83 FR 47625 - Product Identifier Requirements Under the Drug Supply Chain Security Act-Compliance Policy; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 183 (September 20, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 183 (September 20, 2018)
| Page Range | 47625-47626 | |
| FR Document | 2018-20444 |
[Federal Register Volume 83, Number 183 (Thursday, September 20, 2018)] [Notices] [Pages 47625-47626] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-20444] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 This guidance finalizes the draft guidance issued on July 3, 2017.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.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 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
![Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Notices 47625
guidance is also available at https:// to receive an electronic copy of the subject to review by the Office of
www.regulations.gov. Persons unable to document. Please use the document Management and Budget (OMB) under
download an electronic copy of number 1817 to identify the guidance the Paperwork Reduction Act of 1995
‘‘Heparin-Containing Medical Devices you are requesting. (44 U.S.C. 3501–3520). The collections
and Combination Products: IV. Paperwork Reduction Act of 1995 of information in the following FDA
Recommendations for Labeling and regulations and guidance have been
This guidance refers to previously
Safety Testing’’ may send an email approved by OMB as listed in the
approved collections of information.
request to CDRH-Guidance@fda.hhs.gov following table:
These collections of information are
OMB
21 CFR part; guidance; or FDA form Topic control No.
211 ..................................................................... Current good manufacturing practice for finished pharmaceuticals ................... 0910–0139
807, subpart E ................................................... Premarket notification ......................................................................................... 0910–0120
814, subparts A through E ................................ Premarket approval ............................................................................................. 0910–0231
814, subpart H ................................................... Humanitarian Device Exemption ......................................................................... 0910–0332
812 ..................................................................... Investigational Device Exemption ....................................................................... 0910–0078
‘‘De Novo Classification Process (Evaluation of De Novo classification process ........................................................................... 0910–0844
Automatic Class III Designation)’’.
801 ..................................................................... Medical Device Labeling Regulations ................................................................. 0910–0485
803 ..................................................................... Medical Devices; Medical Device Reporting; Manufacturer reporting, importer 0910–0437
reporting, user facility reporting, distributor reporting.
820 ..................................................................... Quality System (QS) Regulation ......................................................................... 0910–0073
Dated: September 17, 2018. Electronic Submissions information submitted, marked and
Leslie Kux, Submit electronic comments in the identified, as confidential, if submitted
Associate Commissioner for Policy. following way: as detailed in ‘‘Instructions.’’
[FR Doc. 2018–20472 Filed 9–19–18; 8:45 am] • Federal eRulemaking Portal: Instructions: All submissions received
BILLING CODE 4164–01–P https://www.regulations.gov. Follow the must include the Docket No. FDA–
instructions for submitting comments. 2017–D–2232 for ‘‘Product Identifier
Comments submitted electronically, Requirements Under the Drug Supply
DEPARTMENT OF HEALTH AND including attachments, to https:// Chain Security Act—Compliance
HUMAN SERVICES www.regulations.gov will be posted to Policy.’’ Received comments will be
the docket unchanged. Because your placed in the docket and, except for
Food and Drug Administration comment will be made public, you are those submitted as ‘‘Confidential
solely responsible for ensuring that your Submissions,’’ publicly viewable at
[Docket No. FDA–2017–D–2232]
comment does not include any https://www.regulations.gov or at the
Product Identifier Requirements Under confidential information that you or a Dockets Management Staff between 9
the Drug Supply Chain Security Act— third party may not wish to be posted, a.m. and 4 p.m., Monday through
Compliance Policy; Guidance for such as medical information, your or Friday.
anyone else’s Social Security number, or • Confidential Submissions—To
Industry; Availability
confidential business information, such submit a comment with confidential
AGENCY: Food and Drug Administration, information that you do not wish to be
as a manufacturing process. Please note
HHS. made publicly available, submit your
that if you include your name, contact
ACTION: Notice of availability. information, or other information that comments only as a written/paper
identifies you in the body of your submission. You should submit two
SUMMARY: The Food and Drug copies total. One copy will include the
Administration (FDA or Agency) is comments, that information will be
posted on https://www.regulations.gov. information you claim to be confidential
announcing the availability of a final with a heading or cover note that states
guidance for industry entitled ‘‘Product • If you want to submit a comment
with confidential information that you ‘‘THIS DOCUMENT CONTAINS
Identifier Requirements Under the Drug CONFIDENTIAL INFORMATION.’’ The
Supply Chain Security Act— do not wish to be made available to the
public, submit the comment as a Agency will review this copy, including
Compliance Policy.’’ This guidance the claimed confidential information, in
describes FDA’s intention with regard to written/paper submission and in the
manner detailed (see ‘‘Written/Paper its consideration of comments. The
enforcement of the Drug Supply Chain second copy, which will have the
Security Act (DSCSA) provision Submissions’’ and ‘‘Instructions’’).
claimed confidential information
requiring manufacturers to begin Written/Paper Submissions redacted/blacked out, will be available
affixing or imprinting product Submit written/paper submissions as for public viewing and posted on
identifiers on their products beginning follows: https://www.regulations.gov. Submit
November 27, 2017. This guidance • Mail/Hand delivery/Courier (for both copies to the Dockets Management
finalizes the draft guidance issued on written/paper submissions): Dockets Staff. If you do not wish your name and
amozie on DSK3GDR082PROD with NOTICES1
July 3, 2017. Management Staff (HFA–305), Food and contact information to be made publicly
DATES: The announcement of the Drug Administration, 5630 Fishers available, you can provide this
guidance is published in the Federal Lane, Rm. 1061, Rockville, MD 20852. information on the cover sheet and not
Register on September 20, 2018. • For written/paper comments in the body of your comments and you
ADDRESSES: You may submit either submitted to the Dockets Management must identify this information as
electronic or written comments on Staff, FDA will post your comment, as ‘‘confidential.’’ Any information marked
Agency Guidance at any time as follows: well as any attachments, except for as ‘‘confidential’’ will not be disclosed
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![47626 Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Notices
except in accordance with 21 CFR 10.20 section 582 of the FD&C Act requires product purchased from repackagers
and other applicable disclosure law. For that each package and homogenous case after November 27, 2018, is affixed or
more information about FDA’s posting of product in the pharmaceutical imprinted with a product identifier.
of comments to public dockets, see 80 distribution supply chain bear a product Finally, FDA removed the
FR 56469, September 18, 2015, or access identifier that is encoded with the recommendations in the draft version of
the information at: https://www.gpo.gov/ product’s standardized numerical this guidance related to the
fdsys/pkg/FR-2015-09-18/pdf/2015- identifier, lot number, and expiration documentation for determining when a
23389.pdf. date by specific dates. Under the statute, product without a product identifier
Docket: For access to the docket to manufacturers were required to begin was introduced in a transaction into
read background documents or the affixing or imprinting a product commerce by a manufacturer. The topic
electronic and written/paper comments identifier to each package and of documentation is addressed in the
received, go to https:// homogenous case of a product intended final grandfathering policy guidance.
www.regulations.gov and insert the to be introduced into commerce no later This guidance is being issued
docket number, found in brackets in the than November 27, 2017. Failure to consistent with FDA’s good guidance
heading of this document, into the comply with this and other practices regulation (21 CFR 10.115).
‘‘Search’’ box and follow the prompts requirements of section 582 is The guidance represents the current
and/or go to the Dockets Management prohibited under section 301(t) of the thinking of FDA on ‘‘Product Identifier
Staff, 5630 Fishers Lane, Rm. 1061, FD&C Act (21 U.S.C. 331(t)) and subject Requirements Under the Drug Supply
Rockville, MD 20852. You may submit to enforcement action under the FD&C Chain Security Act—Compliance
comments on any guidance at any time Act. Policy.’’ It does not establish any rights
(see 21 CFR 10.115(g)(5)). In the Federal Register of July 3, 2017 for any person and is not binding on
Submit written requests for single (82 FR 30868), FDA issued a notice FDA or the public. You can use an
copies of the draft guidance to the announcing the availability of the draft alternative approach if it satisfies the
Division of Drug Information, Center for version of this guidance. As described requirements of the applicable statutes
Drug Evaluation and Research, Food in the guidance, in the years since the and regulations. This guidance is not
and Drug Administration, 10001 New passage of DSCSA, FDA had received subject to Executive Order 12866.
