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Licensing Rules Prescription Drugs

Bass, Berry & Sims PLC

Illinois Board of Pharmacy Adopts New Licensure Requirement for Out-of-State Pharmacists-in-Charge

Beginning January 1, 2026, the Illinois Board of Pharmacy will require “out-of-state” (non-resident) pharmacies licensed or seeking licensure in Illinois to have a pharmacist-in-charge (PIC) who is licensed in Illinois....more

McCarter & English, LLP

New Jersey Regulatory Update Part II - February 2025

We continue our New Jersey Regulatory Update with this Part II, which focuses on regulations that were finalized in the second half of 2024 and impact healthcare. For example, as a continuation of price transparency efforts,...more

Goodwin

Massachusetts Pharmacy Board Now Accepting Nonresident Pharmacy License Applications Under New Licensing Regime

Goodwin on

As of January 1, 2025, the Massachusetts Board of Registration in Pharmacy (the Board) is accepting applications for nonresident pharmacy licenses. Massachusetts law has mandated licensure of out-of-state pharmacies...more

Hendershot Cowart P.C.

Major Changes to Texas Medical Board Rules: What Healthcare Providers Need to Know

Hendershot Cowart P.C. on

On January 9, 2025, the Texas Medical Board (TMB) implemented comprehensive changes to its rules, marking a significant shift in how medical spas, IV hydration clinics, and other healthcare facilities operate in Texas....more

Verrill

Prescription for Change: Massachusetts Pharmacies Undergo Regulatory Revamp

Verrill on

Pharmacies doing business in Massachusetts must act now – The Massachusetts Board of Registration in Pharmacy (the “Board”) has announced a series of new and long-awaited pharmacy licensure regulations that took effect in...more

Ropes & Gray LLP

Adapting to the IRA: Early Lessons Learned on the IRA’s Impact on Deal-Making, Drug Economics, and Business Strategy

Ropes & Gray LLP on

More than two years after the passage of the Inflation Reduction Act (“IRA”) and the Centers for Medicare and Medicaid Services’ (“CMS’”) rapid implementation of the drug price negotiation program, the life sciences industry...more

Smart & Biggar

Agile licensing amendments registered

Smart & Biggar on

Following consultation starting in 2022, on November 29, 2024, Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) were registered. These Regulations amend the Food and Drug...more

Smart & Biggar

Agile licensing amendments registered

Smart & Biggar on

Following consultation starting in 2022, on November 29, 2024, Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) were registered. These Regulations amend the Food and Drug...more

Polsinelli

Massachusetts Issues Additional Update to Non-Resident Pharmacy Rules

Polsinelli on

Following the release of a memo last month detailing upcoming regulations, the Massachusetts Board of Registration in Pharmacy released its long-awaited regulatory changes for non-resident pharmacy licensure last week by...more

McDermott Will & Emery

Massachusetts Implements Long-Awaited Licensing Regime for Out-of-State Pharmacies

McDermott Will & Emery on

Until recently, Massachusetts was the only state that did not maintain a licensing regime for nonresident pharmacies (i.e., out-of-state pharmacies shipping drugs into the state). On December 6, 2024, the Massachusetts Board...more

Quarles & Brady LLP

New York Passes Much-Anticipated Law Authorizing Pharmacy Shared Services Arrangements

Quarles & Brady LLP on

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

Quarles & Brady LLP

Are You Ready for Massachusetts Non-Resident Pharmacy Licensure?

