Drug Quality and Security Act Licensing Standards

red-jumpsuitUnder the Drug Quality and Security Act, 3PLs will  required to comply with national licensing standards (and/or potentially state licensing standards) including:

  • Establish a process for third-party accreditation;
  • provide for periodic inspection;
  • prohibit a facility from having as a manager or designate representative anyone convicted of a felony;
  • provide for mandatory background checks;
  • provide, upon request, list of customers; and
  • storage practices.

Storage Practices

Proper storage practices are a critical part of the licensing program under the Drug Quality and Security Act and these practices will be subject to inspection. A 3PL is required to maintain access to warehouse space of suitable size to facilitate safe operations; include a suitable area to quarantine suspect product; and maintain adequate security.

They must also have written policies and procedures to:

  • Address receipt, security, storage, inventory, shipment, and distribution of a product;
  • identify, record, and report confirmed losses or thefts in the U.S.;
  • correct errors and inaccuracies in inventories;
  • provide support for manufacturer recalls;
  • prepare for, protect against, and address any reasonably foreseeable crisis that affects security or operation at the facility, such as a strike, fire, or flood;
  • ensure that any expired product is segregated from other products and returned to the manufacturer or repackager or destroyed;
  • maintain the capability to trace the receipt and outbound distribution of a product, and supplies and records of inventory; and
  • quarantine or destroy a suspect product if directed to do so by the respective manufacturer, wholesale distributor, dispenser, or an authorized government agency.

These policies and procedures will be further defined by the FDA regulations that are due by November 2015.

 

One response to “Drug Quality and Security Act Licensing Standards

  1. Pingback: Understanding the Drug Quality and Security Act | iwla1891·

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