Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act-Compliance Policies; Guidance for Industry; Availability, 58498-58500 [2023-18359]

Download as PDF 58498 AIRAC date 5-Oct-23 ....... 5-Oct-23 ....... Federal Register / Vol. 88, No. 165 / Monday, August 28, 2023 / Rules and Regulations State AR AR City Airport name Fayetteville .............. Fayetteville .............. Drake Fld ................................. Drake Fld ................................. 3/7180 3/7182 [FR Doc. 2023–18463 Filed 8–25–23; 8:45 a.m.] Electronic Submissions BILLING CODE 4910–13–P 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’’). DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket No. FDA–2023–D–1909] Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act—Compliance Policies; Guidance for Industry; Availability Food and Drug Administration, Department of Health and Human Services (HHS). ACTION: Notification of availability. AGENCY: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled ‘‘Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act—Compliance Policies.’’ This guidance describes FDA’s compliance policies regarding enforcement of requirements for the interoperable, electronic, package level product tracing (referred to as enhanced drug distribution security requirements) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) that will go into effect on November 27, 2023. FDA believes the compliance policies outlined in this guidance will help supply chain stakeholders, particularly trading partners, by accommodating the additional time that may be needed to continue to develop and refine appropriate systems and processes to conduct interoperable, electronic tracing at the package level, to achieve robust supply chain security under the Drug Supply Chain Security Act (DSCSA) while helping ensure continued patient access to prescription drugs. DATES: The announcement of the guidance is published in the Federal Register on August 28, 2023. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: lotter on DSK11XQN23PROD with RULES1 FDC No. VerDate Sep<11>2014 17:47 Aug 25, 2023 Jkt 259001 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– 2023–D–1909 for ‘‘Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act— Compliance Policies.’’ 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, 240–402–7500. PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 FDC date 8/9/23 8/9/23 Procedure name LOC RWY 16, Orig. RNAV (GPS) RWY 34, Amdt 1C. • 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500. 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 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. E:\FR\FM\28AUR1.SGM 28AUR1 Federal Register / Vol. 88, No. 165 / Monday, August 28, 2023 / Rules and Regulations 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: Elizabeth Pepinsky, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4258, Silver Spring, MD 20993–0002, 301– 796–3130, email: drugtrackandtrace@ fda.hhs.gov; or Anne Taylor, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: lotter on DSK11XQN23PROD with RULES1 I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act—Compliance Policies.’’ This guidance describes FDA’s compliance policies regarding enforcement of requirements for the interoperable, electronic, package level product tracing (referred to as enhanced drug distribution security requirements) under section 582(g)(1) of the FD&C Act (21 U.S.C. 360eee-1(g)(1)) that will go into effect on November 27, 2023. FDA believes that these compliance policies will facilitate the continued use of product tracing and verification methods currently being used while accommodating the additional time that may be needed by trading partners to continue to develop and refine the systems and processes for such activities required under section 582(g)(1) of the FD&C Act. We are issuing this guidance consistent with our good guidance practices (GGP) regulation (21 CFR 10.115). We are implementing this guidance without prior public comment because we have determined that prior public participation is not feasible or appropriate (21 CFR 10.115(g)(2)). The Agency made this determination because the Agency needs to communicate its compliance policy in a timely manner and provide stakeholders notice of the compliance policy ahead of the effective date of the enhanced distribution security requirements. Although this guidance document is being implemented immediately, it remains subject to comment in accordance with FDA’s GGP regulation and the Agency will consider all comments received and determine VerDate Sep<11>2014 17:47 Aug 25, 2023 Jkt 259001 whether revisions to the guidance document are appropriate. The DSCSA, enacted on November 27, 2013, outlines critical steps for building an electronic, interoperable system by November 27, 2023, that will identify and trace certain prescription drugs as they are distributed within the United States. Since the enactment of DSCSA, FDA and trading partners have been preparing for the implementation of the enhanced drug distribution security requirements imposed by section 582(g)(1) of the FD&C Act. Trading partners are continuing to work to have the necessary systems and processes in place in anticipation of the November 27, 2023, effective date for these requirements. While trading partners have the obligation to comply with section 582 requirements, including for enhanced drug distribution security, there are other stakeholders involved and affected, including but not limited to: solution providers, standards organizations, trade and professional organizations, state authorities, and other Federal authorities. FDA understands that collaboration and alignment among trading partners and other stakeholders throughout the supply chain are critical for achieving interoperability under the DSCSA. FDA has heard from stakeholders, including a broad representation of trading partners, about concerns regarding trading partner readiness and the need for clarity and flexibility to ensure trading partners can continue to move product through the supply chain when the enhanced drug distribution security requirements under section 582(g)(1) of the FD&C Act take effect. Most recently, at a virtual public meeting on DSCSA Implementation and Readiness Efforts for 2023 held on December 7 and 8, 2022 (87 FR 67047, November 7, 2022), stakeholders indicated that trading partners throughout the supply chain are at different stages of readiness, with some trading partners being further behind not only in terms of understanding their obligations under section 582(g)(1) of the FD&C Act, but also being aware of the time and resources necessary to meet those obligations. Stakeholders also expressed a need for clarity with respect to treatment of product that is already in the supply chain on November 27, 2023, and the need for flexibility when the requirements under section 582(g)(1) take effect, to minimize potential disruptions in the supply chain. In addition, stakeholders are experiencing challenges with predicting and planning for the possible volume of requests for product tracing