharmacy permit in the state to which it shipped the product. This is one factor his own state's Board of Pharmacy takes into account when determining whether an act is compounding (acceptable) or manufacturing (unacceptable). Third, the state where the product was shipped to also required the pharmacy to have a non-resident permit. Because the FDA did not view the pharmacist's overall performance as being consistent with an unlicensed manufacturer, they did not pursue regulatory action. Instead, they deferred to the Board of Pharmacy as is customary in cases such as this one. When the latter also determined that no laws had been broken, the judge threw out the most serious claim, that of strict liability, and the pharmacist made a token settlement on the claim of negligence. The takeaway point from this most tragic case is that compounding pharmacists should be very careful what they compound and for what reasons. If there is a reason to question the appropriateness of a particular product, they probably should not compound it in the first place.
