,,ib ,union ,calendar ,no4 #fe #aacth ,,congress #ast ,session ,h4 ,r4 #aiai ,report ,no4 #aac-ic ,,in ,,the ,,house ,,of ,,representatives ,may #i1 #bjac ,mr4 ,latta 7for himself1 ,mr4 ,matheson1 ,mr4 ,upton1 ,mr4 ,dingell1 ,mr4 ,cassidy1 ,mrs4 ,blackburn1 ,mr4 ,mc,kinley1 ,mr4 ,rogers of ,michigan1 ,mr4 ,burgess1 ,mr4 ,shimkus1 ,mr4 ,guthrie1 ,mr4 ,johnson of ,ohio1 and ,mr4 ,schneider7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,june #c1 #bjac ,additional sponsors3 ,mr4 ,olson1 ,mr4 ,long1 ,mr4 ,latham1 ,mr4 ,valadao1 ,mr4 ,rush1 ,mr4 ,veasey1 ,mr4 ,walberg1 and ,mrs4 ,walorski ,june #c1 #bjac ,reported with an amendment1 committed to the ,committee of the ,whole ,house on the ,state of the ,union1 and ordered to be printed ,strike out all after the enacting clause and insert the part printed in italic ,for text of introduced bill1 see copy of bill as introduced on ,may #i1 #bjac ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act with respect to the pharmaceutical distribution supply chain1 and for other purposes4 #a4 ,short title 7a7 ,short title ,this ,act may be cited as the ,safeguarding ,america's ,pharmaceuticals ,act of #bjac4 7b7 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title4 ,sec4 #b4 ,pharmaceutical distribution supply chain4 ,sec4 #c4 ,enhanced drug distribution security4 ,sec4 #d4 ,national standards for wholesale distributors4 ,sec4 #e4 ,national licensure standards for third-party logistics providers4 ,sec4 #f4 ,penalties4 ,sec4 #g4 ,uniform national policy4 ,sec4 #h ,electronic labeling4 #b4 ,pharmaceutical distribution supply chain ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by adding at the end the following3 ,h ,pharmaceutical ,distribution ,supply ,chain #eha4 ,definitions ,in this subchapter3 7#a7 ,authorized ,the term authorized means-- 7,a7 in the case of a manufacturer or repackager1 having a valid registration in accordance with section #eaj2 and 7,b7 in the case of a wholesale distributor1 third-party logistics provider1 or dispenser1 licensed 7as defined in this section74 7#b7 ,dispenser ,the term dispenser-- 7,a7 subject to subparagraph 7,c71 means a retail pharmacy1 hospital pharmacy1 a group of chain pharmacies under common ownership and control1 or any other person authorized by law to dispense or administer prescription drugs1 to the extent such pharmacy1 group1 or person does not act as a wholesale distributor2 7,b7 includes warehouses and distribution centers under common ownership or control of entities described in subparagraph 7,a7 that are members of an affiliated group pursuant to section #aejd7;a7 of the ,internal ,revenue ,code of #aihf1 to the extent such warehouses and distribution centers do not act as a wholesale distributor2 and 7,c7 does not include a person who only dispenses prescription drug product to be used in animals in accordance with section #eab7;a77#e74 7#c7 ,disposition ,the term disposition1 with respect to a prescription drug product within the possession and control of an entity-- 7,a7 means the removal of such prescription drug product1 or taking measures to prevent the introduction of such prescription drug product1 from the pharmaceutical distribution supply chain2 and 7,b7 may include disposal1 return of the prescription drug product for disposal1 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 agency4 7#d7 ,distribute or distribution ,the terms distribute and distribution mean the sale1 purchase1 trade1 delivery1 handling1 or storage of a prescription drug product4 7#e7 ,illegitimate prescription drug product ,the term illegitimate prescription drug product means a prescription drug product which a manufacturer has confirmed-- 7,a7 is counterfeit1 diverted1 or stolen2 7,b7 is intentionally adulterated such that the prescription drug product would result in serious adverse health consequences or death to humans2 or 7,c7 is otherwise unfit for distribution such that the prescription drug product is reasonably likely to cause serious adverse human health consequences or death4 7#f7 ,licensed ,the term licensed means-- 7,a7 in the case of a wholesale distributor1 having a valid license to make wholesale distributions consistent with the standards under section #ehc2 7,b7 in the case of a third-party logistics provider1 having a valid license to engage in the activities of a third-party logistics provider in accordance with section #ehd2 and 7,c7 in the case of a dispenser1 having a valid license to dispense prescription drugs under ,state law4 7#g7 ,manufacturer ,the term manufacturer means1 with respect to a prescription drug product-- 7,a7 a person that holds an application approved under section #eje or a license issued under section #cea of the ,public ,health ,service ,act for such prescription drug product1 or if such prescription drug product is not the subject of an approved application or license1 the person who manufactured the prescription drug product2 7,b7 a co-licensed partner of the person described in subparagraph 7,a7 that obtains the prescription drug product directly from the