Document ID: FDA-2014-N-0200-0001
Agency: fda
Document Type: Notice
Title: Standards for the Interoperable Exchange of Information for Tracing of
Human, Finished, Prescription Drugs, in Paper or Electronic Format;
Establishment of a Public Docket
Posted Date: 2014-02-20T05:00Z

[Federal Register Volume 79, Number 34 (Thursday, February 20, 2014)]
[Notices]
[Pages 9745-9747]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03592]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0200]

Standards for the Interoperable Exchange of Information for 
Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic 
Format; Establishment of a Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is establishing a 
public docket to receive information and comments on standards for the 
interoperable exchange of information associated with transactions 
involving human prescription drugs in a finished dosage form 
(prescription drugs) to comply with new requirements in the Drug Supply 
Chain Security Act (DSCSA). We are seeking information from drug 
manufacturers, repackagers, wholesale distributors, dispensers 
(primarily pharmacies) and other drug supply chain stakeholders and 
interested parties, including standards organizations, State and 
Federal Agencies, and solution providers. In particular, stakeholders 
and other interested parties are requested to comment about the 
interoperable exchange of transaction information, transaction history, 
and transaction statements, in paper or electronic format, for each 
transfer of product in which a change of ownership occurs. This action 
is related to FDA's implementation of the DSCSA.

DATES: Submit either electronic or written comments by April 21, 2014.

ADDRESSES: 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. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Connie T. Jung, Office of Compliance, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20933, 301-796-3130.

SUPPLEMENTARY INFORMATION:

I. Background

    On November 27, 2013, the DSCSA (Title II, Pub. L. 113-54) was 
signed into law. The DSCSA outlines critical steps to build an 
electronic, interoperable system to identify and trace certain 
prescription drugs as they are distributed within the United States. 
Section 202 of the DSCSA, which adds section 582 to the Federal Food, 
Drug, and Cosmetic Act (FD&C Act), directs the Secretary of Health and 
Human Services (the Secretary) to establish standards for the 
interoperable exchange of transaction information, transaction history, 
and transaction statements, in paper or electronic format, in 
consultation with other appropriate Federal officials, manufacturers, 
repackagers, wholesale drug distributors, dispensers, and other 
pharmaceutical distribution supply chain stakeholders.
    FDA has been engaged in efforts to improve the security of the drug 
supply chain for many years to protect U.S. patients from unsafe, 
ineffective, and poor quality drugs. Since the formation of the first 
FDA Counterfeit Drug Task Force in 2003, FDA has strongly advocated for 
a multilayered approach to securing the supply chain and protecting 
consumers from the threats posed by counterfeit and diverted drugs. The 
ability to track and trace finished prescription drugs plays a 
significant role in providing transparency and accountability in the 
drug supply chain. Under section 505D of the FD&C Act (21 U.S.C. 355e), 
FDA has been evaluating existing and emerging standards, system 
attributes and needs, and adoption of track and trace and 
authentication systems and technology. The system that will be 
established under DSCSA will enhance FDA's ability to help protect U.S. 
consumers from exposure to drugs that may be counterfeit, stolen, 
contaminated, or otherwise harmful by improving detection and removal 
of potentially dangerous drugs from the drug supply chain.
    FDA is announcing the establishment of a public docket to provide 
an opportunity for interested persons to

[[Page 9746]]

share information, current practices, research, and ideas on the 
feasibility of establishing standardized documentation to be used by 
members of the pharmaceutical distribution supply chain to convey the 
transaction information, transaction history, and transaction statement 
to the subsequent purchaser of a product and to facilitate the exchange 
of lot level data.

II. Definitions

    The following definitions for transaction information, transaction 
history, and transaction statement as defined under the DSCSA are 
provided to assist stakeholders in developing comments or responses. In 
addition, FDA is interested in learning about practices, processes, and 
systems that supply chain stakeholders currently use to exchange 
information, such as product information, information related to the 
sale or change of ownership of prescription drugs, or communications 
about drugs in distribution. For other definitions, please refer to 
section 202 of DSCSA.
    Under DSCSA, ``transaction information'' means (A) The proprietary 
or established name or names of the product; (B) the strength and 
dosage form of the product; (C) the National Drug Code number of the 
product; (D) the container size; (E) the number of containers; (F) the 
lot number of the product; (G) the date of the transaction; (H) the 
date of shipment, if more than 24 hours after the date of transaction); 
(I) the business name and address of the person from whom ownership in 
being transferred; and (J) the business name and address of the person 
to whom ownership is being transferred. ``Transaction history'' means a 
statement in paper or electronic form, including the transaction 
information for each prior transaction going back to the manufacturer 
of the product. ``Transaction statement'' is a statement, in paper or 
electronic form, that the entity transferring ownership in a 
transaction--(A) is authorized as required under the DSCSA; (B) 
received the product from a person that is authorized as required under 
the DSCSA; (C) received transaction information and a transaction 
statement from the prior owner of the product, as required under 
section 582 [of the DSCSA]; (D) did not knowingly ship a suspect or 
illegitimate product; (E) had systems and processes in place to comply 
with verification requirements under section 582 [of the DSCSA]; (F) 
did not knowingly provide false transaction information; and (G) did 
not knowingly alter the transaction history.

