Specialty Pharmacy

In this short recording, Healthcare attorneys Wakaba Tessier and Erica Ash discuss a recent Department of Justice (DOJ) settlement involving a specialty pharmacy and its private equity owner. This case is significant because – not only did the DOJ name the compounding pharmacy and its two executives – but it also named the private equity firm that owned

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On June 1, 2019, the United States Pharmacopeia (“USP”) published the final revisions to its pharmaceutical sterile compounding standards (“chapter <797>”).  Chapter <797> sets forth standards for the preparation of compounded sterile medications to help ensure products are safe and effective and reduce risks such as contamination or incorrect dosing. The most recent revisions implement new standards and revise existing ones based on recent scientific and technological developments. The chapter <797> revisions also incorporate stakeholder input raised during the July 2018 to November 2018 public comment period, much of which concerned allergens, beyond-use dating, and the general ambiguity throughout the chapter.

The USP’s most recent revisions to chapter <797> are extensive and those who prepare compounded sterile products (“CSPs”) are advised to familiarize themselves with the new standards. Significant changes include:

On Tuesday, June 18, 2019, our team of legal professionals and industry experts hosted a Compliance Considerations for Pharmacy Sale or Acquisition Webinar that took a look at the regulatory pitfalls and problems that can arise in a pharmacy transaction.

The free on-demand recording will provide real-life examples of what to do – and not…

This year’s National Home Infusion Association (NHIA) conference kicked off with the 2nd Annual Sterile Compounding Forum. The well-attended track provided an overview of the state of sterile compounding, insight into the most common citations confronting sterile compounders, considerations for compliance and risks relating to compounding, background on how states and the FDA are implementing rules and regulations, including those involved in the delivery of home infusion products.

We are pleased to sponsor the NHIA conference and participate in the following activities:

If you happen to miss our NHIA Talk Infusion Webinar on Compliance and Risk Considerations for Compounding Pharmacies, please click on the link to enjoy a free on-demand recording.

Our program guides you through the current landscape and common compliance concerns in compounding. We will help you understand the focus of FDA and state…

The regulation of pharmacies at the state level might not be what Justice Louis Brandeis had in mind as an example of a “laboratory of democracy,” but for pharmacists and consumers, state-level policy-making can have important real-world effects and encourage efforts on the federal stage. Over the past twelve months a number of regulatory trends have played out that define the current operating environment for pharmacies, many of which are anticipated to continue in 2019.

On September 10, 2018, the federal Food & Drug Administration (”FDA”) released its revised draft standard Memorandum of Understanding (“MOU”) between states and the FDA addressing the interstate distribution of compounded drug products.  See 83 Fed. Reg. 175, 45631 et seq. (Sept. 10, 2018). The draft is the latest in the FDA’s decades-long effort to clarify state and federal roles in investigating and responding to complaints related to compounded drug products shipped between states.

In response to the deadly incidents with a compounding pharmacy in Massachusetts that is blamed for a meningitis outbreak that sickened more than 500 people and caused at least 36 deaths, potential federal legislation has been introduced in the U.S. House of Representatives.  Two bills have been introduced in the U.S. House of Representative that…