Opening a drug testing facility can be a rewarding opportunity especially as demand for workplace and healthcare-related testing continues to grow. But before you begin, one step is absolutely essential: FDA facility registration. It confirms your compliance, protects your credibility, and ensures the accuracy of your testing services.
This guide breaks the process down into simple, actionable steps so you can launch your facility with confidence.
Why FDA Facility Registration Matters
FDA registration proves your facility follows Good Manufacturing Practices (GMP) and meets strict quality and safety standards. It helps you:
Build trust with clients and partners
Ensure accurate, reliable drug test results
Protect your business from compliance risks
Operate legally within a regulated industry
Skipping FDA registration can damage your credibility and may result in penalties, delays, or legal consequences.
How to Open a Drug Testing Facility: Step-by-Step
Opening a facility requires planning, budgeting, and regulatory preparation. Here’s a simplified roadmap:
1. Define Your Business Model
Choose services: pre-employment testing, random testing, post-accident testing, etc.
Analyze your target market and competitors.
Prepare a business plan covering goals, revenue, and marketing strategy.
2. Secure Licenses & Certifications
Common requirements include:
State and local permits
CLIA certification
FDA facility registration
Any additional regional licensing needed for laboratory operations
3. Set Up Your Facility
Your location must offer:
Adequate space for sample collection and testing
Secure storage areas
Validated equipment
Strong quality control systems
4. Hire Qualified Staff
Recruit trained professionals such as:
Laboratory technicians
Medical technologists
Administrative support
Provide ongoing training to maintain compliance and ensure testing accuracy.
5. Build Industry Partnerships
Collaborate with:
Hospitals and clinics
Occupational health providers
Employers needing frequent drug screeningStrong relationships help build your client base.
6. Promote Your Facility
Use:
Digital ads
SEO content
Social media
Outreach to employers and healthcare professionals
Highlight strengths such as quick turnaround, accuracy, and compliance.
FAQs
What must the Statement of Identity include on a supplement label?
Every label must clearly state it’s a “Dietary Supplement” or use the ingredient name (e.g., “Calcium supplement”) on the principal display panel
What information is required in the Supplement Facts panel?
Labels must list serving size, ingredients (in descending weight order), amount per serving, and % Daily Value where established
How should proprietary blends be labeled?
Proprietary blends must list the total blend weight and all ingredients in descending order, with a footnote stating “Daily Value Not Established”
What ingredient list formatting is required?
Ingredients (including fillers, binders, excipients) must be listed immediately below the Supplement Facts or to its right, introduced by the term “Ingredients:”
Are there special rules for allergen labeling?
Yes. Under FALCPA, labels must identify major allergens like milk, soy, wheat, peanuts, shellfish, tree nuts, egg, and fish.
What FDA disclaimer must accompany claims?
Any structure/function or general wellness claim must include:
“This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”
What types of claims are allowed?
Labels may include:
Structure/function claims (e.g., “supports immune health”)
Nutrient content claims (e.g., “high in vitamin C”)
Health claims (only if FDA‑approved and backed by evidence)
What warnings and usage instructions are required?
Labels need warnings for known side effects or contraindications, directions for safe use, and contact details for reporting adverse events.
