Post Scrip: The ASPL Pharmacy Law Podcast American Society for Pharmacy Law (ASPL)

In this episode of Post-Scrip, Henry introduces Jeanne M. Brennan, BS Pharm, JD, and, William J. Stilling, BS Pharm, MS, JD.  They discuss the upcoming Semaglutide as a Case Study for Compounding Legal Issues and Barriers

Semaglutide provides a case study for pharmacists who are trying to meet patient and prescriber needs and who strive to comply with federal and state laws and the explosive demand for semaglutide has created opportunities and risks. This demand has created a nationwide shortage of Ozempic and Wegovy. State boards of pharmacy are responding to complaints against pharmacists who are compounding semaglutide.

Obesity has been a national health epidemic for years. There is an insatiable hunger for weight loss solutions. Americans want to lose weight. Semaglutide appears to be the newest wonder weight loss drug. Patients and prescribers are touting its effectiveness on social media. The New England Journal of Medicine published a study in 2021 that has provided credibility to the weight loss industry. There are also the STEP trials providing dosing guidelines for weight loss.

Join us at the 34th annual conference:  Developments in Pharmacy Law Seminar , November 2-5, 2023 in San Antonio, Texas

In this episode of Post-Scrip, Henry introduces Mary Canavan, JD and Kyle A. Vasquez, JD, LLM. They discuss the upcoming 340B Program Preservation and Compliance.

In this session, participants will learn how use the 340B statute and guidance to preserve 340B savings. In a climate where manufacturers and payors are uniformly taking action that harms covered entities (and patients), covered entities need to be prepared and start adapting. While manufacturer restrictions have been at the forefront of the 340B industry recently, there are several other stakeholders that are also taking actions that harm 340B savings such as PBMs. 

As a result of these actions restricting the use of 340B drugs, covered entities have to become creative with how they internally build out their 340B programs, but due to the limited guidance available, the focus on compliance is more important than ever. This session will walk covered entities through case studies that demonstrate how other covered entities are becoming innovators and adjusting their 340B operations to preserve 340B savings. These models assess several areas of compliance, including: 340B, reimbursement, scope of practice, and telehealth.

Join us at the 34th annual conference:  Developments in Pharmacy Law Seminar , November 2-5, 2023 in San Antonio, Texas

In this episode of Post-Scrip, Henry introduces Christopher R. Smith, JD, LLM. Henry and Chris discuss the upcoming. Drug Supply Chain Security Act Changes and Implications for Dispensers.

 The presentation will provide an overview of the enhanced drug distribution requirements under the DSCSA and DSCSA interoperable electronic exchange requirements starting in November 2023. Specifically, the presentation will discuss the transition to a fully interoperable electronic system for transaction data exchange at the drug package level and compliance requirements for dispensers.

 The presentation will further outline new statutory requirements regarding saleable returns and possible changes in government DSCSA enforcement following implementation of the 2023 changes. Finally, our presentation will list the features your pharmacy needs from a DSCSA solution provider, and list resources from the FDA and trade associations that will help ensure that your pharmacy complies with the DSCSA. 

Join us at the 34th annual conference:  Developments in Pharmacy Law Seminar , November 2-5, 2023 in San Antonio, Texas

In this episode of Post-Scrip, Henry introduces  Todd A. Nova, J.D. Henry and Todd discuss the upcoming Current Trends in Retail & Specialty Pharmacy Pricing Compliance: Balancing Opportunity and Risk.
The role that retail and specialty pharmacies play in the healthcare delivery system continues to increase in importance as the drug product pipeline continues its inexorable shift to more self-administered and home-infused drugs. This shift has not gone unnoticed by various pharmacy industry stakeholders.

 The speakers will also address related compliance investigation considerations, including the process for initiating and conducting compliance reviews under the attorney/client privilege and best practices for ongoing monitoring.

Join us at the 34th annual conference:  Developments in Pharmacy Law Seminar , November 2-5, 2023 in San Antonio, Texas

In this episode of Post-Scrip, Henry introduces  Marty Allain, JD. Henry and Marty discuss the upcoming Emerging Pharmacy Practice Innovation - A Regulatory and Legal Obstacle Course.

The session will discuss the emergence of new and non-traditional pharmacy business models that challenge current regulations and supporting legal foundations. Such models are often funded by venture capitalists and led by entrepreneurs who have been successful in other areas and view the pharmacy environment as a similar opportunity. 

Speakers Edward McGinley and Marty Allain have worked with a number of such start-ups and will share with participants their experiences with these new pharmacy strategies and efforts to bring technological and innovative operations to pharmacy. Inherent to the discussion will be the legal and regulatory requirements that serve as needed safeguards and, at times, barriers to change and implementation. Those attending the session will gain a better understanding of changes that are occurring within pharmacy practice and the impact of such changes on existing practices and legal and regulatory requirements.

Join us at the 34th annual conference:  Developments in Pharmacy Law Seminar , November 2-5, 2023 in San Antonio, Texas

In this episode of Post-Scrip, Henry introduces Jaya F. White and, JD, Edward D. Rickert, JD/Rph. They discuss the upcoming Infusion Pharmacy Services: Regulatory Considerations Impacting the Business Model.

This presentation will discuss infusion pharmacy services and the various business models in the industry, including physician, home, and ambulatory infusion suites. It will look at state law approaches on issues such as licensure, reimbursement/billing, consignment, depoting, and white bagging.

Join us at the 34th annual conference:  Developments in Pharmacy Law Seminar , November 2-5, 2023 in San Antonio, Texas