[Federal Register Volume 83, Number 183 (Thursday, September 20, 2018)]
[Notices]
[Pages 47626-47628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20502]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3175]


Product Identifiers Under the Drug Supply Chain Security Act 
Questions and Answers; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Product 
Identifiers Under the Drug Supply Chain Security Act Questions and 
Answers.'' This draft guidance intends to clarify questions relating to 
product identifiers that are required by the Federal Food, Drug, and 
Cosmetic Act

[[Page 47627]]

(FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA) 
for packages and homogenous cases of certain drug products. Sections of 
the FD&C Act require manufacturers and repackagers to affix or imprint 
a product identifier to each package and homogenous case of a product 
intended to be introduced in a transaction into commerce beginning 
November 27, 2017, and November 28, 2018, respectively. This draft 
guidance intends to clarify these requirements.

DATES: Submit either electronic or written comments on the draft 
guidance by November 19, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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 
concerning the collection of information proposed in the draft guidance 
by November 19, 2018.

ADDRESSES: You may submit comments 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 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-2018-D-3175 for ``Product Identifiers Under the Drug Supply Chain 
Security 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.
     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.gpo.gov/fdsys/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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 20993-0002; or to 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.

FOR FURTHER INFORMATION CONTACT: Tia Harper-Velazquez, 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].

SUPPLEMENTARY INFORMATION: 

I. Background

    The DSCSA (Title II of Pub. L. 113-54) was signed into law on 
November 27, 2013. Section 202 of the DSCSA added section 582 to the 
FD&C Act (21 U.S.C. 360eee-1). This section establishes product 
tracing, product identifier, and verification requirements for 
manufacturers, repackagers, wholesale distributors, and dispensers to 
facilitate the tracing of products through the pharmaceutical 
distribution supply chain. Failure to comply with the requirements of 
section 582 is a prohibited act under section 301(t) of the FD&C Act 
(21 U.S.C. 331(t)).
    The effective date for manufacturers to ``affix or imprint a 
product identifier to each package and homogenous case of a product 
intended to be introduced in a transaction into commerce'' under 
section 582(b)(2)(A) of the FD&C Act, is not later than November 27, 
2017. In June 2017, FDA published a draft guidance entitled ``Product 
Identifier Requirements Under the Drug Supply Chain Security Act--
Compliance Policy,'' in which FDA describes its intention regarding the 
enforcement of certain product identifiers under the DSCSA. As 
described in the draft guidance, FDA does not intend to take action 
against manufacturers who do not affix or imprint a product identifier 
to each package and homogenous case of products intended to be 
introduced in a transaction into commerce before November 26, 2018. 
This represents a 1-year delay in enforcement of the requirement for 
manufacturers to affix or imprint product identifiers. The

[[Page 47628]]

effective date for repackagers to ``affix or imprint a product 
identifier to each package and homogenous case of a product intended to 
be introduced in a transaction in commerce'' under section 582(e)(2)(A) 
of the FD&C Act, is not later than November 27, 2018.
    This guidance is intended to assist manufacturers and repackagers 
in understanding the requirements to affix or imprint a product 
identifier on each package and homogenous case of product that they 
introduce in a transaction into commerce to satisfy the product 
identifier requirement of section 582 of the FD&C Act. The 
recommendations in this guidance are intended to assist manufacturers 
and repackagers in standardizing both the human-readable and machine-
readable format of the information that is contained in the product 
identifier. This guidance also intends to clarify that these 
requirements do not change the linear barcode requirements.
    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 current thinking of FDA on ``Product 
Identifiers Under the Supply Chain Security 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. 
This guidance is not subject to Executive Order 12866.

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 (PRA) of 1995 (44 U.S.C. 3501-3520) 
(PRA). In accordance with the PRA, prior to publication of any final 
guidance document, 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 material modifications to those 
previously approved collections of information found in FDA regulations 
or guidances.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: September 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20502 Filed 9-19-18; 8:45 am]
 BILLING CODE 4164-01-P