Waivers, Exemptions, Exceptions

Page 353

TITLE 21—FOOD AND DRUGS

(C) Publication
The Secretary shall publish the standards
established under subparagraph (A) not later
than 1 year after November 27, 2013.
(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—

§ 360eee–1

(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
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 trans1 So

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