April 18, 2024

Strategic sessions: An Owner Summit recap

We kept most of our Owner Summit sessions short and sweet, but some of our Saturday topics were too meaty to cover in 30 minutes. Here’s a quick roundup of three sessions:


Compounding Cases: A Survey of Legal Action By and Against Compounding Pharmacies

A timely Owner Summit session this weekend included a survey on Legal Action by and against compounding pharmacies by Fagron’s Jay McEniry. Jay covered the following cases:

  • Athenex v. Azar
  • Allergan v. Sincerus
  • Nexus v. [Everybody] 
  • Hope v. Fagron
  • SCA Pharmaceuticals v. FDA
  • Absolute Pharmacy v. California BOP
  • Evexias Health Solutions v. FDA

The rulings in these cases will have serious implications on compounding practice today, covering legal issues such as the concept of implied preemption (whereby only the FDA has the right to enforce the FDCA), the appropriate regulatory procedures for Section 705(b) Notices, and the requirement of a state to have a basis in their state law before enforcing federal laws. Here are his slides with more details on the cases.  


Best Practice for Ketamine Compounding

Panelists Jack Korbutov, Peter Koshland, and Gina Besteman, all pharmacists experienced in dispensing compounded ketamine, discussed techniques to avoid diversion of the controlled substance, typical dosage and formulation bioavailability considerations, and typical “red flags” with prescribers and prescriptions.They also touched on documentation best practices, pharmacist corresponding responsibility, and favorite flavors. (One more time: Here’s the ketamine best practices document.)


How FDA Thinks

In this final Owner Summit session, Hyman, Phelps & McNamara attorneys Dara Levy and Karla Palmer discussed how FDA thinks about its bulks lists nominations, reviews, and claims and substantiation.They discussed the history of the 503A bulks list, the most recent update to the list made in September 2023, legal challenges to the list, and the various levels of evidence for substantiating claims about prescription drugs. You can find their slides here.