NABP Accreditation FAQs

Not federally, but many states require NABP accreditation for distributor licensure. Additionally, most manufacturers and trading partners will only do business with accredited distributors.

NABP Drug Distributor Accreditation is a nationally recognized credential that confirms a distributor meets stringent state and federal drug distribution standards. GTC Consulting guides companies through the application, documentation, and inspection process so you can earn accreditation and strengthen trust with regulators and clients.

• SOPs for ordering, receiving, shipping, returns, recalls, diversion prevention, SOM
• Facility security & storage conditions
• Recordkeeping & DSCSA compliance
• Staff licensing, training, background checks
• Compliance with state and federal licensure

• Comprehensive SOP manual
• DEA and state licenses
• Insurance documentation
• Ownership/organizational details
• Security system evidence
• Sample transaction records

The U.S. Pharmacopeia (USP) sets standards for drug quality, safety, and consistency. GTC Consulting provides USP compliance consulting to ensure your pharmaceutical processes, labeling, and handling meet USP standards while aligning with DEA regulations.

On average, 4–6 months, depending on company readiness, SOP quality, and corrective actions needed after inspection.

• Facility walkthrough (security, storage, quarantine)
• Recordkeeping accuracy
• SOP adherence in practice
• Staff training and knowledge
• Corrective action follow-up

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• • NABP Program Fees (Effective Dec. 18,2024):
    
    • Supply Chain Inspection (SCI): $7,900 (previously $7,000)
    • Drug Distributor Accreditation (DDA): $3,720 (previously $2,500)
    • Total 3-Year NABP Accreditation Cost: $12,500 (up from $11,500)
  • Consulting & Preparation Support (Typical Ranges):
    • Small distributors: ~$19,000–$29,000 + Expenses
    • Mid/Large distributors:</strong ~$29,000–$49,000 + Expenses

Note: NABP fees are paid directly to NABP. Consulting and preparation fees are separate and vary depending on company size, readiness, and project scope.

Typically 3 years, with reaccreditation required. NABP may also perform random inspections during the cycle.

• Generic/non-compliant SOPs
• Inadequate quarantine/returns procedures
• Insufficient security or environmental monitoring
• Incomplete staff licensure or training records
• Poor documentation of suspicious order monitoring

Getting started is simple. Contact us through our website or call our team to schedule a consultation. We’ll assess your needs, recommend tailored compliance solutions, and create an action plan that keeps your business secure, compliant, and inspection-ready.

Consultants provide:

• Gap analysis of compliance risks
• Custom SOP drafting and updates
• Mock inspection preparation
• Application and document review
• Real-time support during NABP review and corrective action