On Dec. 1, the FDA's drug pedigree regulations will finally take effect, but much uncertainty remains within the drug-distribution chain. Peter S. Reichertz and Deborah M. Shelton of Sheppard Mullin Richter & Hampton discuss a key concern: Is it feasible for companies to comply with a labyrinth of state-by-state pedigree requirements in addition to the federal regulations? The authors say the current lack of uniformity renders compliance difficult and significantly increases the cost of doing business.
October 11, 2006 at 12:00 AM
1 minute read
The original version of this story was published on Law.Com
On Dec. 1, 2006, after a series of stays, the drug pedigree regulations of the Food and Drug Administration will go into effect.
Lifting the latest stay ends years of uncertainty about whether and when the FDA’s pedigree requirements would take effect, but it also creates much uncertainty within the drug-distribution chain.
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