Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format; Establishment of a Public Docket, 9745-9747 [2014-03592]
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mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 34 / Thursday, February 20, 2014 / Notices
shown to be safe for use under the
conditions that formed the basis upon
which the applications were approved.
In the August 14, 2001, notice, FDA
provided the NDA and ANDA holders
an opportunity to request a hearing to
show why approval of the NDAs or
ANDAs should not be withdrawn. One
company, KV Pharmaceutical, requested
a hearing by letter dated September 13,
2001, but that request was subsequently
withdrawn by letter dated October 15,
2001. No other party requested a hearing
on this matter following publication of
the notice in the Federal Register. As
stated above, all products listed in the
notice were subsequently discontinued.
Subsequent to the August 14, 2001,
notice, one of the ANDAs listed in that
notice was withdrawn. In a notice
published in the Federal Register of
February 20, 2002 (67 FR 7702), FDA
withdrew approval of ANDA 71–099 for
BROMATAPP Extended-Release Tablets
after the application holder informed
FDA that the product was no longer
being marketed and requested
withdrawal.
In a letter to FDA dated February 25,
2013, Pfizer requested on behalf of its
subsidiaries, Wyeth Pharmaceuticals,
Inc. and A.H. Robins, that FDA
withdraw approval of NDA 11–694 for
DIMETANE–DC under § 314.150(d),
noting that the product has been
discontinued and is no longer marketed.
In that letter, Pfizer and its named
subsidiaries waived any opportunity for
a hearing provided under the August 14,
2001, notice. In a response letter of
March 28, 2013, the Agency
acknowledged A.H. Robins’ agreement
to permit FDA to withdraw approval of
DIMETANE–DC under § 314.150(d) and
to waive its opportunity for a hearing.
For the reasons discussed in the
August 14, 2001 notice, the Director,
under section 505(e)(2) of the FD&C Act
and under authority delegated to her by
the Commissioner, finds that new
evidence of clinical experience, not
contained in the applications listed in
table 1 and not available at the time the
applications were approved, shows that
phenylpropanolamine is not shown to
be safe for use under the conditions of
use that formed the basis upon which
the applications were approved (21
U.S.C. 355(e)(2)). Therefore, approval of
the NDAs listed in table 1 is hereby
withdrawn. Furthermore, the Director
finds that the ANDAs listed in table 1
refer to the drugs that are the subject of
the NDAs listed above. Therefore, as
required under section 505(j)(6) of the
FD&C Act, approval of the ANDAs listed
in table 1 is also withdrawn.
Under 21 CFR 314.161 and
314.162(a)(1), FDA will remove the
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18:08 Feb 19, 2014
Jkt 232001
products containing
phenylpropanolamine named in table 1
from the list of drug products with
effective approvals published in FDA’s
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations.’’
FDA will not approve or accept ANDAs
that refer to these drug products.
9745
[FR Doc. 2014–03596 Filed 2–19–14; 8:45 am]
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:
BILLING CODE 4160–01–P
I. Background
Dated: February 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
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.
Notice; establishment of docket;
request for comments.
ACTION:
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 https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
SUMMARY:
PO 00000
Frm 00018
Fmt 4703
Sfmt 4703
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
E:\FR\FM\20FEN1.SGM
20FEN1
9746
Federal Register / Vol. 79, No. 34 / Thursday, February 20, 2014 / Notices
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.
mstockstill on DSK4VPTVN1PROD with NOTICES
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.
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Jkt 232001
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?
PO 00000
Frm 00019
Fmt 4703
Sfmt 4703
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
E:\FR\FM\20FEN1.SGM
20FEN1
Federal Register / Vol. 79, No. 34 / Thursday, February 20, 2014 / Notices
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.
mstockstill on DSK4VPTVN1PROD with NOTICES
III. Submission of Comments
Interested persons may submit either
electronic comments regarding this
document to https://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 https://
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
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Jkt 232001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Notice of Diabetes Mellitus Interagency
Coordinating Committee Meeting
The Diabetes Mellitus
Interagency Coordinating Committee
(DMICC) will hold a meeting on March
12, 2014 from 1:00 to 4:00 p.m. at the
Natcher Conference Center (Building 45)
Conference Room E1/E2, on the NIH
Campus in Bethesda, MD. The topic for
this meeting will be ‘‘Future Needs and
Direction of Surveillance of Diabetes in
Youth and Young Adults.’’ The meeting
is open to the public.
DATES: The meeting will be held on
March 12, 2014 from 1:00 to 4:00 p.m.
Individuals wanting to present oral
comments must notify the contact
person at least 10 days before the
meeting date.
ADDRESSES: The meeting will be held at
the Natcher Conference Center (Building
45) Conference Room E1/E2, on the NIH
Campus in Bethesda, MD.
FOR FURTHER INFORMATION CONTACT: For
further information concerning this
meeting, see the DMICC Web site,
www.diabetescommittee.gov, or contact
Dr. B. Tibor Roberts, Executive
Secretary of the Diabetes Mellitus
Interagency Coordinating Committee,
National Institute of Diabetes and
Digestive and Kidney Diseases, 31
Center Drive, Building 31A, Room
9A19, MSC 2560, Bethesda, MD 20892–
2560, telephone: 301–496–6623; FAX:
301–480–6741; email: dmicc@
mail.nih.gov.
SUMMARY:
The
DMICC, chaired by the National
Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK) comprising
members of the Department of Health
and Human Services and other federal
agencies that support diabetes-related
activities, facilitates cooperation,
communication, and collaboration on
diabetes among government entities.
DMICC meetings, held several times a
year, provide an opportunity for
Committee members to learn about and
discuss current and future diabetes
programs in DMICC member
organizations and to identify
opportunities for collaboration. The
March 12, 2014 DMICC meeting will
focus on ‘‘Future Needs and Direction of
Surveillance of Diabetes in Youth and
Young Adults.’’
Any member of the public interested
in presenting oral comments to the
Committee should notify the contact
person listed on this notice at least 10
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
9747
days in advance of the meeting.
Interested individuals and
representatives or organizations should
submit a letter of intent, a brief
description of the organization
represented, and a written copy of their
oral presentation in advance of the
meeting. Only one representative of an
organization will be allowed to present;
oral comments and presentations will be
limited to a maximum of 5 minutes.
Printed and electronic copies are
requested for the record. In addition,
any interested person may file written
comments with the Committee by
forwarding their statement to the
contact person listed on this notice. The
statement should include the name,
address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Because of time constraints for the
meeting, oral comments will be allowed
on a first-come, first-serve basis.
Members of the public who would
like to receive email notification about
future DMICC meetings should register
for the listserv available on the DMICC
Web site, www.diabetescommittee.gov.
Dated: February 12, 2014.
B. Tibor Roberts,
Executive Secretary, DMICC, Office of
Scientific Program and Policy Analysis,
National Institute of Diabetes and Digestive
and Kidney Diseases, National Institutes of
Health.
[FR Doc. 2014–03634 Filed 2–19–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF THE INTERIOR
Office of the Secretary
[DR.5B211.IA000713]
List of Programs Eligible for Inclusion
in Fiscal Year 2014 Funding
Agreements To Be Negotiated With
Self-Governance Tribes by Interior
Bureaus Other Than the Bureau of
Indian Affairs
Office of the Secretary, Interior.
Notice.
AGENCY:
ACTION:
This notice lists programs or
portions of programs that are eligible for
inclusion in Fiscal Year 2014 funding
agreements with self-governance Indian
tribes and lists programmatic targets for
each of the non-Bureau of Indian Affairs
(BIA) bureaus in the Department of the
Interior, pursuant to the Tribal SelfGovernance Act.
DATES: This notice expires on
September 30, 2014.
ADDRESSES: Inquiries or comments
regarding this notice may be directed to
SUMMARY:
E:\FR\FM\20FEN1.SGM
20FEN1
Agencies
[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 https://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
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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 https://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 https://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