On November 27, 2013, President Obama signed into law the "Drug Quality and Security Act," which amends the Federal Food, Drug, and Cosmetic Act. Title II of the Act, also known as the "Drug Supply Chain Security Act” (DSCSA), establishes a timeline for entities involved in the pharmaceutical distribution chain to implement a national track and trace system. Since its signing, the U.S. Food and Drug Administration (FDA) has been bustling to implement the DSCSA's requirements. In an effort to get you caught up on what has been happening, we have prepared a high-level timeline of the events that have happened thus far, and that the FDA has planned for the future.

November 27, 2013 - President Obama signs House Bill 3204, which includes DSCSA. The DSCSA establishes a timeline for entities involved in the pharmaceutical distribution chain to implement a national track and trace system. Manufacturers and wholesale distributors that transfer ownership of a product will be required to provide the subsequent owner with transaction history, transaction information and a transaction statement in a single document in paper or electronic format. The DSCSA includes requirements to implement an electronic track and trace system that will go into full effect ten years after its enactment. The DSCSA preempts state pedigree laws.

February 13, 2014 - The FDA takes its first steps in implementing the DSCSA by issuing a Notice requesting information from stakeholders and other interested parties on current pedigree practices, standards, and processes. Specifically, the FDA is requesting comments and supporting information regarding the following:

  1. "Current practices and ideas that may be used for the interoperable exchange of transaction information, transaction history, and transaction statements, in paper or electronic format, for each transfer of product in which a change of ownership occurs (i.e., transaction);
  2. [T]he feasibility of establishing standardized documentation to be used by members of the pharmaceutical distribution supply chain to convey the transaction information, transaction history, and transaction statement to the subsequent purchaser of a product and to facilitate the exchange of lot level data; and
  3. [C]urrent practices and ideas that may be used for the exchange of information between members of the pharmaceutical distribution supply chain and FDA to provide, receive, and terminate notifications, respond to requests for verification of product, and respond to requests for information from FDA or other appropriate Federal or State officials in the event of a recall or for the purpose of investigating a suspect or illegitimate product. 

February 21, 2014 – The FDA releases the "Drug Supply Chain Security Act Implementation Plan." Among other things, the FDA notes that it will publish a draft guidance establishing standards for the interoperable exchange of transaction information, transaction history, and transaction statements in paper or electronic format by November 27, 2014. The FDA also gives estimated target dates for publishing guidances on processes for waivers, exceptions, and exemptions, and grandfathering of product.

February 2014 - In response to enactment of the DSCSA, the California Board of Pharmacy (Board) issues a public notice stating that California's e-Pedigree provisions have been inactivated. The Board also notes that it will sponsor legislation to repeal the e-Pedigree provisions that have been inactivated.

May 8 – 9, 2014 – The FDA hosts a public workshop entitled "Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format." The goal of the workshop is to "gather information, current practices, research and ideas on the standards for the exchange of transaction information, transaction history and transaction statements, in paper or electronic format, for each transfer of drug product in which a change of ownership occurs, in addition to the feasibility of establishing standardized documentation to convey this information to the subsequent purchaser of a drug product and to facilitate the exchange of lot level data." Additionally, the workshop allows input from "interested stakeholders on the development of initial standards for the interoperable exchange of information between trading partners."

June 10, 2014 – The FDA issues the "Draft Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification." The Draft Guidance "identifies specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain; provides recommendations on how trading partners can identify the product and determine whether the product is a suspect product as soon as practicable; and sets forth the process by which trading partners should notify FDA of illegitimate product and how they must terminate the notifications, in consultation with FDA." The FDA is requesting that stakeholders and interested parties submit comments regarding the Draft Guidance.

November 27, 2014* – The FDA intends to publish a draft guidance that establishes standards for the interoperable exchange of transaction information/history/statement in paper or electronic format.

November 27, 2015* – The FDA intends to publish a guidance on processes for waivers, exceptions, and  exemptions, and to publish final guidance on grandfathering product.

November 27, 2021* – The FDA intends to develop regulations establishing enhanced drug distribution security systems for interoperable electronic tracing of product at the package level.

November 27, 2022* – The FDA intends to publish a final guidance on system attributes necessary to enable secure tracing at the package level. The FDA also intends to publish a final guidance on standards for interoperable data exchange to enhance secure tracing at the package level.

Please continue to check in with Pharmaspective for more news and updates regarding implementation of the DSCSA.