information from Federal and State authorities and other PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 58499 trading partners, and the resources needed to respond to such requests, in accordance with section 582(g)(1) of the FD&C Act. While FDA generally expects trading partners to have the systems and processes in place to meet the enhanced drug distribution security requirements of section 582(g)(1) as of November 27, 2023, we recognize that some technical and operational issues, including issues involving trading partners and other affected stakeholders, may not be fully resolved by that time. The Agency also understands that additional time beyond November 27, 2023, may be needed for systems to stabilize and be fully interoperable for accurate, secure, and timely electronic data exchange. This guidance is intended to provide clarity and flexibility to trading partners to help ensure continued patient access to prescription drugs as the supply chain transitions to the interoperable, electronic product tracing at the package level under the DSCSA. The compliance policies in this guidance can help trading partners throughout the supply chain implement the requirements under section 582(g)(1) of the FD&C Act by accommodating the additional time that may be needed to implement, troubleshoot, and mature their systems and processes while supporting the continued availability of products to patients. The guidance represents the current thinking of FDA on ‘‘Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act— Compliance Policies.’’ 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.1 II. Paperwork Reduction Act FDA concludes that this guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. III. Electronic Access Persons with access to the internet may obtain the guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ 1 The Office of the Federal Register has published this document under the category ‘‘Rules and Regulations’’ pursuant to its interpretation of 1 CFR 5.9(b). We note that the categorization as such for purposes of publication in the Federal Register does not affect the content or intent of the document. See 1 CFR 5.1(c). E:\FR\FM\28AUR1.SGM 28AUR1 58500 Federal Register / Vol. 88, No. 165 / Monday, August 28, 2023 / Rules and Regulations vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents, or https://www.regulations.gov. Dated: August 22, 2023. Lauren K. Roth, Associate Commissioner for Policy. BILLING CODE 4164–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [USCG–USCG–2023–0043] RIN 1625–AA00 Safety Zone, Illinois River MM 165.5 Peoria, IL Coast Guard, Department of Homeland Security (DHS). ACTION: Temporary final rule. AGENCY: The Coast Guard is establishing a temporary safety zone for all navigable waters within a half mile radius of a crane boom located in the Illinois River at Mile Marker (MM) 165.5. The safety zone is needed to protect personnel, vessels, and the marine environment from all potential hazards associated with a crane boom blocking the navigable channel and the salvage operation for its removal. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Sector Upper Mississippi River (COTP) or a designated representative. DATES: This rule is effective without actual notice from August 28, 2023, through August 29, 2023. For the purposes of enforcement, actual notice will be used from August 23, 2023, until August 28, 2023. ADDRESSES: To view documents mentioned in this preamble as being available in the docket, go to https:// www.regulations.gov, type USCG–2023– 0043 in the search box and click ‘‘Search.’’ Next, in the Document Type column, select ‘‘Supporting & Related Material.’’ FOR FURTHER INFORMATION CONTACT: If you have questions on this rule, call or email MSTC Nathaniel Dibley, Sector Upper Mississippi River Waterways Management Division, U.S. Coast Guard; telephone 314–269–2560, email Nathaniel.D.Dibley@uscg.mil. SUPPLEMENTARY INFORMATION: lotter on DSK11XQN23PROD with RULES1 VerDate Sep<11>2014 17:47 Aug 25, 2023 Jkt 259001 IV. Discussion of the Rule CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code The salvaging of the crane boom will occur at MM 165.5 beginning August 23, 2023. The safety zone is designed to protect waterway users until work is complete. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard (USCG) assigned to units under the operational control of USCG Sector Upper Mississippi River. To seek permission to enter, contact the COTP or a designated representative via VHF–FM channel 16, or through USCG Sector Upper Mississippi River at 314– 269–2332. Persons and vessels permitted to enter the safety zone must comply with all lawful orders or directions issued by the COTP or designated representative. The COTP or a designated representative will inform the public of the effective period for the safety zone as well as any changes in the dates and times of enforcement, as well as reductions in the size of the safety zone through Local Notice to Mariners (LNMs), Broadcast Notices to Mariners (BNMs), and/or Safety Marine Information Broadcast (SMIB), as appropriate. II. Background Information and Regulatory History [FR Doc. 2023–18359 Filed 8–25–23; 8:45 am] SUMMARY: I. Table of Abbreviations The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are ‘‘impracticable, unnecessary, or contrary to the public interest.’’ Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because a temporary safety zone must be established immediately to protect personnel, vessels, and the marine environment from potential hazards created by a crane boom protruding into the navigable channel and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule. It is impracticable to publish an NPRM because we must establish this safety zone by August 23, 2023. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be impracticable because immediate action is needed to respond to the potential safety hazards associated with a crane boom blocking the navigable channel. III. Legal Authority and Need for Rule The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port Sector Upper Mississippi River (COTP) has determined that potential hazards associated with a crane boom blocking the navigable channel and the salvage operation taking place to remove it will be a safety concern for anyone operating or transiting within the Illinois River at MM 165.5. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone until the crane boom has been removed from the waterway. PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 V. Regulatory Analyses We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors. A. Regulatory Planning and Review Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a ‘‘significant regulatory action,’’ under section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB). This regulatory action determination is based on a safety zone located within a half mile radius of a crane boom on the Illinois River at MM 165.5, near Peoria, IL. The safety zone is expected to be active until the crane boom has been salvaged and the channel cleared. E:\FR\FM\28AUR1.SGM 28AUR1

Agencies

[Federal Register Volume 88, Number 165 (Monday, August 28, 2023)]
[Rules and Regulations]
[Pages 58498-58500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18359]


=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2023-D-1909]


Enhanced Drug Distribution Security Requirements Under Section 
582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance 
Policies; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing the availability of a final guidance for industry entitled 
``Enhanced Drug Distribution Security Requirements Under Section 
582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance 
Policies.'' This guidance describes FDA's compliance policies regarding 
enforcement of requirements for the interoperable, electronic, package 
level product tracing (referred to as enhanced drug distribution 
security requirements) under the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) that will go into effect on November 27, 2023. FDA believes 
the compliance policies outlined in this guidance will help supply 
chain stakeholders, particularly trading partners, by accommodating the 
additional time that may be needed to continue to develop and refine 
appropriate systems and processes to conduct interoperable, electronic 
tracing at the package level, to achieve robust supply chain security 
under the Drug Supply Chain Security Act (DSCSA) while helping ensure 
continued patient access to prescription drugs.

DATES: The announcement of the guidance is published in the Federal 
Register on August 28, 2023.

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-2023-D-1909 for ``Enhanced Drug Distribution Security Requirements 
Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--
Compliance Policies.'' 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, 240-
402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    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 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.

[[Page 58499]]

