PDMA Pedigree Temporarily on Hold, But States Press Forward to Regulate Supply Chain
For those of you who are following closely the developments with respect to the PDMA, I wanted to alert your attention to an article by Pharmaceutical Commerce released in December that highlights developments in fifty states regarding drug pedigree requirements. The article, entitled Red State, Blue State--and Green, Yellow and Orange Too, provides the following fifty state summary:
- Two states have passed legislation and approved regulations;
- Ten states are in the process of finalizing regulations;
- Five states have passed legislation but have not drafted regulations;
- Twelve states, including Ohio, have not approved such legislation; and
- Twenty-one states are at various other stages.
As the article rightfully points out, "[f]or a pharma distributor intending to distribute to more than a few states, there's one word for the map: ugly. The problem, basically, is that the number of variations for requirements are multiplying . . . ."
As noted above, this article was released in December, and the current status of each state's legislation may not be accurately reflected. Wholesalers should take care to comply with all applicable state and federal laws and regulations and to track developments closely.
