On November 22, 2024, the Governor of New York signed into law a closely watched bill that expressly authorizes pharmacy shared services arrangements in the state. These models were not previously addressed in New York’s...more
12/2/2024
/ Healthcare ,
Licensing Rules ,
New Legislation ,
New York ,
Pharmaceutical Industry ,
Pharmacies ,
Policies and Procedures ,
Prescription Drugs ,
Product Labels ,
Regulatory Reform ,
Service Agreements
On November 19, 2024, the Massachusetts Board of Registration in Pharmacy (the “Board”) published several memoranda that described the impending non-resident pharmacy licensure requirements and the anticipated timeline for...more
In a previous update, Quarles discussed a new Alabama law that requires individuals serving as the designated representative for an Alabama-licensed facility to register with the Alabama Board of Pharmacy ("the Board”) as of...more
12/15/2023
/ Alabama ,
Drug Distribution ,
Healthcare ,
Healthcare Facilities ,
Licensing Rules ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Registered Representatives ,
Regulatory Requirements ,
Third-Party Service Provider
On May 31, 2023, the Nevada Legislature enacted Assembly Bill 107, which reversed the Nevada Board of Pharmacy’s (the “Board”) interpretation that required Nevada pharmacist licensure for out-of-state pharmacists who dispense...more
On February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay...more
5/17/2022
/ Change of Ownership ,
Comment Period ,
Drug Distribution ,
DSCSA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Licensing Rules ,
Life Sciences ,
Logistics ,
Pharmaceutical Industry ,
Pharmacies ,
Preemption ,
Regulatory Requirements ,
Supply Chain ,
Third-Party Service Provider ,
Wholesale