Monday, December 2, 2013

Hope you had a great Turkey Day , President signs Drug Quality and Security Act

Hope you enjoyed your Thanksgiving Holiday.  In case you missed it,  
just before the break the president signed H.R 3204, The Drug Quality and Security Act.  Now that is has passed here is a quick recap from our friends at HIDA. As your review some of the highlights of the bill,  and  the coming affect on the Healthcare Supply Chain,  feel free to reach out out to TSH to help you navigate the regulatory maze.


Last Wednesday, the president signed the Drug Quality and Security Act (H.R. 3204) into law, creating a national prescription drug pedigree solution. 

 HIDA Government Affairs has created a summary of H.R. 3204, which includes a flowchart highlighting the information required to be passed by trading partners. 

The Drug Quality and Security Act (H.R. 3204) creates a uniform, national standard for tracing pharmaceuticals through the supply chain.  The bill ensures the safety of drugs for patients and the immediate preemption provision eliminates the burdensome patchwork of state pedigree laws. Wholesale distributors can start conducting business the same way in all 50 states

Key Provisions Important to Medical Surgical and Pharma Distributors:

  1.  National uniform standard with immediate state preemption of pedigree laws.  
  2.  Key exemptions for convenience kits, IVs, combination products, etc. 
  3.  Affiliate language so that all companies (C Corps, S Corps and LLCs, etc) can conduct intracompany transfers of pharmaceutical product.
  4.  Medical surgical distributors are not mandated to provide all information required to be passed down the supply chain in one document.
  5.  Federal Licensure standards for pharmaceutical distributors.

Key Terms:  The terms below are important to understand as different trading partners are required to pass different combinations of the documents depending on upstream and downstream trading partners. 

  • The transaction information (TI) includes the name of the product, strength and dosage form,  National Drug Code (NDC), the container size, the number of containers, the lot number, the transaction date, the shipment date, and the name and address of the businesses from which and to which ownership is being transferred. 
  • A transaction history (TH) is a paper or electronic statement that includes the transaction information for each prior transaction back to the manufacturer. 
  • A transaction statement (TS) is a paper or electronic attestation by the business transferring ownership of the product that it has complied with the Act.

Key Dates:

  •  Prior to January 1, 2015:  The federal Prescription Drug Marketing Act of 1987 (PDMA) requirements remain in place during the interim period between enactment and the start of Phase I requirements.  
  •  January 1, 2015:  Phase I begins requiring manufacturers, wholesalers and repackagers to  comply with applicable traceability requirements and engage with only “authorized trading partners”
  •  July 1, 2015:  Dispensers must comply with applicable traceability requirements.
  •  4 Years After Enactment:  Manufacturers must have all product serialized.
  •  5 Years After Enactment:  Repackagers must have all product serialized.
  •  6 Years After Enactment: Wholesalers must only engage in transactions with serialized product.
  •  7 Years After Enactment: Dispensers must only engage in transactions with serialized product.
  •  10 Years After Enactment: Trading partners must be compliant with Phase II.  
Phase II is self effectuating (does not require final FDA regulations) and requires an interoperable electronic system that traces serialized product at the unit level through the supply chain.

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