onthedocket OTC compounding is ruled manufacturing in Iowa he distinction between compounding and manufacturing has been a controversial regulatory issue in pharmacy for several decades. A federal statute brought clarity until the United States Supreme Court struck it down as unconstitutional. Federal district courts have issued ambiguous rulings regarding compounding. The distinction between compoundingandmanufacturingissignificant because pharmacists clearly have authority to extemporaneously compound drug products for patients but they do not have authority to operate as manufacturers. TheSupremeCourtofIowarecentlyadded someclaritytothesituation,rulingthat,in Iowa, a pharmacist who mixes OTC ingredientstomakeanewproducthasengaged in manufacturing if the pharmacist sells that product without a prescription. Background Accordingtothecourt,apatientconsulted a pharmacist about nasal irritation. The pharmacist mixed a nasal spray containing 2-deoxy-d-glucose, dyclonine, miconazole, methylcellulose, sodium chloride, and distilled water. Each of these ingredientswas,byitself,anonprescriptiondrug. The pharmacist sold the product to the patientinacontainernotlabeledwithprescriptioninformation.Thepatientusedthe nasal spray once, experienced increased nasal irritation, and filed a complaint with the Iowa Board of Pharmacy Examiners (IBPE). IBPE filed charges against the pharmacist for unlawfully manufacturing and dispensing a compounded drug without a prescriber's authorization. Following a hearing, the board placed the pharmacist on probation for 3 years and ordered him to refrain from compounding of any kind without authorization from a prescriber. From this ruling, the pharmacist sought review by the district court, which denied ABOuT The AuThOR david B. Brushwood, BPharm, Jd, is Professor of Pharmacy Health Care Administration at the University of Florida College of Pharmacy in Gainesville. 30 Pharmacy Today august 2008 T his petition. That ruling was appealed to the Supreme Court of Iowa. Rationale The Supreme Court noted that an IBPE rule designates all compounded substances prescription drugs, thereby distinguishingbetweentheprescriber'sfunction and the pharmacist's function. The pharmacist contended that IBPE lacked the authority to make that classification. The court ruled that the board does have the authority to classify compounded substances as prescription drugs. The pharmacist contended that this action by the board was irrational. The court disagreed, noting, "The board could rationally and logically have concluded this exercise of discretion clearlyseparatingthepharmacistfunction from that of the prescriber advances the health,safety,andwelfareofpharmacists' customers." The pharmacist contended that the rule was discriminatory toward him because nonpharmacists can mix nonprescription drugs but pharmacists cannot.Againthecourtdisagreed,saying, "Nonpharmacists are not licensed to dispense drugs and do not hold themselves outasexpertsincompoundingsubstances sold to treat health problems suffered by human beings. As a consequence, there is nosignificantmarketforthecompounding services of nonpharmacists. Pharmacists ... are licensed and widely regarded by their customers as experts who reliably dispensedrugsmanufacturedbyothersor compoundedbythem.Theboardcouldlogicallyandrationallyconcludethesubstantial market for the compounding services of pharmacists justifies regulation, and the nonexistent demand for compounding services by nonpharmacists does not." The pharmacist also argued that pharmacists are not prohibited by statute or board rule from recommending nonprescription drugs to patients who describe their symptoms and seek advice. HethuscontendedthatIBPEdoesnottruly draw a line between pharmacy and medicine at "diagnosing" and "dispensing." In response, the court ruled that IBPE could rationally conclude, as it did, that pharmacist compounding of substances consistingentirelyofnonprescriptioncomponents without a prescription poses risks to public health, safety, and welfare. The court concluded that the rule adopted by the board was not irrational, illogical, or wholly unjustifiable. The board's action was supported by substantial evidence in the record. Discussion This approach by IBPE is consistent with the approach taken by federal regulatory authorities.Thegeneralregulatoryviewis that a pharmacist who extemporaneously mixes a preparation for an individual patient pursuant to a prescription from a prescriber for that patient has engaged in compounding. A pharmacist who extemporaneously mixes a preparation outside this view is at risk of engaging in unlawful manufacturing. Thus, the mixing of a preparation for distribution to another pharmacy or health care provider who willdispensethedrugtothatpharmacyor health care provider's patients is outside the general regulatory view of compounding, as is the mixing of a preparation for a patient in the absence of a prescription for that patient. It does not matter that the ingredients of the mixed preparation are all nonprescription ingredients. It is unlikely that federal legislation, agency actions, or judicial decisions will bring clarity to the compounding/manufacturing issue any time soon. However, state legislation, professional licensing agency regulation, and court rulings can help clarify the current ambiguity. Based on: Houck v Iowa Board of Pharmacy Examiners, 2008 Iowa Sup. LEXIS 91 (June 27, 2008). --David B. Brushwood, BPharm, JD Contributing writer www.pharmacytoday.org 06_OnTheDocket.indd 30 7/25/08 10:18:18 AM