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: Elizabeth Pepinsky, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 4258, Silver Spring, MD 20993-0002, 301-
796-3130, email: [email protected]; or Anne Taylor, Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-
0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Enhanced Drug Distribution Security Requirements Under 
Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--
Compliance Policies.'' This guidance describes FDA's compliance 
policies regarding enforcement of requirements for the interoperable, 
electronic, package level product tracing (referred to as enhanced drug 
distribution security requirements) under section 582(g)(1) of the FD&C 
Act (21 U.S.C. 360eee-1(g)(1)) that will go into effect on November 27, 
2023. FDA believes that these compliance policies will facilitate the 
continued use of product tracing and verification methods currently 
being used while accommodating the additional time that may be needed 
by trading partners to continue to develop and refine the systems and 
processes for such activities required under section 582(g)(1) of the 
FD&C Act.
    We are issuing this guidance consistent with our good guidance 
practices (GGP) regulation (21 CFR 10.115). We are implementing this 
guidance without prior public comment because we have determined that 
prior public participation is not feasible or appropriate (21 CFR 
10.115(g)(2)). The Agency made this determination because the Agency 
needs to communicate its compliance policy in a timely manner and 
provide stakeholders notice of the compliance policy ahead of the 
effective date of the enhanced distribution security requirements. 
Although this guidance document is being implemented immediately, it 
remains subject to comment in accordance with FDA's GGP regulation and 
the Agency will consider all comments received and determine whether 
revisions to the guidance document are appropriate.
    The DSCSA, enacted on November 27, 2013, outlines critical steps 
for building an electronic, interoperable system by November 27, 2023, 
that will identify and trace certain prescription drugs as they are 
distributed within the United States. Since the enactment of DSCSA, FDA 
and trading partners have been preparing for the implementation of the 
enhanced drug distribution security requirements imposed by section 
582(g)(1) of the FD&C Act. Trading partners are continuing to work to 
have the necessary systems and processes in place in anticipation of 
the November 27, 2023, effective date for these requirements. While 
trading partners have the obligation to comply with section 582 
requirements, including for enhanced drug distribution security, there 
are other stakeholders involved and affected, including but not limited 
to: solution providers, standards organizations, trade and professional 
organizations, state authorities, and other Federal authorities.
    FDA understands that collaboration and alignment among trading 
partners and other stakeholders throughout the supply chain are 
critical for achieving interoperability under the DSCSA. FDA has heard 
from stakeholders, including a broad representation of trading 
partners, about concerns regarding trading partner readiness and the 
need for clarity and flexibility to ensure trading partners can 
continue to move product through the supply chain when the enhanced 
drug distribution security requirements under section 582(g)(1) of the 
FD&C Act take effect. Most recently, at a virtual public meeting on 
DSCSA Implementation and Readiness Efforts for 2023 held on December 7 
and 8, 2022 (87 FR 67047, November 7, 2022), stakeholders indicated 
that trading partners throughout the supply chain are at different 
stages of readiness, with some trading partners being further behind 
not only in terms of understanding their obligations under section 
582(g)(1) of the FD&C Act, but also being aware of the time and 
resources necessary to meet those obligations. Stakeholders also 
expressed a need for clarity with respect to treatment of product that 
is already in the supply chain on November 27, 2023, and the need for 
flexibility when the requirements under section 582(g)(1) take effect, 
to minimize potential disruptions in the supply chain. In addition, 
stakeholders are experiencing challenges with predicting and planning 
for the possible volume of requests for product tracing information 
from Federal and State authorities and other trading partners, and the 
resources needed to respond to such requests, in accordance with 
section 582(g)(1) of the FD&C Act.
    While FDA generally expects trading partners to have the systems 
and processes in place to meet the enhanced drug distribution security 
requirements of section 582(g)(1) as of November 27, 2023, we recognize 
that some technical and operational issues, including issues involving 
trading partners and other affected stakeholders, may not be fully 
resolved by that time. The Agency also understands that additional time 
beyond November 27, 2023, may be needed for systems to stabilize and be 
fully interoperable for accurate, secure, and timely electronic data 
exchange. This guidance is intended to provide clarity and flexibility 
to trading partners to help ensure continued patient access to 
prescription drugs as the supply chain transitions to the 
interoperable, electronic product tracing at the package level under 
the DSCSA. The compliance policies in this guidance can help trading 
partners throughout the supply chain implement the requirements under 
section 582(g)(1) of the FD&C Act by accommodating the additional time 
that may be needed to implement, troubleshoot, and mature their systems 
and processes while supporting the continued availability of products 
to patients.
    The guidance represents the current thinking of FDA on ``Enhanced 
Drug Distribution Security Requirements Under Section 582(g)(1) of the 
Federal Food, Drug, and Cosmetic Act--Compliance Policies.'' 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.\1\
---------------------------------------------------------------------------

    \1\ The Office of the Federal Register has published this 
document under the category ``Rules and Regulations'' pursuant to 
its interpretation of 1 CFR 5.9(b). We note that the categorization 
as such for purposes of publication in the Federal Register does not 
affect the content or intent of the document. See 1 CFR 5.1(c).
---------------------------------------------------------------------------

II. Paperwork Reduction Act

    FDA concludes that this guidance contains no collection of 
information. Therefore, clearance by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995 is not required.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/

[[Page 58500]]

vaccines-blood-biologics/guidance-compliance-regulatory-information-
biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: August 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-18359 Filed 8-25-23; 8:45 am]
BILLING CODE 4164-01-P

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