III. Request for Comments and Information

    FDA is requesting comments and supporting information on the 
following: (1) Current practices and ideas that may be used for the 
interoperable exchange of transaction information, transaction history, 
and transaction statements, in paper or electronic format, for each 
transfer of product in which a change of ownership occurs (i.e., 
transaction); (2) the feasibility of establishing standardized 
documentation to be used by members of the pharmaceutical distribution 
supply chain to convey the transaction information, transaction 
history, and transaction statement to the subsequent purchaser of a 
product and to facilitate the exchange of lot level data; and (3) 
current practices and ideas that may be used for the exchange of 
information between members of the pharmaceutical distribution supply 
chain and FDA to provide, receive, and terminate notifications, respond 
to requests for verification of product, and respond to requests for 
information from FDA or other appropriate Federal or State officials in 
the event of a recall or for the purpose of investigating a suspect or 
illegitimate product.
    To facilitate this discussion, FDA has included several questions 
in the following paragraphs. These questions, which are not meant to be 
exhaustive, are provided to stimulate public comments that will help 
FDA establish initial standards for the interoperable exchange of 
information for tracing of prescription drugs in paper or electronic 
format. The public is encouraged to address these and/or other related 
issues.
    Questions related to (1) current practices and suggestions for the 
interoperable exchange of transaction information, transaction history, 
and transaction statements and (2) the feasibility of establishing 
standardized documentation to be used by members of the pharmaceutical 
distribution supply chain to convey the transaction information, 
transaction history, and transaction statement to the subsequent 
purchaser of prescription drugs and to facilitate the exchange of lot 
level data:
    1. What types of information about transactions do you exchange? 
What practices, processes, or systems, either paper-based or 
electronic, do supply chain stakeholders use to exchange this 
information? Are the practices, processes, or systems based on a 
standard? Are they interoperable with other systems that supply chain 
stakeholders may be using?
    2. What practices, processes or systems, either paper-based or 
electronic, do supply chain stakeholders use to exchange information 
related to prior transactions? Are the practices, processes, or systems 
based on a standard? Are they interoperable with other systems that 
supply chain stakeholders may be using?
    3. Do the practices, processes, or systems that supply chain 
stakeholders use to exchange transaction information or transaction 
histories include or have the ability to include lot level data?
    4. If you are currently using paper means to exchange transaction 
information or history, when do you plan to move to an electronic 
format?
    5. Are there challenges to adopting and using a system, in paper or 
electronic format, for the interoperable exchange of transaction 
information or history? How can these challenges be addressed?
    6. Are there practices, processes, or systems that supply chain 
stakeholders can use now to exchange the information in the transaction 
statement required by the DSCSA?
    7. Are there challenges to providing the transaction statement to 
supply chain stakeholders in either paper or electronic form? How can 
these challenges be addressed?
    8. Are there standards or current practices that you would 
recommend for FDA to consider as a model for providing any or all of 
the transaction information, transaction history, or transaction 
statement to other supply chain stakeholders?
    9. Are there other technologies, systems, or solutions available 
now that would enable the interoperable exchange of transaction 
information, transaction history, or transaction statements?
    Questions related to (3) current practices and suggestions for the 
exchange of information between supply chain stakeholders or with FDA 
to provide, receive, and terminate notifications, respond to requests 
for verification of suspect product, and respond to requests for 
information from FDA or other appropriate Federal or State officials in 
the event of a recall or for the purpose of investigating a suspect or 
illegitimate product:
    10. Are there current practices, processes, or systems that could 
be used to exchange information between supply chain stakeholders and 
FDA with respect to providing, receiving, and terminating a 
notification that an illegitimate product is found in distribution? Are 
these practices, processes, or systems effective? If not, please 
provide recommendations to

[[Page 9747]]

improve these practices, processes, or systems.
    11. Are there current practices, processes, or systems that could 
be used to exchange information between supply chain stakeholders or 
with FDA to respond to requests to verify the lot number, expiration 
date, and other indices of identity assigned to a product by the 
manufacturer or repackager (i.e., requests for verification of suspect 
product)? Are these practices, processes, or systems effective? If not, 
please provide recommendations to improve these practices, processes, 
or systems.
    12. Are there current practices, processes, or systems that could 
be used for providing information in response to requests from FDA or 
other appropriate Federal or State officials in the event of a recall 
or for the purpose of investigating a suspect or illegitimate product? 
Are these practices, processes, or systems effective? If not, please 
provide recommendations to improve these practices, processes, or 
systems.
    Question related to capturing information that has not necessarily 
been addressed by the previous questions:
    13. Are there other considerations related to standards for the 
interoperable exchange of information for tracing of human, finished, 
prescription drugs that have not been addressed by the previous 
questions? Please provide any additional information that you think 
could be helpful for the Agency to consider as it implements these 
provisions of the DSCSA.

III. Submission of 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.

    Dated: February 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03592 Filed 2-19-14; 8:45 am]
BILLING CODE 4160-01-P