OTC Drug & Dietary Supplement Testing Services | USP Compliance & Quality Verification

Over-the-counter (OTC) drug and dietary supplement manufacturers face intense regulatory scrutiny from the FDA, state agencies, and retailers. A single contamination incident, inaccurate label claim, or failed USP test can trigger recalls, warning letters, and lasting damage to brand reputation. Bureau Veritas Consumer Products Services offers comprehensive dietary supplement testing services and OTC drug testing laboratory capabilities that help brands navigate compliance requirements with confidence.

THE CHALLENGE

Meeting FDA and USP Standards for OTC Drugs & Dietary Supplements

OTC drug and dietary supplement brands operate under stringent FDA regulations and United States Pharmacopeia (USP) standards. Manufacturers must verify that active ingredients and supplement ingredients match label claims for identity, purity, strength, and composition. Products must meet USP microbiological cleanliness limits and pass preservative challenge testing to prevent microbial contamination during shelf life.

At the same time, brands face growing pressure to screen for contaminants — heavy metals (lead, arsenic, cadmium, mercury), pesticide residues, and other chemical adulterants that can trigger FDA enforcement actions or state-level violations. Labeling compliance adds another layer of complexity: Federal and state rules govern ingredient disclosures, allergen warnings, structure/function claims, and supplement facts panels.

The consequences of non-compliance are severe: product holds, mandatory recalls, consent decrees, and loss of retailer shelf space. Brands need a trusted laboratory partner to validate quality, support regulatory submissions, and protect consumer safety.

BV SOLUTIONS

Bureau Veritas OTC Drug & Dietary Supplement Testing Services

Bureau Veritas provides end-to-end testing and compliance services for OTC drugs and dietary supplements at our Buffalo, New York location. Our analytical and wet chemistry laboratories utilize compendial monograph test methods and in-house validated methods to support product quality, safety, and regulatory compliance.

Active Ingredient Claim Substantiation & Verification

Our dietary supplement ingredient verification services validate that active ingredients and supplement ingredients meet label claims through rigorous testing:

  • Identity Testing
  • Purity Testing
  • Strength/Potency Testing
  • Composition Analysis

We apply compendial monograph test methods (USP, NF, FCC) and in-house validated methods tailored to your product matrix.

USP Microbiological Testing

We conduct USP microbiological testing  to verify microbial cleanliness and preservative system efficacy:

  • Microbial Limits Testing — screening per USP <60>, <61>, <62>
  • Microbial Enumeration — quantitative testing per USP <2021> and <2022> guidelines
  • Preservative Challenge Testing — validation of preservative system effectiveness per USP <51> to confirm products resist microbial growth during use and storage

Contaminant & Heavy Metals Analysis

Our supplement contaminant testing services screen for adulterants and toxic substances that pose consumer safety risks and regulatory compliance challenges:

  • Heavy Metals Screening
  • Pesticide Residue Testing
  • Chemical Contaminant Analysis

Labeling Compliance Review 

Our dedicated labeling compliance team reviews OTC drug and dietary supplement labels:

  • Federal & State Labelling Review

Allergen Claim Substantiation

We offer a comprehensive array of Elisa test options that can be applied to support the allergen claim disclosures on the product artwork. 

BENEFITS

Benefits of Partnering with Bureau Veritas

Regulatory Confidence

Navigate FDA and USP requirements with testing services that help verify compliance with ingredient identity standards, microbial limits, contaminant thresholds, and labeling regulations.

Brand Protection

Reduce the risk of recalls, warning letters, and reputational damage through rigorous ingredient verification, contaminant screening, and preservative challenge testing.

Retailer Acceptance

Meet the quality and safety documentation requirements of major retailers with third-party test reports and certificate of analysis (COA) packages.

WHY BUREAU VERITAS

Why Bureau Veritas for OTC & Supplement Testing

Bureau Veritas Consumer Products Services brings over three decades of experience in testing, inspection, and certification for consumer goods. Our Buffalo, New York laboratory offers analytical and wet chemistry capabilities tailored to the unique requirements of OTC drugs and dietary supplements.

35+

Years of CPS expertise

15

Global laboratories

100K+

Test reports annually

12K+

Technical specialists worldwide

Our Buffalo laboratory utilizes compendial test methods (USP, NF, FCC) and maintains ISO/IEC 17025 accreditation for key testing scopes. We work with brands of all sizes — from emerging supplement startups to established OTC manufacturers — to deliver testing solutions that support compliance, quality control, and consumer safety.

Note: The Bureau Veritas Buffalo, New York location is not FDA-registered. If your services require FDA registration, our Milford, Ohio and Knoxville, Tennessee facilities are FDA-registered and ready to assist. Contact us for details.

GET STARTED

Ready to Validate Your OTC Drug or Dietary Supplement?

Contact our OTC drug and dietary supplement testing specialists to discuss your ingredient verification, USP compliance, and contaminant screening needs.