I am very excited to announce that Mazina Law has partnered with The California Society of Health-System Pharmacists (CSHP) to offer exclusive benefits for the members of the CSHP. I have previously heard a lot of praise to the CSHP’s annual seminars and their educational webinars and finally we will be a part of it.
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FDA postpones compliance with DSCSA for small dispensers. What does it mean for pharmacies?
Last week, many pharmacy and healthcare industry organizations sent announcements that FDA granted a two-year exemption to small dispenses for complying with the Drug Supply Chain Security Act (“DSCSA”). However, many pharmacies still have questions whether the exemption applies to them and how it affects them.
To remind, the DSCSA was enacted in 2013 with…
The second-largest criminal fine – $1.53 billion – levied against a pharmaceutical company
If you are following opioid litigation across the nation, you probably wouldn’t be surprised by another billion dollar settlement. But this latest case against Endo Health Solutions Inc. (Endo) is different. It is a criminal fine (not a settlement) with criminal forfeiture. The degree of culpability and burden of proof is very different from the…
Updates on California’s proposed PBM bill
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.”…
You are invited to DIR reform update
K&B Pharmacy group is hosting a DIR reform discussion featuring insightful speakers and guests. If your pharmacy is located in Northern California, we would love to see you and discuss the current state of pharmacy affaires. For more information please contact K&B Pharmacy group.
DIR Reform: what you need to know
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 – PBMs) responsible for reporting true and accurate drug prices to the CMS have used…
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 marijuana access. As far as I know, it is the only state that specifically allows…
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 must be fully compliant, what enforcement vehicles are in the government arsenals, and what types…
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 2024 (still unclear when exactly), there will be no more retroactive DIR fees. Currently PBMs…
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. In the episode, Mike Koelzer interviewed Melinda Su-En Lee – a co-founder of Phill Box…