US Congressional Research Service Report on Pharmaceutical Supply Chain Security

 The Congressional Research Service (CRS) prepares reports for the Members and Committees of the US Congress. On 12 July 2013 they published a report titled “Pharmaceutical Supply Chain Security” that addressed the complexities in the global distribution supply chain for finished drug products.
 

The complexities are well illustrated and described in Figure 1 (page 6) and a textbox (page 5) respectively. Between the time when a finished drug leaves the manufacturer it may pass through multiple primary and secondary wholesale distributors and often multiple dispensers before actually reaching the patient. This supply chain may also include a re-packager and third party logistics providers including temporary transport companies or warehouse providers. The complexity of the supply chain provides multiple opportunities for adulteration, drug diversion and counterfeiting. This report describes how Congress has moved to regulate the supply chain with details on the following:

• Prescription Drug Marketing Act of 1987

• Amendments to the Food and Drug Act in 2007

• Food and Drug Administration Safety and Innovation Act of 2012

• State Activities on Supply Chain Security

• Actions taken by Professional and Industry Associations

• Policy Decision Points under Consideration in the 113th Congress

To view or download the Congressional Research Service Report, click here

To view or download the Rx-360 Summary of the Report, click here