August 8, 2007

Elizabeth Scott Russell, RPh

Executive Director

Virginia Board of Pharmacy

Alcoa Bldg.

6603 W. Broad St., 5th Floor

Richmond, VA 23230-1712

Dear Ms. Russell:

On behalf of the Healthcare Distribution Management Association (HDMA) and our distributor members in Virginia, I submit the following comments regarding the Board of Pharmacy’s Proposed Rules implementing amendments enacted in 2006 by the General Assembly under H 355 requiring the establishment and implementation of a pedigree system for drugs at risk for counterfeit activity.

HDMA commends you for your efforts in this area, as we continue to work in states across the country to identify and implement effective approaches to deter and prevent the introduction of counterfeit and adulterated prescription drug products in the nation’s pharmaceutical supply chain. 

As you know, HDMA and its members have actively participated in the legislative and regulatory process to ensure strict provisions to further enhance the safety of the prescription drug supply in Virginia and we appreciate this opportunity to provide comments.  While HDMA and other industry stakeholders reached agreement on these proposed rules, much time has passed since their development and we urge you to consider an additional amendment to the proposed rules or future rules to implement the following recommendations to make the rules consistent with what is now commonly accepted by the industry.

Normal Distribution Channel

Since working with the Board and other industry stakeholders, several states have moved forward with alternative versions of pedigree legislation and the “normal distribution” concept.  Included in many bills across the country this year was the addition of a transaction path allowing a drug to pass from a manufacturer to an Authorized Distributor of Record to one other Authorized Distributor of Record to an office-based healthcare practitioner authorized by law to dispense or administer such drug to a patient.  HDMA recommends the insertion of the following language in Section A of proposed rule 18 VAC 110-50-160:

6.  Distribution from an authorized distributor of record to one other authorized distributor of record to an office based healthcare practitioner authorized by law to dispense or administer such drug to a patient.

HDMA believes that inclusion of this transaction path will both keep the normal supply channel limited enough to deter the entrance of counterfeits and ensure that small physician practices are able to continue to serve their patients appropriately. 

Drop Shipment Definition

Additionally, we also urge the Board to consider the following alternative to the definition of “drop shipment” in proposed 18VAC 110-50-10:

“Drop shipment” means the sale of a prescription drug to a wholesale distributor by the manufacturer of the prescription drug (or by that manufacturer’s co-licensed product partner, that manufacturer’s third party logistics provider, that manufacturer’s exclusive distributor, or by an authorized distributor of record that purchased the product directly from the manufacturer or from one of these entities) whereby:

(i) the wholesale distributor takes title to but not physical possession of such prescription drug;

(ii) the wholesale distributor invoices the pharmacy, pharmacy warehouse, or other person authorized by law to dispense or administer such drug; and

(iii) the pharmacy, pharmacy warehouse, or other person authorized by law to dispense or administer such drug receives delivery of the prescription drug directly from the manufacturer (or from that manufacturer’s co-licensed product partner, that manufacturer’s third party logistics provider, that manufacturer’s exclusive distributor, or from an authorized distributor of record that purchased the product directly from the manufacturer or from one of these entities).

HDMA believes that that the above definition more clearly reflects the practice of drop shipping prescription drugs and clarifies what transactions and entities are involved in the process.

HDMA fully recognizes the necessity for strict measures to prevent the entry of counterfeits into the legitimate supply channel and we commend the Board for its efforts.  If you have any questions or need further information, please contact me at 703-885-0234 or egallenagh@hdmanet.org.

HDMA supports the approach of requiring increased protections for those prescription drug products found to be susceptible to counterfeiting in order to ensure the safety of the drug supply. 

Sincerely,

Elizabeth A. Gallenagh, Esq.

Senior Director, State Government Affairs