Assume that you are working in a community pharmacy that you own and are fully licensed as a pharmacist by your state Board of Pharmacy (or the government's licensing organization), as is your pharmacy. The medications you dispense to your patients are purchased only from companies that are licensed manufacturers by the FDA. All in all, it's just a normal day in the neighborhood.
Very recently, however, a chain-store business catering to farm and agricultural needs opened a new shop next door. Being the friendly (or maybe just curious) pharmacist that you are, you take it upon yourself to meet the new neighbors. While conversing with the manager, you learn that they have a thriving practice of distributing drugs to customers who have a veterinarian's prescription for their animals. This leads you to wonder why is it that you and your pharmacy have to be licensed to sell prescription drugs, but the guy next door is not a pharmacist and his store is not licensed as a pharmacy. Your conundrum looms even larger when you realize that you are both distributing the same drugs, often from the same manufacturers. Sure, some of his drugs are labeled for animal use only and your drugs are approved for human use, but for all you know, they may still come from the same manufacturing line. If you think about it for a minute, the only significant difference between your patients and his ultimate consumers are the number of legs each employs to stand up on. But what really gets your goat (pun intended) is that folks can buy the same drugs next door at much, much cheaper prices than you can even buy them at. Is that not a serious situation that calls for action on your part?
Being the upstanding citizen that you are (or just a troublemaker whose heart is nevertheless in the right place), you call the Board of Pharmacy to share your concerns, highlighting that you are being treated differently and are unfairly discriminated against because you have to be licensed, but the other guy does not. If you luck out and get to talk to a live human being, chances are that all you are going to get from this conversation is the bureaucrat's promise that the board will look into the matter.
A few months later, you learn from the pharmacy grapevine that the state is going to charge your neighbor with unlawful operation of a pharmacy without a license. If the state wins, the store next door will be shuttered and the owners might be charged with criminal wrongdoing. This result would make you happy (you muckraker). If the state loses, however, you may be annoyed, but it has not cost you anything and you still get to have the same friendly neighbor who in all likelihood will never know that you instigated the investigation.
Now, it's time to decide: Who is going to win this lawsuit? The big bad agricultural vultures stealing money you should have in your pocket or the knight in shining armor representing your state government? Before deciding, be forewarned that this is going to be a close call that will depend on how legislative statutes are interpreted, as well as how the rule of lenity is applied. It's okay if you think the question is unfair because you have never even heard of lenity, let alone know that there is a rule about it. Believe it or not, this whole scenario comes out of a real case. 1
Over the past 20 years, the defendant United Pharmacal sold federal legend drugs (what the rest of the world knows as prescription-only drugs) to consumers who have prescriptions from veterinarians for treatment of their animals. The company does not sell or dispense drugs for human use. As expected, it has engaged in these practices without a license from
Based on this investigation, the pharmacy board issued a "Cease and Desist Warning," declaring that the company's practice of selling prescription-only animal drugs constituted the practice of pharmacy without a license. 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 under the state laws.
The company did not take this notice lightly. It filed a motion with a local trial court, asking for a declaratory ruling that the board does not have authority to regulate veterinary drugs.3 The trial court found, however, that selling animal-only prescription legend drugs violates Missouri law and that the Board of Pharmacy does indeed have jurisdiction to regulate the unauthorized practice of pharmacy. The company appealed to the state's Supreme Court, seeking dismissal of the lawsuit.
Supreme Court Ruling
The seven justices who ruled unanimously found that the Board of Pharmacy does not have the authority to regulate prescription-only drugs intended for use in animals (other than humans, of course). The decision came down to a determination that the governing statutes are ambiguous and could be read to favor either side's arguments.4 The Board of Pharmacy claimed that the statutes should be read broadly to encompass the sale of all prescription drugs, because they do not specifically exempt veterinary drugs, and the dictionary defines "drug" to include substances to treat disease in "man or other animal." However, in support of the animal-feed store's claims, the court acknowledged that the language in the statute concerning "consultation with patients and other health care practitioners" can be construed as being limited to human patients, as the dictionary defines a "patient" as "a sick individual... awaiting or under the care of a physician or surgeon." In addition, another provision exempts veterinarians from regulation when dispensing their own medications. The high court judges concluded that this exemption would be unnecessary if the statute does not apply to veterinary drugs. The justices ruled that because there was no language in the statutes that explicitly grants the board authority to regulate the sale of prescription-only drugs for animal use, it was improper to read such a legislative intent into the act. Furthermore, the court felt no compulsion to defer to the board's recent change in interpreting its statutory authority. As to why they voted this way, the opinion states:
When it investigated United Pharmacal's practices twice in the 1990s, the board apparently concluded the company was not engaged in the practice of pharmacy, as it took no action to regulate the company's practice. The board's statutory scope of authority has not changed since, and the board has not articulated why it changed its interpretation of its statutory authority. Administrative agencies such as the board are legislative creations that possess only those powers expressly conferred or necessarily implied by statute. Because it is uncertain that [the statutes] regulate United Pharmacal's activity, it is equally uncertain that the board legally could license United Pharmacal or regulate that license.1
The court also noted that violations of the statutes constitute a class C felony. This, six of the seven judges thought, required application of a little known or used legal doctrine: the "rule of lenity." The court stated that because criminal charges could be rendered, the rule required the court to construe the statutes so that the sale of veterinary drugs is not considered the "practice of pharmacy."