Quarles & Brady LLP on

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

Quarles & Brady LLP

Kentucky Attorney General Determines Board of Pharmacy Lacks Statutory Authority to Regulate Non-Resident Pharmacists

Quarles & Brady LLP on

The Kentucky Attorney General published a formal opinion yesterday confirming that the Board of Pharmacy cannot require the licensure of pharmacists who reside outside of the Commonwealth of Kentucky. The proposed...more

Polsinelli

Florida Proposes New Pharmacy Benefit Manager Rules

Polsinelli on

On September 18, 2023, the Florida Office of Insurance Regulation (“OIR”) published proposed rules to implement provisions of the Prescription Drug Reform Act (Florida Senate Bill 1550) governing Pharmacy Benefit Managers...more

Foley Hoag LLP

FDA Releases First New COVID-19 Vaccine BLA Guidance Since 2020

Foley Hoag LLP on

Executive Summary - On October 19, 2023, the Food and Drug Administration (FDA) released a final guidance document titled Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry, providing...more

Akerman LLP - Health Law Rx

ACTION REQUIRED TO AVOID FINES! DEADLINE APPROACHING: Florida Pharmacy Benefit Managers Must Be Licensed as a Third-Party...

Pharmacy Benefit Managers (PBMs) take note! Under Florida’s new Prescription Drug Reform Act, PBMs must be licensed as an insurance administrator (also known as a third-party administrator, or TPA). Under this new law, any...more

Polsinelli

Third Party Administrator & Pharmacy Benefit Manager 2023 Newsletter: TPA & PBM Licensing And Compliance Developments

Polsinelli on

Florida OIR Issues Informational Memorandum OIR-23-04M to PBMs - On July 19, 2023, the Florida Office of Insurance Regulation (“OIR”) issued Informational Memorandum OIR-23-04M (“Memorandum”) to Pharmacy Benefit Managers...more

Quarles & Brady LLP

Nevada Legislature Rejects Board of Pharmacy’s Licensing Requirement for Out-of-State Pharmacists

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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

Akerman LLP - Health Law Rx

New Florida Law Will Impose A Third-Party Administrator Licensing Requirement for Pharmacy Benefit Managers

On May 3, 2023, the Florida governor signed a comprehensive law (SB 1550) regarding pharmacy benefit managers (PBMs). This new law imposes significant new requirements on PBMs. This article discusses only one of these new...more

Holland & Hart - Health Law Blog

Idaho’s New Virtual Care [Telehealth] Access Act

Idaho’s new Virtual Care Access Act (the “Act”) amends Idaho’s existing law to make it easier to render telehealth in Idaho effective July 1, 2023. The requirements of the new Act are summarized below....more

Goodwin

Five Key Regulatory Considerations for Virtual Ketamine Clinics

Goodwin on

The off-label use of ketamine to treat anxiety, depression, and other behavioral health disorders —coupled with the COVID-19 telehealth era—has spurred the opening of virtual ketamine clinics nationwide. Some clinics offer a...more

Quarles & Brady LLP

Georgia Board of Pharmacy Continues to Review Licensure Requirements for Pharmacists

Quarles & Brady LLP on

At the April 13, 2022 Georgia Board of Pharmacy meeting, the Board discussed changes to Chapter 480-36 which governs retail pharmacy remote drug order processing. The discussion was aimed at new verbiage that would require...more

Quarles & Brady LLP

Kentucky Board of Pharmacy Regulation Committee Proposes New Requirement of Licensure for All Out-of-State Pharmacists

Quarles & Brady LLP on

On March 15, 2022, the Regulation Committee for the Kentucky Board of Pharmacy reviewed potential amendments and proposed regulations governing non-resident pharmacy licensure in the state. Among the proposed changes is a...more

Foley Hoag LLP

Next Up: Uniform Licensure Standards for Wholesalers and Third-Party Logistics Providers

Foley Hoag LLP on

Key Takeaways: ▪️ FDA has published a proposed rule proposing national licensing standards for prescription drug wholesale distributors and third-party logistics providers as well as standards for third-party accreditation...more

Jones Day

FDA Proposes National Standards for Wholesale Drug Distributors and Third-Party Logistics Providers

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The FDA recently published a proposed rule to create national licensing standards for Wholesale Drug Distributors and Third-Party Logistic Providers....more

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