March 2005                        return to newsletter contents page

Trio of Maryland Representatives Propose Licensure Changes for Prescription Drug/Device Wholesalers

Representatives Joan Stern (D), Emmett Burns, Jr. (D), and Susan Lee (D) are sponsoring the Wholesale Prescription Drug and Device Distribution Protection and Licensing Act of 2005. The Act, House Bill 835, would significantly change licensure requirements for wholesale distributors that engage in the distribution of legend drugs or legend devices in Maryland.

It's purpose, according to the bill text, is to "establish requirements for the distribution of prescription drugs or devices to protect the drug and device supply and consumer safety." Some of the more onerous requirements included in the bill address background checks, adulterated products, counterfeiting, due diligence, surety bonds, product identification tracking, authorized distribution, designated representatives, and recordkeeping.

As introduced, some of the key provisions of HB 835 would require:

• licensure for wholesalers that distribute prescription drugs and/or prescription devices in Maryland;

• criminal and financial background checks for each licensure applicant;

• a surety bond of $100,000 or other comparable means of security -- a $25,000 surety bond may be accepted for distributors with gross receipts equal to or less than $10,000,000;

• the Board to establish a unique product identification tracking system for drugs or devices on or before December 31, 2010;

• the identification of a wholesaler’s designated representative;

• the establishment and maintenance of detailed records for all prescription drug and prescription device transactions; and
  the creation of a prescription drug and device wholesaler advisory council.

House Bill 835 has been referred to the Committee on Health and Government Operations. There will be a hearing on the bill on March 15 at 2:00 pm.

Click here or an Analysis of HB 835 by Bonnie Basham of Capital Ideas and how it compares to the Florida Pedigree Law.

Click here to view the text of the bill.