[Federal Register Volume 83, Number 183 (Thursday, September 20, 2018)]
[Notices]
[Pages 47625-47626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20444]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-2232]


Product Identifier Requirements Under the Drug Supply Chain 
Security Act--Compliance Policy; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``Product 
Identifier Requirements Under the Drug Supply Chain Security Act--
Compliance Policy.'' This guidance describes FDA's intention with 
regard to enforcement of the Drug Supply Chain Security Act (DSCSA) 
provision requiring manufacturers to begin affixing or imprinting 
product identifiers on their products beginning November 27, 2017. This 
guidance finalizes the draft guidance issued on July 3, 2017.

DATES: The announcement of the guidance is published in the Federal 
Register on September 20, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency Guidance 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 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-2017-D-2232 for ``Product Identifier Requirements Under the Drug 
Supply Chain Security Act--Compliance Policy.'' 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

[[Page 47626]]

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 the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Building 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: Connie Jung, 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

    FDA is announcing the availability of a guidance for industry 
entitled ``Product Identifier Requirements Under the Drug Supply Chain 
Security Act--Compliance Policy.'' On November 27, 2013, the DSCSA 
(Title II of Pub. L. 113-54) was signed into law. Section 202 of the 
DSCSA added section 582 to the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 360eee-1) which established product tracing, 
product identifier, authorized trading partner and verification 
requirements for manufacturers, repackagers, wholesale distributors, 
and dispensers to facilitate the tracing of products through the 
pharmaceutical distribution supply chain. Among its provisions, section 
582 of the FD&C Act requires that each package and homogenous case of 
product in the pharmaceutical distribution supply chain bear a product 
identifier that is encoded with the product's standardized numerical 
identifier, lot number, and expiration date by specific dates. Under 
the statute, manufacturers were required to begin affixing or 
imprinting a product identifier to each package and homogenous case of 
a product intended to be introduced into commerce no later than 
November 27, 2017. Failure to comply with this and other requirements 
of section 582 is prohibited under section 301(t) of the FD&C Act (21 
U.S.C. 331(t)) and subject to enforcement action under the FD&C Act.
    In the Federal Register of July 3, 2017 (82 FR 30868), FDA issued a 
notice announcing the availability of the draft version of this 
guidance. As described in the guidance, in the years since the passage 
of DSCSA, FDA had received comments and feedback from manufacturers and 
other trading partners expressing concern with industry-wide readiness 
for implementation of the DSCSA provision requiring manufacturers to 
begin putting product identifiers on their products by November 27, 
2017. Given the implementation challenges that industry has 
encountered, FDA recognized that some manufacturers would need 
additional time beyond November 27, 2017, to ensure that their products 
bear a product identifier as required by the DSCSA. To minimize 
possible disruptions in the distribution of prescription drugs in the 
United States, FDA does not intend to take action against manufacturers 
who do not affix or imprint a product identifier to packages or 
homogenous cases of product that are packaged before November 27, 2018. 
This includes packages and homogenous cases of product that are 
packaged by a manufacturer on or after November 27, 2017. The comment 
period for the draft guidance ended September 1, 2017. FDA received 19 
comments on the draft guidance.
    FDA made several changes to the guidance. We streamlined the 
guidance to remove information that is portions of the draft version of 
this guidance because they were repetitive of the information in the 
final guidance for industry entitled, ``Grandfathering Policy for 
Packages and Homogenous Cases of Product Without a Product 
Identifier.'' In addition, FDA removed the language in the draft 
version of this guidance on wholesale distributor and dispenser 
responsibilities to ensure product purchased from repackagers after 
November 27, 2018, is affixed or imprinted with a product identifier. 
Finally, FDA removed the recommendations in the draft version of this 
guidance related to the documentation for determining when a product 
without a product identifier was introduced in a transaction into 
commerce by a manufacturer. The topic of documentation is addressed in 
the final grandfathering policy guidance.
    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 ``Product Identifier Requirements Under the 
Drug Supply Chain Security Act--Compliance Policy.'' 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. Electronic Access

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

    Dated: September 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20444 Filed 9-19-18; 8:45 am]
 BILLING CODE 4164-01-P