Hampshire Ave., Hillandale Building, comments and feedback from
II. Electronic Access
4th Floor, Silver Spring, MD 20993– manufacturers and other trading
0002, or the Office of Communication, partners expressing concern with Persons with access to the internet
Outreach and Development, Center for industry-wide readiness for may obtain the guidance at https://
Biologics Evaluation and Research, implementation of the DSCSA provision www.fda.gov/Drugs/Guidance
Food and Drug Administration, 10903 requiring manufacturers to begin putting ComplianceRegulatoryInformation/
New Hampshire Ave., Building 71, Rm. product identifiers on their products by Guidances/default.htm, https://
3128, Silver Spring, MD 20993–0002. November 27, 2017. Given the www.fda.gov/BiologicsBloodVaccines/
Send one self-addressed adhesive label implementation challenges that industry GuidanceComplianceRegulatory
to assist that office in processing your has encountered, FDA recognized that Information/Guidances/default.htm, or
requests. See the SUPPLEMENTARY some manufacturers would need https://www.regulations.gov.
INFORMATION section for electronic additional time beyond November 27, Dated: September 14, 2018.
access to the draft guidance document. 2017, to ensure that their products bear Leslie Kux,
a product identifier as required by the Associate Commissioner for Policy.
FOR FURTHER INFORMATION CONTACT:
DSCSA. To minimize possible
Connie Jung, Office of Compliance, [FR Doc. 2018–20444 Filed 9–19–18; 8:45 am]
disruptions in the distribution of
Center for Drug Evaluation and BILLING CODE 4164–01–P
prescription drugs in the United States,
Research, Food and Drug
FDA does not intend to take action
Administration, 10903 New Hampshire
against manufacturers who do not affix DEPARTMENT OF HEALTH AND
Ave., Silver Spring, MD 20993–0002,
or imprint a product identifier to
301–796–3130, drugtrackandtrace@ HUMAN SERVICES
packages or homogenous cases of
fda.hhs.gov. product that are packaged before Food and Drug Administration
SUPPLEMENTARY INFORMATION: November 27, 2018. This includes
packages and homogenous cases of [Docket No. FDA–2018–D–3175]
I. Background
product that are packaged by a
FDA is announcing the availability of Product Identifiers Under the Drug
manufacturer on or after November 27,
a guidance for industry entitled Supply Chain Security Act Questions
2017. The comment period for the draft
‘‘Product Identifier Requirements Under and Answers; Draft Guidance for
guidance ended September 1, 2017.
the Drug Supply Chain Security Act— Industry; Availability
FDA received 19 comments on the draft
Compliance Policy.’’ On November 27, guidance. AGENCY: Food and Drug Administration,
2013, the DSCSA (Title II of Pub. L. FDA made several changes to the HHS.
113–54) was signed into law. Section guidance. We streamlined the guidance ACTION: Notice of availability.
202 of the DSCSA added section 582 to to remove information that is portions of
the Federal Food, Drug, and Cosmetic the draft version of this guidance SUMMARY: The Food and Drug
Act (FD&C Act) (21 U.S.C. 360eee–1) because they were repetitive of the Administration FDA or Agency) is
which established product tracing, information in the final guidance for announcing the availability of a draft
amozie on DSK3GDR082PROD with NOTICES1
product identifier, authorized trading industry entitled, ‘‘Grandfathering guidance for industry entitled ‘‘Product
partner and verification requirements Policy for Packages and Homogenous Identifiers Under the Drug Supply
for manufacturers, repackagers, Cases of Product Without a Product Chain Security Act Questions and
wholesale distributors, and dispensers Identifier.’’ In addition, FDA removed Answers.’’ This draft guidance intends
to facilitate the tracing of products the language in the draft version of this to clarify questions relating to product
through the pharmaceutical distribution guidance on wholesale distributor and identifiers that are required by the
supply chain. Among its provisions, dispenser responsibilities to ensure Federal Food, Drug, and Cosmetic Act
VerDate Sep<11>2014 18:01 Sep 19, 2018 Jkt 244001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\20SEN1.SGM 20SEN1](https://thefederalregister.org/doc/83_FR_47808/page/2.svg)
Document Created: 2018-09-20 02:08:19
Document Modified: 2018-09-20 02:08:19
| 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 | 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] | |
| FR Citation | 83 FR 47625 |
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