NABP - Distributor Compliance ToolsAccreditation and Inspections

Minnesota Board of PharmacyWednesday, July 24, 2019Bill Cover RPh and Gregg Jones RPh

Drug Supply Chain Security Act –Ten (10) Year Stepped Implementation

Nov 27, 2013 201520YY 20YY

DSCSA Enacted

Traceability Info ExchangeSuspect Product Investigation

Serialization of Products

2018

Verification

Full ImplementationTraceability Electronically –Package level

Nov 27, 2023

Serialized Product only to Dispenser

2019 2020

VAWDUpdates

NABP Services for Distributors

• Accreditation– Verified Accredited Wholesale Distributor (VAWD)– Criteria is Compliant with Federal Law (DSCSA) after updates

in 2014• Inspections – Assistance to States in providing:

– Uniform DSCSA compliance assessment of wholesale distributors

– Protection of citizens against the ongoing threats to our nation’s drug supply

NABP Services for Distributors• Accreditations and Inspections available for

States and Facilities: – Wholesale Distributors (including Virtual)– Reverse Distributors– Third Party Logistics Providers (3PLs)– Manufacturers– Repackagers– 503B (Outsourcer Facilities)

NABP Services for Distributors• Accreditation - VAWD

– Launched 2005, almost 15 years ago, to assist States with combating proliferation of counterfeit drugs.

– Covers prescription drugs and devices– 640+ Accredited Facilities– Located in 46 States and 1 Territory– 24 States recognize VAWD– Time to Accreditation based on preparedness of applicant and

willingness to comply with law and criteria. In general 6 – 9 months but as little as 2 – 3 when prepared.

Verified-Accredited Wholesale Distributors (VAWD)

NABP Services for Distributors

• Distributor Inspections– Launched 2019– Based on NABP’s long established expertise and

experience in protecting the nation’s drug supply through its Accreditation of Wholesale Distributors.

– Inspection Focus adopted from VAWD (see comparison)– Snapshot of Wholesaler’s operation at a point in time

Benefits of Inspection Program

• e-Profile Access– Inspection sharing across states– Aids boards of pharmacy in making informed licensure decisions

• Inspection Services– Uniform inspection program – Distributors

• Determine compliance with DSCSA, State licensing requirements

– Personalized state inspection projects

Facility e-Profile: License Dashboard

Facility e-Profile:Overview

Facility e-Profile: Apply to Programs

Benefits of VAWD Accreditation for Distributors

• e-Profile creation and maintenance• NABP industry recognition

–Competitive advantage• State recognition of VAWD• VAWD Expertise

– Staff and Surveyor Industry Experts–All Real Industry Work Experience

NABP Surveyors• There are currently 50+ surveyors located in 24 states• Our staff and surveyor and document reviewers’ backgrounds include:

– Distribution Managers for Major Manufacturers and Wholesale Distributors– Wholesale drug distribution and supply chain integrity experts– Boards of pharmacy and Distributor Regulation Officials - executive officers, board

members, compliance officers, and inspectors (current / retired)– Community pharmacy, hospital pharmacy, sterile compounding, nuclear pharmacy,

home infusion– Law enforcement, regulatory compliance, Federal Bureau of Investigations, Drug

Enforcement Administration, FDA-OCI, Secret Service, and Internal Revenue Service, including undercover work and criminal investigations for these agencies

– Military, Department of Health and Human Services, Medicare fraud, and prescription monitoring programming

VAWD Accreditation vs. Distributor Inspection ComparisonFocus Item VAWD

AccreditationDistributor Inspection

Application submitted to NABP with fee YES YES

Supplemental documents submitted to NABP YES YES

• Policy and Procedures Submitted YES NO

• Policy and Procedures Reviewed and Remediated YES N/A

• Drug Source list submitted and examined closely YES YES

• Records may be requested from Drug Source list YES Reviewed onsite

• License/Registrations verified YES YES

• Attestation of Compliance with VAWD Criteria YES NO

VAWD Accreditation vs. Distributor Inspection Comparison

Focus Item VAWD Accreditation

Distributor Inspection

Time from Application to survey/inspection Varies / 4-5 m < 90 days

Onsite Survey / Inspection YES YES

Survey/Inspection scheduled YES NO

Post-Survey / Inspection Remediation YES NO

Yearly information update and document submission YES NO

Survey/inspection documents available to State NO YES

VAWD Survey and Distributor InspectionOnsite Evaluation Areas

VAWD FOCUS AREA DISTRIBUTOR FOCUS ITEM

LAWS/REGULATIONS LAWS/REGULATIONS

REPORTING AND NOTIFICATIONS REPORTING AND NOTIFICATIONS

FACILITY LICENSES/PERMITS/REGISTRATIONS FACILITY LICENSES/PERMITS/REGISTRATIONS

POLICIES & PROCEDURES AND RECORD RETENTION POLICIES & PROCEDURES AND RECORD RETENTION

PERSONNEL PERSONNEL

AUTHORIZED TRADING PARTNER – SOURCES/VENDORS Authorized Trading Partner-Sources/Vendors

AUTHORIZED TRADING PARTNER – CUSTOMERS Authorized Trading Partner-Customers

VAWD FOCUS AREA DISTRIBUTOR FOCUS ITEM

IT SECURITY Security

QUALITY PROGRAM X

RECALLS Policies and Procedures and Record Retention

CRISIS OPERATIONS Facility

COMMON CARRIER (NA for Virtuals) X

FACILITY FACILITY

VAWD Survey and Distributor InspectionOnsite Evaluation Areas

VAWD FOCUS AREA DISTRIBUTOR FOCUS ITEM

FACILITY SECURITY (NA for Virtuals) Security

IN-BOUND PRODUCT AND RECEIVING (NA for Virtuals) In-Bound Product and Receiving

PRODUCT TRACING Product Tracing/Product Integrity

TEMPERATURE (NA for Virtuals) Temperature and Humidity

HUMIDITY (NA for Virtuals)

CONTROLLED SUBSTANCES (NA for Virtuals) Controlled Substances*

QUARANTINE (NA for Virtuals) Quarantine

* Finalizing Controlled Drug Items in next Version of Inspection Report – August 2019

VAWD Survey and Distributor InspectionOnsite Evaluation Areas

VAWD FOCUS AREA DISTRIBUTOR FOCUS ITEM

INVENTORY (NA for Virtuals) Inventory

ORDER FULFILLMENT AND SHIPPING (NA for Virtuals)

Order Fulfillment and Shipping

VAWD Survey and Distributor InspectionOnsite Evaluation Areas

Verified-Accredited Wholesale Distributors (VAWD) - Findings

Drug Supply - Serious Findings• Purchasing from unlicensed wholesalers• Purchasing from wholesalers that failed to report to

FDA• Purchasing products with incomplete Transactions

Histories • Purchasing products with False Transaction Histories

Verified-Accredited Wholesale Distributors (VAWD) -Findings

• Issues involving Destruction of products• Three way tie:

– Visitor Log of CS cage; – CRT limits; – Cold chain

• Three way tie:– License issues; – Vendor lists; – Personnel issues

Verified-Accredited Wholesale Distributors (VAWD) - Findings

• Crisis plan• Three way tie:

– Facility security– Temperature mapping rationale– Issues with returns

• Two way tie:– No HVAC/No AC– No PnPs for DSCSA

• Three way tie:– Product labeling in trash– Quality program– Training in general

Monitor and Record Temperature (Humidity)

Backup Power for Security and Air Conditioning Systems

Shipping

Questions?