News & Analysis as of

Licensing Rules Regulatory Requirements Pharmaceutical Industry

Gardner Law

State Licensing Requirements: Are You Prepared?

Gardner Law on

Securing FDA clearance or approval is a major accomplishment for medical device and pharmaceutical companies, but it’s not the final step. Before selling your products in most states, you must navigate state licensing...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

Smith Anderson

Biotech Licensing Caselaw Update - 2024 Year in (Brief) Review

Smith Anderson on

Last year was a surprisingly big one for legal decisions impacting the biotechnology transactions and licensing space. Given that most biotech deals are subject to confidential alternative dispute resolution, it is unusual...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

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 & Schulte

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

McDermott Will & Schulte 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

Troutman Pepper Locke

Kentucky AG Checks the Board of Pharmacy’s Regulatory Power

Troutman Pepper Locke on

On November 12, the Kentucky attorney general (AG) issued a formal opinion, concluding that the Kentucky Board of Pharmacy lacks the authority to regulate nonresident pharmacists beyond what is specified in KRS Chapter 315....more

Quarles & Brady LLP

Are You Ready for Alabama’s New Designated Representative Requirements?

Quarles & Brady LLP on

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

McDermott Will & Schulte

Trending in Telehealth: November 8 – 14, 2023

McDermott Will & Schulte on

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...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

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

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

Quarles & Brady LLP

The Clock is Ticking: Comments to Proposed Federal Rules For Wholesalers and 3PLs are Due June 6th and Here’s What We Think

Quarles & Brady LLP on

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

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

Polsinelli

Pharmacy Benefit Managers Licensing and Compliance Developments

Polsinelli on

In response to calls for greater transparency in the prescription drug industry, 2021 continued a nationwide trend of increased state licensing and regulation of Pharmacy Benefit Managers (“PBMs”). In the last year, laws...more

Quarles & Brady LLP

Nevada Seeks Formal AG Opinion Regarding Licensure for Out-of-State Pharmacists

Quarles & Brady LLP on

At its August 31, 2021 meeting, the Nevada Board of Pharmacy moved to seek a formal opinion from the Nevada Attorney General Office regarding the legality of the requirement of all non-resident pharmacists who dispense or...more

Polsinelli

Third Party Administrator (TPA) Licensing and Compliance Developments - January 2020

Polsinelli on

In response to calls for greater transparency in the prescription drug industry, 2019 continued a nationwide trend of increased state licensing and regulation of pharmacy benefit managers (“PBMs”). In the last year, laws...more

18 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide