113 HR 1919 RH: Safeguarding America’s Pharmaceuticals Act of 2013
U.S. House of Representatives
2013-06-03
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
1.
(a)This Act may be cited
as the Safeguarding America’s
Pharmaceuticals Act of 2013
.
(b)The table of
contents of this Act is as follows:
Sec. 1. Short title.
Sec. 2. Pharmaceutical distribution supply
chain.
Sec. 3. Enhanced drug distribution
security.
Sec. 4. National standards for wholesale
distributors.
Sec. 5. National licensure standards for
third-party logistics providers.
Sec. 6. Penalties.
Sec. 7. Uniform national policy.
Sec. 8 Electronic labeling.
2.Pharmaceutical
distribution supply chainChapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at the end the
following:
HPharmaceutical
Distribution Supply Chain
581.In this subchapter:
(1)The
term authorized means—
(A)in the case of a
manufacturer or repackager, having a valid registration in accordance with
section 510; and
(B)in the case of a
wholesale distributor, third-party logistics provider, or dispenser, licensed
(as defined in this section).
(2)The
term dispenser—
(A)subject to subparagraph (C), means a retail
pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership
and control, or any other person authorized by law to dispense or administer
prescription drugs, to the extent such pharmacy, group, or person does not act
as a wholesale distributor;
(B)includes warehouses and
distribution centers under common ownership or control of entities described in
subparagraph (A) that are members of an affiliated group pursuant to section
1504(a) of the Internal Revenue Code of 1986, to the extent such warehouses and
distribution centers do not act as a wholesale distributor; and
(C)does not include a person
who only dispenses prescription drug product to be used in animals in
accordance with section 512(a)(5).
(3)The
term disposition, with respect to a prescription drug product
within the possession and control of an entity—
(A)means the removal of such
prescription drug product, or taking measures to prevent the introduction of
such prescription drug product, from the pharmaceutical distribution supply
chain; and
(B)may include disposal,
return of the prescription drug product for disposal, or other appropriate
handling and other actions such as retaining a sample of the prescription drug
product for additional physical examination or laboratory analysis by a
manufacturer or regulatory or law enforcement agency.
(4)Distribute or
distributionThe terms distribute and
distribution mean the sale, purchase, trade, delivery, handling,
or storage of a prescription drug product.
(5)Illegitimate
prescription drug productThe term illegitimate
prescription drug product means a prescription drug product which a
manufacturer has confirmed—
(A)is counterfeit, diverted,
or stolen;
(B)is intentionally
adulterated such that the prescription drug product would result in serious
adverse health consequences or death to humans; or
(C)is otherwise unfit for
distribution such that the prescription drug product is reasonably likely to
cause serious adverse human health consequences or death.
(6)The
term licensed means—
(A)in the case of a wholesale distributor,
having a valid license to make wholesale distributions consistent with the
standards under section 583;
(B)in the case of a third-party logistics
provider, having a valid license to engage in the activities of a third-party
logistics provider in accordance with section 584; and
(C)in the case of a
dispenser, having a valid license to dispense prescription drugs under State
law.
(7)The
term manufacturer means, with respect to a prescription drug
product—
(A)a person that holds an
application approved under section 505 or a license issued under section 351 of
the Public Health Service Act for such prescription drug product, or if such
prescription drug product is not the subject of an approved application or
license, the person who manufactured the prescription drug product;
(B)a co-licensed partner of
the person described in subparagraph (A) that obtains the prescription drug
product directly from the person described in such subparagraph; or
(C)a person that—
(i)is a member of an
affiliated group (as defined in section 1504(a) of the Internal Revenue Code of
1986) to which a person described in subparagraph (A) or (B) is also a member;
and
(ii)receives the
prescription drug product directly from a person described in subparagraph (A)
or (B).
(8)
(A)The term
package means the smallest individual saleable unit of
prescription drug product for distribution in interstate commerce by a
manufacturer or repackager that is intended by the manufacturer for ultimate
sale to the dispenser of such prescription drug product.
(B)The term
individual saleable unit means the smallest container of
prescription drug product introduced into interstate commerce by the
manufacturer or repackager that is intended by the manufacturer for individual
sale to a dispenser.
(9)The term prescription drug means a drug for
human use subject to section 503(b)(1).
(10)Prescription drug
productThe term
prescription drug product means a prescription drug in a finished
dosage form for administration to a patient without substantial further
manufacturing (such as capsules, tablets, and lyophilized prescription drug
products before reconstitution).
(11)Prescription drug
product identifierThe term prescription drug product
identifier means a standardized graphic that—
(A)includes the standardized
numerical identifier, lot number, and expiration date of a prescription drug
product; and
(B)is in both human-readable
form and on a machine-readable data carrier that conforms to the standards
developed by a widely recognized international standards development
organization.
(12)The term quarantine means to
store or identify a product, for the purpose of preventing distribution or
transfer of the product, in a physically separate area clearly identified for
such use, or through use of other procedures such as automated
designation.
(13)The
term repackager means a person who owns or operates an
establishment that repacks and relabels a prescription drug product or package
for further sale or distribution.
(14)The term return means
providing prescription drug product to the authorized trading partner or
trading partners from which such prescription drug product was purchased or
received, or to a returns processor for handling of such prescription drug
product.
(15)The terms returns processor mean a person
who owns or operates an establishment that provides for the disposition of or
otherwise processes saleable and nonsaleable prescription drug product received
from an authorized trading partner such that the prescription drug product may
be processed for credit to the purchaser, manufacturer, seller, or disposed of
for no further distribution.
(16)The term specific patient need—
(A)means with respect to the
transfer of a prescription drug product from one pharmacy to another, to fill a
prescription for an identified patient; and
(B)does not include the
transfer of a prescription drug product from one pharmacy to another for the
purpose of increasing or replenishing stock in anticipation of a potential
need.
(17)Standardized numerical
identifierThe term
standardized numerical identifier means a set of numbers or
characters that—
(A)is used to uniquely
identify each package or homogenous case of the prescription drug product;
and
(B)is composed of the
National Drug Code that corresponds to the specific prescription drug product
(including the particular package configuration) combined with a unique
alphanumeric serial number of up to 20 characters.
(18)Suspect prescription
drug productThe term suspect prescription drug
product means a prescription drug product for which there is reason to
believe that such prescription drug product—
(A)is potentially
counterfeit, diverted, or stolen;
(B)is potentially
intentionally adulterated such that the prescription drug product would result
in serious adverse health consequences or death to humans; or
(C)appears otherwise unfit
for distribution such that the prescription drug product would result in
serious adverse health consequences or death to humans.
(19)Third-party logistics
providerThe term third-party logistics provider
means an entity that provides or coordinates warehousing, distribution, or
other logistics services of a prescription drug product in interstate commerce
on behalf of a manufacturer, wholesale distributor, or dispenser of a
prescription drug product, but does not take ownership of the prescription drug
product, nor have responsibility to direct the sale or disposition of, the
prescription drug product.
(20)The term trading partner means—
(A)a manufacturer,
repackager, wholesale distributor, or dispenser from whom a manufacturer,
repackager, wholesale distributor, or dispenser accepts ownership of a
prescription drug product or to whom a manufacturer, repackager, wholesale
distributor, or dispenser transfers ownership of a prescription drug product;
or
(B)a third-party logistics
provider from whom a manufacturer, repackager, wholesale distributor, or
dispenser accepts possession of a prescription drug product or to whom a
manufacturer, repackager, wholesale distributor, or dispenser transfers
possession of a prescription drug product.
(21)
(A)The term transaction means the transfer in
interstate commerce of prescription drug product between persons in which a
change of ownership occurs.
(B)The
term transaction does not include—
(i)intracompany distribution of any
prescription drug product, including between members of an affiliated group (as
defined in section 1504(a) of the Internal Revenue Code of 1986);
(ii)the distribution of a
prescription drug product among hospitals or other health care entities that
are under common control;
(iii)the distribution of a
prescription drug product for emergency medical reasons including a public
health emergency declaration pursuant to section 319 of the Public Health
Service Act, except that a drug shortage not caused by a public health
emergency shall not constitute an emergency medical reason;
(iv)the dispensing of a
prescription drug product pursuant to a valid prescription executed in
accordance with section 503(b)(1);
(v)the distribution of
prescription drug product samples by a manufacturer or a licensed wholesale
distributor in accordance with section 503(d);
(vi)the distribution of
blood or blood components intended for transfusion;
(vii)the distribution of
minimal quantities of prescription drug product by a licensed retail pharmacy
to a licensed practitioner for office use;
(viii)the distribution of a
prescription drug product by a charitable organization to a nonprofit affiliate
of the organization to the extent otherwise permitted by law;
(ix)the distribution of a
prescription drug product pursuant to the sale or merger of a pharmacy or
pharmacies or a wholesale distributor or wholesale distributors, except that
any records required to be maintained for the prescription drug product shall
be transferred to the new owner of the pharmacy or pharmacies or wholesale
distributor or wholesale distributors;
(x)the dispensing of a
prescription drug product approved under section 512(b);
(xi)the transfer of
prescription drug products to or from any facility that is licensed by the
Nuclear Regulatory Commission or by a State pursuant to an agreement with such
Commission under section 274 of the Atomic Energy Act of 1954 (42 U.S.C.
2021);
(xii)the distribution of a
combination product that consists of—
(I)a product comprised of
two or more components that are each a drug, biological product, or device and
that are physically, chemically, or otherwise combined or mixed and produced as
a single entity;
(II)two or more separate
products packaged together in a single package or as a unit and comprised of a
drug and device or a device and biological product; or
(III)two or more finished
devices plus one or more drug or biological products which are packaged
together in a medical convenience kit described in clause (xiv);
(xiii)the distribution of a
medical convenience kit which is a collection of finished products (consisting
of devices or drugs) assembled in kit form strictly for the convenience of the
purchaser or user if—
(I)the medical convenience
kit is assembled in an establishment that is registered with the Food and Drug
Administration as a medical device manufacturer;
(II)the person who
manufacturers the medical convenience kit purchased the prescription drug
product directly from the manufacturer or from a wholesale distributor that
purchased the prescription drug product directly from the manufacturer;
(III)the person who
manufacturers the medical convenience kit does not alter the primary container
or label of the prescription drug product as purchased from the manufacturer or
wholesale distributor;
(IV)the medical convenience
kit does not contain a controlled substance (as defined in section 102 of the
Controlled Substances Act); and
(V)the prescription drug
products contained in the medical convenience kit are—
- (aa)intravenous solutions
intended for the replenishment of fluids and electrolytes;
- (bb)drugs intended to
maintain the equilibrium of water and minerals in the body;
- (cc)drugs intended for
irrigation or reconstitution;
- (dd)anesthetics;
- (ee)anticoagulants;
- (ff)vasopressors; or
- (gg)sympathicomimetics;
(xiv)the distribution of an
intravenous prescription drug product that, by its formulation, is intended for
the replenishment of fluids and electrolytes (such as sodium, chloride, and
potassium) or calories (such as dextrose and amino acids);
(xv)the distribution of an
intravenous prescription drug product used to maintain the equilibrium of water
and minerals in the body, such as dialysis solutions;
(xvi)the distribution of a
prescription drug product that is intended for irrigation or reconstitution, or
sterile water, whether intended for such purposes or for injection;
(xvii)the distribution of
compressed medical gas; or
(xviii)(I)the distribution of a product by a
dispenser, or a wholesale distributor acting at the direction of the dispenser,
to a repackager registered under section 510 for the purpose of repackaging the
drug for use by that dispenser or another health care entity that is under the
dispenser’s ownership or control, so long as the dispenser retains ownership of
the prescription drug product; and
(II)the saleable or
nonsaleable return by such repackager of such prescription drug product.
(C)For purposes of subparagraph (B)(xviii), the term
compressed medical gas means any substance in its gaseous or
cryogenic liquid form that meets medical purity standards and has application
in a medical or homecare environment, including oxygen and nitrous
oxide.
(22)The term transaction history means a
statement that—
(A)includes the transaction
information for each transaction conducted with respect to a prescription drug
product beginning with the manufacturer or initial purchase distributor for
each prior transaction going back to the manufacturer of the prescription drug
product or to the initial purchase distributor; and
(B)is in paper or electronic form.
(23)The term transaction information
means—
(A)the proprietary or
established name or names of the prescription drug product;
(B)the strength and dosage
form of the prescription drug product;
(C)the National Drug Code
number of the prescription drug product;
(D)the container
size;
(E)the number of
containers;
(F)the lot number of the
prescription drug product;
(G)the date of the
transaction;
(H)the business name and
address of the person from whom ownership is being transferred; and
(I)the business name and
address of the person to whom ownership is being transferred.
(24)The transaction statement
is a
statement, which states that the manufacturer, repackager, wholesale
distributor, third-party logistics provider, or dispenser transferring
ownership in a transaction—
(A)is authorized;
(B)received transaction information and a
transaction statement as required under section 582 from the prior owner of the
prescription drug product;
(C)did not knowingly and
intentionally ship an illegitimate prescription drug product;
(D)did not knowingly and
intentionally provide false transaction information; and
(E)did not knowingly and
intentionally alter the transaction history.
(25)The terms verification and
verify—
(A)mean determining whether
the prescription drug product identifier affixed to, or imprinted upon, a
package or homogeneous case of the prescription drug product corresponds to the
standardized numerical identifier or lot number, and expiration date assigned
to the prescription drug product by the manufacturer or the repackager, as
applicable; and
(B)include making the
determination under subparagraph (A) using human-readable or machine-readable
methods.
(26)The term
wholesale distributor—
(A)means a person engaged in
wholesale distribution (as defined in section 583); and
(B)excludes—
(i)a manufacturer, a
co-licensed partner of a manufacturer, or a third-party logistics provider, or
a dispenser who does not engage in such wholesale distribution;
(ii)a repackager engaged in
such wholesale distribution; or
(iii)the distribution of prescription drug
product or an offer to distribute prescription drug product by an authorized
repackager that has taken ownership or possession of the prescription drug
product and repacked the prescription drug product in accordance with the
requirements of section 582(e).
582.
(a)
(1)An entity that is a manufacturer, repackager, wholesale
distributor, third-party logistics provider, or dispenser shall comply with the
requirements of this section. If an entity meets the definition of more than
one of the entities referred to in the preceding sentence, such entity shall
comply with all applicable requirements of this section, but shall not be
required to comply with duplicative requirements.
(2)The Secretary shall, in consultation with
other appropriate Federal officials, manufacturers, repackagers, wholesale
distributors, third-party logistics providers, and dispensers, establish, by
regulation, standards for the exchange of transaction information for purposes
of complying with this section. The standards established under this paragraph
shall be in accordance with a form developed by a widely recognized
international standards development organization. In establishing such
standards, the Secretary shall consider the feasibility of establishing
standardized documentation to be used by all members of the pharmaceutical
distribution supply chain to convey the transaction history and transaction
statement to the subsequent owner of a prescription drug product. The Secretary
shall publish such standards not later than 180 days after the date of the
enactment of the Safeguarding America’s
Pharmaceuticals Act of 2013.
(3)Waivers, exceptions,
and exemptionsNot later than one year after the date of the
enactment of the Safeguarding America’s
Pharmaceuticals Act of 2013, the Secretary shall promulgate a
regulation to—
(A)establish a process by which the Secretary
may grant, at the request of an authorized manufacturer, repackager, wholesale
distributor, or dispenser, a waiver from any of the requirements of this
section—
(i)if the Secretary
determines that such requirements would result in an undue economic hardship;
or
(ii)for emergency medical
reasons, including a public health emergency declaration pursuant to section
319 of the Public Health Service Act;
(B)establish a process, with respect to the
prescription drug product identifier requirement under paragraph (2) of
subsections (b), (c), (d), and (e) through which—
(i)a manufacturer or
repackager may request a waiver with respect to prescription drug products that
are packaged in a container too small or otherwise unable to accommodate a
label with sufficient space to bear the information required for compliance
with such requirement; and
(ii)the Secretary determines
whether to waive such requirement; and
(C)establish a process by which the Secretary
may add the prescription drug products or transactions that are exempt from the
requirements of this section.
(4)Grandfathered persons
and prescription drug products
(A)Not later than one
year after the date of the enactment of the Safeguarding America’s Pharmaceuticals Act of
2013, the Secretary shall specify, by regulation, whether and
under what circumstances the prescription drug product identifier requirement
under paragraph (2) of subsections (b), (c), (d), and (e) shall apply to a
prescription drug product that is in the supply chain or in a manufacturer’s
inventory on the date of the enactment of the Safeguarding America’s Pharmaceuticals Act of
2013.
(B)Third-party logistics
provider licensesUntil the
date that is 1 year after the effective date of the third-party logistics
provider licensing requirements under section 584, a third-party logistics
provider shall be considered licensed
under section 581(6)(B)
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.
(C)Changes made to package labels solely to incorporate the
prescription drug product identifier may be submitted to the Secretary in the
annual report of an establishment, in accordance with section 314.70(d) of
chapter 21, Code of Federal Regulations (or any successor regulation).
(b)Manufacturer
requirements
(1)Prescription drug
product tracing
(A)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
prescription drug product, provide the subsequent owner with the transaction
history and a transaction statement; and
(ii)maintain the transaction
information for each such transaction for not less than 3 years after the date
of the transaction.
(B)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 prescription drug product or an illegitimate
prescription drug product, a manufacturer shall, not later than 2 business days
after receiving the request or in such reasonable time as determined by the
Secretary, provide to the Secretary or other official, the applicable
transaction history and transaction statement for the prescription drug
product.
(2)Prescription drug
product identifierBeginning
not later than 5 years after the date of the enactment of the
Safeguarding America’s Pharmaceuticals Act of
2013, a manufacturer shall affix or imprint a prescription drug
product identifier on each package and homogenous case of a prescription drug
product intended to be introduced in a transaction. Such manufacturer shall
maintain the information in the prescription drug product identifier for such
prescription drug product for not less than 3 years after the date of the
transaction.
(3)Authorized trading
partnersBeginning not later than January 1, 2015, a manufacturer
shall ensure that each of its trading partners is authorized.
(4)List of authorized
distributors of recordBeginning not later than January 1, 2015,
each manufacturer of a prescription drug shall—
(A)maintain a list of the
authorized distributors of record of such drug at the corporate offices of such
manufacturer;
(B)make such list publicly
available, including placement on the Internet Website of such manufacturer;
and
(C)update such list not less
than once per quarter.
(5)Beginning not later than January 1, 2015, a
manufacturer shall implement systems and processes to enable the manufacturer
to comply with the following requirements:
(A)Suspect prescription
drug product
(i)Upon making a determination that a prescription drug
product in the possession or control of the manufacturer is a suspect
prescription drug product, or upon receiving a request for verification from
the Secretary that a prescription drug product within the possession or control
of a manufacturer is a suspect prescription drug product, a manufacturer shall
promptly conduct an investigation in coordination with trading partners, as
applicable, to determine whether the prescription drug product is an
illegitimate prescription drug product. Beginning not later than 5 years after
the date of the enactment of the Safeguarding
America’s Pharmaceuticals Act of 2013, such investigation shall
include—
(I)verifying the
prescription drug product at the package level;
(II)validating any
applicable transaction history in the possession of the manufacturer;
and
(III)otherwise investigating
to determine whether the prescription drug product is an illegitimate
prescription drug product.
(ii)Cleared prescription
drug productIf the manufacturer determines that a suspect
prescription drug product is not an illegitimate prescription drug product, the
manufacturer shall promptly notify the Secretary of such determination and such
prescription drug product may be further distributed.
(iii)A
manufacturer shall keep records of its investigation of a suspect prescription
drug product for not less than 3 years after the conclusion of the
investigation.
(B)Illegitimate
prescription drug product
(i)Upon determining that a prescription drug product in the
possession or control of a manufacturer is an illegitimate prescription drug
product, the manufacturer shall—
(I)quarantine such
prescription drug product from prescription drug product intended for
distribution; and
(II)provide for the
disposition of the illegitimate prescription drug product.
(ii)Upon determining that
a prescription drug product in the possession or control of a trading partner
is an illegitimate prescription drug product, the manufacturer shall take
reasonable steps to assist a trading partner to provide for the disposition of
the illegitimate prescription drug product.
(iii)Upon determining that a prescription drug product in
the possession or control of the manufacturer is an illegitimate prescription
drug product, the manufacturer shall notify the Secretary of such determination
not later than 24 hours after making such determination. The Secretary shall
determine whether additional trading partner notification is
appropriate.
(iv)Responding to a
notificationUpon the receipt of a notification from the
Secretary that a determination has been made that a prescription drug product
is an illegitimate prescription drug product, a manufacturer shall—
(I)identify all illegitimate
prescription drug products that are subject to such notification and in the
possession or control of the manufacturer, including any prescription drug
product that is subsequently received; and
(II)perform the activities
described in clause (i).
(v)A
manufacturer shall keep records of the disposition of an illegitimate
prescription drug product for not less than 3 years after the conclusion of the
disposition.
(C)A manufacturer may satisfy the requirements of this
paragraph through the use of a secure electronic database developed and
operated by the manufacturer or 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 verification request submitted by means other than a secure
electronic database.
(D)Returned prescription
drug productBeginning not later than 5 years after the date of
the enactment of the Safeguarding America’s
Pharmaceuticals Act of 2013, upon receipt of a returned
prescription drug product that the manufacturer intends to further distribute,
before further distributing such prescription drug product, the manufacturer
shall—
(i)verify the prescription
drug product identifier for each sealed homogeneous case of such prescription
drug product; or
(ii)if such prescription
drug product is not in a sealed homogeneous case, verify the prescription drug
product identifier on each package.
(c)Wholesale distributor
requirements
(1)Prescription drug
product tracing
(A)Beginning not later than April 1, 2015, a wholesale
distributor shall—
(i)not accept ownership of a
prescription drug product unless the previous owner prior to, or at the time
of, the transaction provides the applicable transaction history and a
transaction statement for the prescription drug product;
(ii)prior to, or at the time of, each
transaction in which the wholesale distributor transfers ownership of a
prescription drug product—
(I)in the case that the
wholesale distributor purchased the prescription drug product directly from the
manufacturer, provide the subsequent owner with transaction history and a
transaction statement for the prescription drug product; or
(II)in the case that the wholesale distributor
did not purchase the prescription drug product directly from the manufacturer,
the exclusive distributor of the manufacturer, or a repackager that purchased
directly from the manufacturer, provide the subsequent owner with transaction
history beginning with the wholesale distributor that did purchase the product
directly from the manufacturer, the exclusive distributor of the manufacturer,
or a repackager that purchased directly from the manufacturer;
(iii)notwithstanding clause (ii), if the
wholesale distributor purchased the prescription drug product directly from the
manufacturer, its exclusive distributor, or a repackager that purchased
directly from the manufacturer or its authorized distributor of record—
(I)provide an initial purchase transaction
statement on the invoice to the customer, stating that the wholesale
distributor purchased the prescription drug product package directly from the
manufacturer, exclusive distributor, or repackager;
(II)make available to the
immediate subsequent recipient of such prescription drug product the
information required under clause (ii) through any combination of
self-generated paper, electronic data, or manufacturer-provided information on
the prescription drug product package; and
(III)for purposes of subclauses (I) and (II),
need not include any transactions occurring before the transfer of the
prescription drug product to the wholesale distributor; and
(iv)maintain the transaction information for
each transaction described in clauses (i) and (ii) for not less than 3 years
after the transaction.
(B)
(i)Notwithstanding
subparagraph (A), a wholesale distributor may—
(I)accept returned prescription drug product
without a transaction history from a dispenser or repackager; and
(II)distribute such returned prescription drug
product with a transaction history that begins with the wholesale distributor
that so accepted the returned product.
(ii)A wholesale distributor may return a nonsaleable
prescription drug to the manufacturer or repackager, to the wholesale
distributor from whom such prescription drug 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).
(C)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 prescription drug product or an illegitimate
prescription drug product a wholesale distributor shall, not later than 2
business days after receiving the request or in such other reasonable time as
determined by the Secretary, provide the applicable transaction history and
transaction statements for the prescription drug product.
(2)Prescription drug
product identifierBeginning not later than 7 years after the
date of the enactment of the Safeguarding
America’s Pharmaceuticals Act of 2013, a wholesale distributor
may engage in transactions involving a prescription drug product only if such
prescription drug product is encoded with a prescription drug product
identifier, except as provided in subsection (a)(4).
(3)Authorized trading
partnersBeginning not later than January 1, 2015, a wholesale
distributor shall ensure that each of its trading partners is
authorized.
(4)Beginning
not later than April 1, 2015, a wholesale distributor shall implement systems
to enable the wholesale distributor to comply with the following
requirements:
(A)Suspect prescription
drug product
(i)Upon making a determination that a prescription drug
product in the possession or control of the wholesale distributor is a suspect
prescription drug product, or upon receiving a request for verification from
the Secretary that a prescription drug product within the possession or control
of a wholesale distributor is a suspect prescription drug product, a wholesale
distributor shall promptly conduct an investigation to determine whether the
prescription drug product is an illegitimate prescription drug product.
Beginning not later than 7 years after the date of the enactment of the
Safeguarding America’s Pharmaceuticals Act of
2013, such investigation shall include—
(I)verifying a package of
the prescription drug product;
(II)validating any
applicable transaction history in the possession of the wholesale distributor;
and
(III)otherwise investigating
to determine whether the prescription drug product is an illegitimate
prescription drug product.
(ii)Cleared prescription
drug productIf the wholesale distributor determines that a
suspect prescription drug product is not an illegitimate prescription drug
product, the wholesale distributor shall promptly notify the Secretary of such
determination and such prescription drug product may be further
distributed.
(iii)A
wholesale distributor shall keep records of its investigation of a suspect
prescription drug product for not less than 3 years after the conclusion of the
investigation.
(B)Illegitimate
prescription drug product
(i)Upon receiving notice that a manufacturer of a
prescription drug product has determined that a prescription drug product in
the possession or control of a wholesale distributor is an illegitimate
prescription drug product, the wholesale distributor shall—
(I)quarantine such prescription drug product
within the possession or control of the wholesale distributor from prescription
drug product intended for distribution; and
(II)provide for the disposition of the
illegitimate prescription drug product within the possession or control of the
wholesale distributor.
(ii)Upon determining that
a prescription drug product in the possession or control of a trading partner
is an illegitimate prescription drug product, the wholesale distributor shall
take reasonable steps to assist a trading partner to provide for the
disposition of the illegitimate prescription drug product.
(iii)Upon determining that a prescription drug product in
the possession or control of the wholesale distributor is an illegitimate
prescription drug product, the wholesale distributor shall notify the Secretary
of such determination not later than 24 hours after making such determination.
The Secretary shall determine whether additional trading partner notification
is appropriate.
(iv)Responding to a
notificationUpon the receipt of a notification from the
Secretary that a determination has been made that a prescription drug product
is an illegitimate prescription drug product, a wholesale distributor
shall—
(I)identify all illegitimate
prescription drug product subject to such notification that is in the
possession or control of the wholesale distributor, including any prescription
drug product that is subsequently received; and
(II)perform the activities
described in clause (i).
(v)A
wholesale distributor shall keep records of the disposition of an illegitimate
prescription drug product for not less than 3 years after the conclusion of the
disposition.
(C)A wholesale distributor may satisfy the requirements of
this paragraph through the use of a secure electronic database developed and
operated by the manufacturer or 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)Returned prescription
drug productBeginning not later than 7 years after the date of
the enactment of the Safeguarding America’s
Pharmaceuticals Act of 2013, upon receipt of a returned
prescription drug product that the wholesale distributor intends to further
distribute, before further distributing such prescription drug product, the
wholesale distributor shall—
(i)verify the prescription
drug product identifier for each sealed homogeneous case of such prescription
drug product; or
(ii)if such prescription
drug product is not in a sealed homogeneous case, verify the prescription drug
product identifier on each package.
(d)
(1)Prescription drug
product tracing
(A)Beginning not later than July 1, 2015, a
dispenser—
(i)shall not accept
ownership of a prescription drug product, unless the previous owner prior to,
or at the time of, the transaction, provides transaction history and a
transaction statement;
(ii)prior to, or at the time
of, each transaction in which the dispenser transfers ownership of a
prescription drug product (but not including dispensing to a patient or
returns) shall provide the subsequent owner with transaction history and a
transaction statement for the prescription drug 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 maintain
transaction information for a period of not less than 3 years after the date of
the transaction.
(B)Agreements with third
partiesA 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 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.
(C)
(i)Notwithstanding
subparagraph (A)(ii), a dispenser may return prescription drug product to the
trading partner from which the dispenser obtained the prescription drug product
without providing the information required under such subparagraph.
(ii)Notwithstanding subparagraph (A)(ii), a dispenser may
return a nonsaleable prescription drug to the manufacturer or repackager, to
the wholesale distributor from whom such prescription drug was purchased, to a
returns processor, or to a person acting on behalf of such persons without
providing the information required under such subparagraph.
(D)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 prescription drug product or an illegitimate
prescription drug 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, provide lot level transaction information.
(2)Prescription drug
product identifierBeginning not later than 8 years after the
date of the enactment of the Safeguarding
America’s Pharmaceuticals Act of 2013, a dispenser may engage in
transactions involving a prescription drug product only if such prescription
drug product is encoded with a prescription drug product identifier, except as
provided in subsection (a)(4).
(3)Authorized trading
partnersBeginning not later
than January 1, 2015, a dispenser shall ensure that each of its trading
partners is authorized.
(4)Beginning
not later than January 1, 2015, a dispenser shall implement systems to enable
the dispenser to comply with the following requirements:
(A)Suspect prescription
drug product
(i)Upon making a determination that a prescription drug
product in the possession or control of the dispenser is a suspect prescription
drug product, or upon receiving a request for verification from the Secretary
that a prescription drug product within the possession or control of a
dispenser is a suspect prescription drug product, a dispenser shall promptly
conduct an investigation to determine whether the prescription drug product is
an illegitimate prescription drug product. Such investigation shall
include—
(I)verifying whether the lot
number of a suspect prescription drug product corresponds with the lot number
for such prescription drug product;
(II)beginning 8 years after the date of the
enactment of the Safeguarding America’s
Pharmaceuticals Act of 2013, verifying that the product
identifier of at least 3 packages or 10 percent of such suspect prescription
drug product, whichever is greater, or all packages, if there are fewer than 3,
corresponds with the prescription drug product identifier for such
product;
(III)validating any
applicable transaction history in the possession of the dispenser; and
(IV)otherwise investigating
to determine whether the prescription drug product is an illegitimate
prescription drug product.
(ii)Cleared prescription
drug productIf the dispenser makes the determination that a
suspect prescription drug product is not an illegitimate prescription drug
product, the dispenser shall promptly notify the Secretary of such
determination and such prescription drug product may be further
dispensed.
(iii)A
dispenser shall keep records of its investigation of a suspect prescription
drug product for not less than 3 years after the conclusion of the
investigation.
(B)Illegitimate
prescription drug product
(i)Upon receiving notice
that a manufacturer of a prescription drug product has determined that a
prescription drug product in the possession or control of a dispenser is an
illegitimate prescription drug product, the dispenser shall—
(I)quarantine such
prescription drug product within the possession or control of the dispenser
from prescription drug product intended for distribution; and
(II)provide for the disposition of the
illegitimate prescription drug product within the possession or control of the
dispenser.
(ii)Upon determining
that a prescription drug product in the possession or control of a trading
partner is an illegitimate prescription drug product, the dispenser shall take
reasonable steps to assist a trading partner to provide for the disposition of
the illegitimate prescription drug product.
(iii)Upon determining that a prescription drug product in
the possession or control of the dispenser is an illegitimate prescription drug
product, the dispenser shall notify the Secretary of such determination not
later than 24 hours after making such determination. The Secretary shall
determine whether additional trading partner notification is
appropriate.
(iv)Responding to a
notificationUpon the receipt of a notification from the
Secretary that a determination has been made that a prescription drug product
is an illegitimate prescription drug product, a dispenser shall—
(I)identify all illegitimate
prescription drug products that are subject to such notification and in the
possession or control of the dispenser, including any prescription drug product
that is subsequently received; and
(II)perform the activities
described in clause (i).
(v)A
dispenser shall keep records of the disposition of an illegitimate prescription
drug product for not less than 3 years after the conclusion of the
disposition.
(C)A dispenser may satisfy the requirements of this
paragraph through the use of a secure electronic database developed and
operated by the manufacturer or another entity. The owner of such database
shall establish the requirements and processes to enable responding 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 dispenser of the requirement under this
paragraph to respond to a verification request submitted by means other than a
secure electronic database.
(e)
(1)Prescription drug
product tracing
(A)Beginning not later
than April 1, 2015, with respect to a prescription drug product received by a
repackager from a wholesale distributor, and beginning not later than January
1, 2015, with respect to any other prescription drug product, a repackager
shall—
(i)not accept ownership of a
prescription drug product unless the previous owner, prior to, or at the time
of, the transaction, provides transaction history and a transaction statement
for the prescription drug product;
(ii)prior to, or at the time
of, each transaction in which the repackager transfers ownership of a
prescription drug product, provide the subsequent owner with transaction
history and a transaction statement;
(iii)maintain the
transaction information for each transaction described in clause (i) or (ii)
for not less than 3 years after the transaction; and
(iv)maintain records that
allow the repackager to associate the prescription drug product identifier the
repackager affixes or imprints with the prescription drug product identifier
assigned by the original manufacturer of the prescription drug product.
(B)Notwithstanding
subparagraph (A)(ii), a repackager may return prescription drug product to the
trading partner from whom the repackager obtained the prescription drug product
without providing the information required under such subparagraph.
(C)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 prescription drug product or an illegitimate
prescription drug product, a repackager shall, not later than 2 business days
after receiving the request or in such other reasonable time as determined by
the Secretary, provide the applicable transaction history and transaction
statement for the prescription drug product.
(2)Prescription drug
product identifierBeginning not later than 6 years after the
date of the enactment of the Safeguarding
America’s Pharmaceuticals Act of 2013, a repackager—
(A)shall affix or imprint a
prescription drug product identifier to each package and homogenous case of
prescription drug product intended to be introduced in a transaction;
(B)shall maintain the
prescription drug product identifier for such prescription drug product for not
less than 3 years after the date of the transaction; and
(C)may engage in
transactions involving a prescription drug product only if such prescription
drug product is encoded with a prescription drug product identifier except as
provided in subsection (a)(4).
(3)Authorized trading
partnersBeginning on January
1, 2015, a repackager shall ensure that each of its trading partners is
authorized.
(4)Beginning
not later than January 1, 2015, a repackager shall implement systems to enable
the repackager to comply with the following requirements:
(A)Suspect prescription
drug product
(i)Upon making a determination that a prescription drug
product in the possession or control of the repackager is a suspect
prescription drug product, or upon receiving a request for verification from
the Secretary that a prescription drug product within the possession or control
of a repackager is a suspect prescription drug product, a repackager shall
promptly conduct an investigation to determine whether the prescription drug
product is an illegitimate prescription drug product, including—
(I)beginning not later than
6 years after the date of the enactment of the
Safeguarding America’s Pharmaceuticals Act of
2013, verifying the prescription drug product at the package
level;
(II)validating any
applicable transaction information in the possession of the repackager;
and
(III)otherwise investigating
to determine whether the prescription drug product is an illegitimate
prescription drug product.
(ii)Cleared prescription
drug productIf the repackager determines that a suspect
prescription drug product is not an illegitimate prescription drug product, the
repackager shall promptly notify the Secretary of such determination and such
prescription drug product may be further distributed.
(iii)A
repackager shall keep records of its investigation of a suspect prescription
drug product for not less than 3 years after the conclusion of the
investigation.
(B)Illegitimate
prescription drug product
(i)Upon receiving notice
that a manufacturer of a prescription drug product has determined that a
prescription drug product in the possession or control of a repackager is an
illegitimate prescription drug product, the repackager shall—
(I)quarantine such
prescription drug product within the possession or control of the repackager
from prescription drug product intended for distribution; and
(II)provide for the disposition of the
illegitimate prescription drug product within the possession or control of the
repackager.
(ii)Upon determining that
a prescription drug product in the possession or control of a trading partner
is an illegitimate prescription drug product, the repackagers shall take
reasonable steps to assist the trading partner to provide for the disposition
of the illegitimate prescription drug product.
(iii)Upon determining that a prescription drug product in
the possession or control of the repackager is an illegitimate prescription
drug product, the repackager shall notify the Secretary of such determination
not later than 24 hours after making such determination. The Secretary shall
determine whether additional trading partner notification is
appropriate.
(iv)Responding to a
notificationUpon the receipt of a notification from the
Secretary that a determination has been made that a prescription drug product
is an illegitimate prescription drug product, a repackager shall—
(I)identify all illegitimate
prescription drug products that are subject to such notification and in the
possession or control of the repackager, including any prescription drug
product that is subsequently received; and
(II)perform the activities
described in clause (i).
(v)A
repackager shall keep records of the disposition of an illegitimate
prescription drug product for not less than 3 years after the conclusion of the
disposition.
(C)A repackager may satisfy the requirements of this
paragraph through the use of a secure electronic database developed and
operated by the manufacturer or 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 this paragraph to
respond to a verification request submitted by means other than a secure
electronic database.
(D)Returned prescription
drug productBeginning not later than 6 years after the date of
the enactment of the Safeguarding America’s
Pharmaceuticals Act of 2013, upon receipt of a returned
prescription drug product that the repackager intends to further distribute,
before further distributing such prescription drug product, the repackager
shall—
(i)verify the prescription
drug product identifier for each sealed homogeneous case of such prescription
drug product; or
(ii)if such prescription
drug product is not in a sealed homogeneous case, verify the prescription drug
product identifier on each package.
(f)Third-Party logistics
provider requirements
(1)Authorized trading
partnersBeginning on January
1, 2015, a third-party logistics provider shall ensure that each of its trading
partners is authorized.
(2)Beginning not later than January 1, 2015, a
third-party logistics provider shall implement systems to enable the
third-party logistics provider to comply with the following
requirements:
(A)Suspect prescription
drug product
(i)Upon making a determination that a prescription drug
product in the possession or control of a third-party logistics provider is a
suspect prescription drug product, a third-party logistics provider shall
promptly notify the owner of such prescription drug product of the need to
conduct an investigation to determine whether the prescription drug product is
an illegitimate prescription drug product.
(ii)Cleared prescription
drug productIf the owner of the prescription drug product
notifies the third-party logistics provider of the determination that a suspect
prescription drug product is not an illegitimate prescription drug product,
such prescription drug product may be further distributed.
(iii)A
third-party logistics provider shall keep records of the activities described
in clauses (i) and (ii) with respect to a suspect prescription drug product for
not less than 3 years after the conclusion of the investigation.
(B)Illegitimate
prescription drug product
(i)Upon receiving notice
that a manufacturer of a prescription drug product has determined that a
prescription drug product in the possession or control of a third-party
logistics provider is an illegitimate prescription drug product, the
third-party logistics provider shall—
(I)quarantine such
prescription drug product within the possession or control of the third-party
logistics provider from prescription drug product intended for
distribution;
(II)promptly notify the owner of such
prescription drug product of the need to provide for the disposition of such
prescription drug product; and
(III)promptly transfer possession of the
prescription drug product to the owner of such prescription drug product to
provide for the disposition of the prescription drug product.
(ii)Upon determining that a prescription drug product in
the possession or control of the third-party logistics provider is an
illegitimate prescription drug product, the third-party logistics provider
shall notify the Secretary not later than 24 hours after making such
determination. The Secretary shall determine whether additional trading partner
notification is appropriate.
(iii)Responding to a
notificationUpon the receipt of a notification from the
Secretary, a third-party logistics provider shall—
(I)identify all illegitimate
prescription drug product subject to such notification that is in the
possession or control of the third-party logistics provider, including any
prescription drug product that is subsequently received; and
(II)perform the activities
described in clause (i).
(iv)A
third-party logistics provider shall keep records of the activities described
in clauses (i) and (ii) with respect to an illegitimate prescription drug
product for not less than 3 years after the conclusion of the
disposition.
(g)This section does not apply to any entity,
notwithstanding its status as a wholesale distributor or repackager, or other
status that is not involved in the physical handling, distribution, or storage
of a prescription drug product. For purposes of this subsection, facilitating
the distribution of a prescription drug product by providing various
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 prescription drug
product.
.
3.Enhanced drug
distribution security
(a)
(1)Not later than 2 years after the date of the enactment of
this Act, the Secretary shall establish one or more pilot projects in
coordination with manufacturers, repackagers, wholesale distributors,
third-party logistics providers, and dispensers to explore and evaluate methods
to enhance the safety and security of the pharmaceutical distribution supply
chain.
(2)
(A)The Secretary shall ensure that the pilot projects under
paragraph (1) collectively—
(i)reflect the diversity of
the pharmaceutical distribution supply chain; and
(ii)include participants
representative of every sector within the pharmaceutical distribution supply
chain, including participants representative of small businesses.
(B)The pilot projects shall be designed to—
(i)utilize the prescription
drug product identifier for tracing of a prescription drug product, which
utilization may include—
(I)verification of the
prescription drug product identifier of a prescription drug product; and
(II)the use of aggregation
and inference;
(ii)improve the technical
capabilities of each sector within the pharmaceutical supply chain to comply
with systems and processes needed to utilize the prescription drug product
identifiers to enhance tracing of a prescription drug product; and
(iii)conduct such other
activities as the Secretary determines appropriate to explore and evaluate
methods to enhance the safety and security of the pharmaceutical distribution
supply chain.
(b)
(1)Not later than 6 months after the date of the enactment
of this Act, and at least every 6 months thereafter until the submission of the
report required by subsection (e)(2), the Secretary shall hold a public meeting
to enhance the safety and security of the pharmaceutical distribution supply
chain. In conducting such meetings, the Secretary shall take all measures
reasonable and practicable to ensure the protection of confidential commercial
information and trade secrets.
(2)In
conducting meetings under this subsection, the Secretary shall seek to address,
in at least one such meeting, each of the following topics:
(A)Best practices in each of
the sectors within the pharmaceutical distribution supply chain to implement
the requirements of section 582 of the Federal Food, Drug, and Cosmetic Act, as
added by section 2.
(B)The costs and benefits of
implementation of such section 582, including the impact on each pharmaceutical
distribution supply chain sector and on public health.
(C)Whether additional
electronic traceability requirements, including tracing of prescription drug
product at the package level, are feasible, cost effective, overly burdensome
on small businesses, and needed to protect public health.
(D)The systems and processes
needed to utilize the prescription drug product identifiers to enhance tracing
of prescription drug product at the package level.
(E)The technical
capabilities and legal authorities, if any, needed to establish an electronic
system that provides for enhanced tracing of prescription drug product at the
package level.
(F)The impact that the
requirements, systems, processes, capabilities, and legal authorities referred
to in subparagraphs (C), (D), and (E) would have on patient safety, the drug
supply, cost and regulatory burden, the timeliness of patient access to
prescription drugs, and small businesses.
(c)Study of the
pharmaceutical distribution supply chain
(1)The Comptroller
General of the United States shall conduct a study to examine implementation of
the requirements established under subchapter H of chapter V of the Federal
Food, Drug, and Cosmetic Act, as added by section 2, in order to inform the
regulations promulgated under this section.
(2)In
conducting the study under this subsection, the Comptroller General shall
provide for stakeholder input and shall consider the following:
(A)The implementation of the
requirements established under such subchapter H with respect to—
(i)the ability of the health
care system collectively to maintain patient access to medicines;
(ii)the scalability of such
requirements, including with respect to prescription drug product lines;
and
(iii)the capability of
different sectors within the pharmaceutical distribution supply chain,
including small businesses, to affix and utilize the prescription drug product
identifier.
(B)The need for additional
legal authorities and activities to address additional gaps in the
pharmaceutical distribution supply chain, if any, after the implementation of
the requirements established under such subchapter H with respect to—
(i)the systems and processes
needed to enhance tracing of prescription drug product at the package
level;
(ii)the impact, feasibility,
and cost effectiveness that additional requirements pursuant to this section
would have on each pharmaceutical distribution supply chain sector and the
public health; and
(iii)the systems and
processes needed to enhance interoperability among trading partners.
(C)Risks to the security and privacy of data
collected, maintained, or exchanged pursuant to the requirements established
under such subchapter H.
(d)
(1)Not later than 10
years after the date of the enactment of this Act, the Secretary shall enter
into a contract with a private, independent consulting firm with relevant
expertise to conduct a technology and software study on the feasibility of
dispensers that have 25 or fewer full-time employees conducting interoperable,
electronic tracing of prescription drug products at the package level.
(2)As a condition of the award of a contract
under paragraph (1), the private independent consulting firm awarded such
contract shall agree to consult with dispensers that have 25 or fewer full-time
employees when conducting the study under such subparagraph.
(3)The study conducted under paragraph (1) shall assess
whether, with respect to conducting interoperable, electronic tracing of
prescription drug products at the package level, the necessary hardware and
software—
(A)is readily accessible to such
dispensers;
(B)is not prohibitively expensive to obtain,
install, and maintain for such dispensers; and
(C)can be integrated into business practices,
such as interoperability with wholesale distributors, for such
dispensers.
(4)The
Secretary shall publish—
(A)the statement of work for the study
conducted under paragraph (1) for public comment not later than 30 days before
commencing the study; and
(B)the final version of such study for public
comment not later than 30 days after such study is completed.
(5)Not later than 30
days after the date on which the study conducted under paragraph (1) is
completed, the Secretary shall submit to the Committee on Energy and Commerce
of the House of Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate, a report on the findings of the study and any
recommendations to improve the technology and software available to small
dispensers for purposes of conducting electronic, interoperable tracing of
prescription drug products at the package level.
(6)Not later than 180
days after the date on which the study conducted under paragraph (1) is
completed, the Secretary shall hold a public meeting at which members of the
public, including stakeholders, may present their views on the study.
(e)
(1)Not later than 12 years after the date of the enactment of
this Act, the Comptroller General shall submit to the Committee on Energy and
Commerce of the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report on the results of the
study conducted under subsection (c).
(2)Not later than 12 years after the date of the enactment of
this Act, the Secretary shall submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health, Education, Labor, and
Pensions of the Senate a report on the results of the pilot program conducted
under subsection (a), taking into consideration—
(A)the comments received
during the public meetings conducted under subsection (b); and
(B)the results of the study
conducted, and the public comments received during the public meeting held,
under subsection (d).
(f)Establishment of
additional requirements
(1)Notwithstanding any
other provision of this Act, including the amendments made by this Act, not
earlier than January 1, 2027, and not later than March 1, 2027, the Secretary
shall issue proposed regulations that establish additional requirements to
prevent a suspect product, illegitimate product, or a product that is
counterfeit, stolen, diverted, or otherwise unfit for distribution from
entering into or being further distributed in the supply chain,
including—
(A)requirements related to the use of
interoperable electronic systems and technologies for enhanced tracing of
prescription drug product at the package level, which may include verification
of the prescription drug product identifier of a package of prescription drug
product and enhanced verification of saleable returns;
(B)requirements related to the use of
additional prescription drug product identifiers or prescription drug product
identifier technology that meet the standards developed under section 582(a)(2)
of the Federal Food, Drug, and Cosmetic Act, as added by section 2;
(C)requirements related to the use of
aggregation, inference, and other methods, if determined to be necessary
components of the systems and technologies referred to in subparagraph (A);
and
(D)other data transmission
and maintenance requirements and interoperability standards.
(2)The
requirements described in paragraph (1) shall provide for flexibility for a
member of the pharmaceutical supply chain, by—
(A)with respect to dispensers, allowing a
dispenser to enter into a written agreement with a third party, including an
authorized wholesale distributor, under which—
(i)the third party
confidentially maintains any information required to be maintained under such
requirements for the dispenser; and
(ii)the dispenser maintains
a copy of the written agreement and is not relieved of the other obligations of
the dispenser under such requirements;
(B)establishing a process by which an
authorized manufacturer, repackager, wholesale distributor, or dispenser may
request a waiver from any such requirements if the Secretary determines that
such requirements would result in an undue economic hardship on the
manufacturer, wholesale distributor, or dispenser;
(C)not requiring the adoption of specific
business systems by a member of the pharmaceutical supply chain for the
maintenance and transmission of prescription drug product tracing data;
and
(D)prescribing alternative methods of
compliance for small businesses, as specified in paragraph (4).
(3)In
issuing proposed regulations under paragraph (1), the Secretary shall
consider—
(A)the results of the pilot project conducted
under subsection (a);
(B)the public meetings held
under subsection (b);
(C)the studies conducted
under subsections (c) and (d);
(D)the reports submitted
under subsection (e);
(E)the public health benefits of such
regulations compared with the cost of compliance with the requirements
contained in such regulations, including with respect to entities of varying
sizes and capabilities; and
(F)the diversity of the pharmaceutical
distribution supply chain by providing appropriate flexibility for each sector
in the supply chain, including small businesses.
(4)Small business
protectionThe Secretary,
taking into consideration the study conducted under paragraph (d), shall, if
the Secretary determines that the requirements established pursuant to
paragraph (1) would result in an undue economic hardship on small businesses,
provide for alternative methods of compliance with any such requirement by
small businesses, including—
(A)establishing timelines for such compliance
(including compliance by dispensers with 25 or fewer full-time employees) that
do not impose undue economic hardship for small businesses, including
dispensers with respect to which the study concluded has insufficient hardware
and software to conduct interoperable, electronic tracing of prescription drug
products at the package level; and
(B)establishing a process by which a dispenser
may request a waiver from any such requirement.
(5)In
issuing regulations to carry out this subsection, the Secretary shall—
(A)issue a notice of proposed rulemaking that
includes a copy of the proposed rule;
(B)provide for a period of not less than 60
days for comments on the proposed rule; and
(C)provide for an effective date of the final
rule that is 2 years after the date on which such final rule is
published.
(6)The requirements regarding the provision
and receipt of transaction history and transaction statements under section 582
of the Federal Food, Drug, and Cosmetic Act, as added by section 2, shall cease
to be effective on the date on which the regulations issued under this section
are fully implemented.
