# Presentation: 246318

## Indiana’s New Wholesale Drug Distributor (WDD) Laws

- February 9, 2006
- Donna S. Wall, PharmD, RPh, BCPS, FASHP
- President, Indiana State Board of Pharmacy
- Critical Care Clinical Pharmacist, Indiana University Hospital, Clarian Health Partners, Indianapolis, Indiana

## Indiana’s New WDD Law

- Increases penalties for counterfeiting RX drugs and distributing contraband drugs
- Rigorous licensing requirements including mandatory accreditation for all wholesalers
- Determines a “Normal Chain of Distribution” (NCOD)
- Requires pedigree for all drugs distributed outside of NCOD

**Notes:**
On May 11, 2005  Indiana Governor Mitch Daniels signed into law Indiana House Bill 1098. This law dramatically changed what was expected of a wholesale drug distributor doing business in the State of Indiana. The changes required basically came down to 4 distinctive areas. See above...

## Counterfeiting Penalties

- Increases the criminal penalties
- New Legend Drug Deception Statute

## Effective Licensing Requirements

- Criminal Background Checks
- Surety Bond
- Authorized Distributor of Record (ADR)
- Due Diligence
- For Cause Authentication
- Comprehensive Application
- Increased Record keeping Requirements
- Mandatory On-Site Inspection

## Mandatory National Accreditation

- VAWD® or other Board Approved Accreditation
- Accreditation will ensure compliance with relevant state and federal laws
- Newly issued licensees must obtain Accreditation prior to issuance
- Existing license holders must obtain prior to next license renewal ( 9/30/06)
- Negligible fiscal and operational impact on state

## Normal Chain of Distribution       “NCOD”

- Manufacturer-ADR-pharmacy- patient
- Manufacturer – pharmacy-patient
- Manufacturer- 3rd party logistic provider-pharmacy – patient
- Manufacturer –3rd party logistic provider- ADR- pharmacy- patient
- Manufacturer – ADR – chain drugstore warehouse – pharmacy- patient
- Manufacturer – 3rd party logistics provider –ADR- chain drugstore warehouse – pharmacy- patient
- Manufacturer- 3rd party logistics provider – ADR – ADR – chain drugstore warehouse – pharmacy- patient
- Manufacturer – 3rd party logistics provider- ADR-ADR-pharmacy-patient

## Pedigrees – Implementation in Two phases

- Phase One – Paper/Electronic system by 7/1/06 for products that leave the NCOD
- Track and Trace system after 1/1/07
- Board may conduct a pilot program
- Board must conduct a viability study
- Board must consult with FDA

## Timeline of Indiana WDD Laws

- Stakeholders Workgroup 6 /05
- Public Hearing on WDD – 9/12/05
- After 1/1/06 – New WDD applicants must be accredited prior to licensure
- 6/30/06 – Pedigree for all drugs outside of NCOD
- 9/30/06 – Renewal of WDD – All accredited
- 1/1/07 – Study completed on Electronic Pedigrees

##  Drug Wholesalers- Issues

- Surety Bonds
- Authorized Distributors
- Pedigrees: Contents, Lot numbers, Invoices vs. Separate Documents
- Normal Chain of Distribution vs. Drug Susceptibility
- Inclusion of ADR to ADR transaction
- Accreditation Process

## Drug Manufacturer  - Issues

- Requested a full exemption – duplicative efforts between SBOP and FDA
- Normal chain of distribution vs. drug susceptibility list
- Wanted ALL products included
- Feared that SBOP could not respond quickly to compromised products
- Pedigrees – want both lot number and contents

## Chain Drug Warehouses - Issues

- Transfers with in same chain considered “wholesale distribution”
- Chain Drug Warehouses are not considered ADRs
- Chain Drug Warehouses NOT in normal chain of distribution
- Criminal History Background Checks for Personnel

## 3rd Party Logistics Providers - Issues

- Acts as an extension of the Manufacturer
- Does not take possession of product title
- Designated Representative
- Pedigree Requirements

## Indiana Pharmacists Alliance

- Supportive
- Concern about authentication requirements at the pharmacy level

## Indiana State Board of Pharmacy

- No accreditation – no go
- Secure the Entire Distribution Chain

## SB 202 – “Pharmacy Matters” Bill

- Pharmacy Board  clean up bill, multiple issues
- Clean up issues on WDD laws
- Senate Health Committee Hearing – 01/25/06
- Supporting testimony – HDMA, Indiana Retail Council, Indiana Hospital Association, Cardinal Health, Indiana Pharmacists Association
- Passed Indiana Senate 2/1/06  (vote of 49 to 1)
- On to the Indiana House of Representatives