Sec. 2. Pharmaceutical distribution supply chain
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/bill/113/hr/1919/rh/section-2A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Chapter 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: In this subchapter: The term authorized means— in the case of a manufacturer or repackager, having a valid registration in accordance with section 510; and in the case of a wholesale distributor, third-party logistics provider, or dispenser, licensed (as defined in this section). The term dispenser — 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; 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 does not include a person who only dispenses prescription drug product to be used in animals in accordance with section 512(a)(5). The term disposition , with respect to a prescription drug product within the possession and control of an entity— 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 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. The terms distribute and distribution mean the sale, purchase, trade, delivery, handling, or storage of a prescription drug product. The term illegitimate prescription drug product means a prescription drug product which a manufacturer has confirmed— is counterfeit, diverted, or stolen; is intentionally adulterated such that the prescription drug product would result in serious adverse health consequences or death to humans; or is otherwise unfit for distribution such that the prescription drug product is reasonably likely to cause serious adverse human health consequences or death. The term licensed means— in the case of a wholesale distributor, having a valid license to make wholesale distributions consistent with the standards under section 583; 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 in the case of a dispenser, having a valid license to dispense prescription drugs under State law. The term manufacturer means, with respect to a prescription drug product— 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; 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 a person that— 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 receives the prescription drug product directly from a person described in subparagraph
(A)or (B). 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. 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. The term prescription drug means a drug for human use subject to section 503(b)(1). The 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). The term prescription drug product identifier means a standardized graphic that— includes the standardized numerical identifier, lot number, and expiration date of a prescription drug product; and 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. 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. 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. 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. 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. The term specific patient need — 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 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. The term standardized numerical identifier means a set of numbers or characters that— is used to uniquely identify each package or homogenous case of the prescription drug product; and 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. The term suspect prescription drug product means a prescription drug product for which there is reason to believe that such prescription drug product— is potentially counterfeit, diverted, or stolen; is potentially intentionally adulterated such that the prescription drug product would result in serious adverse health consequences or death to humans; or appears otherwise unfit for distribution such that the prescription drug product would result in serious adverse health consequences or death to humans. The 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. The term trading partner means— 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 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. The term transaction means the transfer in interstate commerce of prescription drug product between persons in which a change of ownership occurs. The term transaction does not include— 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); the distribution of a prescription drug product among hospitals or other health care entities that are under common control; 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; the dispensing of a prescription drug product pursuant to a valid prescription executed in accordance with section 503(b)(1); the distribution of prescription drug product samples by a manufacturer or a licensed wholesale distributor in accordance with section 503(d); the distribution of blood or blood components intended for transfusion; the distribution of minimal quantities of prescription drug product by a licensed retail pharmacy to a licensed practitioner for office use; 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; 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; the dispensing of a prescription drug product approved under section 512(b); 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); the distribution of a combination product that consists of— 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; 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 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); 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— the medical convenience kit is assembled in an establishment that is registered with the Food and Drug Administration as a medical device manufacturer; 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; 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; the medical convenience kit does not contain a controlled substance (as defined in section 102 of the Controlled Substances Act); and the prescription drug products contained in the medical convenience kit are— intravenous solutions intended for the replenishment of fluids and electrolytes; drugs intended to maintain the equilibrium of water and minerals in the body; drugs intended for irrigation or reconstitution; anesthetics; anticoagulants; vasopressors; or sympathicomimetics; 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); the distribution of an intravenous prescription drug product used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions; 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; the distribution of compressed medical gas; or 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 the saleable or nonsaleable return by such repackager of such prescription drug product. 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. The term transaction history means a statement that— 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 is in paper or electronic form. The term transaction information means— the proprietary or established name or names of the prescription drug product; the strength and dosage form of the prescription drug product; the National Drug Code number of the prescription drug product; the container size; the number of containers; the lot number of the prescription drug product; the date of the transaction; the business name and address of the person from whom ownership is being transferred; and the business name and address of the person to whom ownership is being transferred. 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— is authorized; received transaction information and a transaction statement as required under section 582 from the prior owner of the prescription drug product; did not knowingly and intentionally ship an illegitimate prescription drug product; did not knowingly and intentionally provide false transaction information; and did not knowingly and intentionally alter the transaction history. The terms verification and verify — 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 include making the determination under subparagraph
(A)using human-readable or machine-readable methods. The term wholesale distributor — means a person engaged in wholesale distribution (as defined in section 583); and excludes— 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; a repackager engaged in such wholesale distribution; or 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). 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. 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 . Not 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— 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— 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 319 of the Public Health Service Act; establish a process, with respect to the prescription drug product identifier requirement under paragraph
(2)of subsections (b), (c), (d), and
(e)through which— 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 the Secretary determines whether to waive such requirement; and establish a process by which the Secretary may add the prescription drug products or transactions that are exempt from the requirements of this section. 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 . Until 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. 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). Beginning not later than January 1, 2015, a manufacturer shall— 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 maintain the transaction information for each such transaction for not less than 3 years after the date of the transaction. 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. Beginning 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. Beginning not later than January 1, 2015, a manufacturer shall ensure that each of its trading partners is authorized. Beginning not later than January 1, 2015, each manufacturer of a prescription drug shall— maintain a list of the authorized distributors of record of such drug at the corporate offices of such manufacturer; make such list publicly available, including placement on the Internet Website of such manufacturer; and update such list not less than once per quarter. Beginning not later than January 1, 2015, a manufacturer shall implement systems and processes to enable the manufacturer to comply with the following requirements: 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— verifying the prescription drug product at the package level; validating any applicable transaction history in the possession of the manufacturer; and otherwise investigating to determine whether the prescription drug product is an illegitimate prescription drug product. If 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. 