Because none of the primary wholesalers attended the October 27, 2000, Part
15 Hearing, the Agency decided to submit questions to them through their association
the National Wholesale Druggists Association. Responses to the questions below
have been placed in the Agency's docket 92N-0297.
- At the Agency's Part 15 Hearing on October 27, 2000, we heard representatives
of wholesalers of prescription drugs say that the largest wholesalers would
oppose the requirement of a universal pedigree. Please state whether you would
favor or oppose such a requirement and why.
- We understand that there are computer software and systems readily available
that can be used to create a pedigree. What do you believe it would cost to
create a pedigree and provide it with the drugs that you sell? What would
these costs be associated with specifically? Do you believe these costs could
be accommodated without a significant increase in the cost or decrease in
the availability of prescription drugs?
- Do you believe it would be advisable to eliminate the pedigree requirement
altogether? Please explain your answer.
- Do you believe there would be any consequences to the public health and
safety if the pedigree were eliminated?
- What would your position be on the following requirement?
All distributors (authorized and unauthorized) must maintain and pass on a
pedigree for those prescription drugs that are bought from or sold to a secondary
distributor.
Executive Summary | FDA
Home Page | Search | A-Z
Index | Site Map | Contact
FDA
FDA/Website Management Staff
Web page created by tg 2001-JUL-02.