Quick Take

PekCura Labs has been cited for the sale of unapproved new drugs via the internet, according to a regulatory notice (721709) issued on March 31, 2026. The action highlights the ongoing risks associated with medications distributed outside of standard regulatory approval channels.

Why It Matters

The availability of unapproved drugs online presents a significant safety concern for clinicians, as these products have not been evaluated for purity, potency, or clinical efficacy. Patients may turn to these unregulated sources for cost-savings or as 'alternative' therapies, potentially delaying necessary medical care or risking adverse reactions. For eye care professionals, awareness of these specific vendors is critical when reconciling patient medication lists and investigating unexplained treatment failures or unusual side effects.

Key Details

• The regulatory notice (721709) was issued to PekCura Labs on March 31, 2026.
• The core violation is the marketing and sale of 'unapproved new drugs' through online platforms.
• Unapproved drugs lack the rigorous safety and efficacy data required for legal distribution and have not been vetted for manufacturing quality.

Practice Implications

Clinicians should maintain a high index of suspicion when patients report using medications purchased from non-traditional online sources. It is advisable to specifically ask patients about any 'new' or 'alternative' drugs they have found online to ensure they are not inadvertently using unapproved products from PekCura Labs or similar entities that bypass standard safety oversight.

Who's Affected