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 The leading web portal for pharmacy resources, news, education and careers February 15, 2019
Pharmacy Choice - Pharmaceutical News - Federal Register Extracts - February 15, 2019

Pharmacy News Article

 2/8/19 - Federal Register Extracts

Agency: "Food and Drug Administration, HHS."

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the start of the Pilot Project Program Under the Drug Supply Chain Security Act (DSCSA Pilot Project Program). The DSCSA Pilot Project Program is intended to assist FDA and members of the pharmaceutical distribution supply chain in the development of the electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed within the United States. Under this program, FDA will work with stakeholders to establish one or more pilot projects to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. Participation in the DSCSA Pilot Project Program is voluntary and will be open to pharmaceutical distribution supply chain members to apply to the program. FDA will ensure that participation reflects the diversity of the supply chain, including large and small entities from all industry sectors. This notice establishes the DSCSA Pilot Project Program and includes instructions for submitting a request to participate and expectations for program participants.

DATES:

FDA will be accepting applications for participation in the DSCSA Pilot Project Program beginning February 8, 2019 and continuing through March 11, 2019. The duration of the DSCSA Pilot Project Program will depend on the pilot project(s) accepted into the program and when the projects are completed.

FOR FURTHER INFORMATION CONTACT: Daniel Bellingham, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130, DSCSAPilotProjects@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) (Title II of Pub. L. 113-54) was signed into law. The DSCSA outlines critical steps to build an electronic, interoperable system by November 27, 2023, that 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 Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee and 360eee-1, respectively). Under section 582(j) of the FD&C Act, FDA is required to establish one or more pilot projects, in coordination with authorized manufacturers, repackagers, wholesale distributors, and dispensers, to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain.

FDA is establishing the DSCSA Pilot Project Program to implement section 582(j) of the FD&C Act. This program is intended to assist FDA and members of the pharmaceutical distribution supply chain in the development of the interoperable electronic system to be established by 2023. The 2023 system has the potential to reduce diversion of drugs distributed domestically as well as help deter counterfeit drugs from entering the supply chain. The pilot program will be designed to explore issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, identifying the system attributes that are necessary to implement the requirements established under the DSCSA, and any other issues identified by FDA (see section 582(j)(2)(B) of the FD&C Act).

Particular program goals include: (1) Identifying the system attributes needed to implement the requirements of section 582 of the FD&C Act, particularly the requirement to utilize a product identifier for product tracing and verification purposes and (2) assessing the ability of supply chain members to satisfy the requirements of section 582 of the FD&C Act; identify, manage, and prevent the distribution of suspect and illegitimate products as defined in section 581(21) and 581(8) of the FD&C Act, respectively, and exchange product tracing information across the pharmaceutical distribution supply chain in an electronic and interoperable manner. FDA plans to coordinate with stakeholders to ensure that pilot projects reflect the diversity of the pharmaceutical distribution supply chain, including large and small entities from all industry sectors. The DSCSA Pilot Project Program is intended to help identify and evaluate the most efficient processes and/or systems to operationalize supply chain security requirements.

II. The DSCSA Pilot Project Program

FDA is seeking pilot project participants from the pharmaceutical distribution supply chain (e.g., authorized manufacturers, repackagers, wholesale distributors, and dispensers) and other stakeholders. FDA expects potential participants to propose the design and execution of their pilot project in their submission to FDA; however, FDA intends to meet with selected pilot project participants to ensure that the learnings from the pilot project(s) will be complementary in informing all stakeholders in the development of the electronic, interoperable system that will go into effect in 2023. FDA encourages potential participants to focus their proposed pilot project(s) on the DSCSA requirements related to the interoperable, electronic tracing of products at the package level. Specifically, the pilot project(s) should focus on the enhanced requirements for package-level tracing and verification that go into effect in 2023. Such pilot projects will likely be more useful than pilot projects dedicated to lot-level tracing. If there is an adequate number of pilot project submissions, FDA may establish more than one pilot project to accomplish the goals of the DSCSA Pilot Project Program.

A. Products Eligibility

Pilot projects should focus on applicable requirements to any prescription drug that is a "product" within the meaning of section 581(13) of the FD&C Act. FDA anticipates that packages and homogenous cases of product that are part of a pilot project will generally bear a "product identifier" as described in sections 581(14) and 582(a)(9) of the FD&C Act. FDA may also consider proposed pilot projects involving product that may be subject to a waiver, exception or exemption of certain DSCSA requirements, products that are grandfathered, in addition to products that are outside the scope of section 581(13) of the FD&C Act (e.g., over-the-counter medicines) if such project(s) could further the objectives of the DSCSA Pilot Project Program.

B. Potential Issues To Examine and Evaluation Methods To Use in Pilot Projects

On April 5-6, 2016, FDA held a public workshop entitled "Proposed Pilot Project(s) Under the Drug Supply Chain Security Act (DSCSA)." This public workshop provided a forum for members of the pharmaceutical distribution supply chain to discuss the design objectives of pilot projects established by FDA under section 582(j) of the FD&C Act. Based on the information gathered at that workshop and from the comments submitted to the public docket for the workshop (Docket No. FDA-2016-N-0407), FDA identified several potential issues to examine, and evaluation methods to use, in pilot projects established under the DSCSA Pilot Project Program. These potential issues and evaluation methods are summarized in table 1. This table is intended only to assist in the design of potential pilot projects; it does not represent FDA's views or policies regarding the issues described in the table. For ease of reference, the potential issues to examine and evaluation methods have been grouped by focus areas for the pilot projects.

This is a summary of a Federal Register article originally published on the page number listed below

Notice.

Citation: "84 FR 2879"

Document Number: "Docket No. FDA-2016-N-0407"

Federal Register Page Number: "2879"

"Notices"



Copyright (c) 2019 Federal Information & News Dispatch, Inc.

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