We provide counsel on FDA regulation and enforcement of OTC Drugs, including:
– Assisting with pre-launch compliance, including providing counsel on marketing products under OTC drug monographs, assisting with FDA-compliant labeling and reviewing ingredient and packaging issues
– Counseling on drug registration and listing
– Counseling on GMP matters, including managing third-party laboratory testing
– Counseling on post-market compliance
– Managing product recalls, including determining the possibility of limiting recall scope, FDA and consumer notifications, and recall termination processes
– Management of FDA inspections and responses to Warning Letters, untitled compliance letters, and Forms FDA-483
– Management of import detentions, import refusals, and requests for reconditioning
– Providing counsel on Import Alerts, including petitioning companies from removal from Import Alert, and other import/export issues
– Assisting with petitions for mitigation of liquidated damages assessed by U.S. Customs
– Assisting with import/export issues
Our experience includes representing domestic and international businesses, and import and export matters regulated by FDA, CBP, USDA, and EPA.
Representative OTC Drug Regulatory Experience
- Advised brand on OTC sunscreen formulation, testing and labeling requirements
- Provided counsel on FDA enforcement policies on hand sanitizer products during pandemic
- Responded to FDA-483 for OTC drug manufacturer
- Successfully avoided product recall of OTC drug products
- Counseled on FDA marketing requirements for skin protectants, pain relief products, and antifungal products in compliance with monograph requirements
- Supported development of FDA-compliant labeling
- Counseled on drug registration and listing requirements for various OTC drug manufacturers and distributors
- Counseled on GMP and inspection matters
Why Work With Us?
- Experienced and committed: While it helps that many of the products we advise on are ones we would use or recommend to friends and family, we are invested and care about you and the issues you are facing. We dedicate our resources to resolve your questions, and to help you reach the next peak.
- Responsive: We recognize that business happens quickly. We pride ourselves on being responsive to clients, and available when you need us, whether this means accommodating international time zones or strategizing for an unannounced FDA inspection.
- Client-focused: We focus on identifying the best legal and business solutions with your products and risk tolerance in mind.
- Partnership: We like to view our partnership as a long-term relationship, growing with you as an extension of your regulatory team.
- Specialized: Our practice is niche and our expertise is specialized. Chances are we have experience and the resources to address the regulatory questions keeping you up at night.
Over-The-Counter (OTC) Drugs clients include:
· Importers · Exporters · Manufacturers · Contract manufacturers · Distributors · Trade organizations