80 FR 67408 - The Drug Supply Chain Security Act Implementation: Product Tracing Requirements for Dispensers-Compliance Policy; Updated Guidance for Industry, Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 211 (November 2, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 211 (November 2, 2015)
| Page Range | 67408-67409 | |
| FR Document | 2015-27841 |
[Federal Register Volume 80, Number 211 (Monday, November 2, 2015)] [Notices] [Pages 67408-67409] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27841] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-2270] The Drug Supply Chain Security Act Implementation: Product Tracing Requirements for Dispensers--Compliance Policy; Updated Guidance for Industry, Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; revised guidance document. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is issuing a revised guidance document that extends the compliance policy described in the guidance for industry entitled ``DSCSA Implementation: Product Tracing Requirements for Dispensers--Compliance Policy.'' This revised guidance announces FDA's intention with regard to enforcement of certain product tracing requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) added by the Drug Supply Chain Security Act (DSCSA). FDA does not intend to take action against dispensers who, prior to March 1, 2016, accept ownership of product without receiving transaction information, transaction history, and transaction statements (product tracing information), prior to or at the time of a transaction, or do not capture and maintain the product tracing information, as required by the FD&C Act. DATES: Effective November 2, 2015. For information about enforcement dates, please see the SUPPLEMENTARY INFORMATION section. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2015-D-2270 for ``The Drug Supply Chain Security Act Implementation: Product Tracing Requirements for Dispensers--Compliance Policy; Revised Guidance for Industry.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the [[Page 67409]] Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: 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 On July 6, 2015, FDA published a Notice of Availability in the Federal Register (80 FR 38449) announcing a guidance document entitled ``DSCSA Implementation: Product Tracing Requirements for Dispensers-- Compliance Policy.'' The guidance described FDA's intention with regard to enforcement of the product tracing information requirements under section 582(d)(1) of the FD&C Act (21 U.S.C. 360eee-1(d)(1)). FDA is issuing a revised guidance that extends the compliance policy described in the guidance. We are issuing this guidance consistent with our good guidance practices 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)). We made this determination because this guidance document provides information pertaining to certain statutory requirements that took effect on July 1, 2015, regarding the provisions to provide, capture, and maintain product tracing information under section 582(d)(1) of the FD&C Act, and it extends a compliance policy that would have expired for transactions after November 1, 2015. It is important that FDA provide this information before that date. Although this guidance document is immediately in effect, it remains subject to comment in accordance with the Agency's good guidance practices (21 CFR 10.115(g)(3)). On November 27, 2013, the DSCSA (Title II of Pub. L. 113-54) was signed into law. Section 202 of DSCSA adds sections 581 and 582 to the FD&C Act, which set forth new definitions and requirements for the tracing of products through the pharmaceutical distribution supply chain. Starting in 2015, trading partners (manufacturers, wholesale distributors, dispensers, and repackagers) were required under sections 582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C Act to exchange product tracing information when engaging in transactions involving certain prescription drugs. For dispensers, requirements for the tracing of products through the pharmaceutical distribution supply chain under section 582(d)(1) of the FD&C Act took effect on July 1, 2015. FDA published a guidance document on July 6, 2015, stating that it does not intend to take action against dispensers who, prior to November 1, 2015, (1) accept ownership of product without receiving the product tracing information, as required by section 582(d)(1)(A)(i) of the FD&C Act, or (2) do not capture and maintain the product tracing information, as required by section 582(d)(1)(A)(iii) of the FD&C Act. Some dispensers--primarily smaller, independent pharmacies and health systems--have expressed concern that they will be unable to comply with these requirements by November 1, 2015. Thus, FDA recognizes that these dispensers continue to need additional time to work with trading partners to ensure that the product tracing information required by section 582 of the FD&C Act is captured and maintained by dispensers. In light of these concerns, FDA does not intend to take action against dispensers who, prior to March 1, 2016: (1) Accept ownership of product without receiving product tracing information, prior to or at the time of a transaction, as required by section 582(d)(1)(A)(i) of the FD&C Act or (2) do not capture and maintain the product tracing information, as required by section 582(d)(1)(A)(iii) of the FD&C Act. This compliance policy does not extend to other requirements of the FD&C Act applicable to dispensers and other trading partners, including those in section 582 of the FD&C Act, such as verification related to suspect and illegitimate product (including quarantine, investigation, notification, and recordkeeping) and requirements related to engaging in transactions only with authorized trading partners. The guidance document explains the scope of the compliance policy in further detail. The guidance represents the current thinking of FDA on this topic. 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. II. Electronic Access Persons with access to the Internet may obtain the document at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.regulations.gov. Dated: October 27, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-27841 Filed 10-30-15; 8:45 am] BILLING CODE 4164-01-P
![67408 Federal Register / Vol. 80, No. 211 / Monday, November 2, 2015 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Annual Number of Average Total annual
Instrument number of responses per burden hours burden hours
respondents respondent per response
CIP Annual Meeting Survey ............................................................................ 200 1 .13 26
Center for Courts CQI Workshops .................................................................. 48 1 .17 8
Leadership Interview—States .......................................................................... 13 2 1 26
Leadership Interview—CIPs ............................................................................ 13 2 1 26
Leadership Interview—Tribes .......................................................................... 8 2 1.25 20
Leadership Interview Part II—Tribes ............................................................... 8 2 .67 11
Annual Collaboration Survey ........................................................................... 230 1 .36 83
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND instructions for submitting comments.
Hours: 1,688. HUMAN SERVICES Comments submitted electronically,
In compliance with the requirements including attachments, to http://
Food and Drug Administration www.regulations.gov will be posted to
of Section 506(c)(2)(A) of the Paperwork
the docket unchanged. Because your
Reduction Act of 1995, the [Docket No. FDA–2015–D–2270]
comment will be made public, you are
Administration for Children and
The Drug Supply Chain Security Act solely responsible for ensuring that your
Families is soliciting public comment comment does not include any
on the specific aspects of the Implementation: Product Tracing
Requirements for Dispensers— confidential information that you or a
information collection described above. third party may not wish to be posted,
Compliance Policy; Updated Guidance
Copies of the proposed collection of such as medical information, your or
for Industry, Availability
information can be obtained and anyone else’s Social Security number, or
comments may be forwarded by writing AGENCY: Food and Drug Administration, confidential business information, such
to the Administration for Children and HHS. as a manufacturing process. Please note
Families, Office of Planning, Research ACTION:Notice of availability; revised that if you include your name, contact
and Evaluation, 370 L’Enfant guidance document. information, or other information that
Promenade SW., Washington, DC 20447, identifies you in the body of your
Attn: ACF Reports Clearance Officer. SUMMARY: The Food and Drug comments, that information will be
Email address: infocollection@ Administration (FDA or we) is issuing a posted on http://www.regulations.gov.
acf.hhs.gov. All requests should be revised guidance document that extends • If you want to submit a comment
identified by the title of the information the compliance policy described in the with confidential information that you
collection. guidance for industry entitled ‘‘DSCSA do not wish to be made available to the
Implementation: Product Tracing public, submit the comment as a
The Department specifically requests Requirements for Dispensers— written/paper submission and in the
comments on: (a) Whether the proposed Compliance Policy.’’ This revised manner detailed (see ‘‘Written/Paper
collection of information is necessary guidance announces FDA’s intention Submissions’’ and ‘‘Instructions’’).
for the proper performance of the with regard to enforcement of certain
functions of the agency, including Written/Paper Submissions
product tracing requirements of the
whether the information shall have Federal Food, Drug, and Cosmetic Act Submit written/paper submissions as
practical utility; (b) the accuracy of the (FD&C Act) added by the Drug Supply follows:
agency’s estimate of the burden of the Chain Security Act (DSCSA). FDA does • Mail/Hand delivery/Courier (for
proposed collection of information; (c) not intend to take action against written/paper submissions): Division of
the quality, utility, and clarity of the dispensers who, prior to March 1, 2016, Dockets Management (HFA–305), Food
information to be collected; and (d) accept ownership of product without and Drug Administration, 5630 Fishers
receiving transaction information, Lane, Rm. 1061, Rockville, MD 20852.
ways to minimize the burden of the • For written/paper comments
collection of information on transaction history, and transaction
statements (product tracing submitted to the Division of Dockets
respondents, including through the use Management, FDA will post your
of automated collection techniques or information), prior to or at the time of
a transaction, or do not capture and comment, as well as any attachments,
other forms of information technology. except for information submitted,
Consideration will be given to maintain the product tracing
information, as required by the FD&C marked and identified, as confidential,
comments and suggestions submitted if submitted as detailed in
within 60 days of this publication. Act.
‘‘Instructions.’’
DATES: Effective November 2, 2015. For Instructions: All submissions received
Robert Sargis, information about enforcement dates, must include the Docket No. FDA–
Reports Clearance Officer. please see the SUPPLEMENTARY 2015–D–2270 for ‘‘The Drug Supply
[FR Doc. 2015–27833 Filed 10–30–15; 8:45 am] INFORMATION section. Chain Security Act Implementation:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
BILLING CODE 4184–01–P ADDRESSES: You may submit comments Product Tracing Requirements for
as follows: Dispensers—Compliance Policy;
Revised Guidance for Industry.’’
Electronic Submissions Received comments will be placed in
Submit electronic comments in the the docket and, except for those
following way: submitted as ‘‘Confidential
• Federal eRulemaking Portal: http:// Submissions,’’ publicly viewable at
www.regulations.gov. Follow the http://www.regulations.gov or at the
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![Federal Register / Vol. 80, No. 211 / Monday, November 2, 2015 / Notices 67409
Division of Dockets Management described FDA’s intention with regard these requirements by November 1,
between 9 a.m. and 4 p.m., Monday to enforcement of the product tracing 2015. Thus, FDA recognizes that these
through Friday. information requirements under section dispensers continue to need additional
• Confidential Submissions—To 582(d)(1) of the FD&C Act (21 U.S.C. time to work with trading partners to
submit a comment with confidential 360eee–1(d)(1)). FDA is issuing a ensure that the product tracing
information that you do not wish to be revised guidance that extends the information required by section 582 of
made publicly available, submit your compliance policy described in the the FD&C Act is captured and
comments only as a written/paper guidance. We are issuing this guidance maintained by dispensers. In light of
submission. You should submit two consistent with our good guidance these concerns, FDA does not intend to
copies total. One copy will include the practices regulation (21 CFR 10.115). take action against dispensers who,
information you claim to be confidential We are implementing this guidance prior to March 1, 2016: (1) Accept
with a heading or cover note that states without prior public comment because ownership of product without receiving
‘‘THIS DOCUMENT CONTAINS we have determined that prior public product tracing information, prior to or
CONFIDENTIAL INFORMATION.’’ The participation is not feasible or at the time of a transaction, as required
Agency will review this copy, including appropriate (21 CFR 10.115(g)(2)). We by section 582(d)(1)(A)(i) of the FD&C
the claimed confidential information, in made this determination because this Act or (2) do not capture and maintain
its consideration of comments. The guidance document provides the product tracing information, as
second copy, which will have the information pertaining to certain required by section 582(d)(1)(A)(iii) of
claimed confidential information statutory requirements that took effect the FD&C Act. This compliance policy
redacted/blacked out, will be available on July 1, 2015, regarding the provisions does not extend to other requirements of
for public viewing and posted on to provide, capture, and maintain the FD&C Act applicable to dispensers
http://www.regulations.gov. Submit product tracing information under and other trading partners, including
both copies to the Division of Dockets section 582(d)(1) of the FD&C Act, and those in section 582 of the FD&C Act,
Management. If you do not wish your it extends a compliance policy that such as verification related to suspect
name and contact information to be would have expired for transactions and illegitimate product (including
made publicly available, you can after November 1, 2015. It is important quarantine, investigation, notification,
provide this information on the cover that FDA provide this information and recordkeeping) and requirements
sheet and not in the body of your before that date. Although this guidance related to engaging in transactions only
comments and you must identify this document is immediately in effect, it with authorized trading partners. The
information as ‘‘confidential.’’ Any remains subject to comment in guidance document explains the scope
information marked as ‘‘confidential’’ accordance with the Agency’s good of the compliance policy in further
will not be disclosed except in guidance practices (21 CFR detail.
accordance with 21 CFR 10.20 and other 10.115(g)(3)). The guidance represents the current
applicable disclosure law. For more On November 27, 2013, the DSCSA thinking of FDA on this topic. It does
information about FDA’s posting of (Title II of Pub. L. 113–54) was signed not establish any rights for any person
comments to public dockets, see 80 FR into law. Section 202 of DSCSA adds and is not binding on FDA or the public.
56469, September 18, 2015, or access sections 581 and 582 to the FD&C Act, You can use an alternative approach if
the information at: http://www.fda.gov/ which set forth new definitions and it satisfies the requirements of the
regulatoryinformation/dockets/ requirements for the tracing of products applicable statutes and regulations.
default.htm. through the pharmaceutical distribution
II. Electronic Access
Docket: For access to the docket to supply chain. Starting in 2015, trading
partners (manufacturers, wholesale Persons with access to the Internet
read background documents or the may obtain the document at http://
electronic and written/paper comments distributors, dispensers, and
repackagers) were required under www.fda.gov/Drugs/Guidance
received, go to http:// ComplianceRegulatoryInformation/
sections 582(b)(1), (c)(1), (d)(1), and
www.regulations.gov and insert the Guidances/default.htm, http://
(e)(1) of the FD&C Act to exchange
docket number, found in brackets in the www.fda.gov/BiologicsBloodVaccines/
product tracing information when
heading of this document, into the GuidanceComplianceRegulatory
engaging in transactions involving
‘‘Search’’ box and follow the prompts Information/Guidances/default.htm, or
certain prescription drugs. For
and/or go to the Division of Dockets http://www.regulations.gov.
dispensers, requirements for the tracing
Management, 5630 Fishers Lane, Rm.
of products through the pharmaceutical Dated: October 27, 2015.
1061, Rockville, MD 20852.
distribution supply chain under section Leslie Kux,
FOR FURTHER INFORMATION CONTACT: 582(d)(1) of the FD&C Act took effect on Associate Commissioner for Policy.
Office of Compliance, Center for Drug July 1, 2015. FDA published a guidance
Evaluation and Research, Food and [FR Doc. 2015–27841 Filed 10–30–15; 8:45 am]
document on July 6, 2015, stating that
Drug Administration, 10903 New BILLING CODE 4164–01–P
it does not intend to take action against
Hampshire Ave., Silver Spring, MD dispensers who, prior to November 1,
20993–0002, 301–796–3130, 2015, (1) accept ownership of product
drugtrackandtrace@fda.hhs.gov. DEPARTMENT OF HEALTH AND
without receiving the product tracing HUMAN SERVICES
SUPPLEMENTARY INFORMATION: information, as required by section
asabaliauskas on DSK5VPTVN1PROD with NOTICES
582(d)(1)(A)(i) of the FD&C Act, or (2) Food and Drug Administration
I. Background
do not capture and maintain the product
On July 6, 2015, FDA published a tracing information, as required by [Docket No. FDA–2007–D–0369]
Notice of Availability in the Federal section 582(d)(1)(A)(iii) of the FD&C Bioequivalence Recommendations for
Register (80 FR 38449) announcing a Act. Progesterone; Draft Guidance for
guidance document entitled ‘‘DSCSA Some dispensers—primarily smaller,
Industry; Availability
Implementation: Product Tracing independent pharmacies and health
Requirements for Dispensers— systems—have expressed concern that AGENCY: Food and Drug Administration,
Compliance Policy.’’ The guidance they will be unable to comply with HHS.
VerDate Sep<11>2014 18:55 Oct 30, 2015 Jkt 238001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\02NON1.SGM 02NON1](https://thefederalregister.org/doc/80_FR_67619/page/2.svg)
Document Created: 2018-03-01 11:30:53
Document Modified: 2018-03-01 11:30:53
| 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; revised guidance document. | |
| Dates | Effective November 2, 2015. For information about enforcement dates, please see the SUPPLEMENTARY INFORMATION section. | |
| Contact | 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 | 80 FR 67408 |
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