FDA to Establish Pilot Program Under Drug Supply Chain Security Act

FDA will hold a public workshop in early April to discuss a proposed pilot program to enhance the safety and security of the pharmaceutical distribution supply chain. During this workshop, the Agency seeks to gain input and feedback from interested pharmaceutical distribution supply chain members about issues related to the proposed program.

Supply chain stakeholders that the FDA feels may be interested in attending the workshop, include:

• Manufacturers
• Repackagers
• Wholesale distributors
• Dispensers
• State & Federal authorities
• Solution providers
• Standards organizations

Background

In November 2013, the Drug Supply Chain Security Act (DSCSA) was signed into law. This act “outlines critical steps to build an electronic, interoperable system by November 27, 2023, which will identify and trace certain prescription drugs as they are distributed within the United States.”

Section 202 of the DSCSA added sections 581 and 582 to the Food, Drug, and Cosmetic (FD&C) Act. As stated in section 582(j) of the FD&C Act, the Agency must establish at least one pilot program in which it will work with authorized manufacturers, repackagers, wholesale distributors, and dispensers, to examine and assess the methods used to amplify safety and security within the pharmaceutical distribution supply chain.

As per section 582(j), the FDA plans to develop a pilot project program in which its efforts are coordinated with “stakeholders that reflect the diversity of the pharmaceutical distribution supply chain, including large and small entities from all industry sectors.” FDA’s goals for the program include:

• Assess the ability of supply chain members to satisfy the requirements of section 582, and identify, manage, and prevent the distribution of suspect and illegitimate drugs.
• Identify the system attributes needed to implement the requirements of section 582, particularly the requirement to utilize a product identifier for product tracing purposes.
• Demonstrate the electronic, interoperable exchange of product tracing information across the pharmaceutical supply chain.

Public Workshop

On April 5, 2016, the FDA will hold a public workshop entitled “Proposed Pilot Project(s) under the Drug Supply Chain Security Act (DSCSA),” where the Agency will provide a forum for discussing proposed design objectives of the pilot projects required under section 582(j) of the FD&C Act.

The FDA is pursuing feedback regarding “issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying the system attributes that are necessary to implement the requirements established under the DSCSA.” During the workshop, the FDA intends to provide interesting parties with the opportunity to comment on and discuss the proposed design objectives of the pilot programs.

In addition, the FDA would like to gain insight on the practices, processes, and systems that are currently being used, or plan to be used by supply chain stakeholders to meet the requirements under section 582, particularly the product tracing and verification requirements.   In its notice published in the Federal Register on February 16th, the FDA stated that “these practices, processes, and systems may include those that supply chain stakeholders would consider using in pilot projects or those that supply chain stakeholders have already used in other previous pilot projects.”

The FDA will publish the workshop agenda and other related materials on or before March 29, 2016. Workshop attendees will not be asked to develop consensus opinions during the discussion; rather the Agency is asking participants to provide their personal opinions and perspectives.

Due to space constraints, the FDA is limiting workshop attendance. As such, registration is required for those interested in attending the workshop; registration requests should be received by FDA no later than March 11, 2016, and no onsite registration will be permitted. Although space is limited, the FDA will be recording and Webcasting portions of the public workshop, which will be available in listening-mode only on the day of the workshop.

Regardless of attendance at the public workshop, FDA is asking any interested stakeholders to provide comments related to any of the workshop materials, as well as comments related to the specific design of the proposed pilot projects. The deadline for submitting electronic or written comments is April 21, 2016.