Diverting a Legend Drug in Indiana
In the complex landscape of pharmaceutical regulations, the term “legend drug” often surfaces, especially in legal contexts. Understanding what constitutes a legend drug in Indiana and the legal ramifications associated with its diversion is crucial not just for healthcare professionals but for anyone who handles these substances. This article will delve into the definition of a legend drug and explore the specific Indiana laws that regulate their use and distribution. It will also examine the penalties associated with their illegal diversion, and the possibility of disciplinary action by the Indiana Board of Pharmacy.
If you are currently facing legal or professional matters related to the diversion of a legend drug in Indiana, contact the Indianapolis Law Firm of Keffer Hirschauer LLP. Our firm employs both criminal and pharmacist license defense attorneys who understand the laws pertaining to cases of this nature. Our attorneys have extensive experience representing individuals in court, as well as in front of the various Boards that make up Indiana’s Professional Licensing Agency. Given this, our team can capably represent you in both venues with the stated goal of securing an outcome that protects you, your rights, and your future.
What is Considered a Legend Drug in Indiana?
A legend drug, as defined by both federal and Indiana state law, refers to any medication that cannot be lawfully dispensed without a prescription from a licensed healthcare provider. This classification arises from the drug’s potential for harm if used improperly, its necessity for the treatment of specific medical conditions, and the need for a healthcare provider’s supervision during its use. In Indiana, the handling of these drugs is strictly regulated to ensure public safety and health.
Common examples of legend drugs include medications like antibiotics and antidepressants, as well as drugs that are considered controlled substances in Indiana, like amphetamines, benzodiazepines, hypnotics and opiates. These drugs all play a crucial role in healthcare but require careful management due to their potential side effects and the risks associated with their misuse.
In Indiana, the distinction of a drug as a ‘legend drug’ is significant. It places the drug under stringent regulatory oversight, mandating that it be prescribed by a qualified healthcare professional and dispensed by a licensed pharmacist. This classification is not just a bureaucratic label; it is a crucial part of Indiana’s commitment to safeguarding the health and well-being of its citizens. The state takes the responsibility of monitoring and controlling these substances seriously, as their misuse can lead to significant health risks and contribute to the broader issues of drug abuse and addiction.
For individuals and entities involved in the pharmaceutical industry in Indiana, understanding the classification and regulation of legend drugs is not just important — it is essential. It ensures compliance with state laws and regulations, safeguards patient health, and upholds the integrity of medical practice and pharmaceutical distribution within the state.
Criminal Offenses Involving Legend Drugs
In Indiana, the laws governing legend drugs are both comprehensive and stringent, reflecting the state’s commitment to ensuring the safe and responsible use of these medications. Central to these regulations is the Indiana Code, which delineates clear guidelines for the prescription, distribution, and handling of legend drugs.
Criminal Offenses Relating to Registration Labeling and Prescription Forms
As outlined in Indiana Code 35-48-4-14, a person who is subject to registration by the Indiana Board of Pharmacy under Indiana Code 35-48-3-3(b) – often doctors, nurse practitioners, pharmacists and pharmacist technicians – recklessly, knowingly, or intentionally, distributes or dispenses a controlled substance in a manner that violates the rules set forth in Indiana Code 34-48-3-3, they commit a Level 6 felony in Indiana. Furthermore, registrants may be charged with a Level 6 felony for failing to make, keep, or furnish a record, notification, order form, statement, invoice, or information required by Indiana’s controlled substance laws.
In addition, under Indiana Code 35-48-4-14(b), a registrant who knowingly or intentionally distributes a controlled substance classified in Schedule I or II in manner non-compliant manner; or “furnishes false or fraudulent material information in, or omits any material information from, an application, report, or other document required to be kept or filed” by Indiana law, may be charged with a Level 6 felony. Finally, Under Indiana Code 35-48-4-14(c), a person who knowingly or intentionally acquires possession of a controlled substance by misrepresentation, fraud, forgery, deception, subterfuge, alteration of a prescription order, concealment of a fact, or use of a false name or address,” commits a Level 6 felony. This charge, however, may be enhanced to a Level 5 felony if the person has a previous, but unrelated conviction for this crime.
Theft and Possession of a Controlled Substance
While the crimes listed above deal more so with committing acts of fraud and deception in the act of diverting legend drugs in Indiana, it’s also possible for individuals who take legend drugs from pharmacies to be charged with theft and/or drug possession.
Under Indiana Code 35-42-4-2, a person who knowingly or intentionally exerts unauthorized control over the property of another person with the intent to deprive the other person of any of its value or use commits theft, a Class A misdemeanor. This charge, however, may be enhanced if the value of the property exceeds $750 or the person has been previously convicted of theft.
Under Indiana Code 35-48-4-7, a person who, without a valid prescription, knowingly or intentionally possesses a controlled substance classified in Schedule I, II, III, or IV commits a Class A misdemeanor. This offense may be elevated to a Level 6 felony if an enhancing circumstance in Indiana applies.
Potential Criminal Penalties for Legend Drug Offenses
In Indiana, the diversion of legend drugs can lead to various charges, depending on the nature and severity of the offense. For example, a pharmacist who diverts the waste of a controlled substance, like Fentanyl, for personal use could be charged with “Obtaining a Controlled Substance by Fraud or Deceit,” a Level 6 Felony; however, if they have been convicted of this crime before, they could be charged with a Level 5 felony.