One judge also agreed with the majority opinion that those engaged in the retail sale of veterinary drugs are not subject to regulation by the board, but she did not believe it was necessary to employ the lenity rule. This justice wrote:
The rule of lenity applies only in criminal cases and is not appropriately applied in this case, in which the Court has been asked to determine generally whether an administrative agency has authority to regulate the retail dispensing of veterinary drugs, not whether someone can be sanctioned or held criminally accountable for a violation of the relevant statutes… Application of laws that are largely remedial in character, such as this, normally is determined by ascertaining whether a particular provision should be given a broad or narrow construction, not by applying the rule of lenity.1
Thus, the judge agreed with the majority opinion on the outcome because, in her opinion, the same result would have occurred without reference to the lenity rule.
So what is the rule of lenity and how can you make use of it? Lenity is defined as "the condition or quality of being lenient." Leniency, mildness, mercy, and mercifulness as a consequence of being lenient or tolerant are terms commonly associated with lenity.5
Now that you know what lenity is and how and when it should be applied, what good is that to a pharmacist? First of all, let us all hope that none of us will ever be charged with criminal misconduct. That said, history shows that pharmacists are charged with violating controlled substance laws on more than just the rare occasion. To illustrate, imagine you receive a prescription for oxycodone HCL with acetaminophen, a schedule II drug.9 Using a heightened level of scrutiny, as should always happen with prescriptions for addictive narcotic drugs, you find the number of the prescribing physician in the phone book, call it for verification, and the person on the other end tells you that the name on the prescription is a patient of the doctor and the prescription is valid. Moments after you give the medication to the patient, the storm troopers rush the counter and drag you away under arrest for knowingly distributing a narcotic without a valid prescription. While in jail waiting to be arraigned for this heinous crime, you learn from your cell mates (a bunch of folks who understand drug use at least as well as any pharmacist) that the doctor who prescribed the drug lost his license several weeks earlier. That is sobering news that you wish you had known earlier that week. After you are charged with this criminal activity, the Board of Pharmacy seeks revocation of your pharmacist and controlled substance licenses.
In the criminal trial, your exceptionally clever lawyer asks the judge to apply the rule of lenity to determine that you could not have possibly known that the doctor was not authorized to practice medicine, as that term is used by the statute you have been charged with violating. All criminal allegations are dismissed, and you are free to go back to work except for just one thing. The Board of Pharmacy's proceeding seeks to revoke your licenses. You figure that lenity thing worked before, so let's try it again. But this time, the concept is not followed and you lose your pharmacist license. What went wrong? The Board of Pharmacy allegations are administrative, not criminal. The rule of lenity is not available in administrative hearings.10 (Think O.J. Simpson, not guilty of criminal charges but liable for wrongful death in a civil claim.) Of course, there are other ways to avoid punishment for doing what you thought was right at the time. Just don't expect that every allegation against you should be dropped because some other judge in a different proceeding gave you leniency. For practice, ask your spouse or other loved ones to cut you a break using the rule of lenity when you do something especially stupid and know you are going to be in trouble. Claim that the rules are not clear and you had no idea that you were violating the rules. Offer to throw yourself on the mercy of the family court and see what happens. But do not try this tactic more than once or twice in a lifetime.
1. United Pharmacal Company of
2. RSMo (2000) 338.010.1 and 338.220.
3. This was actually the second time that the case came to this court. In the first case, the Supreme Court of Missouri first ruled that the case had been filed in the wrong county and remanded the matter to a trial court in the correct county. United Pharmacal Company of Missouri, Inc. v. Missouri Board of Pharmacy, 159 S.W.3d 361, 363 (
4. Section 338.010, defining the "practice of pharmacy," provides in relevant part: 1. The "practice of pharmacy" 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.
Section 338.210, defining "pharmacy," provides in part: 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 premise or other place: where the practice of pharmacy is offered or conducted; where drugs, chemicals, medicines, prescriptions, or poisons are compounded, prepared, dispensed, or sold or offered for sale at retail; where the words "pharmacist," "apothecary," "drugstore," "drugs," and any other symbols, words, or phrases of similar meaning or understanding are used in any form to advertise retail products or services; where 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.
5. See www.answers.com/topic/lenity. Accessed December 31, 2006.
6. See www.answers.com/topic/within-the-statute. Accessed January 4, 2007.
7. Papachristou v.
8. See Note 6, supra.
9. Percocet, Endo Pharmaceuticals, see www.endo.com/healthcare/products/percocet.html. Accessed January 5, 2007.
10. In re: Kostas, Food and Drug Administration [Docket No. 92N-0429] [ Federal Register: June 25, 1998;64(122)] [pages 34,652-34,655], Constantine I. Kostas; Denial of Hearing; Final Debarment Order, www.fda.gov/ora/compliance_ref/debar/dbarfedreg/kostas98.txt. Accessed December 31, 2006.
To comment on this article, contact email@example.com.