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Alabama Stream of Commerce Regulation
Alabama Stream of Commerce Regulation Written-by: Michael Crow, Compliance Attorney In 2017, Alabama changed many items regarding the Board of Pharmacy. Most changes were for brevity or vocabulary. But from a compliance perspective the largest impact of the Act was on...
Recent Articles
Puerto Rico’s Regulation of the Drug Supply Chain: Past, Present and Future
Puerto Rico became a U.S. territory over 100 years ago after the conclusion of the Spanish-American War. As a territory that is still citing laws passed as early as 1912 to regulate the pharmaceutical supply chain, there are many nuances to ensuring compliance when doing business on the island.
Market Viability of Canadian Importation
Drug Importation has been a longtime coming. The law that developed a framework for importation of prescription drugs originally became effective in January 2012 but over 7 years later, not much has been done. In September 2018, Vermont passed a bill SB175 (read our article on it here) which had specific challenges: DSCSA compliance, Diversion, Manufacturer tactics, Politics, Quality concerns, Relabeling costs, just to name a few.
A Generic Manufacturer’s Current Pressures and Opportunities
Consolidation of purchase power in the past 20 years has dramatically changed the landscape for generic manufacturers; and recent events are making it worse: active prosecution for price-fixing, the FDA recently announcing a wave of unannounced FDA audits, and blame for the Opioid Epidemic. So what is a generic manufacturer to do? There are opportunities still available for a generic manufacturer to increase their top and bottom lines.
New York Opioid Tax & Minnesota Regulatory Fee Changes
New York Opioid Tax & Minnesota Regulatory Fee Changes As the changes to state laws per DSCSA continues to sweep the country, the Opioid...
10 Key Takeaways from the 2019 Controlled Substances Summit
10 Key Takeaways from the 2019 Controlled Substances Summit ACI Controlled Substances Summit 1. Suspicious Order Monitoring ("SOM") Systems: DEA...
Could OptumRx’s 2016 Requirement Be a Quid Pro Quo Arrangement?
Could OptumRx’s 2016 Requirement Be a Quid Pro Quo Arrangement? The ongoing legal case has shed new light on the motivations behind, and the...
