Document ID: FDA-2014-D-1411-0022
Agency: fda
Document Type: Notice
Title: Drug Product Tracing: The Effect of Section 585 of the Federal Food, Drug, and Cosmetic Act—Questions and Answers; Guidance for Industry; Availability
Posted Date: 2022-02-04T05:00Z

[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Notices]
[Pages 6572-6574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01926]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Drug Product Tracing: The Effect of Section 585 of the Federal 
Food, Drug, and Cosmetic Act--Questions and Answers; Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``Drug 
Product Tracing: The Effect of Section 585 of the FD&C Act--Questions 
and Answers.'' FDA is issuing this guidance to assist industry and 
State and local governments in understanding the effects of the uniform 
national policy set forth in the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) that was added by the Drug Supply Chain Security Act, which 
was enacted on November 27, 2013. This guidance is intended to help 
industry and States understand the law as it is currently in effect and 
clarify its effect on State product tracing. This guidance finalizes 
the draft guidance entitled ``The Effect of Uniform National Policy on 
Drug Product Tracing and Wholesale Drug Distributor and Third-Party 
Logistics Provider Standards: Questions and Answers'' issued on October 
8, 2014.

DATES: The announcement of the guidance is published in the Federal 
Register on February 4, 2022.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note

[[Page 6573]]

that if you include your name, contact information, or other 
information that identifies you in the body of your comments, that 
information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-D-1411 for ``Drug Product Tracing: The Effect of Section 585 
of the FD&C Act--Questions and Answers.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this 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 20993-0002; 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Aaron Weisbuch, 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, 
[email protected]; or Stephen Ripley, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm.7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Drug Product Tracing: The Effect of 585 of the FD&C Act--
Questions and Answers.'' Title II of the Drug Quality and Security Act 
(Pub. L. 113-54), which is also referred to as the Drug Supply Chain 
Security Act (DSCSA), enacted on November 27, 2013, established 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 third-party logistics 
providers (3PLs); the Agency is publishing a proposed rule with respect 
to those standards concurrently with this final guidance. Section 585 
of the FD&C Act (21 U.S.C. 360eee-4) sets forth a uniform national 
policy preempting States from establishing or continuing in effect 
certain standards and requirements. The guidance is intended to (1) 
help industry and States understand the law as it is currently in 
effect and (2) clarify the effect of section 585(a) on State product 
tracing.
    This guidance finalizes the draft guidance entitled ``The Effect of 
Uniform National Policy on Drug Product Tracing and Wholesale Drug 
Distributor and Third-Party Logistics Provider Standards: Questions and 
Answers'' issued on October 8, 2014 (79 FR 60853). The draft guidance 
covered section 585(a) and (b) of the FD&C Act. This guidance does not 
cover the effect of section 585(b) of the FD&C Act, given that section 
585(b) is addressed in the preamble to the proposed rule with respect 
to the standards for licensing wholesale distributors and 3PLs, 
published elsewhere in this issue of the Federal Register. FDA 
considered comments received on the draft guidance as the guidance was 
finalized. Changes from the draft to the final guidance include the 
removal of the discussion of the effect of 585(b) of the FD&C Act. The 
title of the guidance has been updated to reflect this change in 
content. In addition, editorial changes were made to improve clarity
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Drug Product Tracing: The Effect of 585 of 
the FD&C Act--Questions and Answers.'' It does not establish any rights 
for any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://

[[Page 6574]]

www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-
drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: January 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01926 Filed 2-3-22; 8:45 am]
BILLING CODE 4164-01-P