person described in such subparagraph2 or 7,c7 a person that-- 7i7 is a member of an affiliated group 7as defined in section #aejd7;a7 of the ,internal ,revenue ,code of #aihf7 to which a person described in subparagraph 7,a7 or 7,b7 is also a member2 and 7ii7 receives the prescription drug product directly from a person described in subparagraph 7,a7 or 7,b74 7#h7 ,package 7,a7 ,in general ,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 product4 7,b7 ,individual saleable unit ,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 dispenser4 7#i7 ,prescription drug ,the term prescription drug means a drug for human use subject to section #ejc7;b77#a74 7#aj7 ,prescription drug product ,the term prescription drug product means a prescription drug in a finished dosage form for administration to a patient without substantial further manufacturing 7such as capsules1 tablets1 and lyophilized prescription drug products before reconstitution74 7#aa7 ,prescription drug product identifier ,the term prescription drug product identifier means a standardized graphic that-- 7,a7 includes the standardized numerical identifier1 lot number1 and expiration date of a prescription drug product2 and 7,b7 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 organization4 7#ab7 ,quarantine ,the term quarantine means to store or identify a product1 for the purpose of preventing distribution or transfer of the product1 in a physically separate area clearly identified for such use1 or through use of other procedures such as automated designation4 7#ac7 ,repackager ,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 distribution4 7#ad7 ,return ,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 received1 or to a returns processor for handling of such prescription drug product4 7#ae7 ,returns processor ,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 purchaser1 manufacturer1 seller1 or disposed of for no further distribution4 7#af7 ,specific patient need ,the term specific patient need-- 7,a7 means with respect to the transfer of a prescription drug product from one pharmacy to another1 to fill a prescription for an identified patient2 and 7,b7 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 need4 7#ag7 ,standardized numerical identifier ,the term standardized numerical identifier means a set of numbers or characters that-- 7,a7 is used to uniquely identify each package or homogenous case of the prescription drug product2 and 7,b7 is composed of the ,national ,drug ,code that corresponds to the specific prescription drug product 7including the particular package configuration7 combined with a unique alphanumeric serial number of up to #bj characters4 7#ah7 ,suspect prescription drug product ,the term suspect prescription drug product means a prescription drug product for which there is reason to believe that such prescription drug product-- 7,a7 is potentially counterfeit1 diverted1 or stolen2 7,b7 is potentially intentionally adulterated such that the prescription drug product would result in serious adverse health consequences or death to humans2 or 7,c7 appears otherwise unfit for distribution such that the prescription drug product would result in serious adverse health consequences or death to humans4 7#ai7 ,third-party logistics provider ,the term third-party logistics provider means an entity that provides or coordinates warehousing1 distribution1 or other logistics services of a prescription drug product in interstate commerce on behalf of a manufacturer1 wholesale distributor1 or dispenser of a prescription drug product1 but does not take ownership of the prescription drug product1 nor have responsibility to direct the sale or disposition of1 the prescription drug product4 7#bj7 ,trading partner ,the term trading partner means-- 7,a7 a manufacturer1 repackager1 wholesale distributor1 or dispenser from whom a manufacturer1 repackager1 wholesale distributor1 or dispenser accepts ownership of a prescription drug product or to whom a manufacturer1 repackager1 wholesale distributor1 or dispenser transfers ownership of a prescription drug product2 or 7,b7 a third-party logistics provider from whom a manufacturer1 repackager1 wholesale distributor1 or dispenser accepts possession of a prescription drug product or to whom a manufacturer1 repackager1 wholesale distributor1 or dispenser transfers possession of a prescription drug product4 7#ba7 ,transaction 7,a7 ,in general ,the term transaction means the transfer in interstate commerce of prescription drug product between persons in which a change of ownership occurs4 7,b7 ,exemptions ,the term transaction does not include-- 7i7 intracompany distribution of any prescription drug product1 including between members of an affiliated group 7as defined in section #aejd7;a7 of the ,internal ,revenue ,code of #aihf72 7ii7 the distribution of a prescription drug product among hospitals or other health care entities that are under common control2 7iii7 the distribution of a prescription drug product for emergency medical reasons including a public health emergency declaration pursuant to section #cai of the ,public ,health ,service ,act1 except that a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason2 7iv7 the dispensing of a prescription drug product pursuant to a valid prescription executed in accordance with section #ejc7;b77#a72 7v7 the distribution of prescription drug product samples by a manufacturer or a licensed wholesale distributor in accordance with section #ejc7;d72 7vi7 the distribution of blood or blood components intended for transfusion2 7vii7 the distribution of minimal quantities of prescription drug product by a licensed retail pharmacy to a licensed practitioner for office use2 7viii7 the distribution of a prescription drug product by a charitable organization to a nonprofit affiliate of the organization to the extent otherwise permitted by law2 7ix7 the distribution of a prescription drug product pursuant to the sale or merger of a pharmacy or pharmacies or a wholesale distributor or wholesale distributors1 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 distributors2 7x7 the dispensing of a prescription drug product approved under section #eab7;b72 7xi7 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 #bgd of the ,atomic ,energy ,act of #aied 7#db ,u4,s4,c4 #bjba72 7xii7 the distribution of a combination product that consists of-- 7,i7 a product comprised of two or more components that are each a drug1 biological product1 or device and that are physically1 chemically1 or otherwise combined or mixed and produced as a single entity2 7,,ii7 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 product2 or 7,,iii7 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 7xiv72 7xiii7 the distribution of a medical convenience kit which is a collection of finished products 7consisting of devices or drugs7 assembled in kit form strictly for the convenience of the purchaser or user if-- 7,i7 the medical convenience kit is assembled in an establishment that is registered with the ,food and ,drug ,administration as a medical device manufacturer2 7,,ii7 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 manufacturer2 7,,iii7 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 distributor2 7,,iv7 the medical convenience kit does not contain a controlled substance 7as defined in section #ajb of the ,controlled ,substances ,act72 and 7,v7 the prescription drug products contained in the medical convenience kit are-- 7aa7 intravenous solutions intended for the replenishment of fluids and electrolytes2 7bb7 drugs intended to maintain the equilibrium of water and minerals in the body2 7cc7 drugs intended for irrigation or reconstitution2 7dd7 anesthetics2 7ee7 anticoagulants2 7ff7 vasopressors2 or 7gg7 sympathicomimetics2 7xiv7 the distribution of an intravenous prescription drug product that1 by its formulation1 is intended for the replenishment of fluids and electrolytes 7such as sodium1 chloride1 and potassium7 or calories 7such as dextrose and amino acids72 7xv7 the distribution of an intravenous prescription drug product used to maintain the equilibrium of water and minerals in the body1 such as dialysis solutions2 7xvi7 the distribution of a prescription drug product that is intended for irrigation or reconstitution1 or sterile water1 whether intended for such purposes or for injection2 7xvii7 the distribution of compressed medical gas2 or 7xviii7 7,i7 the distribution of a product by a dispenser1 or a wholesale distributor acting at the direction of the dispenser1 to a repackager registered under section #eaj 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 control1 so long as the dispenser retains ownership of the prescription drug product2 and 7,,ii7 the saleable or nonsaleable return by such repackager of such prescription drug product4 7,c7 ,compressed medical gas ,for purposes of subparagraph 7,b77xviii71 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 environment1 including oxygen and nitrous oxide4 7#bb7 ,transaction history ,the term transaction history means a statement that-- 7,a7 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 distributor2 and 7,b7 is in paper or electronic form4 7#bc7 ,transaction information ,the term transaction information means-- 7,a7 the proprietary or established name or names of the prescription drug product2 7,b7 the strength and dosage form of the prescription drug product2 7,c7 the ,national ,drug ,code number of the prescription drug product2 7,d7 the container size2 7,e7 the number of containers2 7,f7 the lot number of the prescription drug product2 7,g7 the date of the transaction2 7,h7 the business name and address of the person from whom ownership is being transferred2 and 7,i7 the business name and address of the person to whom ownership is being transferred4 7#bd7 ,transaction statement ,the transaction statement is a statement1 which states that the manufacturer1 repackager1 wholesale distributor1 third-party logistics provider1 or dispenser transferring ownership in a transaction-- 7,a7 is authorized2 7,b7 received transaction information and a transaction statement as