FDA issues new guidance for dispensers covered under the Drug Supply Chain Integrity Act

Posted on July 29, 2015

By Nancy Panos

The product tracing requirements in sections 582(d)(1) of the Drug Supply Chain Integrity Act took effect for dispensers July 1. However, some dispensers had expressed concern that electronic systems used to exchange, capture and maintain product tracing information would not be in operation by the effective date. But in a July 1 guidance document, the FDA stated it does not intend to take enforcement action against dispensers who, prior to November 1, 2015, accept ownership of product without receiving the product tracing information, as required by the Act.


The Act puts a 10-year plan in place to regulate the exchange of information about covered products, which are prescription drugs in finished dosage form for administration to a patient without substantial further manufacturing, such as capsules, tablets and lyophilized products before reconstitution. The goal is to build an electronic system to identify and trace certain prescription drugs as they are distributed in the United States. It is intended to provide information about where a drug has been in the supply chain, as well as enable verification of the validity of the drug, detection of illegitimate drug products and support of recalls.

The Act imposes requirements for manufacturers, wholesalers and distributors, as well as dispensers, which are defined as retail pharmacies, hospital pharmacies and group chain pharmacies authorized to dispense or administer prescription drugs. It requires the ability to exchange product tracing information among trading partners. The subsequent purchaser must be able to successfully capture and maintain the product tracing information, regardless of whether the information is provided in a paper or electronic format.

Of immediate concern to dispensers are the requirements that went into effect on July 1, 2015. They include requirements that a pharmacy:

  1. Not accept a drug covered under the Act unless the previous owner provides the transaction history, transaction information and transaction statement
  2. Capture and maintain the tracing information, including the lot information, for six years
    1. Transaction information
      1. Name
      2. Strength and dose
  • NDC
  1. Container size
  2. Lot number
  3. Date of transaction
  • Date of shipment
  • Seller and buyer in the transfer of ownership of the product
  1. Transaction history
  2. Transaction statement

The rules allow for both paper-based and electronic capture of this information.

The FDA has posted self-running webinars outlining the rules for compliance guidance on the Act for both wholesalers/manufacturers and dispensers on their website.  To find more information, go to http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default.htm.

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