21 USC 360eee-1 Drug Supply Chain Security

Page 351

TITLE 21—FOOD AND DRUGS
REFERENCES IN TEXT

The Comprehensive Drug Abuse Prevention and Control Act of 1970, referred to in par. (24)(B)(xiii)(II), is
Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236, which is classified principally to chapter 13 (§ 801 et seq.) of this
title. For complete classification of this Act to the
Code, see Short Title note set out under section 801 of
this title and Tables.
The Drug Supply Chain Security Act, referred to in
par. (27)(A), (B), is Pub. L. 113–54, title II, Nov. 27, 2013,
127 Stat. 599. For complete classification of this Act to
the Code, see Short Title note set out under section 301
of this title and Tables.

§ 360eee–1. Requirements
(a) In general
(1) Other activities
Each manufacturer, repackager, wholesale
distributor, and dispenser shall comply with
the requirements set forth in this section with
respect to the role of such manufacturer, repackager, wholesale distributor, or dispenser
in a transaction involving product. If an entity meets the definition of more than one of
the entities listed in the preceding sentence,
such entity shall comply with all applicable
requirements in this section, but shall not be
required to duplicate requirements.
(2) Initial standards
(A) In general
The Secretary shall, in consultation with
other appropriate Federal officials, manufacturers, repackagers, wholesale distributors, dispensers, and other pharmaceutical
distribution supply chain stakeholders, issue
a draft guidance document that establishes
standards for the interoperable exchange of
transaction information, transaction history, and transaction statements, in paper
or electronic format, for compliance with
this subsection and subsections (b), (c), (d),
and (e). In establishing such standards, the
Secretary shall consider 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. The standards established under this paragraph shall take
into consideration the standards established
under section 355e of this title and shall
comply with a form and format developed by
a widely recognized international standards
development organization.
(B) Public input
Prior to issuing the draft guidance under
subparagraph (A), the Secretary shall gather
comments and information from stakeholders and maintain such comments and information in a public docket for at least 60 days
prior to issuing such guidance.
(C) Publication
The Secretary shall publish the standards
established under subparagraph (A) not later
than 1 year after November 27, 2013.

§ 360eee–1

(3) Waivers, exceptions, and exemptions
(A) In general
Not later than 2 years after November 27,
2013, the Secretary shall, by guidance—
(i) establish a process by which an authorized manufacturer, repackager, wholesale distributor, or dispenser may request
a waiver from any of the requirements set
forth in this section, which the Secretary
may grant if the Secretary determines
that such requirements would result in an
undue economic hardship or for emergency
medical reasons, including a public health
emergency declaration pursuant to section
247d of title 42;
(ii) establish a process by which the Secretary determines exceptions, and a process through which a manufacturer or repackager may request such an exception,
to the requirements relating to product
identifiers if a product is packaged in a
container too small or otherwise unable to
accommodate a label with sufficient space
to bear the information required for compliance with this section; and
(iii) establish a process by which the
Secretary may determine other products
or transactions that shall be exempt from
the requirements of this section.
(B) Content
The guidance issued under subparagraph
(A) shall include a process for the biennial
review and renewal of such waivers, exceptions, and exemptions, as applicable.
(C) Process
In issuing the guidance under this paragraph, the Secretary shall provide an effective date that is not later than 180 days prior
to the date on which manufacturers are required to affix or imprint a product identifier to each package and homogenous case of
product intended to be introduced in a transaction into commerce consistent with this
section.
(4) Self-executing requirements
Except where otherwise specified, the requirements of this section may be enforced
without further regulations or guidance from
the Secretary.
(5) Grandfathering product
(A) Product identifier
Not later than 2 years after November 27,
2013, the Secretary shall finalize guidance
specifying whether and under what circumstances product that is not labeled with a
product identifier and that is in the pharmaceutical distribution supply chain at the
time of the effective date of the requirements of this section shall be exempted from
the requirements of this section.
(B) Tracing
For a product that entered the pharmaceutical distribution supply chain prior to
January 1, 2015—
(i) authorized trading partners shall be
exempt from providing transaction information as required under subsections

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TITLE 21—FOOD AND DRUGS

(b)(1)(A)(i), (c)(1)(A)(ii), (d)(1)(A)(ii), and
(e)(1)(A)(ii);
(ii) transaction history required under
this section shall begin with the owner of
such product on such date; and
(iii) the owners of such product on such
date shall be exempt from asserting receipt of transaction information and
transaction statement from the prior
owner as required under this section.
(6) Wholesale distributor licenses
Notwithstanding section 360eee(9)(A) of this
title, until the effective date of the wholesale
distributor licensing regulations under section
360eee–2 of this title, the term ‘‘licensed’’ or
‘‘authorized’’, as it relates to a wholesale distributor with respect to prescription drugs,
shall mean a wholesale distributor with a
valid license under State law.
(7) Third-party logistics provider licenses
Until the effective date of the third-party logistics provider licensing regulations under
section 360eee–3 of this title, a third-party logistics provider shall be considered ‘‘licensed’’
under section 360eee(9)(B) of this title unless
the Secretary has made a finding that the
third-party logistics provider does not utilize
good handling and distribution practices and
publishes notice thereof.
(8) Label changes
Changes made to package labels solely to incorporate the product identifier may be submitted to the Secretary in the annual report
of an establishment, in accordance with section 314.70(d) of chapter 1 21, Code of Federal
Regulations (or any successor regulation).
(9) Product identifiers
With respect to any requirement relating to
product identifiers under this part—
(A) unless the Secretary allows, through
guidance, the use of other technologies for
data instead of or in addition to the technologies described in clauses (i) and (ii), the
applicable data—
(i) shall be included in a 2-dimensional
data matrix barcode when affixed to, or
imprinted upon, a package; and
(ii) shall be included in a linear or 2-dimensional data matrix barcode when affixed to, or imprinted upon, a homogeneous case; and
(B) verification of the product identifier
may occur by using human-readable or machine-readable methods.
(b) Manufacturer requirements
(1) Product tracing
(A) In general
Beginning not later than January 1, 2015, a
manufacturer shall—
(i) prior to, or at the time of, each transaction in which such manufacturer transfers ownership of a product, provide the
subsequent owner with transaction history, transaction information, and a trans1 So

in original. Probably should be ‘‘title’’.

Page 352

action statement, in a single document in
an 2 paper or electronic format; and
(ii) capture the transaction information
(including lot level information), transaction history, and transaction statement
for each transaction and maintain such information, history, and statement for not
less than 6 years after the date of the
transaction.
(B) Requests for information
Upon a request by the Secretary or other
appropriate Federal or State official, in the
event of a recall or for the purpose of investigating a suspect product or an illegitimate
product, a manufacturer shall, not later
than 1 business day, and not to exceed 48
hours, after receiving the request, or in
other such reasonable time as determined by
the Secretary, based on the circumstances of
the request, provide the applicable transaction information, transaction history, and
transaction statement for the product.
(C) Electronic format
(i) In general
Beginning not later than 4 years after
November 27, 2013, except as provided
under clause (ii), a manufacturer shall provide the transaction information, transaction history, and transaction statement
required under subparagraph (A)(i) in electronic format.
(ii) Exception
A manufacturer may continue to provide
the transaction information, transaction
history, and transaction statement required under subparagraph (A)(i) in a
paper format to a licensed health care
practitioner authorized to prescribe medication under State law or other licensed
individual under the supervision or direction of such a practitioner who dispenses
product in the usual course of professional
practice.
(2) Product identifier
(A) In general
Beginning not later than 4 years after November 27, 2013, a manufacturer shall affix or
imprint a product identifier to each package
and homogenous case of a product intended
to be introduced in a transaction into commerce. Such manufacturer shall maintain
the product identifier information for such
product for not less than 6 years after the
date of the transaction.
(B) Exception
A package that is required to have a standardized numerical identifier is not required
to have a unique device identifier.
(3) Authorized trading partners
Beginning not later than January 1, 2015, the
trading partners of a manufacturer may be
only authorized trading partners.
(4) Verification
Beginning not later than January 1, 2015, a
manufacturer shall have systems in place to
2 So

in original. Probably should be ‘‘a’’.

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TITLE 21—FOOD AND DRUGS

enable the manufacturer to comply with the
following requirements:
(A) Suspect product
(i) In general
Upon making a determination that a
product in the possession or control of the
manufacturer is a suspect product, or upon
receiving a request for verification from
the Secretary that has made a determination that a product within the possession
or control of a manufacturer is a suspect
product, a manufacturer shall—
(I) quarantine such product within the
possession or control of the manufacturer from product intended for distribution until such product is cleared or
dispositioned; and
(II) promptly conduct an investigation
in coordination with trading partners, as
applicable, to determine whether the
product is an illegitimate product, which
shall include validating any applicable
transaction history and transaction information in the possession of the manufacturer and otherwise investigating to
determine whether the product is an illegitimate product, and, beginning 4 years
after November 27, 2013, verifying the
product at the package level, including
the standardized numerical identifier.
(ii) Cleared product
If the manufacturer makes the determination that a suspect product is not an
illegitimate product, the manufacturer
shall promptly notify the Secretary, if applicable, of such determination and such
product may be further distributed.
(iii) Records
A manufacturer shall keep records of the
investigation of a suspect product for not
less than 6 years after the conclusion of
the investigation.
(B) Illegitimate product
(i) In general
Upon determining that a product in the
possession or control of a manufacturer is
an illegitimate product, the manufacturer
shall, in a manner consistent with the systems and processes of such manufacturer—
(I) quarantine such product within the
possession or control of the manufacturer from product intended for distribution until such product is dispositioned;
(II) disposition the illegitimate product within the possession or control of
the manufacturer;
(III) take reasonable and appropriate
steps to assist a trading partner to disposition an illegitimate product not in
the possession or control of the manufacturer; and
(IV) retain a sample of the product for
further physical examination or laboratory analysis of the product by the manufacturer or Secretary (or other appropriate Federal or State official) upon request by the Secretary (or other appropriate Federal or State official), as necessary and appropriate.

§ 360eee–1

(ii) Making a notification
(I) Illegitimate product
Upon determining that a product in
the possession or control of the manufacturer is an illegitimate product, the
manufacturer shall notify the Secretary
and all immediate trading partners that
the manufacturer has reason to believe
may have received such illegitimate
product of such determination not later
than 24 hours after making such determination.
(II) High risk of illegitimacy
A manufacturer shall notify the Secretary and immediate trading partners
that the manufacturer has reason to believe may have in the trading partner’s
possession a product manufactured by,
or purported to be a product manufactured by, the manufacturer not later
than 24 hours after determining or being
notified by the Secretary or a trading
partner that there is a high risk that
such product is an illegitimate product.
For purposes of this subclause, a ‘‘high
risk’’ may include a specific high risk
that could increase the likelihood that
illegitimate product will enter the pharmaceutical distribution supply chain and
other high risks as determined by the
Secretary in guidance pursuant to subsection (h).
(iii) Responding to a notification
Upon the receipt of a notification from
the Secretary or a trading partner that a
determination has been made that a product is an illegitimate product, a manufacturer shall identify all illegitimate product subject to such notification that is in
the possession or control of the manufacturer, including any product that is subsequently received, and shall perform the activities described in subparagraph (A).
(iv) Terminating a notification
Upon making a determination, in consultation with the Secretary, that a notification is no longer necessary, a manufacturer shall promptly notify immediate
trading partners that the manufacturer
notified pursuant to clause (ii) that such
notification has been terminated.
(v) Records
A manufacturer shall keep records of the
disposition of an illegitimate product for
not less than 6 years after the conclusion
of the disposition.
(C) Requests for verification
Beginning 4 years after November 27, 2013,
upon receiving a request for verification
from an authorized repackager, wholesale
distributor, or dispenser that is in possession
or control of a product such person believes
to be manufactured by such manufacturer, a
manufacturer shall, not later than 24 hours
after receiving the request for verification
or in other such reasonable time as determined by the Secretary, based on the cir-

§ 360eee–1

TITLE 21—FOOD AND DRUGS

cumstances of the request, notify the person
making the request whether the product
identifier, including the standardized numerical identifier, that is the subject of the request corresponds to the product identifier
affixed or imprinted by the manufacturer. If
a manufacturer responding to a request for
verification identifies a product identifier
that does not correspond to that affixed or
imprinted by the manufacturer, the manufacturer shall treat such product as suspect
product and conduct an investigation as described in subparagraph (A). If the manufacturer has reason to believe the product is an
illegitimate product, the manufacturer shall
advise the person making the request of such
belief at the time such manufacturer responds to the request for verification.
(D) Electronic database
A manufacturer may satisfy the requirements of this paragraph by developing a secure electronic database or utilizing a secure
electronic database developed or operated by
another entity. The owner of such database
shall establish the requirements and processes to respond to requests and may provide
for data access to other members of the
pharmaceutical distribution supply chain, as
appropriate. The development and operation
of such a database shall not relieve a manufacturer of the requirement under this paragraph to respond to a request for verification submitted by means other than a secure
electronic database.
(E) Saleable returned product
Beginning 4 years after November 27, 2013
(except as provided pursuant to subsection
(a)(5)), upon receipt of a returned product
that the manufacturer intends to further
distribute, before further distributing such
product, the manufacturer shall verify the
product identifier, including the standardized numerical identifier, for each sealed homogeneous case of such product or, if such
product is not in a sealed homogeneous case,
verify the product identifier, including the
standardized numerical identifier, on each
package.
(F) Nonsaleable returned product
A manufacturer may return a nonsaleable
product to the manufacturer or repackager,
to the wholesale distributor from whom such
product was purchased, or to a person acting
on behalf of such a person, including a returns processor, without providing the information described in paragraph (1)(A)(i).
(c) Wholesale distributor requirements
(1) Product tracing
(A) In general
Beginning not later than January 1, 2015,
the following requirements shall apply to
wholesale distributors:
(i) A wholesale distributor shall not accept ownership of a product unless the previous owner prior to, or at the time of, the
transaction provides the transaction history, transaction information, and a transaction statement for the product, as applicable under this subparagraph.

Page 354

(ii)(I)(aa) If the wholesale distributor
purchased a product directly from the
manufacturer, the exclusive distributor of
the manufacturer, or a repackager that
purchased directly from the manufacturer,
then prior to, or at the time of, each transaction in which the wholesale distributor
transfers ownership of a product, the
wholesale distributor shall provide to the
subsequent purchaser—
(AA) a transaction statement, which
shall state that such wholesale distributor, or a member of the affiliate of such
wholesale distributor, purchased the
product directly from the manufacturer,
exclusive distributor of the manufacturer, or repackager that purchased the
product directly from the manufacturer;
and
(BB) subject to subclause (II), the
transaction history and transaction information.
(bb) The wholesale distributor shall provide the transaction history, transaction
information, and transaction statement
under item (aa)—
(AA) if provided to a dispenser, on a
single document in a paper or electronic
format; and
(BB) if provided to a wholesale distributor, through any combination of
self-generated paper, electronic data, or
manufacturer-provided information on
the product package.
(II) For purposes of transactions described in subclause (I), transaction history and transaction information shall not
be required to include the lot number of
the product, the initial transaction date,
or the initial shipment date from the manufacturer (as defined in subparagraphs (F),
(G), and (H) of section 360eee(26) of this
title).
(iii) If the wholesale distributor did not
purchase a product directly from the manufacturer, the exclusive distributor of the
manufacturer, or a repackager that purchased directly from the manufacturer, as
described in clause (ii), then prior to, or at
the time of, each transaction or subsequent transaction, the wholesale distributor shall provide to the subsequent purchaser a transaction statement, transaction history, and transaction information, in a paper or electronic format that
complies with the guidance document issued under subsection (a)(2).
(iv) For the purposes of clause (iii), the
transaction history supplied shall begin
only with the wholesale distributor described in clause (ii)(I), but the wholesale
distributor described in clause (iii) shall
inform the subsequent purchaser that such
wholesale distributor received a direct
purchase statement from a wholesale distributor described in clause (ii)(I).
(v) A wholesale distributor shall—
(I) capture the transaction information
(including lot level information) consistent with the requirements of this sec-

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TITLE 21—FOOD AND DRUGS

tion, transaction history, and transaction statement for each transaction
described in clauses (i), (ii), and (iii) and
maintain such information, history, and
statement for not less than 6 years after
the date of the transaction; and
(II) maintain the confidentiality of the
transaction information (including any
lot level information consistent with the
requirements of this section), transaction history, and transaction statement for a product in a manner that prohibits disclosure to any person other
than the Secretary or other appropriate
Federal or State official, except to comply with clauses (ii) and (iii), and, as applicable, pursuant to an agreement under
subparagraph (D).
(B) Returns
(i) Saleable returns
Notwithstanding subparagraph (A)(i),
the following shall apply:
(I) Requirements
Until the date that is 6 years after November 27, 2013 (except as provided pursuant to subsection (a)(5)), a wholesale
distributor may accept returned product
from a dispenser or repackager pursuant
to the terms and conditions of any agreement between the parties, and, notwithstanding subparagraph (A)(ii), may distribute such returned product without
providing the transaction history. For
transactions subsequent to the return,
the transaction history of such product
shall begin with the wholesale distributor that accepted the returned product,
consistent with the requirements of this
subsection.
(II) Enhanced requirements
Beginning 6 years after November 27,
2013 (except as provided pursuant to subsection (a)(5)), a wholesale distributor
may accept returned product from a dispenser or repackager only if the wholesale distributor can associate returned
product with the transaction information and transaction statement associated with that product. For all transactions after such date, the transaction
history, as applicable, of such product
shall begin with the wholesale distributor that accepted and verified the returned product. For purposes of this subparagraph, the transaction information
and transaction history, as applicable,
need not include transaction dates if it is
not reasonably practicable to obtain
such dates.
(ii) Nonsaleable returns
A wholesale distributor may return a
nonsaleable product to the manufacturer
or repackager, to the wholesale distributor
from whom such product was purchased, or
to a person acting on behalf of such a person, including a returns processor, without
providing the information required under
subparagraph (A)(i).

§ 360eee–1

(C) Requests for information
Upon a request by the Secretary or other
appropriate Federal or State official, in the
event of a recall or for the purpose of investigating a suspect product or an illegitimate
product, a wholesale distributor shall, not
later than 1 business day, and not to exceed
48 hours, after receiving the request or in
other such reasonable time as determined by
the Secretary, based on the circumstances of
the request, provide the applicable transaction information, transaction history, and
transaction statement for the product.
(D) Trading partner agreements
Beginning 6 years after November 27, 2013,
a wholesale distributor may disclose the
transaction information, including lot level
information, transaction history, or transaction statement of a product to the subsequent purchaser of the product, pursuant to
a written agreement between such wholesale
distributor and such subsequent purchaser.
Nothing in this subparagraph shall be construed to limit the applicability of subparagraphs (A) through (C).
(2) Product identifier
Beginning 6 years after November 27, 2013, a
wholesale distributor may engage in transactions involving a product only if such product is encoded with a product identifier (except as provided pursuant to subsection (a)(5)).
(3) Authorized trading partners
Beginning not later than January 1, 2015, the
trading partners of a wholesale distributor
may be only authorized trading partners.
(4) Verification
Beginning not later than January 1, 2015, a
wholesale distributor shall have systems in
place to enable the wholesale distributor to
comply with the following requirements:
(A) Suspect product
(i) In general
Upon making a determination that a
product in the possession or control of a
wholesale distributor is a suspect product,
or upon receiving a request for verification
from the Secretary that has made a determination that a product within the possession or control of a wholesale distributor
is a suspect product, a wholesale distributor shall—
(I) quarantine such product within the
possession or control of the wholesale
distributor from product intended for
distribution until such product is cleared
or dispositioned; and
(II) promptly conduct an investigation
in coordination with trading partners, as
applicable, to determine whether the
product is an illegitimate product, which
shall include validating any applicable
transaction history and transaction information in the possession of the wholesale distributor and otherwise investigating to determine whether the product is an illegitimate product, and, beginning 6 years after November 27, 2013

§ 360eee–1

TITLE 21—FOOD AND DRUGS

(except as provided pursuant to subsection (a)(5)), verifying the product at
the package level, including the standardized numerical identifier.
(ii) Cleared product
If the wholesale distributor determines
that a suspect product is not an illegitimate product, the wholesale distributor
shall promptly notify the Secretary, if applicable, of such determination and such
product may be further distributed.
(iii) Records
A wholesale distributor shall keep
records of the investigation of a suspect
product for not less than 6 years after the
conclusion of the investigation.
(B) Illegitimate product
(i) In general
Upon determining, in coordination with
the manufacturer, that a product in the
possession or control of a wholesale distributor is an illegitimate product, the
wholesale distributor shall, in a manner
that is consistent with the systems and
processes of such wholesale distributor—
(I) quarantine such product within the
possession or control of the wholesale
distributor from product intended for
distribution until such product is
dispositioned;
(II) disposition the illegitimate product within the possession or control of
the wholesale distributor;
(III) take reasonable and appropriate
steps to assist a trading partner to disposition an illegitimate product not in
the possession or control of the wholesale distributor; and
(IV) retain a sample of the product for
further physical examination or laboratory analysis of the product by the manufacturer or Secretary (or other appropriate Federal or State official) upon request by the manufacturer or Secretary
(or other appropriate Federal or State
official), as necessary and appropriate.
(ii) Making a notification
Upon determining that a product in the
possession or control of the wholesale distributor is an illegitimate product, the
wholesale distributor shall notify the Secretary and all immediate trading partners
that the wholesale distributor has reason
to believe may have received such illegitimate product of such determination not
later than 24 hours after making such determination.
(iii) Responding to a notification
Upon the receipt of a notification from
the Secretary or a trading partner that a
determination has been made that a product is an illegitimate product, a wholesale
distributor shall identify all illegitimate
product subject to such notification that is
in the possession or control of the wholesale distributor, including any product
that is subsequently received, and shall

Page 356

perform the activities described in subparagraph (A).
(iv) Terminating a notification
Upon making a determination, in consultation with the Secretary, that a notification is no longer necessary, a wholesale
distributor shall promptly notify immediate trading partners that the wholesale
distributor notified pursuant to clause (ii)
that such notification has been terminated.
(v) Records
A wholesale distributor shall keep
records of the disposition of an illegitimate product for not less than 6 years
after the conclusion of the disposition.
(C) Electronic database
A wholesale distributor may satisfy the requirements of this paragraph by developing
a secure electronic database or utilizing a
secure electronic database developed or operated by another entity. The owner of such
database shall establish the requirements
and processes to respond to requests and
may provide for data access to other members of the pharmaceutical distribution supply chain, as appropriate. The development
and operation of such a database shall not
relieve a wholesale distributor of the requirement under this paragraph to respond
to a verification request submitted by means
other than a secure electronic database.
(D) Verification of saleable returned product
Beginning 6 years after November 27, 2013,
upon receipt of a returned product that the
wholesale distributor intends to further distribute, before further distributing such
product, the wholesale distributor shall verify the product identifier, including the
standardized numerical identifier, for each
sealed homogeneous case of such product or,
if such product is not in a sealed homogeneous case, verify the product identifier,
including the standardized numerical identifier, on each package.
(d) Dispenser requirements
(1) Product tracing
(A) In general
Beginning July 1, 2015, a dispenser—
(i) shall not accept ownership of a product, unless the previous owner prior to, or
at the time of, the transaction, provides
transaction history, transaction information, and a transaction statement;
(ii) prior to, or at the time of, each
transaction in which the dispenser transfers ownership of a product (but not including dispensing to a patient or returns)
shall provide the subsequent owner with
transaction history, transaction information, and a transaction statement for the
product, except that the requirements of
this clause shall not apply to sales by a
dispenser to another dispenser to fulfill a
specific patient need; and
(iii) shall capture transaction information (including lot level information, if

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TITLE 21—FOOD AND DRUGS

provided), transaction history, and transaction statements, as necessary to investigate a suspect product, and maintain
such information, history, and statements
for not less than 6 years after the transaction.
(B) Agreements with third parties
A dispenser may enter into a written
agreement with a third party, including an
authorized wholesale distributor, under
which the third party confidentially maintains the transaction information, transaction history, and transaction statements
required to be maintained under this subsection on behalf of the dispenser. If a dispenser enters into such an agreement, the
dispenser shall maintain a copy of the written agreement and shall not be relieved of
the obligations of the dispenser under this
subsection.
(C) Returns
(i) Saleable returns
A dispenser may return product to the
trading partner from which the dispenser
obtained the product without providing
the information required under subparagraph (A).
(ii) Nonsaleable returns
A dispenser may return a nonsaleable
product to the manufacturer or repackager, to the wholesale distributor from
whom such product was purchased, to a returns processor, or to a person acting on
behalf of such a person without providing
the information required under subparagraph (A).
(D) Requests for information
Upon a request by the Secretary or other
appropriate Federal or State official, in the
event of a recall or for the purpose of investigating a suspect or an illegitimate product, a dispenser shall, not later than 2 business days after receiving the request or in
another such reasonable time as determined
by the Secretary, based on the circumstances of the request, provide the applicable transaction information, transaction
statement, and transaction history which
the dispenser received from the previous
owner, which shall not include the lot number of the product, the initial transaction
date, or the initial shipment date from the
manufacturer unless such information was
included in the transaction information,
transaction statement, and transaction history provided by the manufacturer or wholesale distributor to the dispenser. The dispenser may respond to the request by providing the applicable information in either
paper or electronic format. Until the date
that is 4 years after November 27, 2013, the
Secretary or other appropriate Federal or
State official shall grant a dispenser additional time, as necessary, only with respect
to a request to provide lot level information
described in subparagraph (F) of section
360eee(26) of this title that was provided to
the dispenser in paper format, limit the re-

§ 360eee–1

quest time period to the 6 months preceding
the request or other relevant date, and, in
the event of a recall, the Secretary, or other
appropriate Federal or State official may request information only if such recall involves a serious adverse health consequence
or death to humans.
(2) Product identifier
Beginning not later than 7 years after November 27, 2013, a dispenser may engage in
transactions involving a product only if such
product is encoded with a product identifier
(except as provided pursuant to subsection
(a)(5)).
(3) Authorized trading partners
Beginning not later than January 1, 2015, the
trading partners of a dispenser may be only
authorized trading partners.
(4) Verification
Beginning not later than January 1, 2015, a
dispenser shall have systems in place to enable
the dispenser to comply with the following requirements:
(A) Suspect product
(i) In general
Upon making a determination that a
product in the possession or control of the
dispenser is a suspect product, or upon receiving a request for verification from the
Secretary that has made a determination
that a product within the possession or
control of a dispenser is a suspect product,
a dispenser shall—
(I) quarantine such product within the
possession or control of the dispenser
from product intended for distribution
until such product is cleared or
dispositioned; and
(II) promptly conduct an investigation
in coordination with trading partners, as
applicable, to determine whether the
product is an illegitimate product.
(ii) Investigation
An investigation conducted under clause
(i)(II) shall include—
(I) beginning 7 years after November
27, 2013, verifying whether the lot number of a suspect product corresponds
with the lot number for such product;
(II) beginning 7 years after November
27, 2013, verifying that the product identifier, including the standardized numerical identifier, of at least 3 packages or
10 percent of such suspect product,
whichever is greater, or all packages, if
there are fewer than 3, corresponds with
the product identifier for such product;
(III) validating any applicable transaction history and transaction information in the possession of the dispenser;
and
(IV) otherwise investigating to determine whether the product is an illegitimate product.
(iii) Cleared product
If the dispenser makes the determination that a suspect product is not an ille-

§ 360eee–1

TITLE 21—FOOD AND DRUGS

gitimate product, the dispenser shall
promptly notify the Secretary, if applicable, of such determination and such product may be further distributed or dispensed.
(iv) Records
A dispenser shall keep records of the investigation of a suspect product for not
less than 6 years after the conclusion of
the investigation.
(B) Illegitimate product
(i) In general
Upon determining, in coordination with
the manufacturer, that a product in the
possession or control of a dispenser is an
illegitimate product, the dispenser shall—
(I) disposition the illegitimate product
within the possession or control of the
dispenser;
(II) take reasonable and appropriate
steps to assist a trading partner to disposition an illegitimate product not in
the possession or control of the dispenser; and
(III) retain a sample of the product for
further physical examination or laboratory analysis of the product by the manufacturer or Secretary (or other appropriate Federal or State official) upon request by the manufacturer or Secretary
(or other appropriate Federal or State
official), as necessary and appropriate.
(ii) Making a notification
Upon determining that a product in the
possession or control of the dispenser is an
illegitimate product, the dispenser shall
notify the Secretary and all immediate
trading partners that the dispenser has
reason to believe may have received such
illegitimate product of such determination
not later than 24 hours after making such
determination.
(iii) Responding to a notification
Upon the receipt of a notification from
the Secretary or a trading partner that a
determination has been made that a product is an illegitimate product, a dispenser
shall identify all illegitimate product subject to such notification that is in the possession or control of the dispenser, including any product that is subsequently received, and shall perform the activities described in subparagraph (A).
(iv) Terminating a notification
Upon making a determination, in consultation with the Secretary, that a notification is no longer necessary, a dispenser
shall promptly notify immediate trading
partners that the dispenser notified pursuant to clause (ii) that such notification has
been terminated.
(v) Records
A dispenser shall keep records of the disposition of an illegitimate product for not
less than 6 years after the conclusion of
the disposition.

Page 358

(C) Electronic database
A dispenser may satisfy the requirements
of this paragraph by developing a secure
electronic database or utilizing a secure
electronic database developed or operated by
another entity.
(5) Exception
Notwithstanding any other provision of law,
the requirements under paragraphs (1) and (4)
shall not apply to licensed health care practitioners authorized to prescribe or administer
medication under State law or other licensed
individuals under the supervision or direction
of such practitioners who dispense or administer product in the usual course of professional practice.
(e) Repackager requirements
(1) Product tracing
(A) In general
Beginning not later than January 1, 2015, a
repackager described in section 360eee(16)(A)
of this title shall—
(i) not accept ownership of a product unless the previous owner, prior to, or at the
time of, the transaction, provides transaction history, transaction information,
and a transaction statement for the product;
(ii) prior to, or at the time of, each
transaction in which the repackager transfers ownership of a product, provide the
subsequent owner with transaction history, transaction information, and a transaction statement for the product; and
(iii) capture the transaction information
(including lot level information), transaction history, and transaction statement
for each transaction described in clauses
(i) and (ii) and maintain such information,
history, and statement for not less than 6
years after the transaction.
(B) Returns
(i) Nonsaleable product
A repackager described in section
360eee(16)(A) of this title may return a
nonsaleable product to the manufacturer
or repackager, or to the wholesale distributor from whom such product was purchased, or to a person acting on behalf of
such a person, including a returns processor, without providing the information
required under subparagraph (A)(ii).
(ii) Saleable or nonsaleable product
A repackager described in section
360eee(16)(B) of this title may return a
saleable or nonsaleable product to the
manufacturer, repackager, or to the
wholesale distributor from whom such
product was received without providing
the information required under subparagraph (A)(ii) on behalf of the hospital or
other health care entity that took ownership of such product pursuant to the terms
and conditions of any agreement between
such repackager and the entity that owns
the product.
(C) Requests for information
Upon a request by the Secretary or other
appropriate Federal or State official, in the

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TITLE 21—FOOD AND DRUGS

event of a recall or for the purpose of investigating a suspect product or an illegitimate
product, a repackager described in section
360eee(16)(A) of this title shall, not later
than 1 business day, and not to exceed 48
hours, after receiving the request or in other
such reasonable time as determined by the
Secretary, provide the applicable transaction information, transaction history, and
transaction statement for the product.
(2) Product identifier
(A) In general
Beginning not later than 5 years after November 27, 2013, a repackager described in
section 360eee(16)(A) of this title—
(i) shall affix or imprint a product identifier to each package and homogenous
case of product intended to be introduced
in a transaction in commerce;
(ii) shall maintain the product identifier
information for such product for not less
than 6 years after the date of the transaction;
(iii) may engage in transactions involving a product only if such product is encoded with a product identifier (except as
provided pursuant to subsection (a)(5));
and
(iv) shall maintain records for not less
than 6 years to allow the repackager to associate the product identifier the repackager affixes or imprints with the product
identifier assigned by the original manufacturer of the product.
(B) Exception
A package that is required to have a standardized numerical identifier is not required
to have a unique device identifier.
(3) Authorized trading partners
Beginning January 1, 2015, the trading partners of a repackager described in section
360eee(16) of this title may be only authorized
trading partners.
(4) Verification
Beginning not later than January 1, 2015, a
repackager described in section 360eee(16)(A)
of this title shall have systems in place to enable the repackager to comply with the following requirements:
(A) Suspect product
(i) In general
Upon making a determination that a
product in the possession or control of the
repackager is a suspect product, or upon
receiving a request for verification from
the Secretary that has made a determination that a product within the possession
or control of a repackager is a suspect
product, a repackager shall—
(I) quarantine such product within the
possession or control of the repackager
from product intended for distribution
until such product is cleared or
dispositioned; and
(II) promptly conduct an investigation
in coordination with trading partners, as
applicable, to determine whether the

§ 360eee–1

product is an illegitimate product, which
shall include validating any applicable
transaction history and transaction information in the possession of the repackager and otherwise investigating to
determine whether the product is an illegitimate product, and, beginning 5 years
after November 27, 2013 (except as provided pursuant to subsection (a)(5)), verifying the product at the package level,
including the standardized numerical
identifier.
(ii) Cleared product
If the repackager makes the determination that a suspect product is not an illegitimate product, the repackager shall
promptly notify the Secretary, if applicable, of such determination and such product may be further distributed.
(iii) Records
A repackager shall keep records of the
investigation of a suspect product for not
less than 6 years after the conclusion of
the investigation.
(B) Illegitimate product
(i) In general
Upon determining, in coordination with
the manufacturer, that a product in the
possession or control of a repackager is an
illegitimate product, the repackager shall,
in a manner that is consistent with the
systems and processes of such repackager—
(I) quarantine such product within the
possession or control of the repackager
from product intended for distribution
until such product is dispositioned;
(II) disposition the illegitimate product within the possession or control of
the repackager;
(III) take reasonable and appropriate
steps to assist a trading partner to disposition an illegitimate product not in
the possession or control of the repackager; and
(IV) retain a sample of the product for
further physical examination or laboratory analysis of the product by the manufacturer or Secretary (or other appropriate Federal or State official) upon request by the manufacturer or Secretary
(or other appropriate Federal or State
official), as necessary and appropriate.
(ii) Making a notification
Upon determining that a product in the
possession or control of the repackager is
an illegitimate product, the repackager
shall notify the Secretary and all immediate trading partners that the repackager
has reason to believe may have received
the illegitimate product of such determination not later than 24 hours after
making such determination.
(iii) Responding to a notification
Upon the receipt of a notification from
the Secretary or a trading partner, a repackager shall identify all illegitimate

§ 360eee–1

TITLE 21—FOOD AND DRUGS

product subject to such notification that is
in the possession or control of the repackager, including any product that is subsequently received, and shall perform the activities described in subparagraph (A).
(iv) Terminating a notification
Upon making a determination, in consultation with the Secretary, that a notification is no longer necessary, a repackager
shall promptly notify immediate trading
partners that the repackager notified pursuant to clause (ii) that such notification
has been terminated.
(v) Records
A repackager shall keep records of the
disposition of an illegitimate product for
not less than 6 years after the conclusion
of the disposition.
(C) Requests for verification
Beginning 5 years after November 27, 2013,
upon receiving a request for verification
from an authorized manufacturer, wholesale
distributor, or dispenser that is in possession
or control of a product they believe to be repackaged by such repackager, a repackager
shall, not later than 24 hours after receiving
the verification request or in other such reasonable time as determined by the Secretary, based on the circumstances of the request, notify the person making the request
whether the product identifier, including the
standardized numerical identifier, that is
the subject of the request corresponds to the
product identifier affixed or imprinted by
the repackager. If a repackager responding
to a verification request identifies a product
identifier that does not correspond to that
affixed or imprinted by the repackager, the
repackager shall treat such product as suspect product and conduct an investigation as
described in subparagraph (A). If the repackager has reason to believe the product is an
illegitimate product, the repackager shall
advise the person making the request of such
belief at the time such repackager responds
to the verification request.
(D) Electronic database
A repackager may satisfy the requirements of paragraph (4) by developing a secure electronic database or utilizing a secure
electronic database developed or operated by
another entity. The owner of such database
shall establish the requirements and processes to respond to requests and may provide
for data access to other members of the
pharmaceutical distribution supply chain, as
appropriate. The development and operation
of such a database shall not relieve a repackager of the requirement under subparagraph
(C) to respond to a verification request submitted by means other than a secure electronic database.
(E) Verification of saleable returned product
Beginning 5 years after November 27, 2013,
upon receipt of a returned product that the
repackager intends to further distribute, before further distributing such product, the
repackager shall verify the product identi-

Page 360

fier for each sealed homogeneous case of
such product or, if such product is not in a
sealed homogeneous case, verify the product
identifier on each package.
(f) Drop shipments
(1) In general
A wholesale distributor that does not physically handle or store product shall be exempt
from the provisions of this section, except the
notification requirements under clauses (ii),
(iii), and (iv) of subsection (c)(4)(B), provided
that the manufacturer, repackager, or other
wholesale distributor that distributes the
product to the dispenser by means of a drop
shipment for such wholesale distributor includes on the transaction information and
transaction history to the dispenser the contact information of such wholesale distributor
and provides the transaction information,
transaction history, and transaction statement directly to the dispenser.
(2) Clarification
For purposes of this subsection, providing
administrative services, including processing
of orders and payments, shall not by itself, be
construed as being involved in the handling,
distribution, or storage of a product.
(g) Enhanced drug distribution security
(1) In general
On the date that is 10 years after November
27, 2013, the following interoperable, electronic
tracing of product at the package level requirements shall go into effect:
(A) The transaction information and the
transaction statements as required under
this section shall be exchanged in a secure,
interoperable, electronic manner in accordance with the standards established under
the guidance issued pursuant to paragraphs
(3) and (4) of subsection (h), including any
revision of such guidance issued in accordance with paragraph (5) of such subsection.
(B) The transaction information required
under this section shall include the product
identifier at the package level for each package included in the transaction.
(C) Systems and processes for verification
of product at the package level, including
the standardized numerical identifier, shall
be required in accordance with the standards
established under the guidance issued pursuant to subsection (a)(2) and the guidances issued pursuant to paragraphs (2), (3), and (4)
of subsection (h), including any revision of
such guidances issued in accordance with
paragraph (5) of such subsection, which may
include the use of aggregation and inference
as necessary.
(D) The systems and processes necessary
to promptly respond with the transaction information and transaction statement for a
product upon a request by the Secretary (or
other appropriate Federal or State official)
in the event of a recall or for the purposes of
investigating a suspect product or an illegitimate product shall be required.
(E) The systems and processes necessary to
promptly facilitate gathering the informa-

Page 361

TITLE 21—FOOD AND DRUGS

tion necessary to produce the transaction information for each transaction going back
to the manufacturer, as applicable, shall be
required—
(i) in the event of a request by the Secretary (or other appropriate Federal or
State official), on account of a recall or for
the purposes of investigating a suspect
product or an illegitimate product; or
(ii) in the event of a request by an authorized trading partner, in a secure manner that ensures the protection of confidential commercial information and
trade secrets, for purposes of investigating
a suspect product or assisting the Secretary (or other appropriate Federal or
State official) with a request described in
clause (i).
(F) Each person accepting a saleable return shall have systems and processes in
place to allow acceptance of such product
and may accept saleable returns only if such
person can associate the saleable return
product with the transaction information
and transaction statement associated with
that product.
(2) Compliance
(A) Information maintenance agreement
A dispenser may enter into a written
agreement with a third party, including an
authorized wholesale distributor, under
which the third party shall confidentially
maintain any information and statements
required to be maintained under this section. If a dispenser enters into such an
agreement, the dispenser shall maintain a
copy of the written agreement and shall not
be relieved of the obligations of the dispenser under this subsection.
(B) Alternative methods
The Secretary, taking into consideration
the assessment conducted under paragraph
(3), shall provide for alternative methods of
compliance with any of the requirements set
forth in paragraph (1), including—
(i) establishing timelines for compliance
by small businesses (including small business dispensers with 25 or fewer full-time
employees) with such requirements, in
order to ensure that such requirements do
not impose undue economic hardship for
small businesses, including small business
dispensers for whom the criteria set forth
in the assessment under paragraph (3) is
not met, if the Secretary determines that
such requirements under paragraph (1)
would result in undue economic hardship;
and
(ii) establishing a process by which a dispenser may request a waiver from any of
the requirements set forth in paragraph (1)
if the Secretary determines that such requirements would result in an undue economic hardship, which shall include a
process for the biennial review and renewal of any such waiver.
(3) Assessment
(A) In general
Not later than the date that is 18 months
after the Secretary issues the final guidance

§ 360eee–1

required under subsection (h), the Secretary
shall enter into a contract with a private,
independent consulting firm with expertise
to conduct a technology and software assessment that looks at the feasibility of dispensers with 25 or fewer full-time employees conducting interoperable, electronic tracing of
products at the package level. Such assessment shall be completed not later than 81⁄2
years after November 27, 2013.
(B) Condition
As a condition of the award of the contract
under subparagraph (A), the private, independent consulting firm shall agree to consult with dispensers with 25 or fewer fulltime employees when conducting the assessment under such subparagraph.
(C) Content
The assessment under subparagraph (A)
shall assess whether—
(i) the necessary software and hardware
is readily accessible to such dispensers;
(ii) the necessary software and hardware
is prohibitively expensive to obtain, install, and maintain for such dispensers;
and
(iii) the necessary hardware and software
can be integrated into business practices,
such as interoperability with wholesale
distributors, for such dispensers.
(D) Publication
The Secretary shall—
(i) publish the statement of work for the
assessment under subparagraph (A) for
public comment prior to beginning the assessment;
(ii) publish the final assessment for public comment not later than 30 calendar
days after receiving such assessment; and
(iii) hold a public meeting not later than
180 calendar days after receiving the final
assessment at which public stakeholders
may present their views on the assessment.
(4) Procedure
Notwithstanding section 553 of title 5, the
Secretary, in promulgating any regulation
pursuant to this section, shall—
(A) provide appropriate flexibility by—
(i) not requiring the adoption of specific
business systems for the maintenance and
transmission of data;
(ii) prescribing alternative methods of
compliance for any of the requirements set
forth in paragraph (1) or set forth in regulations implementing such requirements,
including—
(I) timelines for small businesses to
comply with the requirements set forth
in the regulations in order to ensure that
such requirements do not impose undue
economic hardship for small businesses
(including small business dispensers for
whom the criteria set forth in the assessment under paragraph (3) is not met), if
the Secretary determines that such requirements would result in undue economic hardship; and

§ 360eee–1

TITLE 21—FOOD AND DRUGS

(II) the establishment of a process by
which a dispenser may request a waiver
from any of the requirements set forth in
such regulations if the Secretary determines that such requirements would result in an undue economic hardship; and
(iii) taking into consideration—
(I) the results of pilot projects, including pilot projects pursuant to this section and private sector pilot projects, including those involving the use of aggregation and inference;
(II) the public meetings held and related guidance documents issued under this
section;
(III) the public health benefits of any
additional regulations in comparison to
the cost of compliance with such requirements, including on entities of
varying sizes and capabilities;
(IV) the diversity of the pharmaceutical distribution supply chain by
providing appropriate flexibility for each
sector, including both large and small
businesses; and
(V) the assessment pursuant to paragraph (3) with respect to small business
dispensers, including related public comment and the public meeting, and requirements under this section;
(B) issue a notice of proposed rulemaking
that includes a copy of the proposed regulation;
(C) provide a period of not less than 60
days for comments on the proposed regulation; and
(D) publish in the Federal Register the
final regulation not less than 2 years prior
to the effective date of the regulation.
(h) Guidance documents
(1) In general
For the purposes of facilitating the successful and efficient adoption of secure, interoperable product tracing at the package level in
order to enhance drug distribution security
and further protect the public health, the Secretary shall issue the guidance documents as
provided for in this subsection.
(2) Suspect and illegitimate product
(A) In general
Not later than 180 days after November 27,
2013, the Secretary shall issue a guidance
document to aid trading partners in the
identification of a suspect product and notification termination. Such guidance document shall—
(i) identify specific scenarios that could
significantly increase the risk of a suspect
product entering the pharmaceutical distribution supply chain;
(ii) provide recommendation on how
trading partners may identify such product and make a determination on whether
the product is a suspect product as soon as
practicable; and
(iii) set forth the process by which manufacturers, repackagers, wholesale distributors, and dispensers shall terminate notifi-

Page 362

cations in consultation with the Secretary
regarding illegitimate product pursuant to
subsections (b)(4)(B), (c)(4)(B), (d)(4)(B),
and (e)(4)(B).
(B) Revised guidance
If the Secretary revises the guidance issued under subparagraph (A), the Secretary
shall follow the procedure set forth in paragraph (5).
(3) Unit level tracing
(A) In general
In order to enhance drug distribution security at the package level, not later than 18
months after conducting a public meeting on
the system attributes necessary to enable
secure tracing of product at the package
level, including allowing for the use of verification, inference, and aggregation, as necessary, the Secretary shall issue a final
guidance document that outlines and makes
recommendations with respect to the system
attributes necessary to enable secure tracing at the package level as required under
the requirements established under subsection (g). Such guidance document shall—
(i) define the circumstances under which
the sectors within the pharmaceutical distribution supply chain may, in the most
efficient manner practicable, infer the contents of a case, pallet, tote, or other aggregate of individual packages or containers
of product, from a product identifier associated with the case, pallet, tote, or other
aggregate, without opening each case, pallet, tote, or other aggregate or otherwise
individually scanning each package;
(ii) identify methods and processes to enhance secure tracing of product at the
package level, such as secure processes to
facilitate the use of inference, enhanced
verification activities, the use of aggregation and inference, processes that utilize
the product identifiers to enhance tracing
of product at the package level, including
the standardized numerical identifier, or
package security features; and
(iii) ensure the protection of confidential
commercial information and trade secrets.
(B) Procedure
In issuing the guidance under subparagraph (A), and in revising such guidance, if
applicable, the Secretary shall follow the
procedure set forth in paragraph (5).
(4) Standards for interoperable data exchange
(A) In general
In order to enhance secure tracing of a
product at the package level, the Secretary,
not later than 18 months after conducting a
public meeting on the interoperable standards necessary to enhance the security of
the pharmaceutical distribution supply
chain, shall update the guidance issued pursuant to subsection (a)(2), as necessary and
appropriate, and finalize such guidance document so that the guidance document—
(i) identifies and makes recommendations with respect to the standards necessary for adoption in order to support the

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TITLE 21—FOOD AND DRUGS

secure, interoperable electronic data exchange among the pharmaceutical distribution supply chain that comply with a
form and format developed by a widely
recognized international standards development organization;
(ii) takes into consideration standards
established pursuant to subsection (a)(2)
and section 355e of this title;
(iii) facilitates the creation of a uniform
process or methodology for product tracing; and
(iv) ensures the protection of confidential commercial information and trade secrets.
(B) Procedure
In issuing the guidance under subparagraph (A), and in revising such guidance, if
applicable, the Secretary shall follow the
procedure set forth in paragraph (5).
(5) Procedure
In issuing or revising any guidance issued
pursuant to this subsection or subsection (g),
except the initial guidance issued under paragraph (2)(A), the Secretary shall—
(A) publish a notice in the Federal Register for a period not less than 30 days announcing that the draft or revised draft
guidance is available;
(B) post the draft guidance document on
the Internet Web site of the Food and Drug
Administration and make such draft guidance document available in hard copy;
(C) provide an opportunity for comment
and review and take into consideration any
comments received;
(D) revise the draft guidance, as appropriate;
(E) publish a notice in the Federal Register for a period not less than 30 days announcing that the final guidance or final revised guidance is available;
(F) post the final guidance document on
the Internet Web site of the Food and Drug
Administration and make such final guidance document available in hard copy; and
(G) provide for an effective date of not earlier than 1 year after such guidance becomes
final.
(i) Public meetings
(1) In general
The Secretary shall hold not less than 5 public meetings to enhance the safety and security of the pharmaceutical distribution supply
chain and provide for comment. The Secretary
may hold the first such public meeting not
earlier than 1 year after November 27, 2013. In
carrying out the public meetings described in
this paragraph, the Secretary shall—
(A) prioritize topics necessary to inform
the issuance of the guidance described in
paragraphs (3) and (4) of subsection (h); and
(B) take all measures reasonable and practicable to ensure the protection of confidential commercial information and trade secrets.
(2) Content
Each of the following topics shall be addressed in at least one of the public meetings
described in paragraph (1):

§ 360eee–1

(A) An assessment of the steps taken under
subsections (b) through (e) to build capacity
for a unit-level system, including the impact
of the requirements of such subsections on—
(i) the ability of the health care system
collectively to maintain patient access to
medicines;
(ii) the scalability of such requirements,
including as it relates to product lines; and
(iii) the capability of different sectors
and subsectors, including both large and
small businesses, to affix and utilize the
product identifier.
(B) The system attributes necessary to
support the requirements set forth under
subsection (g), including the standards necessary for adoption in order to support the
secure, interoperable electronic data exchange among sectors within the pharmaceutical distribution supply chain.
(C) Best practices in each of the different
sectors within the pharmaceutical distribution supply chain to implement the requirements of this section.
(D) The costs and benefits of the implementation of this section, including the impact on each pharmaceutical distribution
supply chain sector and on public health.
(E) Whether electronic tracing requirements, including tracing of product at the
package level, are feasible, cost effective,
and needed to protect the public health.
(F) The systems and processes needed to
utilize the product identifiers to enhance
tracing of product at the package level, including allowing for verification, aggregation, and inference, as necessary.
(G) The technical capabilities and legal authorities, if any, needed to establish an
interoperable, electronic system that provides for tracing of product at the package
level.
(H) The impact that such additional requirements would have on patient safety,
the drug supply, cost and regulatory burden,
and timely patient access to prescription
drugs.
(I) Other topics, as determined appropriate
by the Secretary.
(j) Pilot projects
(1) In general
The Secretary shall establish 1 or more pilot
projects, in coordination with authorized manufacturers, repackagers, wholesale distributors, and dispensers, to explore and evaluate
methods to enhance the safety and security of
the pharmaceutical distribution supply chain.
Such projects shall build upon efforts, in existence as of November 27, 2013, to enhance the
safety and security of the pharmaceutical distribution supply chain, take into consideration any pilot projects conducted prior to November 27, 2013, including any pilot projects
that use aggregation and inference, and inform the draft and final guidance under paragraphs (3) and (4) of subsection (h).
(2) Content
(A) In general
The Secretary shall ensure that the pilot
projects under paragraph (1) reflect the di-

§ 360eee–2

TITLE 21—FOOD AND DRUGS

versity of the pharmaceutical distribution
supply chain and that the pilot projects,
when taken as a whole, include participants
representative of every sector, including
both large and small businesses.
(B) Project design
The pilot projects under paragraph (1)
shall be designed to—
(i) utilize the product identifier for tracing of a product, which may include verification of the product identifier of a
product, including the use of aggregation
and inference;
(ii) improve the technical capabilities of
each sector and subsector to comply with
systems and processes needed to utilize
the product identifiers to enhance tracing
of a product;
(iii) identify system attributes that are
necessary to implement the requirements
established under this section; and
(iv) complete other activities as determined by the Secretary.
(k) Sunset
The following requirements shall have no
force or effect beginning on the date that is 10
years after November 27, 2013:
(1) The provision and receipt of transaction
history under this section.
(2) The requirements set forth for returns
under
subsections
(b)(4)(E),
(c)(1)(B)(i),
(d)(1)(C)(i), and (e)(4)(E).
(3) The requirements set forth under subparagraphs (A)(v)(II) and (D) of subsection
(c)(1), as applied to lot level information only.
(l) Rule of construction
The requirements set forth in subsections
(g)(4), (i), and (j) shall not be construed as a condition, prohibition, or precedent for precluding
or delaying the provisions becoming effective
pursuant to subsection (g).
(m) Requests for information
On the date that is 10 years after November 27,
2013, the timeline for responses to requests for
information from the Secretary, or other appropriate Federal or State official, as applicable,
under subsections (b)(1)(B), (c)(1)(C), and
(e)(1)(C) shall be not later than 24 hours after receiving the request from the Secretary or other
appropriate Federal or State official, as applicable, or in such other reasonable time as determined by the Secretary based on the circumstances of the request.
(June 25, 1938, ch. 675, § 582, as added and amended Pub. L. 113–54, title II, §§ 202, 203, Nov. 27, 2013,
127 Stat. 605, 623.)
AMENDMENTS
2013—Subsecs. (g) to (m). Pub. L. 113–54, § 203, added
subsecs. (g) to (m).

§ 360eee–2. National standards for prescription
drug wholesale distributors
(a) In general
The Secretary shall, not later than 2 years
after November 27, 2013, establish by regulation
standards for the licensing of persons under sec-

Page 364

tion 353(e)(1) of this title, including the revocation, reissuance, and renewal of such license.
(b) Content
For the purpose of ensuring uniformity with
respect to standards set forth in this section,
the standards established under subsection (a)
shall apply to all State and Federal licenses described under section 353(e)(1) of this title and
shall include standards for the following:
(1) The storage and handling of prescription
drugs, including facility requirements.
(2) The establishment and maintenance of
records of the distributions of such drugs.
(3) The furnishing of a bond or other equivalent means of security, as follows:
(A)(i) For the issuance or renewal of a
wholesale distributor license, an applicant
that is not a government owned and operated wholesale distributor shall submit a
surety bond of $100,000 or other equivalent
means of security acceptable to the State.
(ii) For purposes of clause (i), the State or
other applicable authority may accept a surety bond in the amount of $25,000 if the annual gross receipts of the previous tax year
for the wholesaler is $10,000,000 or less.
(B) If a wholesale distributor can provide
evidence that it possesses the required bond
in a State, the requirement for a bond in another State shall be waived.
(4) Mandatory background checks and
fingerprinting of facility managers or designated representatives.
(5) The establishment and implementation of
qualifications for key personnel.
(6) The mandatory physical inspection of
any facility to be used in wholesale distribution within a reasonable time frame from the
initial application of the facility and to be
conducted by the licensing authority or by the
State, consistent with subsection (c).
(7) In accordance with subsection (d), the
prohibition of certain persons from receiving
or maintaining licensure for wholesale distribution.
(c) Inspections
To satisfy the inspection requirement under
subsection (b)(6), the Federal or State licensing
authority may conduct the inspection or may
accept an inspection by the State in which the
facility is located, or by a third-party accreditation or inspection service approved by the Secretary or the State licensing such wholesale distributor.
(d) Prohibited persons
The standards established under subsection (a)
shall include requirements to prohibit a person
from receiving or maintaining licensure for
wholesale distribution if the person—
(1) has been convicted of any felony for conduct relating to wholesale distribution, any
felony violation of subsection (i) or (k) of section 331 of this title, or any felony violation of
section 1365 of title 18 relating to product tampering; or
(2) has engaged in a pattern of violating the
requirements of this section, or State requirements for licensure, that presents a threat of
serious adverse health consequences or death
to humans.