The U.S. Drug Enforcement Administration (DEA) and other federal agencies are stepping up their enforcement efforts against online pharmacies that allegedly sell controlled substances unlawfully. Recognizing both the prevalence and dangers of online sales of prescription drugs, federal authorities are prioritizing enforcement under the Ryan Haight Online Pharmacy Consumer Protection Act and the Controlled Substances Act (CSA). Controlled substances are categorized under the Controlled Substances Act based on their medical use and potential for abuse or dependency. This puts both online pharmacy owners and other entities at risk for civil or criminal penalties.
What Constitutes Selling Prescription Drugs Illegally Online?
The Ryan Haight Act is a federal law that specifically targets the unlawful sale of prescription medications online. Among other provisions, the law imposes strict requirements for selling prescription drugs online, whether a business operates as an online pharmacy or in any other capacity. Particularly relevant to online pharmacies are the following requirements:
- Online pharmacies cannot sell prescription medications unless “the online pharmacy has a valid prescription for [the] controlled substance issued for a legitimate medical purpose in the usual course of professional practice by a practitioner who has conducted at least one in-person medical evaluation of the patient.”
- Online pharmacies can only lawfully operate if they are registered with the DEA and the applicable state agency in the state where the pharmacy is located.
- Online pharmacies must obtain separate registrations from the DEA and state agencies in all states where they sell prescription medications online.
- Online pharmacies must provide detailed notifications to the DEA at least 30 days before they begin selling prescription medications both online and in each state where they begin to operate.
- Online pharmacies must disclose the following information on their websites in a readily accessible and visible location:
- Name and address as it appears on the pharmacy’s DEA registration;
- Name(s) and professional title(s) of the pharmacy’s principal owner(s) or pharmacist in charge;
- Name(s) and professional title(s) of all practitioners contracted to provide consultations or issue prescriptions;
- A telephone number for patients to contact the pharmacy;
- A disclaimer stating that the pharmacy will dispense medications based on prescriptions or a “consultation” with a contracted physician; and,
- An electronic version of the DEA registration certificate for the pharmacy.
Again, these are just select examples of the numerous requirements that apply to selling prescription drugs online under the provisions of the Ryan Haight Act. If pharmacy owners or other entities fail to comply with any of these requirements, they can be at risk for criminal prosecution under the CSA.
What Penalties Are On the Table for Selling Prescription Drugs Illegally Online?
Criminal violations of the CSA carry substantial fines and potential prison time. The fines and prison time imposed under the CSA depend on the circumstances involved in the alleged offense. For online pharmacies and other entities accused of selling prescription medications illegally online, critical factors will likely include:
- The number and types of violations;
- The amount of revenue generated through illegal sales;
- The number and types of controlled substances sold;
- Any harm resulting from the illegal distribution of dangerous or counterfeit drugs (including fatal and non-fatal overdoses); and,
- When the violations occurred and how long the violations continued.
Based on these and other factors, online pharmacy owners and other business owners could face charges for violations of Section 841, 843(b), and/or 846 of the CSA. Currently, this is what these three provisions say about the criminal penalties for controlled substance violations:
§ 841: Prohibited Acts A
Section 841 of the CSA provides that it is unlawful to dispense, distribute, or possess with intent to dispense or distribute any prohibited or counterfeit controlled substance. The penalties for Section 841 violations are set forth in 21 U.S.C. § 841(b). In cases that do not involve Schedule I or II narcotic substances and do not involve death or serious bodily injury, the penalties can include a fine and up to 20 years of imprisonment for a first offense. For a second offense, the penalties can include a $2,000,000 fine and up to 30 years of imprisonment.
§ 843(b): Unlawful Acts
Section 843 of the CSA generally prohibits any person from engaging in any transaction that involves any prohibited controlled substance. As a result, even if online pharmacies and other entities selling prescription medications online do not physically possess drugs that they sell, they can still face prosecution under the CSA. The penalties for violating Section 843(b) are set forth in 21 U.S.C. § 843(d), and include a fine and up to four years of imprisonment for a first offense. For a second offense, prosecutors can seek a fine and up to eight years of imprisonment.
§ 846: Attempt and Conspiracy
Section 846 of the CSA allows for the prosecution of attempts and conspiracies to sell prescription drugs illegally online in addition to successful online transactions. As a result, even if federal agents or healthcare fraud investigators stop an operation before a business or individual sells prescription medications to patients online, they can still face the same penalties as if they had completed millions of dollars’ worth of transactions. Under Section 846, if a person or entity attempts or conspires to commit any other criminal offense under the CSA, then the person or entity can face the same penalties as would apply if the offense had been successfully perpetrated.
What Constitutes an “Online Pharmacy”?
While the Ryan Haight Act and CSA generally target sales of controlled substances by pharmacies, the CSA’s criminal penalty provisions potentially apply to other business owners and executives as well. There are a couple of reasons why this is the case.
First, the definition of an “online pharmacy” under the Ryan Haight Act is extremely broad. Under the law, “[t]he term ‘online pharmacy’ [includes] a person, entity, or Internet site, whether in the United States or abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or dispense, a controlled substance by means of the Internet.” This means that businesses and individuals that supply controlled substances for sale online can face prosecution under the CSA, even if they are not registered with the DEA or state authorities as pharmacies.
Second, even if a business or individual does not sell prescription medications online, in many cases it will be possible for prosecutors to pursue CSA conspiracy charges as a result of their role in an illegal online transaction. The possibilities here range from marketing and logistics companies that facilitate unlawful online sales to individual practitioners who write inappropriate prescriptions.
What Defense Strategies Are Available in Online Pharmacy Cases?
Given the breadth of potential application of the CSA’s criminal penalty provisions, there are a multitude of potential defense strategies that businesses and individuals can use to challenge federal charges. With that said, effectively challenging federal charges requires a customized defense strategy based on the specific facts of the case at hand. For example, a prosecution involving an online pharmacy accused of operating without DEA registration will warrant a different approach from a prosecution involving a medical professional accused of writing prescriptions without conducting in-person exams.
While specific defense strategies must be tailored to the specific facts of the case at hand, there are some general defense strategies that can be effective in many cases as well. These include:
- Lack of Intent – The CSA is an “intent-based” statute, which means that prosecutors must be able to prove intent in order to secure a criminal conviction. A lack of intent can serve as a defense to both culpability and sentencing.
- Procedural Errors – In many cases, it is possible to prevent prosecutors from using evidence obtained during an online pharmacy investigation. Effective defense counsel can do this by dealing with procedural errors that violate a business or individual’s constitutional rights.
- Statute of Limitations – The CSA’s statute of limitations imposes deadlines for filing criminal charges. If this has passed by the time the DEA and prosecutors execute their search and secure an indictment, this may serve as a defense in your case.
These are just a few examples of the defense strategies that are available in online pharmacy cases. If you are facing prosecution for violations of the CSA, it is imperative that you speak with an attorney as soon as possible.
Discuss Your Case with a Federal Defense Lawyer at Spodek Law Group P.C.
Are you under investigation or facing charges for selling prescription drugs illegally online? If so, we strongly encourage you to contact us promptly for more information.
