October 15, 2024: FDA issues new DSCSA guidance
Major Stories
The FDA granted exemptions for certain trading partners and small dispensers.
The FDA announced exemptions for connected trading partners and small dispensers as the agency approaches the full implementation of the Drug Supply Chain Security Act. The agency granted these exemptions in order to avoid drug supply chain disruptions and to ensure that patients do not face delays in receiving their medication.
CNBC examined how the popularity of GLP-1 drugs has led to countries around the globe battling to keep counterfeit versions out and how easy it is for counterfeit and diverted versions to make their way into the hands of U.S. citizens.
What's the DSCSA? Find out in our 90 second video, or delve more deeply into the topic on our pharmacists page.
Domestic News
More Americans are living in pharmacy deserts. Cases involving pill presses in three states.
Pharmacies around the U.S. continue to shutter, leaving more and more Americans living in pharmacy deserts. Pharmacy owners point to low reimbursement rates from pharmacy benefit managers as one of the main drivers of these closures.
Six Texans received federal prison sentences for their roles in a drug trafficking organization that used a pill press to manufacture counterfeit pills that were sold to residents across the U.S. via the dark web.
A mother and son in Massachusetts received prison sentences for their roles in a North Shore drug trafficking ring that manufactured and distributed counterfeit pills containing methamphetamine and fentanyl.
Police in Chester County, South Carolina seized a pill press while executing a search warrant on a suspect’s home.
Two men pleaded guilty in federal court for their roles in a scheme that paid marketers kickbacks for generating prescriptions for specific compounded medications. One of the men, Safe Chain Solutions co-owner Adam Brosius, is also under indictment for allegedly using his company to purchase and distribute over $90 million worth of diverted and misbranded prescription drugs.
This 2-page summary explains the problem of PBM under reimbursements.
International News
Counterfeit drug manufacturing ring busted in Uzbekistan.
Customs officials in Uzbekistan’s Fergana Valley seized over 1 billion UZS (over $78,000 USD) worth of counterfeit medicine. Authorities seized the fake medicine from a private residence and a pharmacy.
Counterfeit medicine operation, Uzbekistan. Source: KUN.UZ