The 340B Drug Pricing Program (the Program) has long been a cornerstone for healthcare providers seeking to deliver affordable care to underserved communities. However, as the regulatory and compliance landscape evolves, stakeholders—including covered entities, pharmaceutical manufacturers, and pharmacies—must navigate an increasingly complex array of legal requirements and enforcement trends.
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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS
FDA’s recent focus on potentially harmful color additives in food products has expanded to the pharmaceutical sector. In May 2025, FDA issued a draft guidance titled Replacing Color Additives in Approved or Marketed Drug Products. This guidance signals FDA’s increasing attention to the use of colors in all consumable products, including both prescription and over-the-counter (OTC) drugs.