Earlier this year, California Senator Scott Wiener (D-San Francisco) introduced SB 966 that would require PBMs doing business in California to be licensed and regulated. The objective is to curb PBMs anticompetitive practices  contributing to rising drug costs. The press release calls the effort “the most comprehensive regulation of PBMs yet attempted by any state.”

Since the new United States Pharmacopeia (USP) guidelines went into effect on November 1, 2023, I have been receiving many inquiries regarding their impact on compounders. Because the changes are fairly recent, compounders want to know how and when they must be fully compliant, what enforcement vehicles are in the government arsenals, and what types

The DEA’s administrative action against Truepill is what first prompted me to write this blog post. Initially, I thought “interesting,” but I deal with over-dispensing allegations on a daily basis, so I didn’t think of writing about it. Then I started digging into the bedrock of this case. And the Truepill case has morphed into

Safety-net providers play a critical role in delivering healthcare services in this country. Recognizing their importance and to help them face escalating drug prices, Congress created the 340B Drug Pricing Program back in 1992. The program, however, is currently undergoing significant changes and facing serious challenges.

On one hand, the program is challenged by drug

Effective July 1, 2022, California pharmacies providing auto-refill services must:

  • have a written policy and procedure describing the auto-refill program listing medications that may be refilled through the program;
  • obtain patients’ written consent to auto-refills;
  • provide a written notice to the patient summarizing the program and on how to withdraw from the program (such written