83 FR 47622 - Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 183 (September 20, 2018)

Page Range		47622-47623
FR Document		2018-20503

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.'' This guidance specifies whether and under what circumstances packages and homogenous cases of product not labeled with a product identifier shall be grandfathered from certain requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance finalizes the draft guidance issued on November 27, 2017.

Federal Register, Volume 83 Issue 183 (Thursday, September 20, 2018)

[Federal Register Volume 83, Number 183 (Thursday, September 20, 2018)]
[Notices]
[Pages 47622-47623]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20503]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6526]


Grandfathering Policy for Packages and Homogenous Cases of 
Product Without a Product Identifier; 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 
``Grandfathering Policy for Packages and Homogenous Cases of Product 
Without a Product Identifier.'' This guidance specifies whether and 
under what circumstances packages and homogenous cases of product not 
labeled with a product identifier shall be grandfathered from certain 
requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 
This guidance finalizes the draft guidance issued on November 27, 2017.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 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 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-6526 for ``Grandfathering Policy for Packages and Homogenous 
Cases of Product Without a Product Identifier.'' 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.thefederalregister.org/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 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: Abha Kundi, 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].

[[Page 47623]]


SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Grandfathering Policy for Packages and Homogenous Cases of 
Product Without a Product Identifier.'' On November 27, 2013, the Drug 
Supply Chain Security Act (DSCSA) (Title II of Pub. L. 113-54) was 
signed into law. Section 202 of the DSCSA added section 582 to the FD&C 
Act (21 U.S.C. 360eee-1), which established product tracing 
requirements for manufacturers, repackagers, wholesale distributors, 
and dispensers. The DSCSA phases in its requirements over a 10-year 
period.
    A critical set of phased product tracing requirements outlined in 
section 582 of the FD&C Act relates to the product identifier. 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. Repackagers are required to 
do the same no later than November 27, 2018.
    Sections 582(c)(2), (d)(2), and (e)(2)(A)(iii) of the FD&C Act 
restrict trading partners' ability to engage in transactions involving 
packages and homogenous cases of product that are not labeled with a 
product identifier after specific dates. Beginning November 27, 2018, 
repackagers may not engage in a transaction involving a package or 
homogenous case of a product that is not encoded with a product 
identifier. Similar restrictions go into effect for wholesale 
distributors and dispensers on November 27, 2019, and November 27, 
2020, respectively.
    In addition, section 582 of the FD&C Act requires trading partners 
to verify product identifiers on packages and homogenous cases starting 
on November 27, 2017, for manufacturers (section 582(b)(4)); on 
November 27, 2019, for wholesale distributors (section 582(c)(4)); on 
November 27, 2020, for dispensers (section 582(d)(4)); and on November 
27, 2018, for repackagers (section 582(e)(4)). Manufacturers, 
repackagers, wholesale distributors, and dispensers are also required 
to verify the product identifier of a saleable returned package or 
sealed homogenous case on November 27, 2017, November 27, 2018, 
November 27, 2019, and November 27, 2020, respectively.
    In section 582(a)(5)(A) of the FD&C Act, Congress directed FDA to 
issue guidance specifying ``whether and under what circumstances 
product that is not labeled with a product identifier and that is in 
the pharmaceutical supply chain at the time at the time of the 
effective date of the requirements of [section 582] shall be exempted'' 
from the product tracing requirements discussed previously. The 
guidance addresses this requirement. As explained in the guidance, only 
packages and homogenous cases of product that are in the pharmaceutical 
distribution supply chain at the time of the effective date of the 
requirements of section 582 are eligible for grandfathering under 
section 582(a)(5)(A) of the FD&C Act.
    In the Federal Register of November 27, 2017 (82 FR 56033), FDA 
issued a notice announcing the availability of the draft version of 
this guidance. The comment period for the draft guidance ended January 
26, 2018. FDA received approximately 10 comments on the draft guidance. 
In response to received comments or on its own initiative, FDA made 
several changes. The most significant change FDA made was to revise the 
grandfathering exemption to include products repackaged by a repackager 
before November 27, 2018. FDA made this change in response to comments 
indicating that repackagers will need time beyond November 27, 2018, to 
sell such product. In addition, FDA made editorial and formatting 
changes 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 ``Grandfathering Policy for Packages and 
Homogenous Cases of Product Without a Product Identifier.'' It does not 
establish any rights for any person and, with the exception of 
specified material in section IV, 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. 2018-20503 Filed 9-19-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Notices 47623

