Ilisa Bernstein on LinkedIn: 2024 Traceability Webinar Series | Healthcare Distribution Alliance (2024)

What does the pharmacy law landscape look like in a post- Chevron/Loper Bright regulatory environment? Join Stephanie Trunk, Hunter DeKoninck, Kala K. Shankle, and me on 8/13/24 as we discuss the implications on FDA, CMS, and DEA. Webinar sponsored by the American Society for Pharmacy Law. CPE and CLE are offered!https://lnkd.in/eSGTMeTw

39

2 Comments

Well said Josh Bolin and National Association of Boards of Pharmacy. All pharmacies/dispensers and other drug supply chain trading partners should read this to understand if they should file a request for a waiver or exemption from certain DSCSA requirements, and what to do if they aren’t ready to comply by this November. FDA recommends that requests be filed by August 1, 2024.

23

1 Comment

Yes…pharmacy law is fun! Thanks to for inviting me to speak at their 10th Annual Pharmacy Law Symposium. Enjoyed chatting with Edward Rickert on a panel about “Current Pharmacy and Regulatory Issues and Insights” and catching up with Roger Morris RPh, JD. I’ve had the honor of being in these pharmacy law leaders’ circle for nearly 3 decades.

143

1 Comment

Thanks to the Reagan-Udall Foundation for the FDA for inviting me to speak on addressing false and misleading online promotion and sale of ketamine and being a part of the robust and informative discussion on ketamine use. Susan Winckler and her team at the FDA Foundation are top notch!

47

2 Comments

I am excited to share that I have launched Bernstein Rx Solutions, LLC, a consulting firm assisting clients in understanding and maneuvering through drug and pharmacy regulatory policy and compliance issues, strategies, and advocacy. I am capitalizing on my over 35 years of experience and expertise in the government, non-profit, and private sectors in achieving successful outcomes and advancing innovation. I will cherish my nearly 5-year tenure at the American Pharmacists Association, leading the organization as the 14th CEO and EVP and as SVP, advocating for pharmacy, pharmacists, and patients. Still, it was time to move on and start anew! I am tapping into my pharmacy and legal roots and over 30 years at FDA and will continue to move the ball to improve public health and ensure patient safety. Thanks to all who have supported me, and I look forward to continuing to partner with you! I’m happy to chat about my new venture!

752

357 Comments

Independent pharmacies…FDA just granted an exemption to small dispensers (pharmacies), and where applicable their trading partners, until November 27, 2026. This provides small dispensers additional time to stabilize their operations to fully implement the enhanced drug distribution security requirements of the Drug Supply Chain Security Act (DSCSA). Thanks FDA for listening to our pleas. Much needed and much appreciated!#DSCSA #FDA https://lnkd.in/eBugQhJC

64

6 Comments

Read this article. Thanks Katherine Eban.Although our nation’s drug supply may be among the safest in the world, vulnerabilities exist. For patient safety, the entire drug supply chain must be vigilant and move toward full implementation of the Drug Supply Chain Security Act. #DSCSA#forpharmacy

43

5 Comments

Congratulations CAPT Connie Jung, RPh, PhD on your retirement after 24 years of service in the Commissioned Corps of the U.S. Public Health Service and the FDA. You made a tremendous impact on securing our nation’s drug supply and assuring patient safety, and through deployments and other assignments, you enhanced public health. I’m proud and grateful to be your friend, colleague, and mentor. Enjoy some well deserved time off!

290

57 Comments