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
Due to the new Medicare Part D requirements effective the next year, direct and indirect remunerations (DIR) fees – that are so favored by PBMs – must be included and deducted from reimbursements at point-of-sale. In other words, starting with 2024 (still unclear when exactly), there will be no more retroactive DIR fees. Currently PBMs
“Climate change is the single biggest threat to our world and health.”The International Pharmaceutical Federation’s address to the WHO
A recent episode of “The Business of Pharmacy” podcast made me think about the environmental impact and sustainability of a pharmacy. In the episode, Mike Koelzer interviewed Melinda Su-En Lee – a co-founder of Phill Box
This year the American Society for Pharmacy Law (ASPL) is organizing its annual conference in San Antonio November 2-5. To register or to check out the schedule, please go to the conference website. Some of the highlights of the conference:
As many of you know, the U.S. Department of Health and Human Services (HHS) has recently recommended rescheduling marijuana from Schedule I to Schedule III under federal law.
The DEA has the final say here but a review of healthcare news shows that most commentators believe that the DEA will follow the recommendation and will
DEA regulations require DEA registrants to notify their local Field Division Office, in writing, of any theft or significant loss of any controlled substances within one business day of discovery of such. Registrants must complete and submit to their local DEA Field Division a DEA Form 106 regarding the theft or loss.
Prior to July
I recently assisted a pharmacy in a PBM audit where we had to address unauthorized refills. The PBM was recouping a substantial amount of money because a medical assistant was signing refill authorizations. While medical assistants often sign for refills, they need do so with their supervising prescriber’s credentials.
California law defines medical assistants as
The Drug Supply Chain Security Act (“DSCSA”) was enacted in 2013 with the goal of creating an interoperable electronic system to trace certain prescription drugs as they are distributed in the United States.
The DSCSA’s requires[1]:
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
