United Pharmacal Co. of Missouri, Inc. v. Missouri Board of Pharmacy
UNITED PHARMACAL COMPANY OF MISSOURI, INC., Appellant, v. MISSOURI BOARD OF PHARMACY, Respondent
Attorneys
R. Dan Boulware, R. Todd Ehlert, Sharon Kennedy, St. Joseph, for Appellant., Jeremiah W. (Jay) Nixon, Atty. Gen., Sharon K. Euler, Asst. Atty. Gen., Kansas City, for Respondent.
Full Opinion (html_with_citations)
Is the retail sale of veterinary drugs the âpractice of pharmacyâ regulated by the state board of pharmacy?
The state board of pharmacy administers and enforces the statutes and regulations relating to licensing and regulation of pharmacists and pharmacies. Sections 338.110 and 338.140.
For about 20 years, United Pharmacal has also sold federal legend drugs â i.e., prescription drugs â to consumers who
In 1994 and 1997, the pharmacy board investigated United Pharmacal for selling animal legend drugs without a pharmacy license, each time taking no action. In 2000, however, a board staff member undertook a third investigation of United Pharmacal. The staff member concluded that this conduct is the practice of pharmacy, in violation of the Missouri Pharmacy Practices Act, chapter 338.
Based on this investigation, the pharmacy board issued a âCease and Desist Warningâ letter to United Pharmacal, declaring that the companyâs practices constituted the âpractice of pharmacyâ without a license in violation of sections 338.010.1 and 338.220. The letter ordered United Pharmacal to stop selling animal legend drugs to consumers without a pharmacy license and informed the company that violating the Act also constituted a crime.
In response, United Pharmacal filed a declaratory judgment action in the circuit court of Buchanan County seeking a declaration that the pharmacy board engaged in improper rulemaking and that the pharmacy board did not have authority to regulate United Phaimacalâs activity. This Court held that venue was improper in Buchanan County, vacated the trial courtâs judgment, and remanded the case for transfer to the Cole County Circuit Court. United Pharmacal Company of Missouri, Inc. v. Missouri Board of Pharmacy, 159 S.W.3d 361, 363 (Mo. banc 2005).
On remand, United Pharmacal amended its petition requesting a declaration that the Act does not grant the pharmacy board the authority to regulate the retail sale of veterinary prescription drugs. United Pharmacal also argued that, if the circuit court determined the act regulated this activity, it would be unconstitutionally vague. United Pharmacal moved for summary judgment. The circuit court denied the motion and entered judgment, holding that the sale of veterinary legend drugs is within the pharmacy boardâs regulatory powers because it is âthe practice of pharmacy.â United Pharmacal appeals.
Because this action involves the validity of a statute, this Court has exclusive appellate jurisdiction. Mo. Const, art. V, section 3.
Does the Pharmacy Act Cover Veterinary Drugs?
United Pharmacal presents two arguments on appeal: first, that the circuit court erred in holding that the retail sale of veterinary prescription drugs used for treating animals constitutes âthe practice of pharmacyâ under the Act; and, second, that the Act, as construed by the circuit court, violates due process because it is unconstitutionally vague and it fails to inform persons of ordinary intelligence that the retail sale of veterinary prescriptions drugs to consumers for use in animals is the âpractice of pharmacy.â This Court reviews this question of law de novo. Smith v. Shaw, 159 S.W.3d 830, 832 (Mo. banc 2005).
This controversy can be resolved by reading the statute. It is unnecessary to reach United Pharmacalâs constitutional challenge.
The statutory language guides this Courtâs analysis. The goal of statutory analysis is to ascertain the intent of the legislature, as expressed in the words of the statute. American Healthcare Management, Inc. v. Director of Revenue, 984
The Statutes
Section 338.010, defining the âpractice of pharmacy,â provides in relevant part:
1. The âpractice of pharmacyâ shall mean the interpretation and evaluation of prescription orders; the compounding, dispensing and labeling of drugs and devices pursuant to prescription orders; the participation in drug selection according to state law and participation in drug utilization reviews; the proper and safe storage of drugs and devices and the maintenance of proper records thereof; consultation with patients and other health care practitioners about the safe and effective use of drugs and devices; and the offering or performing of those acts, services, operations, or transactions necessary in the conduct, operation, management and control of a pharmacy. No person shall engage in the practice of pharmacy unless he is licensed under the provisions of this chapter.... This chapter shall also not be construed to prohibit or interfere with any legally registered practitioner of medicine, dentistry, podiatry, or veterinary medicine, or the practice of optometry in accordance with and as provided in sections 195.070 and 336.220, RSMo, in the compounding or dispensing of his own prescriptions. (Emphasis added).
Section 338.210, defining âpharmacy,â is also relevant to this Courtâs analysis. It provides in part:
1. Pharmacy refers to any location where the practice of pharmacy occurs or such activities are offered or provided by a pharmacist or another acting under the supervision and authority of a pharmacist, including every premises or other place:
(1) Where the practice of pharmacy is offered or conducted;
(2) Where drugs, chemicals, medicines, prescriptions, or poisons are compounded, prepared, dispensed or sold or offered for sale at retail;
(3) Where the words âpharmacistâ, âapothecaryâ, âdrugstoreâ, âdrugsâ, and any other symbols, words or phrases of similar meaning or understanding are used in any form to advertise retail products or services;
(4) Wdiere patient records or other information is maintained for the purpose of engaging or offering to engage in the practice of pharmacy or to comply with any relevant laws regulating the acquisition, possession, handling, transfer, sale or destruction of drugs, chemicals, medicines, prescriptions or poisons.
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The pharmacy board asserts that United Pharmacalâs sale of veterinary legend drugs constitutes âthe dispensingâ of drugs that require a prescription and, therefore, is the âpractice of pharmacyâ under section 338.010. Under the boardâs analysis, United Pharmacal would also qualify as a pharmacy under section 338.210. The board argues that section 338.010 applies to any entity that dispenses prescription drugs, and since the statute
United Pharmacal maintains that its activity is not regulated because the Act does not expressly empower the pharmacy board to regulate the sale of drugs for animal use pursuant to veterinary prescriptions. United Pharmacal relies on section 388.010âs inclusion of âconsultation with patients and other health care practitionersâ as the practice of pharmacy, arguing that this demonstrates a legislative intent to limit the Actâs scope to drugs dispensed for human use. United Phar-macal bolsters its argument by pointing to other portions of the Act, specifically to section 338.220, which contains a list of eleven classifications for pharmacy licenses, none of which applies to persons or businesses engaged in the retail sale of veterinary drugs.
These arguments highlight the statuteâs ambiguity. Both partiesâ arguments are supported by parts of section 338.010. For example, section 338.010 can be construed broadly, as the pharmacy board suggests, to encompass the sale of all prescription drugs because it does not exempt veterinary drugs. Because âdrugâ is not defined in the statute, its meaning is ascertained from the dictionary definition. One definition of âdrugâ is âa substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animal.â WEBSTERâS THIRD NEW INTERNATIONAL DICTIONARY (1993). This definition supports the boardâs contention that veterinary drugs are within the Act.
Despite this definition, the statute does not expressly state that veterinary drugs are covered under the statute. There is no express language giving the pharmacy board authority to regulate United Phar-macalâs activity. Internal ambiguity also results from section 338.010âs reference to âconsultation with patientsâ as the âpractice of pharmacy.â This language appears to limit the scope of the statute to human patients, notably because of the âconsultationâ language and based on the dictionary definition of âpatientâ â âa sick individual esp. when awaiting or under the care and treatment of a physician or surgeon,â or âa client for medical service (as of a physician or dentist).â WEBSTERâS THIRD NEW INTERNATIONAL DICTIONARY (1993). This definition of âpatientâ suggests that the statute is limited to drugs dispensed for human use.
Section 338.010 creates further ambiguity by providing an exception from regulation under chapter 338 for veterinarians dispensing their own medications. This provision is unnecessary if the statute does not cover veterinary drugs. In summary, section 338.010âs ambiguity is evident â the definition of âdrugsâ supports the boardâs position but the definition of âpatientâ supports United Pharmacalâs position. Legislative intent on this issue cannot be discerned from section 338.010âs plain language.
Because the plain language does not answer this question, this Court must turn to recognized principles of statutory construction. To discern legislative intent,
A review of the Act provides little clarity. Nowhere does chapter 388 discuss the retail sale of veterinary prescription drugs. The Act does not define âdrugsâ or âpatients.â Nor does it indicate whether the act applies to prescriptions written for all drugs, or just those prescription drugs intended for use in humans. Neither does section 330.210, defining âpharmacy,â provide any clear intent that the sale of veterinary legend drugs is governed by the Act. The section listing classifications for pharmacy licenses does not include a license for the dispensing of veterinary drugs. The pharmacy boardâs authority to regulate United Pharmacal can be inferred from some of the Actâs language, but it is not explicit.
This Court declines to infer, or read into the statute, a legislative intent to regulate veterinary prescriptions, when it is not clear from the act.
