News & Analysis as of

Prescription Drugs Compliance Pharmacies

Mintz - Health Care Viewpoints

Will Sustained Pressure on the 340B Program Finally Lead to Much Needed Reform?

As we enter into the final months of 2024, new developments in the administration of the 340B Drug Pricing Program signal that additional reform may be on the way. Although recent revisions to the 340B program’s...more

Hinshaw & Culbertson - Health Care

Don’t Jeopardize Your License: Ensure Compliance With California State Board of Pharmacy Notification and Reporting Obligations

Pharmacies, wholesalers, third-party logistics providers, outsourcing facilities, clinics, and pharmacists must obtain the California State Board of Pharmacy’s (the “Board”) approval or otherwise notify the Board about...more

Health Care Compliance Association (HCCA)

340B Drug Pricing Program Compliance

The 340B Drug Pricing Program was created to protect safety net hospitals from rising drug prices. It allows them to purchase outpatient drugs, and pharma companies to sell those drugs, at a discount. In this podcast, Jason...more

Gardner Law

FDA Issues Numerous Warning Letters

Gardner Law on

The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more

Smart & Biggar

PMPRB publishes scoping paper for consultation on guidelines, and invites stakeholder feedback

Smart & Biggar on

As we have previously reported, the Patented Medicine Prices Review Board (PMPRB) announced that it will launch the first phase of consultations on new guidelines. On November 10, 2023, the PMPRB published its Scoping Paper...more

Oberheiden P.C.

The Importance of a Pharmacy Compliance Program

Oberheiden P.C. on

As federal agencies and law enforcement investigate pharmacies around the country for health care fraud and kickback schemes, pharmacies should be proactive in understanding their regulatory environment and the importance of...more

Foley Hoag LLP - Medicaid and the Law

The 340B Contract Pharmacy Saga Continues

Donald Trump extended two directives restricting the admission of certain immigrants and nonimmigrants to the U.S. Specifically, Presidential Proclamation (PP) 10014 restricting the admission of first-time immigrants and PP...more

Troutman Pepper

EPA'S Hazardous Waste Pharmaceuticals Rules May Impose Significant Burdens on Health Care Facilities - Comment Period Runs Until...

Troutman Pepper on

The Environmental Protection Agency (EPA) has promulgated its proposed regulation of “hazardous waste pharmaceuticals,” i.e., pharmaceutical residues discarded from health care facilities which also meet EPA’s long-standing...more

Holland & Knight LLP

HHS Issues Proposed 340B Program Omnibus Guidance: Five Things to Watch

Holland & Knight LLP on

The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more

BakerHostetler

340B Guidance: Eight Key Points Covered Entities Should Consider

BakerHostetler on

On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to...more

Ballard Spahr LLP

EPA Proposes New Rules for Pharmaceutical Hazardous Waste Management and for Other Hazardous Waste Generators

Ballard Spahr LLP on

The U.S. Environmental Protection Agency (EPA) has announced two new proposed hazardous waste rules that EPA believes would clarify and simplify requirements for health care facilities and retail pharmacies to manage their...more

K&L Gates LLP

HRSA Issues 340B Program Omnibus Guidance

K&L Gates LLP on

On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more

Baker Donelson

HRSA Issues Long-Awaited 340B Program Omnibus Guidance Proposal

Baker Donelson on

After much anticipation, the Health Resources and Services Administration (HRSA) late last week released its 340B Drug Pricing Program Omnibus Guidance Proposal (the Proposal). HRSA indicates that its goal in issuing the...more

BakerHostetler

Special Edition: Health Law Update: Senate Passes "Drug Quality and Security Act"

BakerHostetler on

On November 18, 2013, the Senate, by voice vote, approved the Drug Quality and Security Act (DQSA), intended to bolster the Food and Drug Administration's (FDA) oversight of compounding pharmacies in light of last year's...more

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