[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]
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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.
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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availability of a draft guidance for industry entitled ``DSCSA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 The draft guidance addresses the drug supply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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by January 27, 2015.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comments concerning the collection of information proposed in the draft
guidance by January 27, 2015.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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