The Drug Supply Chain Security Act Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How To Exchange Product Tracing Information; Availability, 70878-70879 [2014-28085]

Download as PDF 70878 Federal Register / Vol. 79, No. 229 / Friday, November 28, 2014 / Notices the last 3 years, we believe that OMB approval of these information collection provisions should be extended to provide for the potential future need of a firm in the dietary supplement industry to petition for an exemption from 100 percent identity testing of dietary ingredients. Dated: November 21, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–28087 Filed 11–26–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–1981] The Drug Supply Chain Security Act Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How To Exchange Product Tracing Information; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How To Exchange Product Tracing Information.’’ The draft guidance addresses the drug supply chain security provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), which requires the Secretary of the Department of Health and Human Services to establish initial standards for the interoperable exchange of transaction information, transaction history, and transaction statements, in paper or electronic format. Specifically, the guidance establishes standards for how transaction information, transaction history, and transaction statements should be exchanged among trading partners through the extension and/or use of current systems and processes. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 27, 2015. Submit either electronic or written comments concerning the tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:58 Nov 26, 2014 Jkt 235001 collection of information proposed in the draft guidance by January 27, 2015. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993; or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance 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. 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, drugtrackandtrace@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background On November 27, 2013, the Drug Supply Chain Security Act (Title II of Public Law 113–54) was signed into law. Section 202 of the Drug Supply Chain Security Act (DSCSA), which adds new sections 581 and 582 to the FD&C Act (21 U.S.C. 360eee and 360eee–1), sets forth new definitions and requirements related to product tracing. The DSCSA outlines critical steps to build an electronic, interoperable system by November 27, 2023, that will identify and trace certain prescription drugs as they are distributed within the United States. Starting in 2015, certain 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 capture, maintain, and provide the subsequent purchaser with transaction information, transaction history, and a transaction statement (product tracing information) for certain prescription drug products. Manufacturers, wholesale distributors, and repackagers must meet these requirements by January 1, 2015; dispensers must meet them by July 1, 2015. In addition, each manufacturer, PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 wholesale distributor, dispenser, and repackager must comply with all applicable requirements in the event they meet the definition of more than one trading partner under section 582(a)(1), but trading partners are not required to duplicate requirements. Section 582(a)(2)(A) of the FD&C Act directs FDA to establish initial standards to facilitate the interoperable exchange of transaction information, transaction history, and transaction statements between trading partners. FDA obtained stakeholder input on the development of the initial standards for the interoperable exchange of product tracing information, in paper and electronic formats, through a public docket established in February 2014, as required under section 582(a)(2)(B), and a public workshop that was held May 8 and 9, 2014. The public workshop provided a forum for FDA to obtain input from stakeholders in the pharmaceutical distribution supply chain on how trading partners can best comply with the requirements for the interoperable exchange of product tracing information beginning in 2015, using currently available standards or practices. Comments to the public dockets and from the workshop were considered in the development of this guidance, and will be considered in developing additional guidance to further elaborate on the standards for the interoperable exchange of product tracing information. This initial draft guidance establishes standards to help trading partners comply with the requirements of sections 582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C Act to provide the subsequent trading partners with product tracing information, in paper or electronic format, through the extension and/or use of current systems and processes. Under these provisions, trading partners are also required to capture and maintain the applicable product tracing information for not less than 6 years after the date of the transaction. Implementation of these provisions will help further improve the security of the pharmaceutical distribution supply chain and increase confidence in the safety and authenticity of human prescription drugs. FDA intends to issue additional guidance to facilitate the interoperable exchange of product tracing information through standardization of data and documentation practices. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). This guidance is marked as a ‘‘draft’’ consistent with its description in section 582(a)(2)(A) of the FD&C Act. E:\FR\FM\28NON1.SGM 28NON1 Federal Register / Vol. 79, No. 229 / Friday, November 28, 2014 / Notices Under section 582(h)(4) of the FD&C Act, FDA intends to eventually ‘‘update . . ., as necessary and appropriate, and finalize’’ this document to reflect standards for interoperable data exchange at the package level. Because the DSCSA clearly intends for stakeholders to rely upon this guidance document before finalization, however, FDA is immediately implementing this document under 21 CFR 10.115(g)(2). As a result, it reflects FDA’s current thinking on this topic and is intended to provide guidance to stakeholders as they implement the DSCSA. Guidance documents generally do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 III. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify 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. tkelley on DSK3SPTVN1PROD with NOTICES IV. Electronic Access Persons with access to the Internet may obtain the document at http:// www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm, http://www.fda.gov/ BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, or http://www. regulations.gov. 16:58 Nov 26, 2014 Jkt 235001 [FR Doc. 2014–28085 Filed 11–26–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–1862] Recommended Warning for Over-theCounter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions.’’ The draft guidance is intended to inform manufacturers, members of the medical and scientific community, and other interested persons that at this time we do not intend to object to the marketing of single- and combination-ingredient, acetaminophen-containing, nonprescription (commonly referred to as over-the-counter (OTC)) drug products bearing a warning as described in the draft guidance alerting consumers that the use of acetaminophen may cause severe skin reactions. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final guidance, submit either electronic or written comments on the draft guidance by January 27, 2015. ADDRESSES: Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the SUMMARY: This draft guidance includes information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520). FDA intends to solicit public comment and obtain OMB approval for any information collections recommended in this guidance that are new or that would represent modifications to those previously approved collections of information found in FDA regulations or guidances. VerDate Sep<11>2014 Dated: November 21, 2014. Leslie Kux, Associate Commissioner for Policy. PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 70879 Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Sudha Shukla, Office of Unapproved Drugs and Labeling Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–3110, Sudha.Shukla@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Recommended Warning for Over-theCounter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions.’’ Acetaminophen, included in many prescription and OTC products, is a common active ingredient indicated to treat pain and reduce fever. On August 1, 2013, FDA issued a Drug Safety Communication (DSC) informing the public that use of acetaminophen has been associated with a risk of rare but serious skin reactions.1 These skin reactions, including Stevens-Johnson Syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis, can be fatal. The DSC explained that reddening of the skin, rash, blisters, and detachment of the upper surface of the skin can occur with the use of drug products that contain acetaminophen. These skin reactions can occur with the first-time use of acetaminophen or at any time while it is being taken. FDA advised health care professionals to be aware of this rare risk and consider acetaminophen, along with other drugs already known to have such an association, when assessing patients with potentially drug-induced skin reactions. FDA also advised that anyone who develops a skin rash or reaction while using acetaminophen or any other pain reliever/fever reducer should stop taking the drug and seek medical attention right away. Furthermore, the announcement advised that anyone who has experienced a serious skin reaction when taking acetaminophen in the past should not take the drug again and should contact their health care professional to discuss alternative pain relievers/fever reducers. In the announcement, FDA stated that it planned to require manufacturers of acetaminophen-containing prescription 1 FDA Drug Safety Communication: FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen. http:// www.fda.gov/Drugs/DrugSafety/ucm363041.htm. E:\FR\FM\28NON1.SGM 28NON1

