When Does Compounding Become Manufacturing?

Issue of the Case:

Some issues just do not go away.While the US Supreme Court and theFDA have both provided general guidelinesand principles regarding pharmacists'compounding, it may take sometime for state jurisdictions to interpretand apply the federal decisions. Thismonth's case is a malpractice actionthat asks whether a pharmacist wasmanufacturing or compounding whenmaking customized "fen-phen"capsulesfor a patient.

Facts of the Case:

The plaintiff was prescribed fenfluramine3 times a day and phentermineonce a day (a combination oftenreferred to as fen-phen) as a weightlossmeasure. The owner of the defendantpharmacy noticed that a numberof patients who took this combinationwere not complying with their prescriptions.In particular, the patientsoften failed to take all the fenfluramine.

Based on his experience in compoundingother time-release products,the pharmacist determined that aonce-a-day dosage form might improvepatient compliance. He contacteda number of physicians who indicatedthey were interested and wouldprescribe the dosage form. The pharmacistmade the time-release capsuleswith raw materials provided by manufacturersand a national compoundingorganization.

When a friend who worked for oneof the physicians informed the plaintiffabout a "one-a-day fen-phen"available at the defendant pharmacy,she began to have her medicationscompounded there. After about 5refills of the prescription, she began toexperience nausea, chest pain, anddizziness and required open-heart surgeryto repair 2 damaged heart valves.The plaintiff sued the prescribingphysician, the dispensing pharmacy,and the providers of the raw materials.

The Court's Ruling:

The physician was dismissed fromthe lawsuit and the plaintiff settledwith the national compounding organizationand the manufacturers. Thetrial court found that the plaintiff hadnot provided any evidence to supporta negligence claim against the pharmacy.In fact, the plaintiff admittedthat dispensing the compoundedproduct did not increase the risk ofharm over taking the individual drugs.

The pharmacy could only be heldliable if it was considered the manufacturer.Claims against manufacturers areoften based on strict liability, sometimestermed liability without fault. Neitherthe trial court nor the UtahSupreme Court could support such aclaim, and the case was dismissed.

The Court's Reasoning:

Based on a US Supreme Court case,the Utah court concluded that "drugcompounding is recognized as a traditionalfunction of pharmaceuticalpractice."The court was not convincedthat the actions of the pharmacistin this case constituted manufacturing.Instead, it noted, "Consultingwith physicians regarding the complianceproblems of their patients,designing a new drug product that isnot otherwise available...and dispensingthe new drug product directly topatients, only after receipt of a validprescription, appear to be legitimateactivities for a licensed pharmacist.

"For a pharmacy to cross the lineand become a manufacturer, theremust be evidence of a large-scale compoundingactivity, third party resale orwholesale distribution efforts, or othersignificant indicators of questionableand nontraditional pharmaceutical behavior.

"A pharmacy taking steps to improvecompliance within a smallgroup of patients in the local communityit serves, through legitimate marketingefforts and without violatingstate or federal regulations, is notstrictly liable as a manufacturer for thecompounded drug it provides."

These comments by the UtahSupreme Court are most enlightening.It confirms the right of pharmacists tomeet the needs of their patientsthrough specialty compounding ifdone in a limited scope. The court alsotook time to consider the marketingstrategies used by the pharmacy.Again, based on the US SupremeCourt, it concluded that pharmacistsmay not be prohibited from exercisingtheir free speech rights and may advertiseor promote the compounding ofdrugs. The dismissal of the case againstthe pharmacy was affirmed.

Larry M. Simonsmeier isEmeritus Professor ofPharmacy Law atWashington State UniversityCollege of Pharmacy.