[Federal Register Volume 79, Number 250 (Wednesday, December 31, 2014)]
[Notices]
[Pages 78874-78875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30608]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-2254]


The Drug Supply Chain Security Act Implementation: Product 
Tracing Requirements--Compliance Policy; Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``DSCSA 
Implementation: Product Tracing Requirements--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), as added by the Drug Supply Chain Security Act 
(DSCSA). FDA does not intend to enforce these requirements against 
manufacturers, wholesale distributors, and repackagers who do not, 
prior to May 1, 2015, provide or capture the transaction information, 
transaction history, and transaction statement required by the FD&C Act 
(product tracing information) for transaction of certain human, 
finished prescription drugs that are covered in the statute.

DATES: Effective December 31, 2014. For information about enforcement 
dates, please see the SUPPLEMENTARY INFORMATION section.

ADDRESSES: All responses to this notice should be identified with 
Docket No. FDA-2014-D-2254 and directed to the office listed in the FOR 
FURTHER INFORMATION CONTACT section of this document.

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, 301-796-3100, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``DSCSA Implementation: Product Tracing Requirements--
Compliance Policy.'' This guidance is being issued consistent with 
FDA's good guidance practices regulation (21 CFR 10.115). This guidance 
has been implemented without prior public comment because the Agency 
has determined that prior public participation is not feasible or 
appropriate. (Sec.  10.115(g)(2)). This guidance document provides 
information pertaining to statutory requirements that will take effect 
on January 1, 2015, regarding the provisions to provide and capture 
product tracing information under section 582(b)(1), (c)(1), and (e)(1) 
of the FD&C Act (21 U.S.C. 360eee-1(b)(1), (c)(1), and (e)(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. (Sec.  
10.115(g)(3)).
    On November 27, 2013, the DSCSA (Title II of Pub. L. 113-54) was 
signed into law. Section 202 of the DSCSA added 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) will be required under 
section 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. Manufacturers, wholesale 
distributors, and repackagers must meet these requirements by January 
1, 2015; dispensers must meet these requirements by July 1, 2015.
    Although the product tracing requirements under section 582(b), 
(c), and (e) of the FD&C Act go into effect for manufacturers, 
wholesale distributors, and repackagers on January 1, 2015, some 
trading partners have expressed concern that unforeseen complications 
with the exchange of the required information may result in disruptions 
in the pharmaceutical supply chain, and ultimately could impact 
patients' access to needed prescription drugs. FDA recognizes that some 
manufacturers, wholesale distributors, and repackagers may need time 
beyond January 1, 2015, to work

[[Page 78875]]

with trading partners to ensure that all the proper product tracing 
information is provided and captured. To minimize possible disruptions 
in the distribution of prescription drugs in the United States, FDA 
does not intend to take action against trading partners who do not, 
prior to May 1, 2015, provide or capture the product tracing 
information required by section 582(b)(1), (c)(1), and (e)(1) of the 
FD&C Act. This compliance policy is limited to the requirements that 
trading partners provide and capture product tracing information; it 
does not extend to other requirements in section 582 of the FD&C Act, 
such as verification of suspect and illegitimate products (including 
quarantine, investigation, notification, and recordkeeping) or the 
requirement to engage only in transactions with authorized trading 
partners.

II. Comments

    This guidance is for immediate implementation. FDA is issuing this 
guidance for immediate implementation in accordance with Sec.  
10.115(g)(2). Submit one set of either electronic or written comments 
on this guidance at any time. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. You should identify all comments with 
Docket No. FDA-2014-D-2254.

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: December 23, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30608 Filed 12-30-14; 8:45 am]
BILLING CODE 4164-01-P