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 this law, also known as the Drug Supply Chain Security Act (Act), 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 Act includes requirements to implement an electronic track and trace system that will go into full effect ten years after the Act’s enactment. The Act preempts state pedigree laws. The track and trace timeline requirements will become effective January 1, 2015, with product tracing requirements for manufacturers, repackagers, and wholesale distributors.
In an effort to implement the key provisions outlined in the Act, the U.S. Food and Drug Administration (FDA) has released a Drug Supply Chain Security Act Implementation Plan. Among other things, the FDA indicates in the plan that it will publish a draft guidance establishing standards for interoperable exchange of transaction information, transaction history, and transaction statements in paper or electronic format by November 27, 2014. The FDA has also given estimate target dates for publishing guidances on processes for waivers, exceptions, and exemptions, and on grandfathering product.
On February 13, 2014, the FDA took its first steps in implementing the plan by issuing a Notice requesting information from stakeholders and other interested parties regarding current pedigree practices, standards, and processes. Specifically, the FDA is requesting comments and supporting information regarding the following:
- "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);
- [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
- [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."
To facilitate discussion of these issues, the FDA has included in the Notice several questions related to each point. The FDA encourages commenters to address these questions, as well as other related issues.
Commenters may submit electronic comments to http://www.regulations.gov, or written comments to the Division of Dockets Management. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to at http://www.regulations.gov.