State Licensing Body Begins Issuing Notices to Nonresident Pharmacies Engaged in Compounding or Dispensing Prescription Drugs for Controlled Substances
It is common for a board of pharmacy to require a nonresident pharmacy to be licensed in its state before allowing that pharmacy to deliver, mail, or ship a prescription drug to any of its residents.
It also is becoming increasingly common for a board to require a pharmacist-in-charge to be designated and registered for a nonresident pharmacy to engage in such activity in that state. This process is understood by pharmacy practitioners engaged in cross-state dispensing and general pharmacy practice activity.
Recent actions by the Nevada Board of Pharmacy, however, are not common and are causing confusion and dismay.
After reviewing Nevada state law NRS 639.100(1)(a), the board has started issuing notices to nonresident pharmacies engaged in the pharmacy practice of compounding or dispensing prescription drugs for any controlled substance or “dangerous drug” for a Nevada patient.1
The supporting documents require any pharmacist engaged in such practice to pay a $250 annual registration fee to Nevada and to be subject to state oversight.2 This requirement goes beyond simply requiring a pharmacist-in-charge to register with the board. It applies to all pharmacists engaged in compounding or dispensing activities in Nevada.
It has long been understood that in Nevada only the nonresident pharmacy and a pharmacist-in-charge must be registered with the board. The turnabout by the board has been referenced in a recent opinion letter issued by the board’s general counsel. The July 22, 2021, letter makes clear that it is illegal for any pharmacist to dispense or compound a drug in Nevada unless that pharmacist is properly registered with the board. In addition to the financial burden for nonresident pharmacists paying the annual fee to Nevada, such pharmacists also will be subject to Nevada legal and regulatory oversight for any errors or omissions in their daily pharmacy practice. This appears to be the most extreme registration requirement that any state has undertaken when it comes to the breadth of licensing requirements for nonresident pharmacy professionals in that they are directly legally binding for a pharmacist or pharmacy when engaging in compounding or dispensing.
The board’s general counsel says that NRS 639.100(1)(a) states that it is not lawful for any individual to compound or dispense, or permit to be compounded or dispensed, any drug into the state unless the individual “holds the appropriate certificate, license, or permit” required by applicable Nevada law.1
If a pharmacist is dispensing into Nevada and is not licensed there, there is also the added complication that a third-party payer might not honor any claims submitted for reimbursement to the extent that it is alleged that the pharmacist was not engaged in the authorized practice of pharmacy because of not holding a valid license pursuant to Nevada law.
Many industry stakeholders have taken the position that the new interpretation by the board of its own statute is improper, and they are stunned that a longstanding statute is suddenly being interpreted in a materially different way. Further, stakeholders have voiced concern that this new requirement is onerous, unnecessary, and simply a way to generate revenue for Nevada. To obtain an independent opinion, the board recently asked the Nevada state attorney general (AG) to weigh in on whether the board and its counsel have properly interpreted the meaning of the statute. As of this writing, the board and industry are awaiting the issuance of an opinion letter from the AG’s office.
To ease the initial burden of licensure reciprocity, the board is offering applicants the option to obtain a temporary pharmacist registration request application, which can be found on the Nevada Board of Pharmacy website.1 This new temporary registration is intended to be valid for 6 months after issuance or until pharmacists can reciprocate licensure with Nevada from their home state, whichever occurs first.
Pharmacies and pharmacists should determine their staffing needs accordingly when dispensing into Nevada under the new interpretation of the laws by its board. Business decisions and to what extent they intend to comply with the new requirements should not be taken lightly, and consultations with legal counsel are needed to understand the benefits and risks of pursuing this new form of licensure requirement.
Because the landscape is evolving rapidly, stakeholders should take the time to analyze new developments frequently.
Ned Milenkovich, PharmD, JD, is cochair of the health care law practice at Much PC in Chicago, Illinois.
1. Nevada State Board of Pharmacy. Accessed October 8, 2021. https:// bop.nv.gov/
2. Meza N, Morris R, Rickert E, Zillmer K. Nevada to require out-of- state pharmacists that dispense or compound for Nevada patients to hold a Nevada pharmacist’s license. Quarles & Brady LLP. August 4, 2021. Accessed October 8, 2021. https://www.jdsupra.com/legal- news/nevada-to-require-out-of-state-9631666/