80 FR 38449 - The Drug Supply Chain Security Act Implementation: Product Tracing Requirements for Dispensers-Compliance Policy; Guidance for Industry, Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 128 (July 6, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 128 (July 6, 2015)
| Page Range | 38449-38450 | |
| FR Document | 2015-16401 |
[Federal Register Volume 80, Number 128 (Monday, July 6, 2015)] [Notices] [Pages 38449-38450] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-16401] ----------------------------------------------------------------------- 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; Guidance for Industry, Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``DSCSA Implementation: Product Tracing Requirements for Dispensers--Compliance Policy.'' This 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 November 1, 2015, accept ownership of product without receiving 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 July 1, 2015. For information about enforcement dates, please see the SUPPLEMENTARY INFORMATION section. ADDRESSES: All communications in response to this notice should be identified with Docket No. FDA-2015-D-2270, and should be directed to the office listed in the FOR FURTHER INFORMATION CONTACT section. 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 We are announcing the availability of a guidance for industry entitled ``DSCSA Implementation: Product Tracing Requirements for Dispensers--Compliance Policy.'' 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 statutory requirements that take effect on July 1, 2015, regarding the provisions to provide and capture product tracing information under section 582(d)(1) of the FD&C Act (21 U.S.C 360eee-1(d)(1)). 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) are 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 go into effect on July 1, 2015. Some dispensers have expressed concern that electronic systems used to exchange, capture, and maintain product tracing information will not be operational by this effective date. Although the DSCSA allows product tracing information to be exchanged through paper in certain circumstances, FDA understands that many dispensers intend to utilize electronic systems to capture and maintain product tracing information. Thus, FDA recognizes that some dispensers may need additional time beyond July 1, 2015, to work with trading partners to ensure that the product tracing information required by section 582 is captured and maintained by dispensers. In light of these concerns, FDA does not intend to take action against dispensers who, prior to November 1, 2015: (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 [[Page 38450]] those in section 582, 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. Comments Interested persons may submit either electronic comments to http://www.regulations.gov or written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify all comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. III. 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: June 29, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-16401 Filed 7-2-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 128 / Monday, July 6, 2015 / Notices 38449
Individuals who would like to DEPARTMENT OF HEALTH AND appropriate (21 CFR 10.115(g)(2)). We
participate via conference call may do HUMAN SERVICES made this determination because this
so by dialing toll-free 888–469–0957, guidance document provides
when prompted enter pass code: Food and Drug Administration information pertaining to statutory
8955387. Individuals whose full [Docket No. FDA–2015–D–2270] requirements that take effect on July 1,
participation in the meeting will require 2015, regarding the provisions to
special accommodations (e.g., sign The Drug Supply Chain Security Act provide and capture product tracing
language interpreting services, assistive Implementation: Product Tracing information under section 582(d)(1) of
listening devices, materials in Requirements for Dispensers— the FD&C Act (21 U.S.C 360eee–1(d)(1)).
alternative format such as large print or Compliance Policy; Guidance for It is important that FDA provide this
Braille) should notify Dr. MJ Karimi, Industry, Availability information before that date. Although
PCPID Team Lead, via email at this guidance document is immediately
MJ.Karimie@acl.hhs.gov, or via AGENCY: Food and Drug Administration, in effect, it remains subject to comment
telephone at 202–357–3588, no later HHS. in accordance with the Agency’s good
than Monday, July 27, 2015. The PCPID ACTION: Notice. guidance practices (21 CFR
will attempt to accommodate requests 10.115(g)(3)).
made after this date, but cannot SUMMARY: The Food and Drug On November 27, 2013, the DSCSA
guarantee the ability to grant requests Administration (FDA or we) is (Title II of Pub. L. 113–54) was signed
received after the deadline. All meeting announcing the availability of a into law. Section 202 of DSCSA adds
sites are barrier free, consistent with the guidance for industry entitled ‘‘DSCSA sections 581 and 582 to the FD&C Act,
Americans with Disabilities Act (ADA) Implementation: Product Tracing which set forth new definitions and
and the Federal Advisory Committee Requirements for Dispensers— requirements for the tracing of products
Act (FACA). Compliance Policy.’’ This guidance through the pharmaceutical distribution
Agenda: The Committee Members announces FDA’s intention with regard supply chain. Starting in 2015, trading
will discuss, finalize and approve the to enforcement of certain product partners (manufacturers, wholesale
2015 PCPID Report to the President. tracing requirements of the Federal distributors, dispensers, and
They will also begin exploring the Food, Drug, and Cosmetic Act (FD&C repackagers) are required under sections
topics for the next PCPID Report to the Act) added by the Drug Supply Chain 582(b)(1), (c)(1), (d)(1), and (e)(1) of the
President. Security Act (DSCSA). FDA does not FD&C Act to exchange product tracing
intend to take action against dispensers information when engaging in
FOR FURTHER INFORMATION CONTACT: For
who, prior to November 1, 2015, accept transactions involving certain
further information, please contact Dr. ownership of product without receiving prescription drugs. For dispensers,
MJ Karimi, Team Lead, President’s product tracing information, prior to or requirements for the tracing of products
Committee for People with Intellectual at the time of a transaction or do not through the pharmaceutical distribution
Disabilities, One Massachusetts Avenue capture and maintain the product supply chain under section 582(d)(1) of
NW., Room 4206, Washington, DC tracing information, as required by the the FD&C Act go into effect on July 1,
20201. Telephone: 202–357–3588. Fax: FD&C Act. 2015.
202–205–8037. Email: MJ.Karimie@ Some dispensers have expressed
DATES: Effective July 1, 2015. For
acl.hhs.gov concern that electronic systems used to
information about enforcement dates,
SUPPLEMENTARY INFORMATION: The please see the SUPPLEMENTARY exchange, capture, and maintain
PCPID acts in an advisory capacity to INFORMATION section. product tracing information will not be
the President and the Secretary of operational by this effective date.
ADDRESSES: All communications in
Health and Human Services on a broad Although the DSCSA allows product
response to this notice should be
range of topics relating to programs, tracing information to be exchanged
identified with Docket No. FDA–2015–
services and support for individuals through paper in certain circumstances,
D–2270, and should be directed to the FDA understands that many dispensers
with intellectual disabilities. The PCPID office listed in the FOR FURTHER
executive order stipulates that the intend to utilize electronic systems to
INFORMATION CONTACT section.
Committee shall: (1) Provide such capture and maintain product tracing
FOR FURTHER INFORMATION CONTACT: information. Thus, FDA recognizes that
advice concerning intellectual
Office of Compliance, Center for Drug some dispensers may need additional
disabilities as the President or the
Evaluation and Research, Food and time beyond July 1, 2015, to work with
Secretary of Health and Human Services
Drug Administration, 10903 New trading partners to ensure that the
may request; and (2) provide advice to
Hampshire Ave., Silver Spring, MD product tracing information required by
the President concerning the following
20993–0002, 301–796–3130, section 582 is captured and maintained
for people with intellectual disabilities:
drugtrackandtrace@fda.hhs.gov. by dispensers. In light of these concerns,
(A) expansion of educational
opportunities; (B) promotion of SUPPLEMENTARY INFORMATION: FDA does not intend to take action
homeownership; (C) assurance of against dispensers who, prior to
I. Background
workplace integration; (D) improvement November 1, 2015: (1) Accept
of transportation options; (E) expansion We are announcing the availability of ownership of product without receiving
of full access to community living; and a guidance for industry entitled product tracing information, prior to or
(F) increasing access to assistive and ‘‘DSCSA Implementation: Product at the time of a transaction, as required
universally designed technologies. Tracing Requirements for Dispensers— by section 582(d)(1)(A)(i) of the FD&C
Lhorne on DSK7TPTVN1PROD with NOTICES
Compliance Policy.’’ We are issuing this Act or (2) do not capture and maintain
Dated: June 24, 2015. guidance consistent with our good the product tracing information, as
Aaron Bishop, guidance practices regulation (21 CFR required by section 582(d)(1)(A)(iii) of
Commissioner, Administration on Intellectual 10.115). We are implementing this the FD&C Act. This compliance policy
and Developmental Disabilities (AIDD). guidance without prior public comment does not extend to other requirements of
[FR Doc. 2015–16488 Filed 7–2–15; 8:45 am] because we have determined that prior the FD&C Act applicable to dispensers
BILLING CODE 4154–01–P public participation is not feasible or and other trading partners, including
VerDate Sep<11>2014 14:37 Jul 02, 2015 Jkt 235001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\06JYN1.SGM 06JYN1](https://thefederalregister.org/doc/80_FR_38577/page/1.svg)
![38450 Federal Register / Vol. 80, No. 128 / Monday, July 6, 2015 / Notices
those in section 582, such as verification Research, Care, and Services provides dementia, and others. Following this
related to suspect and illegitimate advice on how to prevent or reduce the session, the Advisory Council will also
product (including quarantine, burden of Alzheimer’s disease and hold a discussion of the expected
investigation, notification and related dementias on people with the bypass budget from NIA, required in the
recordkeeping) and requirements related disease and their caregivers. During the CRomnibus Bill. The Council will also
to engaging in transactions only with July meeting, the Advisory Council will discuss updates to international events
authorized trading partners. The hear from experts on related dementias, on dementia.
guidance document explains the scope such as Frontotemporal dementia, Lewy Procedure and Agenda: This meeting
of the compliance policy in further Body dementia, and others. Following is open to the public. Please allow 30
detail. this session, the Advisory Council will minutes to go through security and walk
The guidance represents the current also hold a discussion of the expected to the meeting room. The meeting will
thinking of FDA on this topic. It does bypass budget from NIA, required in the also be webcast at www.hhs.gov/live .
not establish any rights for any person CRomnibus Bill. The Council will also Authority: 42 U.S.C. 11225; Section 2(e)(3)
and is not binding on FDA or the public. discuss updates to international events of the National Alzheimer’s Project Act. The
You can use an alternative approach if on dementia. panel is governed by provisions of Public
it satisfies the requirements of the DATES: The meeting will be held on Law 92–463, as amended (5 U.S.C. Appendix
applicable statutes and regulations. April 28th, 2015 from 9:00 a.m. to 5:00 2), which sets forth standards for the
p.m. EDT. formation and use of advisory committees.
II. Comments
ADDRESSES: The meeting will be held in Dated: June 26, 2015.
Interested persons may submit either the Great Hall in the Hubert H. Richard G. Frank,
electronic comments to http:// Humphrey Building, 200 Independence Assistant Secretary for Planning and
www.regulations.gov or written Avenue SW., Washington, DC 20201. Evaluation.
comments to the Division of Dockets Comments: Time is allocated in the [FR Doc. 2015–16490 Filed 7–2–15; 8:45 am]
Management (HFA–305), Food and Drug afternoon on the agenda to hear public BILLING CODE 4150–05–P
Administration, 5630 Fishers Lane, Rm. comments. The time for oral comments
1061, Rockville, MD 20852. Identify all will be limited to two (2) minutes per
comments with the docket number individual. In lieu of oral comments, DEPARTMENT OF HEALTH AND
found in brackets in the heading of this formal written comments may be HUMAN SERVICES
document. Received comments may be submitted for the record to Rohini
seen in the Division of Dockets Khillan, OASPE, 200 Independence National Institutes of Health
Management between 9 a.m. and 4 p.m., Avenue SW., Room 424E, Washington,
Monday through Friday, and will be National Institute on Drug Abuse;
DC 20201. Comments may also be sent
posted to the docket at http:// Notice of Closed Meetings
to napa@hhs.gov. Those submitting
www.regulations.gov. written comments should identify Pursuant to section 10(d) of the
III. Electronic Access themselves and any relevant Federal Advisory Committee Act, as
organizational affiliations. amended (5 U.S.C. App), notice is
Persons with access to the Internet
FOR FURTHER INFORMATION CONTACT: hereby given of the following meetings.
may obtain the document at http:// The meetings will be closed to the
www.fda.gov/Drugs/ Rohini Khillan (202) 690–5932,
rohini.khillan@hhs.gov. Note: Seating public in accordance with the
GuidanceCompliance provisions set forth in sections
RegulatoryInformation/Guidances/ may be limited. Those wishing to attend
the meeting must send an email to 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
default.htm, http://www.fda.gov/ as amended. The grant applications and
BiologicsBloodVaccines/ napa@hhs.gov and put ‘‘July 27 Meeting
Attendance’’ in the Subject line by the discussions could disclose
GuidanceCompliance confidential trade secrets or commercial
RegulatoryInformation/Guidances/ Friday, July 17, so that their names may
be put on a list of expected attendees property such as patentable material,
default.htm, or http:// and personal information concerning
www.regulations.gov. and forwarded to the security officers at
the Department of Health and Human individuals associated with the grant
Dated: June 29, 2015. Services. Any interested member of the applications, the disclosure of which
Leslie Kux, public who is a non-U.S. citizen should would constitute a clearly unwarranted
Associate Commissioner for Policy. include this information at the time of invasion of personal privacy.
[FR Doc. 2015–16401 Filed 7–2–15; 8:45 am] registration to ensure that the Name of Committee: National Institute on
BILLING CODE 4164–01–P appropriate security procedure to gain Drug Abuse Special Emphasis Panel; R13
entry to the building is carried out. Conference Grant Review (PA 13–347).
Although the meeting is open to the Date: July 23, 2015.
DEPARTMENT OF HEALTH AND Time: 1:00 p.m. to 3:00 p.m.
public, procedures governing security
Agenda: To review and evaluate grant
HUMAN SERVICES and the entrance to Federal buildings applications.
may change without notice. If you wish Place: National Institutes of Health,
Advisory Council on Alzheimer’s to make a public comment, you must Neuroscience Center, 6001 Executive
Research, Care, and Services; Meeting note that within your email. Boulevard, Rockville, MD 20852 (Virtual
SUPPLEMENTARY INFORMATION: Notice of Meeting).
AGENCY: Assistant Secretary for
these meetings is given under the Contact Person: Susan O. McGuire, Ph.D.,
Planning and Evaluation, HHS. Scientific Review Officer, Office of
Lhorne on DSK7TPTVN1PROD with NOTICES
ACTION: Notice of meeting. Federal Advisory Committee Act (5 Extramural Affairs, National Institute on
U.S.C. App. 2, section 10(a)(1) and Drug Abuse, National Institutes of Health,
SUMMARY: This notice announces the (a)(2)). DHHS, 6001 Executive Blvd., Room 4245,
public meeting of the Advisory Council Topics of the Meeting: The Advisory Rockville, MD 20852, 301–435–1426,
on Alzheimer’s Research, Care, and Council will hear from experts on mcguireso@mail.nih.gov.
Services (Advisory Council). The related dementias, such as Name of Committee: National Institute on
Advisory Council on Alzheimer’s Frontotemporal dementia, Lewy Body Drug Abuse Special Emphasis Panel;
VerDate Sep<11>2014 14:37 Jul 02, 2015 Jkt 235001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 E:\FR\FM\06JYN1.SGM 06JYN1](https://thefederalregister.org/doc/80_FR_38577/page/2.svg)
Document Created: 2015-12-15 13:17:47
Document Modified: 2015-12-15 13:17:47
| 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. | |
| Dates | Effective July 1, 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 38449 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR