News
State Drug Price Transparency Reporting: Why Multi-State Compliance Is Becoming More Complicated
State drug price transparency reporting is becoming an increasingly important compliance consideration for pharmaceutical manufacturers, distributors, and compounding pharmacies. As more states adopt their own approaches to prescription drug pricing...
December Is Coming: Why State License Renewals Require More Than Checking a Box
For pharmaceutical manufacturers, distributors, 3PLs, and compounding pharmacies, the final months of the year can bring a familiar compliance challenge: state license renewals. As December approaches, companies operating across multiple states may be facing a...
How Secure Is Your Licensing Service Provider?
State licensing compliance involves more than keeping track of expiration dates. It also involves protecting the sensitive information behind every license application and renewal. Cybersecurity has become a critical consideration for companies across the...
National Pharmaceutical Licensing vs. State-by-State Licensing: What Companies Need to Know
For years, pharmaceutical companies operating across the United States have faced a familiar compliance challenge: there is no single license that allows a company to conduct every regulated pharmaceutical activity in every state. Instead companies must navigate a...
The Risk of AI in Pharmaceutical Compliance: Why Regulatory Judgment Should Stay Human
Artificial intelligence is quickly becoming one of the most talked-about technologies in the pharmaceutical industry. AI is being promoted as a way to analyze enormous amounts of information, automate repetitive tasks, improve efficiency, and help companies manage...
The Licensing Risks Hiding in Your Next Acquisition
In a pharmaceutical transaction, due diligence typically focuses on revenue, contracts, intellectual property, customers, employees, facilities, inventory, and financial liabilities. But there is another area that can quietly create significant risk after closing:...
The Rise of Compounding Pharmacies: Why Growth Is Bringing New State Licensing Challenges
For years, compounding pharmacies operated in a specialized corner of the pharmaceutical industry by serving patients whose medical needs could not be met by commercially available medications. Today, compounding has moved much closer to the center of the healthcare...
Alabama Raises the Stakes: Higher Penalties Signal a Tougher Era for Pharmaceutical Compliance
For pharmaceutical companies, a regulatory violation has always carried consequences. But in Alabama the potential financial consequences of discipline are about to become much more significant. The Alabama State Board of Pharmacy has adopted new civil penalty...
Regulatory Changes Do Not Stop at Your State Lines: Why Pharmaceutical Companies Must Continuously Monitor Compliance Changes Across Their Supply Chain
The regulatory landscape for pharmaceutical and medical device companies is not static. State boards of pharmacy, departments of health, controlled substance authorities, and other regulatory agencies are continually issuing new requirements, revising existing...