(g)In this section:
(1)The terms defined in section 581 of the
Federal Food, Drug, and Cosmetic Act, as added by section 2, shall have the
same meanings in this section as such terms are given in such section
581.
(2)The term
Secretary means the Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs.
4.National standards for
wholesale distributors
(a)Chapter
V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is
amended—
(1)in section 503 (21 U.S.C.
353), by striking (e)(1)(A)
and all that follows through
(3) For the purposes of this subsection and subsection (d)—
and
inserting the following:
(e)For purposes of subsection
(d)—
;
(2)in section 503(e) (21 U.S.C. 353(e)), by
redesignating subparagraphs (A) and (B) as paragraphs (1) and (2),
respectively; and
(3)in subchapter H, as added
by section 2, by adding at the end the following:
583.National standards for
wholesale distributors
(a)
(1)The Secretary shall establish, by regulation, standards
for the licensing of persons that make wholesale distributions.
(2)The
standards under paragraph (1) shall, with respect to wholesale distributions,
include requirements for—
(A)the storage and handling
of drugs subject to section 503(b)(1), including facility requirements;
(B)the establishment and
maintenance of records of the distributions of such drugs;
(C)the furnishing of a bond
or other equivalent means of security in accordance with paragraph (3);
(D)mandatory background
checks and fingerprinting of facility managers or designated
representatives;
(E)the establishment and
implementation of qualifications for key personnel;
(F)the mandatory physical
inspection of any facility to be used in wholesale distribution within a
reasonable timeframe from the initial application for licensure of the
wholesale distributor; and
(G)in accordance with
paragraph (5), the prohibition of certain persons from engaging in wholesale
distribution.
(3)The requirements under paragraph (2)(C) shall provide
for the following:
(A)An applicant that is not
a government-owned-and-operated wholesale distributor, for the issuance or
renewal of a wholesale distributor license, shall submit a surety bond of
$100,000 or other equivalent means of security acceptable to the applicable
licensing authority.
(B)For purposes of
subparagraph (A), the applicable licensing authority may accept a surety bond
less than $100,000 if the annual gross receipts of the previous tax year for
the wholesale distributor is $10,000,000 or less, in which case the surety bond
may not be less than $25,000.
(C)If a wholesale
distributor can provide evidence that it possesses the required bond in a
State, the requirement for a bond in another State is waived.
(4)To
satisfy the inspection requirement under paragraph (2)(F), the Secretary may
conduct the inspection, or may accept an inspection by—
(A)the government of the
State in which the facility is located; or
(B)a third-party
accreditation or inspection service approved by the Secretary.
(5)The requirements under paragraph (2) shall include
requirements to prohibit a person from receiving or maintaining licensure for
wholesale distribution if the person—
(A)has been convicted of any
felony for conduct relating to wholesale distribution; any felony violation of
section 301(i) or 301(k); or any felony violation of section 1365 of title 18,
United States Code, relating to prescription drug product tampering; or
(B)has engaged in a pattern
of violating the requirements of this section that presents a threat of serious
adverse health consequences or death to humans.
(b)Reporting by licensed
wholesale distributors
(1)Beginning not later than 1 year after the date of the
enactment of this section, each person engaged in wholesale distribution in
interstate commerce shall submit on an annual basis, and update as necessary, a
report to the Secretary including—
(A)the wholesale
distributor’s name;
(B)the wholesale
distributor’s address;
(C)a listing of each State
in which the wholesale distributor is licensed for wholesale distribution;
and
(D)any disciplinary actions
taken by a State, the Federal Government, or a foreign government during the
reporting period against the wholesale distributor.
(2)The Secretary shall post on the public Internet Website
of the Food and Drug Administration the name of each wholesale distributor, and
the State in which each such distributor is licensed, based on reports under
paragraph (1).
(c)Preservation of State
authorityThis subchapter does not prohibit a State from—
(1)licensing wholesale
distributors for the conduct of wholesale distribution activities in the State
in accordance with this subchapter; and
(2)collecting fees from
wholesale distributors in connection with such licensing,
so
long as the State does not require such licensure to the extent to which an
entity is engaged in third-party logistics provider activities.(d)In
this section, the term wholesale distribution means the
distribution of a drug subject to section 503(b)(1) to a person other than a
consumer or patient, but does not include—
(1)intracompany distribution
of any drug between members of an affiliated group (as defined in section
1504(a) of the Internal Revenue Code of 1986);
(2)the distribution of a
drug, or an offer to distribute a drug among hospitals or other health care
entities which are under common control;
(3)the distribution of a
drug or an offer to distribute a drug for emergency medical reasons, including
a public health emergency declaration pursuant to section 319 of the Public
Health Service Act, except that a drug shortage not caused by a public health
emergency shall not constitute such an emergency medical reason;
(4)dispensing of a drug
pursuant to a valid prescription executed in accordance with subsection
503(b)(1);
(5)the distribution of
minimal quantities of drug by a licensed retail pharmacy to a licensed
practitioner for office use;
(6)the distribution of a
drug or an offer to distribute a drug by a charitable organization to a
nonprofit affiliate of the organization to the extent otherwise permitted by
law;
(7)the purchase or other
acquisition by a dispenser, hospital, or other health care entity of a drug for
use by such dispenser, hospital, or other health care entity;
(8)the distribution of a
drug by the manufacturer of such drug;
(9)the receipt or transfer
of a drug by an authorized third-party logistics provider provided that such
third-party logistics provider does not take ownership of the drug;
(10)the transport of a drug
by a common carrier, provided that the common carrier does not take ownership
of the drug;
(11)the distribution of a
drug, or an offer to distribute a drug, by an authorized repackager that has
taken ownership of the drug and repacked it in accordance with section
582(e);
(12)saleable drug returns
when conducted by a dispenser in accordance with section 203.23 of title 21,
Code of Federal Regulations (or any successor regulation);
(13)the distribution of a
combination prescription drug product described in section
581(20)(B)(xiii);
(14)the distribution of a
medical convenience kit described in section 581(21)(B)(xiv);
(15)the distribution of an
intravenous drug that, by its formulation, is intended for the replenishment of
fluids and electrolytes (such as sodium, chloride, and potassium) or calories
(such as dextrose and amino acids);
(16)the distribution of an
intravenous drug used to maintain the equilibrium of water and minerals in the
body, such as dialysis solutions;
(17)the distribution of a
drug that is intended for irrigation or reconstitution, or sterile water,
whether intended for such purposes or for injection;
(18)the distribution of
compressed medical gas (as defined in section 581(21)(C));
(19)facilitating the
distribution of a prescription drug product by providing administrative
services, such as processing of orders and payments, without physical handling,
distribution, or storage of a prescription drug product; or
(20)(A)the distribution of a
product by a dispenser, or a wholesale distributor acting at the direction of
the dispenser, to a repackager registered under section 510 for the purpose of
repackaging the drug for use by that dispenser or another health care entity
that is under the dispenser’s ownership or control, so long as the dispenser
retains ownership of the prescription drug product; and
(B)the saleable or nonsaleable return by such
repackager of such prescription drug product.
(e)The standards required by subsection (a) shall take effect
not later than 2 years after the date of the enactment of this section. The
Secretary shall issue the regulations required by subsection (a) not later than
1 year after the date of the enactment of this
Act.
.
(b)Section 804(a)(5)(A) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 384(a)(5)(A)) is amended by striking
503(e)(2)(A)
and inserting 583(a)
.
5.National licensure
standards for third-party logistics providersSubchapter H of chapter V of the Federal
Food, Drug, and Cosmetic Act, as amended by section 4, is further amended by
adding at the end the following:
584.National licensure
standards for third-party logistics providers
(a)No facility may engage in the activities of a
third-party logistics provider in any State unless—
(1)the facility is
licensed—
(A)by the State from which the drug is
distributed by the third-party logistics provider in accordance with a
qualified licensing program, if the State has such a program; or
(B)by the Secretary under
this section, if the State from which the drug is distributed does not have
such a program; and
(2)if the drug is distributed interstate and
the facility is not licensed by the Secretary under paragraph (1)(B), registers
with the State into which the drug is distributed if such State requires such
registration.
(b)Reporting by licensed
third-Party logistics providers
(1)Beginning not later than 1 year after the date of the
enactment of this section, each facility engaged in the activities of a
third-party logistics provider shall submit on an annual basis, and update as
necessary, a report to the Secretary including—
(A)the facility’s
name;
(B)the facility’s
address;
(C)a listing of each
jurisdiction (whether State or Federal) in which the facility is licensed for
third-party logistics provider activities; and
(D)any disciplinary actions
taken by a State or Federal licensing authority during the reporting period
against the facility.
(2)The Secretary shall
post on the public Internet Website of the Food and Drug Administration the
name of each third-party logistics provider, and each jurisdiction (whether
State or Federal) in which the provider is licensed, based on reports under
paragraph (1).
(c)Preservation of State
authorityThis subchapter does not prohibit a State from—
(1)licensing third-party
logistic providers for the conduct of third-party logistics provider activities
in the State in accordance with this subchapter; and
(2)collecting fees from
third-party logistics providers in connection with such licensing,
so
long as the State does not require such licensure to the extent to which an
entity is engaged in wholesale distribution.(d)
(1)Authorized licensure
feesIn the case of a facility engaging in the activities of a
third-party logistics provider licensed by the Secretary under this section,
the Secretary may assess and collect a reasonable fee in an amount equal to the
costs to the Federal Government of establishing and administering the licensure
program established, and conducting period inspections, under this
section.
(2)The
Secretary shall adjust the amount of the fee under paragraph (1) on an annual
basis, if necessary, to generate an amount of revenue equal to the costs
referred to in such paragraph.
(3)Fees assessed and collected under this
subsection shall be available for obligation only to the extent and in the
amount provided in advance in appropriations Acts. Such fees shall remain
available until expended.
(e)
(1)The Secretary shall establish, by regulation, standards,
terms, and conditions for licensing persons to engage in third-party logistics
provider activities.
(2)The
regulations under paragraph (1) shall—
(A)include standards relating to eligibility
for, and revocation and reissuance of, licenses;
(B)establish a process by
which the applicable licensing authority will, upon request by a third-party
logistics provider that is accredited by a third-party accreditation program
approved by the Secretary, issue a license to the provider;
(C)establish a process by
which the Secretary shall issue a license to a third-party logistics provider
if the Secretary is not able to approve a third-party accreditation program
because no such program meets the Secretary’s requirements necessary for
approval of such a third-party accreditation program;
(D)require that the
third-party logistics provider comply with storage practices, as determined by
the Secretary, at the provider’s facilities, including—
(i)maintaining access to
warehouse space of suitable size to facilitate safe operations, including a
suitable area to quarantine suspect prescription drug product;
(ii)maintaining adequate
security; and
(iii)having written policies
and procedures to—
(I)address receipt,
security, storage, inventory, shipment, and distribution of a prescription drug
product;
(II)identify, record, and
report confirmed losses or thefts in the United States;
(III)correct errors and
inaccuracies in inventories;
(IV)provide support for
manufacturer recalls;
(V)prepare for, protect
against, and address any reasonably foreseeable crisis that affects security or
operation at the facility, such as a strike, fire, or flood;
(VI)ensure that any expired
prescription drug product is segregated from other prescription drug products
and returned to the manufacturer or repackager or destroyed;
(VII)maintain the capability
to electronically trace the receipt and outbound distribution of a prescription
drug product, and supplies and records of inventory; and
(VIII)quarantine or destroy
a suspect prescription drug product if directed to do so by the respective
manufacturer, wholesale distributor, dispenser, or an authorized government
agency;
(E)provide for periodic
inspection, as determined by the Secretary, of such facility warehouse space to
ensure compliance with this section;
(F)prohibit a facility from
having as a manager or designated representative anyone convicted of any felony
violation of section 301(i) or 301(k) or any felony violation of section 1365
of title 18, United States Code, relating to prescription drug product
tampering;
(G)perform mandatory
background checks of the provider’s facility managers or designated
representatives of such managers;
(H)require a third-party
logistics provider to provide to the applicable licensing authority, upon the
authority’s request, a list of all prescription drug product manufacturers,
wholesale distributors, and dispensers for whom the third-party logistics
provider provides services at the provider’s facilities; and
(I)include procedures under
which any third-party logistics provider license—
(i)will expire on the date
that is 3 years after issuance of the license; and
(ii)may be renewed for
additional 3-year periods.
(f)A license issued under this section shall remain valid as
long as such third-party logistics provider remains accredited by the
Secretary, subject to renewal under subsection (d). If the Secretary finds that
the third-party accreditation program demonstrates that all applicable
requirements for licensure under this section are met, the Secretary shall
issue a license under this section to a third-party logistics provider
receiving accreditation.
(g)Qualified licensing
program definedIn this section, the term qualified
licensing program means a program meeting the requirements of this
section and the regulations thereunder.
(h)The requirements of this section shall take effect not later
than 1 year after the date of the enactment of this section. The Secretary
shall issue the regulations required by subsection (d) not later than 180 days
after the date of the enactment of this
section.
.
6.
(a)Section 301(t) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 331(t)) is amended by striking or the distribution of drugs
in violation of section 503(e) or the failure to otherwise comply with the
requirements of section 503(e)
and inserting the failure to
comply with any requirement of section 582, engaging in the wholesale
distribution of a drug in violation of section 583 or the failure to otherwise
comply with the requirements of section 583, or engaging in the activities of a
third-party logistics provider in violation of section 584 or the failure to
otherwise comply with the requirements of section 584
.
(b)Enhanced penalty for
knowing unlicensed activitiesSection 303(b)(1)(D) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 333(b)(1)(D)) is amended by striking
503(e)(2)(A)
and inserting 583 or 584
.
(c)Section
502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by
adding at the end the following:
(bb)If it is a drug and it
fails to bear a prescription drug product identifier as required by section
582.
.
7.Subchapter H of chapter
V of the Federal Food, Drug, and Cosmetic Act, as amended by section 5, is
further amended by adding at the end the following:
585.
(a)Preemption of State
prescription drug product tracing and other
requirementsBeginning on the date of the enactment of the
Safeguarding America’s Pharmaceuticals Act of
2013, no State or political subdivision of a State may establish
or continue in effect any requirements for tracing drugs through the
distribution system (including any requirements with respect to paper or
electronic pedigrees, track and trace, statements of distribution history,
transaction history, or transaction statements, or verification, investigation,
disposition, alerts, or recordkeeping relating to the pharmaceutical
distribution supply chain system) that—
(1)are inconsistent with,
more stringent than, or in addition to any requirements applicable under this
Act; or
(2)are inconsistent with any
applicable waiver, exception, or exemption issued by the Secretary under
section 582(a).
(b)
(1)Beginning on the date of the enactment of
Safeguarding America’s Pharmaceuticals Act of
2013, no State or political subdivision of a State may establish
or continue any standards, requirements, or regulations with respect to
wholesale drug distributor or third-party logistics provider licensure which
are inconsistent with, less stringent than, in addition to, or more stringent
than, the standards and requirements under this Act.
(2)Paragraph (1) does not
affect the authority of a State to collect fees from wholesale drug
distributors or third-party logistics providers in connection with State
licensing under section 583 or 584 pursuant to a licensing program meeting the
requirements of such sections.
(3)Enforcement,
suspension, and revocation of licensesNotwithstanding paragraph (1), a
State—
(A)may take administrative
action, including fines, to enforce a licensure requirement promulgated by the
State in accordance with this Act;
(B)may provide for the
suspension or revocation of licenses issued by the State for violations of the
laws of such State;
(C)upon conviction of a
person for a violation of Federal, State, or local controlled substance laws or
regulations, may provide for fines, imprisonment, or civil penalties;
and
(D)may regulate activities
of entities licensed pursuant to section 583 or 584 in a manner that is
consistent with the provisions of this
subchapter.
.
8
(a)Section 502(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)) is amended by adding at
the end the following new sentence: Required labeling (other than
immediate container or carton labels) that is intended for use by a physician,
a pharmacist, or another health care professional, and that provides directions
for human use of a drug subject to section 503(b)(1), may (except as necessary
to mitigate a safety risk, as specified by the Secretary in regulation) be made
available by electronic means instead of paper form, provided that such
labeling complies with all applicable requirements of law, the manufacturer or
distributor, as applicable, affords health care professionals and authorized
dispensers (as defined in section 581) the opportunity to request the labeling
in paper form, and after such a request the manufacturer or distributor
promptly provides the requested information without additional
cost.
.
(b)The Secretary of Health and Human Services
shall promulgate regulations implementing the amendment made by subsection
(a).
(c)The
last sentence of section 502(f) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 352(f)), as added by subsection (a), shall apply beginning on the
earlier of—
(1)the effective date of
final regulations promulgated under subsection (b); or
(2)the day that is 180 days
after the date of enactment of this Act.
June 3, 2013
Reported with an amendment, committed to the Committee of
the Whole House on the State of the Union, and ordered to be
printed