Agencies

[Federal Register Volume 79, Number 229 (Friday, November 28, 2014)]
[Notices]
[Pages 70878-70879]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28085]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1981]


The Drug Supply Chain Security Act Standards for the 
Interoperable Exchange of Information for Tracing of Certain Human, 
Finished, Prescription Drugs: How To Exchange Product Tracing 
Information; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``DSCSA 
Standards for the Interoperable Exchange of Information for Tracing of 
Certain Human, Finished, Prescription Drugs: How To Exchange Product 
Tracing Information.'' The draft guidance addresses the drug supply 
chain security provisions of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act), which requires the Secretary of the Department of 
Health and Human Services to establish initial standards for the 
interoperable exchange of transaction information, transaction history, 
and transaction statements, in paper or electronic format. 
Specifically, the guidance establishes standards for how transaction 
information, transaction history, and transaction statements should be 
exchanged among trading partners through the extension and/or use of 
current systems and processes.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by January 27, 2015. Submit either electronic or written 
comments concerning the collection of information proposed in the draft 
guidance by January 27, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 
20993; or the Office of Communication, Outreach and Development, Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance 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.

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, 
drugtrackandtrace@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    On November 27, 2013, the Drug Supply Chain Security Act (Title II 
of Public Law 113-54) was signed into law. Section 202 of the Drug 
Supply Chain Security Act (DSCSA), which adds new sections 581 and 582 
to the FD&C Act (21 U.S.C. 360eee and 360eee-1), sets forth new 
definitions and requirements related to product tracing. The DSCSA 
outlines critical steps to build an electronic, interoperable system by 
November 27, 2023, that will identify and trace certain prescription 
drugs as they are distributed within the United States.
    Starting in 2015, certain 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 
capture, maintain, and provide the subsequent purchaser with 
transaction information, transaction history, and a transaction 
statement (product tracing information) for certain prescription drug 
products. Manufacturers, wholesale distributors, and repackagers must 
meet these requirements by January 1, 2015; dispensers must meet them 
by July 1, 2015. In addition, each manufacturer, wholesale distributor, 
dispenser, and repackager must comply with all applicable requirements 
in the event they meet the definition of more than one trading partner 
under section 582(a)(1), but trading partners are not required to 
duplicate requirements. Section 582(a)(2)(A) of the FD&C Act directs 
FDA to establish initial standards to facilitate the interoperable 
exchange of transaction information, transaction history, and 
transaction statements between trading partners.
    FDA obtained stakeholder input on the development of the initial 
standards for the interoperable exchange of product tracing 
information, in paper and electronic formats, through a public docket 
established in February 2014, as required under section 582(a)(2)(B), 
and a public workshop that was held May 8 and 9, 2014. The public 
workshop provided a forum for FDA to obtain input from stakeholders in 
the pharmaceutical distribution supply chain on how trading partners 
can best comply with the requirements for the interoperable exchange of 
product tracing information beginning in 2015, using currently 
available standards or practices. Comments to the public dockets and 
from the workshop were considered in the development of this guidance, 
and will be considered in developing additional guidance to further 
elaborate on the standards for the interoperable exchange of product 
tracing information.
    This initial draft guidance establishes standards to help trading 
partners comply with the requirements of sections 582(b)(1), (c)(1), 
(d)(1), and (e)(1) of the FD&C Act to provide the subsequent trading 
partners with product tracing information, in paper or electronic 
format, through the extension and/or use of current systems and 
processes. Under these provisions, trading partners are also required 
to capture and maintain the applicable product tracing information for 
not less than 6 years after the date of the transaction. Implementation 
of these provisions will help further improve the security of the 
pharmaceutical distribution supply chain and increase confidence in the 
safety and authenticity of human prescription drugs. FDA intends to 
issue additional guidance to facilitate the interoperable exchange of 
product tracing information through standardization of data and 
documentation practices.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). This guidance is marked 
as a ``draft'' consistent with its description in section 582(a)(2)(A) 
of the FD&C Act.

[[Page 70879]]

Under section 582(h)(4) of the FD&C Act, FDA intends to eventually 
``update . . ., as necessary and appropriate, and finalize'' this 
document to reflect standards for interoperable data exchange at the 
package level. Because the DSCSA clearly intends for stakeholders to 
rely upon this guidance document before finalization, however, FDA is 
immediately implementing this document under 21 CFR 10.115(g)(2). As a 
result, it reflects FDA's current thinking on this topic and is 
intended to provide guidance to stakeholders as they implement the 
DSCSA. Guidance documents generally do not create or confer any rights 
for or on any person and do not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance includes information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). 
FDA intends to solicit public comment and obtain OMB approval for any 
information collections recommended in this guidance that are new or 
that would represent modifications to those previously approved 
collections of information found in FDA regulations or guidances.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify 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.

IV. 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: November 21, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28085 Filed 11-26-14; 8:45 am]
BILLING CODE 4164-01-P