On August 21, 2025, the Mayor of Long Beach approved an ordinance requiring staffing for self-checkout at drug retail establishments and grocery stores. The ordinance will go into effect on September 21, 2025, the 31st day...more
On July 12, 2024, the FDA provided small dispensers—those employing 25 or fewer full-time pharmacists or pharmacy technicians—with an exemption from the Drug Supply Chain Security Act’s (“DSCSA”) enhanced drug distribution...more
On October 9, 2024, the Food and Drug Administration (“FDA”) issued a document that provides exemptions to the enhanced drug distribution security requirements (enhanced requirements) required by section 582(g) of the Food,...more
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
In 2020, over 142 million prescriptions for opioid medications were filled in the U.S. That same year, 16,416 people died from overdoses on prescription opioids—a 376% increase from 1999....more
On September 13, the Alaska Board of Pharmacy (Board) issued a notice summarizing a regulatory update stating that pharmacies, wholesale drug distributors, outsourcing facilities, third-party logistics providers, and...more
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
On Friday, August 25th, the Food and Drug Administration (“FDA”) issued a guidance document extending the November 27, 2023 enforcement deadline for drug and device manufacturers, wholesale distributors, dispensers, and...more
On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more
On February 17, Daniel Russo, a Long Island resident, pleaded guilty in federal court in Brooklyn to multiple charges in connection with illegally distributing oxycodone. Russo faces decades in federal prison when he is...more
In one year (plus a few days, as of this writing), regulation of the U.S. drug supply chain will be historically changed. On November 27, 2023, the final phase of the Drug Supply Chain Security Act (DSCSA) goes into effect....more
While critics keep throwing up a false narrative about “ambulance chasing,” self-enriching lawyers, their labors and the civil legal system have proven yet again their effectiveness in wringing financial justice for those...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
On May 3, 2022, the Texas Board of Pharmacy reviewed proposed amendments to its Central Fill Rule, 22 Tex. Admin. Code § 291.125, and voted to send the revised language for final adoption in the next Board meeting tentatively...more
Since our last update, the Senate confirmed Dr. Robert Califf as commissioner of the U.S. Food and Drug Administration. The FDA resumed domestic and foreign inspections. The agency also published a proposed rule to update...more
A federal court in Delaware recently determined that the Health Resources and Services Administration (HRSA) – the federal agency responsible for administering the 340B drug pricing program – did not comply with the...more
The regular folks who make up juries may give more heed than judges and justices do to the how and why of patients’ push for justice in the civil system, as has been shown in yet another bellwether decision involving major...more
Earlier in the summer, the FDA issued a quartet of guidance documents setting forth the Agency’s plan for implementing requirements under the Drug Supply Chain Security Act (DSCSA). The DSCSA directs FDA to build an...more
For most Florida prescribers whose licenses haven’t renewed since 2019, it’s time to commence electronic prescribing. In 2019, the legislature enacted legislation that required electronic prescribing. However, this...more
Health workers with legal prescribing privileges have gotten newly revised federal guidelines — once again — making it easier for them to help those addicted to powerful opioid painkillers by prescribing buprenorphine,...more
On March 16, 2021, the United States District Court in Indiana granted plaintiff Eli Lilly’s request for a preliminary injunction to halt implementation of a Department of Health and Human Services (HHS) rule published in...more
The United States Department of Justice (DOJ) recently announced the nation’s largest settlement involving allegations of drug diversion at a health care system. The settlement, totaling $7,750,000, came after a years-long...more
The opioid abuse and drug overdose crisis has tarred yet another of the nation’s business titans: McKinsey, a globally renowned consulting firm, has discovered that providing corporate clients sketchy advice about addictive,...more
In Washington: A group of 10 GOP senators unveiled an estimated $618 billion coronavirus relief proposal on Monday ahead of a meeting with President Biden to discuss relief legislation. The group will meet with Biden and Vice...more
The Justice Department handed Walmart a huge slap in the face last year with the filing of a comprehensive civil case alleging that Walmart knowingly distributed large quantities of opioids in disregard of the law that fueled...more