The 340B Program has continued to undergo significant upheaval in 2024 that has the potential to bring about impactful changes to how the 340B Program operates moving forward. These developments have left 340B stakeholders in...more
12/31/2024
/ Department of Health and Human Services (HHS) ,
Drug Pricing ,
Healthcare ,
HRSA ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Proposed Legislation ,
Rebates ,
Section 340B
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
Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts....more
3/14/2024
/ Drug Distribution ,
Drug Pricing ,
Food & Drug Regulations ,
Healthcare ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Agenda ,
Request For Information ,
Section 340B
In a decision likely to send shockwaves through the 340B Program space, the United States District Court of South Carolina recently provided a favorable ruling to 340B-participating covered entities hoping to take a more...more
11/7/2023
/ Drug Pricing ,
FQHC ,
Health Care Providers ,
Healthcare ,
HRSA ,
Life Sciences ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B
Although 340B-participating covered entities likely don’t need the reminder, numerous manufacturers continue to significantly restrict 340B pricing available via traditional “bill to/ship to” contract pharmacy models, with...more
9/20/2023
/ Drug Distribution ,
DSCSA ,
Food & Drug Regulations ,
Healthcare ,
Life Sciences ,
Manufacturers ,
Payor Contracts ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B ,
Suppliers ,
Supply Chain
Over the last few months the California Board of Pharmacy has been busy considering several changes to its current rules and how it regulates various entities under its purview....more
In a move signaling the increasing importance of pharmacists in the overall continuum of patient care, Rhode Island (RI) recently enacted new statutory language that expands pharmacists’ ability to administer medications...more
Retail chain pharmacies should be aware of California’s recent passage of SB 362, signed into law by Governor Gavin Newson late last month, and the potential impact of the law on how chains evaluate their pharmacy staff and...more
10/22/2021
/ Business & Professions Code ,
California ,
Life Sciences ,
New Legislation ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Quotas ,
Regulatory Standards ,
Retail Market ,
Retailers