[Federal Register Volume 80, Number 128 (Monday, July 6, 2015)]
[Notices]
[Pages 38449-38450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16401]
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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.
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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