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. Upon determining that a prescription drug product in the possession or control of a manufacturer is an illegitimate prescription drug product, the manufacturer shall— quarantine such prescription drug product from prescription drug product intended for distribution; and provide for the disposition of the illegitimate prescription drug product. 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. 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. Upon 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— 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 perform the activities described in clause (i). 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. 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. Beginning 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— verify the prescription drug product identifier for each sealed homogeneous case of such prescription drug product; or if such prescription drug product is not in a sealed homogeneous case, verify the prescription drug product identifier on each package. Beginning not later than April 1, 2015, a wholesale distributor shall— 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; prior to, or at the time of, each transaction in which the wholesale distributor transfers ownership of a prescription drug product— 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 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; 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— 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; 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 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 maintain the transaction information for each transaction described in clauses
(i)and
(ii)for not less than 3 years after the transaction. Notwithstanding subparagraph (A), a wholesale distributor may— accept returned prescription drug product without a transaction history from a dispenser or repackager; and distribute such returned prescription drug product with a transaction history that begins with the wholesale distributor that so accepted the returned product. 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). 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. Beginning 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). Beginning not later than January 1, 2015, a wholesale distributor shall ensure that each of its trading partners is authorized. Beginning not later than April 1, 2015, a wholesale distributor shall implement systems to enable the wholesale distributor to comply with the following requirements: 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— verifying a package of the prescription drug product; validating any applicable transaction history in the possession of the wholesale distributor; and otherwise investigating to determine whether the prescription drug product is an illegitimate prescription drug product. If 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. 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. 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— quarantine such prescription drug product within the possession or control of the wholesale distributor from prescription drug product intended for distribution; and provide for the disposition of the illegitimate prescription drug product within the possession or control of the wholesale distributor. 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. 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. Upon 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— 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 perform the activities described in clause (i). 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. 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. Beginning 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— verify the prescription drug product identifier for each sealed homogeneous case of such prescription drug product; or if such prescription drug product is not in a sealed homogeneous case, verify the prescription drug product identifier on each package. Beginning not later than July 1, 2015, a dispenser— 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; 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 shall maintain transaction information for a period of not less than 3 years after the date of the transaction. A dispenser may enter into a written agreement with a third party, including an authorized wholesale distributor, under which the third party confidentially maintains the transaction information 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. 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. 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. 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. Beginning 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). Beginning not later than January 1, 2015, a dispenser shall ensure that each of its trading partners is authorized. Beginning not later than January 1, 2015, a dispenser shall implement systems to enable the dispenser to comply with the following requirements: 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— verifying whether the lot number of a suspect prescription drug product corresponds with the lot number for such prescription drug product; 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; validating any applicable transaction history in the possession of the dispenser; and otherwise investigating to determine whether the prescription drug product is an illegitimate prescription drug product. If 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. 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. 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— quarantine such prescription drug product within the possession or control of the dispenser from prescription drug product intended for distribution; and provide for the disposition of the illegitimate prescription drug product within the possession or control of the dispenser. 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. 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. Upon 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— 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 perform the activities described in clause (i). 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. 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. 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— 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; 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; maintain the transaction information for each transaction described in clause
(i)or
(ii)for not less than 3 years after the transaction; and 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. 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. 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. Beginning not later than 6 years after the date of the enactment of the Safeguarding America’s Pharmaceuticals Act of 2013 , a repackager— 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; 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 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). Beginning on January 1, 2015, a repackager shall ensure that each of its trading partners is authorized. Beginning not later than January 1, 2015, a repackager shall implement systems to enable the repackager to comply with the following requirements: 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— 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; validating any applicable transaction information in the possession of the repackager; and otherwise investigating to determine whether the prescription drug product is an illegitimate prescription drug product. If 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. 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. 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— quarantine such prescription drug product within the possession or control of the repackager from prescription drug product intended for distribution; and provide for the disposition of the illegitimate prescription drug product within the possession or control of the repackager. 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. 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. Upon 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— 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 perform the activities described in clause (i). 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. 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. Beginning 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— verify the prescription drug product identifier for each sealed homogeneous case of such prescription drug product; or if such prescription drug product is not in a sealed homogeneous case, verify the prescription drug product identifier on each package. Beginning on January 1, 2015, a third-party logistics provider shall ensure that each of its trading partners is authorized. 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: 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. If 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. 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. 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— quarantine such prescription drug product within the possession or control of the third-party logistics provider from prescription drug product intended for distribution; promptly notify the owner of such prescription drug product of the need to provide for the disposition of such prescription drug product; and 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. 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. Upon the receipt of a notification from the Secretary, a third-party logistics provider shall— 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 perform the activities described in clause (i). 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. 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. .
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