Board's Web Site Information Not Legally Official and Binding
Issue of the Case
When a Board of Pharmacy uses aWeb site or newsletter to communicateits interpretations of state law and citesappropriate statutes, is that legally binding?Or is such a communication merelyan interpretation or guidance issued bythe agency without force or legal effect?
Facts of the Case
The Board of Pharmacy in a midwesternstate issued a cease-and-desist letterto a business firm that sold animal supplies,including federal veterinary legendmedications, to animal owners. It didrequire presentation of a prescriptionfrom a veterinarian for those medicationssubject to restricted, prescriptiononlydistribution. The labeling of thesemedications bore the mandatory federalwarning, "Caution: Federal law restrictsthis drug to use by or on the order of alicensed veterinarian."
The cease-and-desist letter cited specificprovisions in state statutes thatwere allegedly being violated by the veterinarysupply firm. The companyresponded by challenging the claim bythe regulatory board that it had statutoryauthority over both human drugs andveterinary drugs prescribed by thoseauthorized to practice on the respectivepopulations, humans, and animals otherthan man. The Board of Pharmacy identifiedno rules or regulations in support ofits position, and the firm made the connectionof the Board's position back towording posted on its Web site under a"Frequently Asked Questions" heading.
Q: Does an entity have to be licensedas a pharmacy to sell veterinarylegend drugs to the consumer/owner of the animal(s)?
A: Yes. Veterinary legend drugs mayonly be sold based on theorder/prescription of a veterinarian.An entity may not sell veterinarylegend drugs directly to theconsumer (owner of the animal)based on a prescription withoutbeing licensed as a pharmacy.
The firm sought a declaratory judgmentat the trial court level; ie, askingthe court to declare what the law is ona specific point, that the Board hadadopted a rule requiring all those whosell federal veterinary drugs to consumersto have a pharmacist presentand to operate as a pharmacy subject tothe jurisdiction of the Board. Further,the company sought a declaratory judgmentthat a rule like this is outside thestatutory authority of the board, whatthe law refers to as being ultra vires,and was void and of no effect becauseit was promulgated without notice andhearing—mandatory steps before sucha rule or regulation can be established.The Board argued that the informationposted on the Web site was not a rule orregulation; it based its cease-and-desistletter on provisions in the state pharmacypractice act. The trial court ruled infavor of the veterinary supply companyand the Board appealed to the stateSupreme Court.
The Court's Ruling
The Supreme Court ruled that theresponse to the Frequently AskedQuestion the Board had posted on itsWeb site was not a rule or regulationunder the law of the state. It merely wasan expression of the Board's interpretationof the law without force or legaleffect, an unenforceable suggestion.Because it was not a rule or regulation,the veterinary supply firm could notchallenge its validity.
The Court's Reasoning
The judge writing the opinion for theCourt emphasized that not everythingwritten or published by a governmentagency is a rule or regulation. In thiscase, the Board had made no effort tofollow the required procedures for promulgatinga rule or regulation as mandatedby the state's Administrative ProceduresAct (APA). Such statutes are in effect invirtually every jurisdiction and outline theprocesses and procedures that must befollowed by administrative agencieswhen doing what they do.
The Supreme Court made the directstatement that, "Here, the Board madeno attempt to promulgate the frequentlyasked question as a rule pursuant to therequirements of the [APA]. It merely wasan expression of the Board's interpretationof the law without force or legaleffect," an unenforceable suggestion.
If one wants to challenge a rule orregulation adopted by an administrativeagency, the attack could be based onlack of statutory authority by the agencyto issue the rule, an argument that therule conflicts with state statutes, or thatthe agency engaged in arbitrary andcapricious action in adopting the regulation.None of those applied herebecause the rule or regulation hadnever been adopted; it was merely aninterpretation advanced by the Boardwithout force of law.
The court went on to rule that the casehad been filed in the wrong county. Beinga case against a state agency, suchclaims are required by state law to befiled in the county where the capital islocated.
Dr. Fink is professor of pharmacylaw and policy at theUniversity of KentuckyCollege of Pharmacy,Lexington.