Late last week, the Massachusetts Board of Registration in Pharmacy (“BOP”) issued a reminder that it intends to begin requiring non-resident pharmacies to obtain a Massachusetts’s non-resident pharmacy license to do business in the state. This requirement is expected to take effect in the next several months. Although Mass. Gen. Laws ch. 112, § 39J was enacted in 2014, to date the BOP has not enforced this requirement or otherwise provided non-resident pharmacies with details regarding the forthcoming licensing requirement process. While the communication issued last week did not provide greater specificity on the timing of licensing for pharmacies, it encouraged out-of-state pharmacies to begin the licensing process of their pharmacists, as the new rules will require at least one pharmacist—but not necessarily the pharmacist-in-charge—to be licensed in Massachusetts, a process that can take up to 60 days.
While the BOP has announced its intent to begin licensing non-resident pharmacies in the near term, it does not currently plan to implement a non-resident licensing process for wholesalers, distributors, 3PLs, or manufacturers. However, the BOP does maintain a registration procedure for 503B outsourcing facilities.
Historically, Massachusetts has not directly regulated nonresident pharmacies through a non-resident license or permit requirement. Accordingly, pharmacies duly licensed and in good standing in other states were not necessarily prohibited from mailing to patients located in Massachusetts.
If your pharmacy is currently shipping into or otherwise doing business in (or intends to do business in) Massachusetts based on a license in your home state, now is the time to prepare for the BOP’s new licensing process. One step is to ensure you have a Massachusetts licensed pharmacist on staff or are in the process of obtaining such licensure. This is critical because one of the most common issues that can lead to disciplinary action by a board of pharmacy, including now the Massachusetts BOP, is dispensing into a state without being properly licensed to do so. Another very common and related scenario leading to disciplinary action is a pharmacy inadvertently violating a newly implemented rule or regulation without knowledge of the rule or regulation taking effect. In these instances, pharmacies and other licensees will commonly believe that because the violation was inadvertent, and perhaps innocent, that the applicable Board will overlook the violation so long as the pharmacy promptly takes steps to resolve or correct the issue. However, it is well established that a lack of awareness, or ignorance of a law, is not a sufficient defense to these matters. This is especially true in the administrative agency setting, as with a board of pharmacy, where agencies are historically granted substantial authority and discretion to monitor and regulate the licensees operating in their state within the rules and regulations of the corresponding agency.
Given this background, it is critical that pharmacies doing business in Massachusetts take steps now to proactively comply with the applicable rules and regulations that will soon apply to non-resident pharmacies. If you require assistance with filing for the relevant application, or have questions about your pharmacy’s nonresident practices, contact Frier Levitt to speak with an attorney who can help.
