Monday, July 1, 2013

US Senate Posts Amended Pharma Serialization and Traceability Bill and Compounding Bill--Debated Expected Week of July 8, 2013


Entitled the "Pharmaceutical Quality, Security, and Accountability Act", this bill is the result of the merging of the compounding and drug security bills which were passed earlier in June by the Senate HELP committee.
The new consolidated bill includes certain amendments to the drug security bill previous passed by the HELP committee. Highlights include:
  • Provisions for Manufacturers to provide transaction history, information and statements in a single document, paper or electronic, to downstream trading partners
  • Verification procedures for Manufacturers, Wholesale Distributors and Dispensers in the event of potentially suspect product that should specifically include the standardized numerical identifier when verifying the package starting on or after the respective serialization deadlines for each industry segment
Debate on the bill in the full Senate is expected the week of July 8th. If the bill passes, it will have to be reconciled with the House drug security bill that differs on a few key components.
To hear a detailed breakdown of the serialization, transaction traceability, product verification and other provisions of both the Senate and House bills, you can watch a streaming replay of our analysis here: Federal Pharmaceutical Serialization and Traceability Webinar. Or, drop us a note and we'd love to discuss what the potential national legislation would mean to your business!
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