Over-the-Counter (OTC) and Pharmaceuticals Services

Overview

Over-the-counter (OTC) drug products are purchased and used without a prescription, making product quality, label accuracy, active ingredient performance and regulatory compliance essential to consumer confidence and brand protection. UL Solutions helps organizations evaluate products against applicable requirements, specifications, label claims and quality objectives throughout the product life cycle.

Our capabilities are designed to support:

• Active ingredient identity and strength verification 
• Product-release and ongoing quality decisions 
• Product stability and shelf-life programs
• Microbiological quality evaluation
• Drug Facts panel and label compliance reviews
• Comparative evaluations and benchmarking
• Product or packaging assessments

By combining analytical, microbiological, physical, sensory, stability, packaging and labeling expertise, we help customers develop testing strategies aligned with regulatory requirements, customer expectations and business objectives.

Why OTC drug testing matters

OTC drug testing plays an important role in supporting consumer protection, quality assurance and product performance.

Independent evaluation can help organizations:

• Verify active ingredient identity and strength against specifications and label claims
• Identify microbiological contamination, objectionable organisms, impurities and degradants
• Evaluate dissolution, disintegration and dosage-form performance
• Support product release decisions through analytical and microbiological evidence
• Assess stability and monitor product quality over time
• Review Drug Facts information, directions, warnings and labeling elements
• Support failure investigations, supplier monitoring and risk-based quality decisions

OTC testing capabilities

UL Solutions offers a broad range of OTC drug testing services, including:

Analytical chemistry

• Active ingredient assay
• Content uniformity
• Impurity analysis
• Dissolution, disintegration and rupture testing
• Release and stability testing support

Microbiology

• Microbial limits testing
• Cleanliness and pathogen screening
• Preservative effectiveness testing
• Microbiological testing support for stability programs

Labeling and regulatory support

• Drug Facts panel review
• Label compliance evaluation
• Regulatory guidance support
• Product claim substantiation support

Product quality and performance

• Physical characteristic testing, including pH, viscosity, weight and dimensional measurements
• Technical quality assessments against specifications or benchmark products
• American Society for Testing and Materials (ASTM) trained sensory judges
• Comparative product evaluations
• Benchmarking studies
• Product or packaging assessments

Benefits of testing OTC products with UL Solutions

UL Solutions helps organizations make informed decisions across the OTC product life cycle by providing independent, objective data that can support:

• Consumer protection initiatives
• Regulatory and good manufacturing practice (GMP) readiness
• Product release decisions
• Stability and expiration-dating programs
• Retailer acceptance and specification reviews
• Failure investigation and corrective-action activities
• Supplier oversight and risk management
• Brand protection and consumer confidence
• Private-brand differentiation and benchmarking efforts