Health Law Daily Wrap Up, EXPERT INSIGHTS—Massachusetts Board Of Pharmacy To Take A Big Step: Licensing Nonresident Pharmacies, (Sep 20, 2024)
Organizations Mentioned:Holland & Knight, LLP
By Tayler Chambless and Ilenna Stein of Holland & Knight
Nonresident licensing procedure will implement almost decade old statute requirement.
In a move that could reshape the regulatory landscape for pharmacies servicing Massachusetts residents, the Massachusetts Board of Pharmacy has announced that it will soon begin licensing nonresident pharmacies and requiring at least one nonresident pharmacist to be licensed in Massachusetts, thereby finally establishing a procedure to implement a statute that has been on the books for almost 10 years. This decision marks a significant shift in how the Board oversees out-of-state pharmacies that ship and dispense drugs into the state. As a result, all pharmacies operating within its borders will be subject to regulatory oversight and required to adhere to the Massachusetts Board of Pharmacy standards.
Implications for Out-of-State Pharmacies Doing Business in Massachusetts
All states currently require out-of-state pharmacies that ship into their states to have a nonresident pharmacy license, but Massachusetts is the only state that has no mechanism for obtaining such a license. Since July 1, 2015, Massachusetts statutes (Gen. Laws ch. 112 §39J) have mandated for licensure for nonresident pharmacies, including both sterile and complex nonsterile compounding nonresident pharmacies. However, without implementing regulations, the process for securing a nonresident pharmacy license never went into effect. This will soon change as the Board is expected to adopt its draft regulations soon. On Aug. 30, 2024, the Board announced that "[t]he licensing of non-resident pharmacies will become available in the coming months" (emphasis added).
Nonresident pharmacies seeking to do or currently doing business in Massachusetts will have to navigate a new layer of state regulatory requirements going forward, which may cause disruption to operations if they do not stay informed of the new licensure requirements, as well as increase administrative and operational costs. In addition to initial licensure, nonresident pharmacies will be subject to periodic review as part of licensure renewal. Buyers and sellers of nonresident pharmacies conducting business in Massachusetts will also have to factor the licensure process into their transaction timelines and comply with any Board of Pharmacy change of ownership requirements.
Who Must Be Licensed?
The new Massachusetts Board of Pharmacy licensing requirements will apply only to nonresident pharmacies:
nonresident drug store pharmacies (retail)
nonresident sterile compounding pharmacies
nonresident complex nonsterile compounding pharmacies
The Board clarified in an FAQ document that it does not intend to license nonresident nondispensing pharmacies, wholesalers, distributors, third-party logistics providers or manufacturers. However, the Board already licenses nonresident 503B outsourcing facilities.
The Licensing Process The licensing process for nonresident pharmacies is expected to involve several key steps:
Application Submission. Nonresident pharmacies must submit a comprehensive application, including detailed information about the pharmacy's operations, staff qualifications and compliance with federal and state regulations.
Massachusetts Designated Pharmacist-in-Charge. Each nonresident pharmacy must have at least one pharmacist licensed in Massachusetts who serves as the "Designated Pharmacist-in-Charge" (PIC) responsible for compliance with Massachusetts pharmacy laws and regulations. While some states have a similar requirement for PICs, the majority of states do not, so pharmacies should take note and start planning in advance.
Inspection and Review. Nonresident pharmacies will have to submit to inspection from, and provide inspection reports to, a Board-approved inspector.
Ongoing Compliance. Licensed nonresident pharmacies will be subject to periodic review for ongoing compliance as part of the licensure renewal process.
Looking Ahead
The Massachusetts nonresident pharmacy licensing requirements are expected to take effect in the coming months, with detailed guidelines and application procedures to be outlined soon. Until licensure becomes available, nonresident pharmacies may continue dispensing medications into Massachusetts if licensed and in good standing in the pharmacy's home state. However, in preparation for obtaining pharmacy licensure, nonresident pharmacies and their pharmacists should commence the pharmacist licensing process as soon as possible. The Board currently anticipates that pharmacist licensure approval may take 30 to 60 days, but this timeline potentially could be extended depending on the volume of applications the Board receives. View pharmacist applications and instructions.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
Tayler Chambless and Ilenna Stein
Holland & Knight
10 St. James Avenue
11th Floor
Boston
MA 02116United States
Tel.: +1 617 5232700
E-mail: [email protected]
URL: www.hklaw.com/
(c) Mondaq Ltd, 2024 - Tel. +44 (0)20 8544 8300 - http://www.mondaq.com
ExpertInsights: NewsStory GeneralNews DrugNews DrugBiologicNews PrescriptionDrugNews