required under section #ehb from the prior owner of the prescription drug product2 7,c7 did not knowingly and intentionally ship an illegitimate prescription drug product2 7,d7 did not knowingly and intentionally provide false transaction information2 and 7,e7 did not knowingly and intentionally alter the transaction history4 7#be7 ,verification and verify ,the terms verification and verify-- 7,a7 mean determining whether the prescription drug product identifier affixed to1 or imprinted upon1 a package or homogeneous case of the prescription drug product corresponds to the standardized numerical identifier or lot number1 and expiration date assigned to the prescription drug product by the manufacturer or the repackager1 as applicable2 and 7,b7 include making the determination under subparagraph 7,a7 using human-readable or machine-readable methods4 7#bf7 ,wholesale distributor ,the term wholesale distributor-- 7,a7 means a person engaged in wholesale distribution 7as defined in section #ehc72 and 7,b7 excludes-- 7i7 a manufacturer1 a co-licensed partner of a manufacturer1 or a third-party logistics provider1 or a dispenser who does not engage in such wholesale distribution2 7ii7 a repackager engaged in such wholesale distribution2 or 7iii7 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 #ehb7;e74 #ehb4 ,requirements 7a7 ,in general 7#a7 ,compliance required ,an entity that is a manufacturer1 repackager1 wholesale distributor1 third-party logistics provider1 or dispenser shall comply with the requirements of this section4 ,if an entity meets the definition of more than one of the entities referred to in the preceding sentence1 such entity shall comply with all applicable requirements of this section1 but shall not be required to comply with duplicative requirements4 7#b7 ,standards ,the ,secretary shall1 in consultation with other appropriate ,federal officials1 manufacturers1 repackagers1 wholesale distributors1 third-party logistics providers1 and dispensers1 establish1 by regulation1 standards for the exchange of transaction information for purposes of complying with this section4 ,the standards established under this paragraph shall be in accordance with a form developed by a widely recognized international standards development organization4 ,in establishing such standards1 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 product4 ,the ,secretary shall publish such standards not later than #ahj days after the date of the enactment of the ,safeguarding ,america's ,pharmaceuticals ,act of #bjac4 7#c7 ,waivers1 exceptions1 and exemptions ,not later than one year after the date of the enactment of the ,safeguarding ,america's ,pharmaceuticals ,act of #bjac1 the ,secretary shall promulgate a regulation to-- 7,a7 establish a process by which the ,secretary may grant1 at the request of an authorized manufacturer1 repackager1 wholesale distributor1 or dispenser1 a waiver from any of the requirements of this section-- 7i7 if the ,secretary determines that such requirements would result in an undue economic hardship2 or 7ii7 for emergency medical reasons1 including a public health emergency declaration pursuant to section #cai of the ,public ,health ,service ,act2 7,b7 establish a process1 with respect to the prescription drug product identifier requirement under paragraph 7#b7 of subsections 7b71 7c71 7d71 and 7e7 through which-- 7i7 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 requirement2 and 7ii7 the ,secretary determines whether to waive such requirement2 and 7,c7 establish a process by which the ,secretary may add the prescription drug products or transactions that are exempt from the requirements of this section4 7#d7 ,grandfathered persons and prescription drug products 7,a7 ,in general ,not later than one year after the date of the enactment of the ,safeguarding ,america's ,pharmaceuticals ,act of #bjac1 the ,secretary shall specify1 by regulation1 whether and under what circumstances the prescription drug product identifier requirement under paragraph 7#b7 of subsections 7b71 7c71 7d71 and 7e7 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 #bjac4 7,b7 ,third-party logistics provider licenses ,until the date that is #a year after the effective date of the third-party logistics provider licensing requirements under section #ehd1 a third-party logistics provider shall be considered licensed under section #eha7f77;,b7 unless the ,secretary has made a finding that the third-party logistics provider does not utilize good handling and distribution practices and publishes notice thereof4 7,c7 ,label changes ,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 establishment1 in accordance with section #cad4gj7;d7 of chapter #ba1 ,code of ,federal ,regulations 7or any successor regulation74 7b7 ,manufacturer requirements 7#a7 ,prescription drug product tracing 7,a7 ,in general ,beginning not later than ,january #a1 #bjae1 a manufacturer shall-- 7i7 prior to1 or at the time of1 each transaction in which such manufacturer transfers ownership of a prescription drug product1 provide