In this episode of Post-Scrip, Henry introduces Jenni Wai, RPh. , MBA, Josh Bolin and Christopher R. Smith, JD, LLM. They discuss the upcoming "Regulatory, Industry and Legal Perspectives on the Future of the DSCSA".

This presentation will provide an update on the final stages of implementation of the DSCSA and anticipated future regulatory efforts. We will begin with a brief high level overview of the DSCSA, including a summary of recent regulatory developments, such as any new regulations or guidance documents issued by the FDA in 2024 with regard to the DSCSA. We will then pivot to address the end of the one-year FDA stabilization period, recent feedback from the pharmacy industry regarding DSCSA compliance concerns, and the readiness of the pharmacy industry to fully implement and obstacles to implementation of the interoperable electronic exchange of transaction data.

We plan to include a discussion of the tools available to pharmacies to assist with compliance with DSCSA requirements as DSCSA implementation evolves. We will further discuss the challenges that state regulators face with regard to ensuring that dispensers, wholesalers and manufacturers comply with the DSCSA, particularly with regard to ensuring that stakeholders have robust processes for identifying, investigating and responding to suspect and illegitimate products.

Join us at the 35th annual conference: Developments in Pharmacy Law Seminar , November 7-10, 2024 in Phoenix, Arizona

In this episode of Post-Scrip, Henry introduces Marty Allain, JD. They discuss the upcoming "How Drug Manufacturer Restrictions and Recent Court Decisions are Re-Shaping 340B Drug Distribution and Delivery Models".

Pharmaceutical manufacturers continue to restrict the delivery of 340B drug discounts to contract pharmacies in response to the growth of 340B sales, perceived non-compliance with 340B program requirements, and statutory interpretation. These restrictions have a significant financial impact on hospitals, health centers, and other health care providers that participate as “covered entities” in the 340B program.

This presentation will also cover other “hot topics” with respect to 340B contract pharmacy arrangements, including the impact of the U.S. District Court Decision, Genesis vs. Becerra, rejecting a restrictive interpretation of “patient” under the 340B program.

Join us at the 35th annual conference: Developments in Pharmacy Law Seminar , November 7-10, 2024 in Phoenix, Arizona

In this episode of Post-Scrip, Henry introduces Amanda Ward, PharmD, MS, BCGP. They discuss the upcoming "DASPL Class II Capsule Projects".

As pharmacists continue to move beyond traditional roles in a dispensing pharmacy, state boards of pharmacy may have additional types of licensure pharmacists must have to perform those services. A review of all 50 states boards of pharmacy will reveal if the pharmacists must license their non-dispensing services as a pharmacy or if their licensure as a pharmacist is sufficient.

Join us at the 35th annual conference: Developments in Pharmacy Law Seminar , November 7-10, 2024 in Phoenix, Arizona