SUPPLEMENTARY INFORMATION: November 27, 2019, and November 27, Dated: September 14, 2018.
2020, respectively. Leslie Kux,
I. Background In section 582(a)(5)(A) of the FD&C Associate Commissioner for Policy.
FDA is announcing the availability of Act, Congress directed FDA to issue [FR Doc. 2018–20503 Filed 9–19–18; 8:45 am]
a guidance for industry entitled guidance specifying ‘‘whether and BILLING CODE 4164–01–P
‘‘Grandfathering Policy for Packages and under what circumstances product that
Homogenous Cases of Product Without is not labeled with a product identifier
a Product Identifier.’’ On November 27, and that is in the pharmaceutical supply DEPARTMENT OF HEALTH AND
2013, the Drug Supply Chain Security chain at the time at the time of the HUMAN SERVICES
Act (DSCSA) (Title II of Pub. L. 113–54) effective date of the requirements of
was signed into law. Section 202 of the [section 582] shall be exempted’’ from Food and Drug Administration
DSCSA added section 582 to the FD&C the product tracing requirements [Docket No. FDA–2015–D–2167]
Act (21 U.S.C. 360eee–1), which discussed previously. The guidance
established product tracing addresses this requirement. As Heparin-Containing Medical Devices
requirements for manufacturers, explained in the guidance, only and Combination Products:
repackagers, wholesale distributors, and packages and homogenous cases of Recommendations for Labeling and
dispensers. The DSCSA phases in its product that are in the pharmaceutical Safety Testing; Guidance for Industry
requirements over a 10-year period. distribution supply chain at the time of and Food and Drug Administration
A critical set of phased product the effective date of the requirements of Staff; Availability
tracing requirements outlined in section section 582 are eligible for
582 of the FD&C Act relates to the grandfathering under section AGENCY: Food and Drug Administration,
product identifier. Among its 582(a)(5)(A) of the FD&C Act. HHS.
provisions, section 582 of the FD&C Act In the Federal Register of November ACTION: Notice of availability.
requires that each package and 27, 2017 (82 FR 56033), FDA issued a
homogenous case of product in the notice announcing the availability of the SUMMARY: The Food and Drug
pharmaceutical distribution supply draft version of this guidance. The Administration (FDA or Agency) is
chain bear a product identifier that is comment period for the draft guidance announcing the availability of a final
encoded with the product’s ended January 26, 2018. FDA received guidance entitled ‘‘Heparin-Containing
standardized numerical identifier, lot approximately 10 comments on the draft Medical Devices and Combination
number, and expiration date by specific guidance. In response to received Products: Recommendations for
dates. Under the statute, manufacturers comments or on its own initiative, FDA Labeling and Safety Testing.’’ The
were required to begin affixing or made several changes. The most United States Pharmacopeia (USP) drug
imprinting a product identifier to each significant change FDA made was to substance monograph for Heparin
package and homogenous case of a revise the grandfathering exemption to Sodium, and drug product monographs
product intended to be introduced into include products repackaged by a for Heparin Lock Flush Solution and
commerce no later than November 27, repackager before November 27, 2018. Heparin Sodium Injection, recently have
2017. Repackagers are required to do the FDA made this change in response to undergone several revisions following
same no later than November 27, 2018. comments indicating that repackagers serious and fatal events related to the
Sections 582(c)(2), (d)(2), and will need time beyond November 27, use of heparin sodium products.
(e)(2)(A)(iii) of the FD&C Act restrict 2018, to sell such product. In addition, Investigation of heparin product
trading partners’ ability to engage in FDA made editorial and formatting overdose errors identified the
transactions involving packages and changes to improve clarity. expression of drug strength in the labels
homogenous cases of product that are This guidance is being issued as a major contributing factor in these
not labeled with a product identifier consistent with FDA’s good guidance errors. This guidance document
after specific dates. Beginning practices regulation (21 CFR 10.115). addresses these safety concerns by
November 27, 2018, repackagers may The guidance represents the current clarifying new expectations for labeling
not engage in a transaction involving a thinking of FDA on ‘‘Grandfathering with regard to the revised heparin USP
package or homogenous case of a Policy for Packages and Homogenous monographs, as well as outlining safety
product that is not encoded with a Cases of Product Without a Product testing recommendations.
product identifier. Similar restrictions Identifier.’’ It does not establish any DATES: The announcement of the
go into effect for wholesale distributors rights for any person and, with the guidance is published in the Federal
and dispensers on November 27, 2019, exception of specified material in Register on September 20, 2018.
and November 27, 2020, respectively. section IV, is not binding on FDA or the ADDRESSES: You may submit either
In addition, section 582 of the FD&C public. You can use an alternative electronic or written comments on
Act requires trading partners to verify approach if it satisfies the requirements Agency guidances at any time as
product identifiers on packages and of the applicable statutes and follows:
homogenous cases starting on November regulations. This guidance is not subject
27, 2017, for manufacturers (section to Executive Order 12866. Electronic Submissions
582(b)(4)); on November 27, 2019, for Submit electronic comments in the
wholesale distributors (section II. Electronic Access following way:
582(c)(4)); on November 27, 2020, for Persons with access to the internet • Federal eRulemaking Portal:
dispensers (section 582(d)(4)); and on may obtain the guidance at https:// https://www.regulations.gov. Follow the
amozie on DSK3GDR082PROD with NOTICES1

November 27, 2018, for repackagers www.fda.gov/Drugs/Guidance instructions for submitting comments.
(section 582(e)(4)). Manufacturers, ComplianceRegulatoryInformation/ Comments submitted electronically,
repackagers, wholesale distributors, and Guidances/default.htm, https:// including attachments, to https://
dispensers are also required to verify the www.fda.gov/BiologicsBloodVaccines/ www.regulations.gov will be posted to
product identifier of a saleable returned GuidanceComplianceRegulatory the docket unchanged. Because your
package or sealed homogenous case on Information/Guidances/default.htm, or comment will be made public, you are
November 27, 2017, November 27, 2018, https://www.regulations.gov. solely responsible for ensuring that your

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Document Created: 2018-09-20 02:08:50
Document Modified: 2018-09-20 02:08:50

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
Dates		The announcement of the guidance is published in the Federal Register on September 20, 2018.
Contact		Abha Kundi, 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]
FR Citation		83 FR 47622

83 FR 47622 - Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 183 (September 20, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration