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)

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.

[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]


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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