“On November 27, the president signed the Drug Quality and Security Act (H.R. 3204) into law, creating a national prescription drug pedigree monitoring system,” writes HIDA’s Linda O’neill in the latest column for Repertoire. “This development marks a major legislative victory in our industry’s efforts to create a uniform, national pedigree solution, but it also represents the culmination of several years of hard work by HIDA. All of our member priorities were included in the final bill, which allows distributors to conduct business the same way in all 50 states.”
HIDA key wins
- Provides a national uniform solution immediately preempting the current patchwork of state pedigree laws.
- Exempts convenience kits, combination products, and IV solutions – among other medical items – from traceability requirements.
- Fixes language so that all companies – C corporations, S corporations, LLCs, etc. – can conduct intracompany transfers of pharmaceutical products. Previous legislation tied the definition to the tax code and C corporations only.
- Removes a proposed mandate requiring medical-surgical distributors to provide all required pedigree information in one initial document to be passed through the supply chain.
- Establishes national licensure standards for pharmaceutical wholesalers that ensures uniformity in all 50 states for the provisions outlined in the bill around such issues as background checks, physical inspections, bonding requirements, and fingerprinting.