STATE OF TENNESSEE
OFFICE OF THE ATTORNEY GENERAL
January 9, 2014,
Opinion No. 14-05
Inspection Fees for Out-of-State Pharmacies Licensed in Tennessee
QUESTIONS
1. Does the Tennessee Board of Pharmacy have the statutory authority to enact a rule imposing a fee or charge on Tennessee-licensed pharmacies that are physically located in other states and that engage in the practice of compounding sterile products, where such fee or charge is related to the additional expense incurred in inspecting these pharmacies and would not be imposed on similar pharmacies located inside the state?
2. Would such a rule violate the Commerce Clause of the United States Constitution?
OPINIONS
1. Based upon the provisions of the Tennessee Pharmacy Practice Act, and particularly of recently enacted Tenn. Code Ann. § 63-10-216, the Tennessee Board of Pharmacy is not authorized to enact a rule that would implement licensing-related inspections of out-of-state compounding pharmacies by Board personnel and that would impose additional fees or charges upon those pharmacies for the costs of such inspections.
2. Because of the answer to the first question, the question about the Commerce Clause is pretermitted.
ANALYSIS
In an effort to ensure that the same compounding standards are followed by all licensees that compound sterile products, regardless of physical location, the Tennessee Board of Pharmacy is