Under the Indiana Sentencing Guidelines, a conviction of this level could result in the offender facing between 6mo and 2.5 years in prison for a Level 6 felony and 1-6 years in prison for a Level 5 felony. In addition, a person convicted of a felony offense in Indiana may be fined up to $10,000.
Indiana Board of Pharmacy Regulations on Legend Drugs
Not only does the Indiana Board of Pharmacy regulate the licensing and operation of pharmacists and pharmacies in Indiana, but they also ensure that they comply with all legal requirements regarding legend drugs. This includes maintaining proper records, adhering to dispensing protocols, and ensuring that all prescriptions are legitimate and properly filled. If the Board finds that pharmacists or pharmacies are acting in violation of these regulations, they’ll take appropriate disciplinary action.
When it comes to the topic of diverting a legend drug in Indiana, pharmacists, pharmacist technicians, and other healthcare providers could face administrative penalties from the Board for violating the Health Professions Standards of Practice, outlined in Indiana Code 25-1-9-4. This regulation clearly states that practitioners shall conduct their practice in accordance with the standards regulated by the board and can be subject to disciplinary actions if, after a hearing, the board finds that they have:
- Engaged in or cooperated in fraud or material deception to obtain a license to practice
- Engaged in or cooperated in fraud or material deception in the course of professional services or activities
- Advertised services in a false or misleading manner
- Been convicted of a crime or assessed a civil penalty involving fraudulent billing practices
- Been convicted of a crime that has a direct bearing on the practitioner’s ability to continue to practice competently or is harmful to the public
- Violated any state statute or rule, or federal regulation, regulating the profession in question
- Continued to practice although they have been found to be unfit to practice due to professional incompetence, failure to keep abreast of current professional theory/practice, physical or mental disability, or addiction, abuse of, or severe dependency upon alcohol or other drugs.
- Engaged in a course of lewd or immoral conduct in connect with the delivery of services to the public
- Allowed the practitioner’s name or license to be used in connection with an individual who renders services beyond the scope of that individuals training, experience or competence
- Had disciplinary action taken against the practitioner or the practitioner’s license to practice in any state or jurisdiction on grounds similar to those listed in this section
- Diverted a legend drug or any other drug or device issued under a drug order for another person
- Knowingly prescribed, sold, or administered any drug classified as narcotic, addicting, or dangerous to a habitue or addict, except as otherwise provided by law
- Failed to comply with an order imposing a sanction
- Engaged in sexual contact with a patient under the practitioner’s care or has used the practitioner-patient relationship to solicit sexual contact with a patient under the practitioner’s care
- Assisted another person in committing an act that would be grounds for disciplinary sanctions under this chapter
- Failed to report to the Department of Child Servies or local law enforcement agency suspected child abuse
Potential Sanctions by the Indiana Board of Pharmacy
Under Indiana Code 25-1-9-9, the Indiana Board of Pharmacy has the authority to impose various penalties on those who violate legend drug regulations. These penalties can range from fines and reprimands to the suspension or revocation of licenses. The Board considers the severity and nature of the violation when determining the appropriate penalty; however, for many pharmacists, technicians, and pharmacies found in violation, these consequences can be career-altering.
Prior to sanctions being placed, practitioners facing allegations of a professional violation related to a legend drug in Indiana will often be called before the board for an evidentiary hearing on the matter at hand. At this hearing, the Board will hear evidence from both sides, including from the practitioner facing the allegations. At the end of the hearing, the Board must issue written findings of fact and conclusions of law and determine the appropriate disciplinary action. As outlined in Indiana Code, the Board may impose any of the following sanctions, singly or in combination, against a practitioner:
- Permanent revocation of license
- Suspension of license
- Censure of the licensee
- Written reprimand of licensee
- Placement of the licensee on probation
- Required participation in the Indiana Professional Recovery Program
- Assessment of a civil penalty of not more than $1,000 per violation
Professional License and Criminal Defense Attorneys
For licensed professionals in the pharmaceutical and healthcare fields, understanding and complying with the regulations regarding legend drugs in Indiana is not just a legal requirement, but a fundamental aspect of ethical practice. The misuse or illegal diversion of legend drugs can have serious public health implications, and as such, Indiana’s strict stance on these matters is both necessary and harsh.
Given the current landscape, it’s vital that all licensed healthcare and pharmacy practitioners facing disciplinary action from the Board seek experienced legal counsel. Violations regarding legend drugs often have both professional and criminal implications, and thus require swift attention and legal action. To best ensure that everything is being done to protect your career and your future, contact the Indiana Board of Pharmacy defense attorneys at Keffer Hirschauer LLP today at 317-857-0160 or complete our online contact form to schedule a free consultation.
Our Indianapolis-based attorneys have experience in both criminal and professional license defense. This means they routinely represent clients before the various Boards that make up the Indiana professional licensing agency; as well as in the courtroom. They understand Indiana’s drug laws inside and out, yet also possess extensive knowledge of the rules and regulations governing your Indiana pharmacy license. No matter how serious the allegations, our team stands ready to work with you in building a strong, effective defense strategy aimed at mitigating or minimizing any potential long-term consequences that will put your career in jeopardy.