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U.S. Department of Health and Human Services

Regulatory Information

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Attachment F: Questions on PDMA for the Primary Wholesalers

Prescription Drug Marketing Act Report to Congress (2001): Back to Table of Contents

Previous Section: Attachment E: The 1988 Guidance Letter

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.

  1. 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.
  2. 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?
  3. Do you believe it would be advisable to eliminate the pedigree requirement altogether? Please explain your answer.
  4. Do you believe there would be any consequences to the public health and safety if the pedigree were eliminated?
  5. 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.

Next Section: Attachment G: Profile of the Prescription Drug Wholesaling Industry