Document ID: FDA-2014-D-1411-0001
Agency: fda
Document Type: Notice
Title: The Effect of Uniform National Policy on Drug Product Tracing and
Wholesale Drug Distributor and Third-Party Logistics Provider Standards:
Questions and Answers; Draft Guidance for Industry; Availability
Posted Date: 2014-10-08T04:00Z

[Federal Register Volume 79, Number 195 (Wednesday, October 8, 2014)]
[Notices]
[Pages 60853-60854]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23972]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1411]

The Effect of Uniform National Policy on Drug Product Tracing and 
Wholesale Drug Distributor and Third-Party Logistics Provider 
Standards: Questions and Answers; Draft Guidance for Industry; 
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availability of a draft guidance for industry entitled ``The Effect of 
Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug 
Distributor and Third-Party Logistics Provider Licensing Standards and 
Requirements: Questions and Answers.'' FDA is issuing these questions 
and answers to assist industry and State governments in understanding 
the effects of section 585 (Uniform National Policy) of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) added by Title II of the Drug 
Quality and Security Act (DQSA), which was enacted on November 27, 
2013, on State product tracing requirements and on standards, 
requirements, and regulations with respect to wholesale distributor and 
third-party logistics provider (3PL) licensing. Title II is also 
referred to as the Drug Supply Chain Security Act (DSCSA).

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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by December 8, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; or 
the Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New

[[Page 60854]]

Hampshire Ave., 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, 
drugtrackandtrace@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``The Effect of Section 585 of the FD&C Act on Drug Product 
Tracing and Wholesale Drug Distributor and Third-Party Logistics 
Provider Licensing Standards and Requirements: Questions and Answers.'' 
On November 27, 2013, the DSCSA (Title II of Pub. L.113-54) was signed 
into law. The DSCSA outlines critical steps to build an electronic, 
interoperable system to identify and trace certain prescription drugs 
as they are distributed in the United States. The DSCSA adds sections 
581 through 585 as Subchapter H of the FD&C Act. These sections 
establish definitions (section 581), requirements for supply chain 
participants (section 582), standards for and licensing of wholesale 
drug distributors (section 583) and 3PL providers (section 584), and a 
Uniform National Policy (section 585).
    The DSCSA establishes a Federal system for tracing prescription 
drug products through the pharmaceutical distribution supply chain and 
requires trading partners to provide, receive, and maintain certain 
product and distribution information. The DSCSA also requires FDA to 
establish Federal standards for licensing of wholesale drug 
distributors and 3PL providers. Section 585 of the FD&C Act sets forth 
a Uniform National Policy, preempting States and political subdivisions 
of states from establishing or continuing in effect certain standards 
and requirements. FDA is issuing this guidance to: (1) Help industry 
and States understand the immediate effects of the law and (2) clarify 
section 585's effect on State product tracing requirements and on 
standards, requirements, and regulations with respect to wholesale 
distributor and 3PL licensing.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on the effect 
of section 585 of the FD&C Act on drug product tracing and wholesale 
drug distributor and 3PL provider licensing and requirements. It does 
not create or confer any rights for or on any person and does 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.

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/default.htm, or http://www.regulations.gov.

    Dated: October 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-23972 Filed 10-7-14; 8:45 am]
BILLING CODE 4164-01-P