U.S Code last checked for updates: May 02, 2024
All TitlesTitle 21Chapter 9Subchapter VPart H
§ 360eee–1.
Requirements
(a)
In general
(1)
Other activities
(2)
Initial standards
(A)
In general
(B)
Public input
(C)
Publication
(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
(C)
Process
(4)
Self-executing requirements
(5)
Grandfathering product
(A)
Product identifier
(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 (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
(7)
Third-party logistics provider licenses
(8)
Label changes
(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 transaction statement, in a single document in an 2
2
 So in original. Probably should be “a”.
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
(C)
Electronic format
(i)
In general
(ii)
Exception
(2)
Product identifier
(A)
In general
(B)
Exception
(3)
Authorized trading partners
(4)
Verification
Beginning not later than January 1, 2015, a manufacturer shall have systems in place to 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
(iii)
Records
(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.
(ii)
Making a notification
(I)
Illegitimate product
(II)
High risk of illegitimacy
(iii)
Responding to a notification
(iv)
Terminating a notification
(v)
Records
(C)
Requests for verification
(D)
Electronic database
(E)
Saleable returned product
(F)
Nonsaleable returned product
(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.
(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 section, 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
(II)
Enhanced requirements
(ii)
Nonsaleable returns
(C)
Requests for information
(D)
Trading partner agreements
(2)
Product identifier
(3)
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 (except as provided pursuant to subsection (a)(5)), verifying the product at the package level, including the standardized numerical identifier.
(ii)
Cleared product
(iii)
Records
(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
(iii)
Responding to a notification
(iv)
Terminating a notification
(v)
Records
(C)
Electronic database
(D)
Verification of saleable returned product
(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 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
(C)
Returns
(i)
Saleable returns
(ii)
Nonsaleable returns
(D)
Requests for information
(2)
Product identifier
(3)
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
(iv)
Records
(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
(iii)
Responding to a notification
(iv)
Terminating a notification
(v)
Records
(C)
Electronic database
(5)
Exception
(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
(ii)
Saleable or nonsaleable product
(C)
Requests for information
(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
(3)
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 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
(iii)
Records
(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
(iii)
Responding to a notification
(iv)
Terminating a notification
(v)
Records
(C)
Requests for verification
(D)
Electronic database
(E)
Verification of saleable returned product
(f)
Drop shipments
(1)
In general
(2)
Clarification
(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 information 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
(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
(B)
Condition
(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
(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
(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 notifications 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
(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
(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 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
(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):
(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
(2)
Content
(A)
In general
(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
(m)
Requests for information
(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.)
cite as: 21 USC 360eee-1
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