The cases suggest it may be helpful to look to the agencyâs interpretation of the statute it enforces. See, e.g., Morton v. Missouri Air Conservation Comân, 944 S.W.2d 231, 236-237 (Mo.App.1997). But to what interpretation should this Court defer? The board apparently concluded, after two previous investigations, that United Pharmacal was not engaged in the practice of pharmacy. The board was aware of United Pharmacalâs practice for nearly ten years, yet took no action to regulate this practice. At the time the board sent its âCease and Desistâ letter, there had been no intervening statutory change altering the boardâs scope of authority. The board has not articulated why it has changed its statutory interpretation.
The board does not have the power to broaden the scope of its statutory authority. Soars v. Soars-Lovelace, Inc., 346 Mo. 710, 142 S.W.2d 866, 871 (1940). As a regulatory body, the board regularly deals with the general assembly. For many years, the board left the regulation of veterinary pharmacies out of the boardâs duties, and there was no legislative response. There is no reason for this Court to defer to the boardâs recent change in statutory interpretation.
The board also argues that this Court should look to chapters 196 and 195 for guidance. Chapter 196, the Food, Drug and Cosmetic Act, contains provisions to protect the public by ensuring that drugs are accurately labeled and pure. Chapter 195, the Comprehensive Drug Control Act of 1989, regulates dispensing certain controlled substances. Both of these chapters define âdrugâ as including substances or articles used by both humans and animals. Sections 196.010(5) and 195.010(14). The board argues that these statutes should be read in pari material with chapter 338 so as to include within its scope those drugs sold for animal use. This argument is unpersuasive largely because both chapters 196 and 195 expressly encompass drugs for animal use. Their intent to regulate drugs for animal use is clear. The Missouri Pharmacy Practices Act does not expressly regulate veterinary drugs. Had the general assembly intended to grant the pharmacy board the authority to regulate the dispensing of animal drugs, it could
The decision not to include the sale of veterinary drugs as the practice of pharmacy is a policy decision for the general assembly. â[A]dministrative agenciesâ legislative creations â possess only those powers expressly conferred or necessarily implied by statute.â Bodenhausen v. Missouri Bd. of Registration for Healing Arts, 900 S.W.2d 621, 622 (Mo. banc 1995). Because it is uncertain that United Pharma-cars activity is regulated under chapter 338, it is equally uncertain that the pharmacy board could legally issue United Pharmacal a license and regulate that license.
Because there is a possibility that United Pharmacal could face a criminal penalty, this Court will apply the rule of lenity. The rule of lenity dictates that ambiguity in a criminal statute must be resolved against the government. Goings v. Missouri Department of Corrections, 6 S.W.3d 906, 908 (Mo. banc 1999); State v. Harper, 855 S.W.2d 474, 479 (Mo.App.1993); Fainter v. State, 174 S.W.3d 718, 721 (Mo.App.2005). Traditionally, this rule applies to statutes defining criminal behavior and providing for sentencing. State v. Jones, 899 S.W.2d 126, 127 (Mo.App.1995); State v. Rowe, 63 S.W.3d 647, 650 (Mo. banc 2002); Woods v. State, 176 S.W.3d 711, 712-713 (Mo. banc.2005). The rule, however, is applicable where violation of a civil statute has penal consequences. J.S. v. Beaird, 28 S.W.3d 875, 877 (Mo. banc 2000); See also, City of Kansas City v. Tyson, 169 S.W.3d 927 (Mo.App.2005). Section 338.195 provides that failing to comply with chapter 338 is a class C felony. Under the rule of lenity, the statute should be construed so that the sale of veterinary drugs is not considered the âpractice of pharmacyâ and subject to the criminal sanctions of section 338.195.
Conclusion
The âpractice of pharmacyâ statute cannot be read to cover the retail sale of veterinary prescription drugs used for treating animals. Because this issue is dispositive, the Court does not reach United Pharmaealâs contention that the provisions of the pharmacy practices act are unconstitutional. The judgment of the circuit court is reversed.
. Unless otherwise noted, all references are to RSMo 2000.
. 1. The following classes of pharmacy permits or licenses are hereby established:
(1) Class A: Community/ambulatory;
(2) Class B: Hospital outpatient pharmacy;
(3) Class C: Long-term care;
(4) Class D: Nonsterile compounding;
(5) Class E: Radio pharmaceutical;
(6) Class F: Renal dialysis;
(7) Class G: Medical gas;
(8) Class H: Sterile product compounding;
(9) Class I: Consultant services;
(10) Class J: Shared service;
(11) Class K: Internet.
. See section 338.050, a license applicant must qualify under sections 338.010 and 338.020 in order for the board to issue a license.