
[Federal Register Volume 82, Number 126 (Monday, July 3, 2017)]
[Notices]
[Pages 30868-30870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13979]


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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Security Act--Compliance Policy; Draft Guidance for Industry; 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the availability of a draft guidance for industry entitled ``Product 
Identifier Requirements Under the Drug Supply Chain Security Act--
Compliance Policy.'' This draft guidance describes FDA's intention with 
regard to enforcement of requirements related to product identifiers 
under the Drug Supply Chain Security Act (DSCSA). Specifically, this 
guidance addresses manufacturers' product identifier and verification 
requirements, which begin November 27, 2017. This guidance also 
addresses certain requirements for repackagers, wholesale distributors, 
and dispensers to only engage in transactions involving products with 
product identifiers and to verify the product identifier when 
investigating suspect product, in addition to repackager and wholesale 
distributor requirements related to saleable returned products.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 1, 2017.

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-2017-D-2232 for ``Product Identifier Requirements Under the Drug 
Supply Chain Security Act--Compliance Policy; Draft Guidance for 
Industry; Availability.'' Received comments, those filed in a timely 
manner (see DATES), will be placed in the docket and, except for those 
submitted as

[[Page 30869]]

``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.
    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: 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, 
drugtrackandtrace@fda.hhs.gov.

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 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360eee-
1). This section established 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 also a prohibited act under 
section 301(t) of the FD&C Act (21 U.S.C. 331(t)).
    Beginning November 27, 2017, manufacturers are required, under 
section 582(b)(2)(A) of the FD&C Act, 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.'' Also beginning on 
November 27, 2017, section 582(b)(4)(A)(i)(II) of the FD&C Act requires 
manufacturers to verify the product at the package level, including the 
standardized numerical identifier, which is part of the product 
identifier, when they determine that the product in their possession or 
control is suspect or they receive a verification request from FDA. 
Section 582(b)(4)(C) of the FD&C Act requires a manufacturer, upon 
receiving a request from an authorized trading partner that believes a 
product in its possession or control was manufactured by the 
manufacturer, to verify whether the product identifier on a product 
corresponds with the product identifier affixed or imprinted by the 
manufacturer. Section 582(b)(4)(E) of the FD&C Act requires 
manufacturers to verify the product identifier of a package or a sealed 
homogenous case of a saleable returned product before the manufacturer 
further distributes such product.
    In addition, under section 582(e)(2)(A)(iii) of the FD&C Act, 
beginning on November 27, 2018, repackagers may engage in transactions 
involving a product only if such product is encoded with a product 
identifier, unless the product is grandfathered under section 582(a)(5) 
of the FD&C Act. This same requirement applies to wholesale 
distributors beginning on November 27, 2019, under section 582(c)(2) of 
the FD&C Act, and to dispensers beginning on November 27, 2020, under 
section 582(d)(2) of the FD&C Act. Additionally, under section 
582(c)(4)(A)(i)(II), (d)(4)(A)(ii)(II), and (e)(4)(A)(i)(II) of the 
FD&C Act, wholesale distributors, dispensers, and repackagers are 
required to verify the product at the package level, including the 
standardized numerical identifier, which is part of the product 
identifier, to investigate a suspect product. For a saleable returned 
product, the wholesale distributor or repackager must verify the 
product identifier, including the standardized numerical identifier, of 
each package or sealed homogenous case of such product before it 
further distributes such product, under section 582(c)(4)(D) and 
(e)(4)(E) of the FD&C Act, respectively.
    As described in the draft guidance, FDA has received comments and 
feedback from manufacturers and other trading partners expressing 
concern with industry-wide readiness for implementation of the product 
identifier requirements for manufacturers and describing challenges 
they face. Given the concerns expressed, FDA recognizes that some 
manufacturers may need additional time beyond November 27, 2017, to 
ensure that products are properly labeled with a product identifier. To 
minimize possible disruptions in the distribution of prescription drugs 
in the United States, FDA has adopted the compliance policy described 
in the guidance.
    Under this compliance policy, FDA does not intend to take action 
against manufacturers who do not affix or imprint a product identifier 
to their packages and homogenous cases of product that are intended to 
be introduced in a transaction into commerce between November 27, 2017, 
and November 26, 2018. For such product that does not contain a product 
identifier and was first introduced in a transaction into commerce by 
the manufacturer between November 27, 2017, and November 26, 2018, FDA 
also does not intend to take action against manufacturers who do not 
use the product identifier to verify a product at the package level 
when investigating suspect product, upon receiving a verification 
request from FDA, after receiving a request from an authorized trading 
partner, or for a saleable returned product.
    This guidance also explains that, for a product that does not have 
a product identifier and that was first introduced

[[Page 30870]]

in a transaction into commerce by the manufacturer between November 27, 
2017, and November 26, 2018, FDA does not intend to take action 
against: (1) Repackagers who accept ownership of such product in a 
transaction; (2) wholesale distributors who engage in transactions 
involving such product; and (3) dispensers who engage in transactions 
involving such product, or repackagers, wholesale distributors, and 
dispensers who do not verify the product at the package level, using 
the product identifier, when investigating suspect product or for a 
saleable returned product as applicable. In addition, the guidance 
explains that FDA does not intend to take action against a 
manufacturer, repackager, or wholesale distributor who engages in 
certain prohibited acts involving products that are misbranded based on 
lack of product identifier alone, where the package and/or homogeneous 
case of product that lacks a product identifier was introduced in a 
transaction into commerce by a manufacturer between November 27, 2017, 
and November 26, 2018. The guidance document explains the scope of the 
compliance policy in further detail. FDA invites comment on the 
compliance policy, including comments on how manufacturers can indicate 
the date they initially introduced the product in a transaction into 
commerce and how downstream trading partners can determine that product 
was initially introduced by manufacturers in a transaction into 
commerce during that time period.
    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 
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 is not a significant regulatory action subject to 
Executive Order 12866.

II. Electronic Access

    Persons with access to the Internet may obtain the draft 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: June 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13979 Filed 6-30-17; 8:45 am]
BILLING CODE 4164-01-P


