By Bhavesh Desai, PharmD, J.D.
DIR fees have been a focus of debate since their implementation and for the past decade, they have been increasingly scrutinized in congress as well as at the state level. The companies (Pharmacy Benefit Manager
Latest from Mazina Law - Page 3
DEA warns (again) pharmacies of selling THC products
Even if your state has legalized cannabis products, it does not mean that your pharmacy can start selling them. This axiom has been tested and proven again and this time in Georgia.
Georgia took an interesting approach regarding expanding medical
Summary of recent USP changes and potential pitfalls for compounders
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
Tips on dealing with double DIR fees
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
Sustainability in Pharmacy. Possible?
“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.
You are invited: ASPL Pharmacy Law Conference
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
Rescheduling Cannabis? More possible than ever…
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
Changes in reporting loss/theft of controlled substances
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
Who needs to sign refill authorization? A lesson from a recent PBM audit
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,
Upcoming Changes to the DSCSA – what do pharmacies need to start doing now?
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]:
- Product identification