Wickliffe Compounding Case Inspires Change In Kentucky Pharmacy Regulation

by | 05.12.2017 | 1:27pm
Wickliffe Pharmacy in Lexington, Ky.

Three years after an incorrectly-mixed medication for Equine Protozoal Myeloencephalitis killed several horses, the Kentucky Board of Pharmacy has instituted stricter regulation of human and animal compounding pharmacies. The Blood-Horse reports that the case, out of Wickliffe Pharmacy in Lexington, inspired state regulators to change language in the codes bringing Kentucky's compounding pharmacy standards more in line with national standards. Previous language allowed pharmacies to opt out of meeting national guidelines if they determined a standard was not “practical.”

The new measure met with some resistance by the Kentucky Pharmacists Association, which believed pharmacists should be allowed to determine whether it was practical to meet national standards. The new language does include a provision allowing compounders to request a waiver ahead of time from parts of the rule, which would have to be approved by the Kentucky Board of Pharmacy.

Wickliffe reached a settlement with the Kentucky Board of Pharmacy over the equine deaths, which resulted in a $100,000 fine and three years' probation with quarterly inspection. The pharmacy settled a suit with Florida-based owners of Thoroughbreds that became sick or died as a result of the incorrectly-mixed medication in 2015.

The Paulick Report has covered the challenges of regulating compounding pharmacies before. Compounding pharmacies can fill vital gaps for human and veterinary patients, providing medications during temporary supply disruptions or putting medications in different doses or administrations (oral versus injectable) for a specific patient. States are responsible for holding pharmacies of all kind to standards and issuing sanctions for violations, while the Food and Drug Administration is technically responsible for policing pharmacies behaving like manufacturers by mixing medications in large batches independent of prescriptions. Some compounders also offer products termed as nutritional or performance supplements which are named or described similar to drugs or performance-enhancing substances.

Learn more about selecting a responsible compounder here.

Read more at The Blood-Horse

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