[Federal Register Volume 79, Number 229 (Friday, November 28, 2014)]
[Notices]
[Pages 70878-70879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-28085]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1981]


The Drug Supply Chain Security Act Standards for the 
Interoperable Exchange of Information for Tracing of Certain Human, 
Finished, Prescription Drugs: How To Exchange Product Tracing 
Information; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``DSCSA 
Standards for the Interoperable Exchange of Information for Tracing of 
Certain Human, Finished, Prescription Drugs: How To Exchange Product 
Tracing Information.'' The draft guidance addresses the drug supply 
chain security provisions of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act), which requires the Secretary of the Department of 
Health and Human Services to establish initial standards for the 
interoperable exchange of transaction information, transaction history, 
and transaction statements, in paper or electronic format. 
Specifically, the guidance establishes standards for how transaction 
information, transaction history, and transaction statements should be 
exchanged among trading partners through the extension and/or use of 
current systems and processes.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by January 27, 2015. Submit either electronic or written 
comments concerning the collection of information proposed in the draft 
guidance by January 27, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 
20993; or the Office of Communication, Outreach and Development, Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Office of Compliance, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3100, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On November 27, 2013, the Drug Supply Chain Security Act (Title II 
of Public Law 113-54) was signed into law. Section 202 of the Drug 
Supply Chain Security Act (DSCSA), which adds new sections 581 and 582 
to the FD&C Act (21 U.S.C. 360eee and 360eee-1), sets forth new 
definitions and requirements related to product tracing. 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.
    Starting in 2015, certain trading partners (manufacturers, 
wholesale distributors, dispensers, and repackagers) are required under 
sections 582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C Act to 
capture, maintain, and provide the subsequent purchaser with 
transaction information, transaction history, and a transaction 
statement (product tracing information) for certain prescription drug 
products. Manufacturers, wholesale distributors, and repackagers must 
meet these requirements by January 1, 2015; dispensers must meet them 
by July 1, 2015. In addition, each manufacturer, wholesale distributor, 
dispenser, and repackager must comply with all applicable requirements 
in the event they meet the definition of more than one trading partner 
under section 582(a)(1), but trading partners are not required to 
duplicate requirements. Section 582(a)(2)(A) of the FD&C Act directs 
FDA to establish initial standards to facilitate the interoperable 
exchange of transaction information, transaction history, and 
transaction statements between trading partners.
    FDA obtained stakeholder input on the development of the initial 
standards for the interoperable exchange of product tracing 
information, in paper and electronic formats, through a public docket 
established in February 2014, as required under section 582(a)(2)(B), 
and a public workshop that was held May 8 and 9, 2014. The public 
workshop provided a forum for FDA to obtain input from stakeholders in 
the pharmaceutical distribution supply chain on how trading partners 
can best comply with the requirements for the interoperable exchange of 
product tracing information beginning in 2015, using currently 
available standards or practices. Comments to the public dockets and 
from the workshop were considered in the development of this guidance, 
and will be considered in developing additional guidance to further 
elaborate on the standards for the interoperable exchange of product 
tracing information.
    This initial draft guidance establishes standards to help trading 
partners comply with the requirements of sections 582(b)(1), (c)(1), 
(d)(1), and (e)(1) of the FD&C Act to provide the subsequent trading 
partners with product tracing information, in paper or electronic 
format, through the extension and/or use of current systems and 
processes. Under these provisions, trading partners are also required 
to capture and maintain the applicable product tracing information for 
not less than 6 years after the date of the transaction. Implementation 
of these provisions will help further improve the security of the 
pharmaceutical distribution supply chain and increase confidence in the 
safety and authenticity of human prescription drugs. FDA intends to 
issue additional guidance to facilitate the interoperable exchange of 
product tracing information through standardization of data and 
documentation practices.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). This guidance is marked 
as a ``draft'' consistent with its description in section 582(a)(2)(A) 
of the FD&C Act.

[[Page 70879]]

Under section 582(h)(4) of the FD&C Act, FDA intends to eventually 
``update . . ., as necessary and appropriate, and finalize'' this 
document to reflect standards for interoperable data exchange at the 
package level. Because the DSCSA clearly intends for stakeholders to 
rely upon this guidance document before finalization, however, FDA is 
immediately implementing this document under 21 CFR 10.115(g)(2). As a 
result, it reflects FDA's current thinking on this topic and is 
intended to provide guidance to stakeholders as they implement the 
DSCSA. Guidance documents generally do not create or confer any rights 
for or on any person and do not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance includes information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). 
FDA intends to solicit public comment and obtain OMB approval for any 
information collections recommended in this guidance that are new or 
that would represent modifications to those previously approved 
collections of information found in FDA regulations or guidances.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. 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 the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
http://www.regulations.gov.

    Dated: November 21, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28085 Filed 11-26-14; 8:45 am]
BILLING CODE 4164-01-P