the subsequent owner with the transaction history and a transaction statement2 and 7ii7 maintain the transaction information for each such transaction for not less than #c years after the date of the transaction4 7,b7 ,requests for information ,upon a request by the ,secretary or other appropriate ,federal or ,state official1 in the event of a recall or for the purpose of investigating a suspect prescription drug product or an illegitimate prescription drug product1 a manufacturer shall1 not later than #b business days after receiving the request or in such reasonable time as determined by the ,secretary1 provide to the ,secretary or other official1 the applicable transaction history and transaction statement for the prescription drug product4 7#b7 ,prescription drug product identifier ,beginning not later than #e years after the date of the enactment of the ,safeguarding ,america's ,pharmaceuticals ,act of #bjac1 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 transaction4 ,such manufacturer shall maintain the information in the prescription drug product identifier for such prescription drug product for not less than #c years after the date of the transaction4 7#c7 ,authorized trading partners ,beginning not later than ,january #a1 #bjae1 a manufacturer shall ensure that each of its trading partners is authorized4 7#d7 ,list of authorized distributors of record ,beginning not later than ,january #a1 #bjae1 each manufacturer of a prescription drug shall-- 7,a7 maintain a list of the authorized distributors of record of such drug at the corporate offices of such manufacturer2 7,b7 make such list publicly available1 including placement on the ,internet ,website of such manufacturer2 and 7,c7 update such list not less than once per quarter4 7#e7 ,verification ,beginning not later than ,january #a1 #bjae1 a manufacturer shall implement systems and processes to enable the manufacturer to comply with the following requirements3 7,a7 ,suspect prescription drug product 7i7 ,in general ,upon making a determination that a prescription drug product in the possession or control of the manufacturer is a suspect prescription drug product1 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 product1 a manufacturer shall promptly conduct an investigation in coordination with trading partners1 as applicable1 to determine whether the prescription drug product is an illegitimate prescription drug product4 ,beginning not later than #e years after the date of the enactment of the ,safeguarding ,america's ,pharmaceuticals ,act of #bjac1 such investigation shall include-- 7,i7 verifying the prescription drug product at the package level2 7,,ii7 validating any applicable transaction history in the possession of the manufacturer2 and 7,,iii7 otherwise investigating to determine whether the prescription drug product is an illegitimate prescription drug product4 7ii7 ,cleared prescription drug product ,if the manufacturer determines that a suspect prescription drug product is not an illegitimate prescription drug product1 the manufacturer shall promptly notify the ,secretary of such determination and such prescription drug product may be further distributed4 7iii7 ,records ,a manufacturer shall keep records of its investigation of a suspect prescription drug product for not less than #c years after the conclusion of the investigation4 7,b7 ,illegitimate prescription drug product 7i7 ,in general ,upon determining that a prescription drug product in the possession or control of a manufacturer is an illegitimate prescription drug product1 the manufacturer shall-- 7,i7 quarantine such prescription drug product from prescription drug product intended for distribution2 and 7,,ii7 provide for the disposition of the illegitimate prescription drug product4 7ii7 ,trading partner ,upon determining that a prescription drug product in the possession or control of a trading partner is an illegitimate prescription drug product1 the manufacturer shall take reasonable steps to assist a trading partner to provide for the disposition of the illegitimate prescription drug product4 7iii7 ,making a notification ,upon determining that a prescription drug product in the possession or control of the manufacturer is an illegitimate prescription drug product1 the manufacturer shall notify the ,secretary of such determination not later than #bd hours after making such determination4 ,the ,secretary shall determine whether additional trading partner notification is appropriate4 7iv7 ,responding to a notification ,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 product1 a manufacturer shall-- 7,i7 identify all illegitimate prescription drug products that are subject to such notification and in the possession or control of the manufacturer1 including any prescription drug product that is subsequently received2 and 7,,ii7 perform the activities described in clause 7i74 7v7 ,records ,a manufacturer shall keep records of the disposition of an illegitimate prescription drug product for not less than #c years after the conclusion of the disposition4 7,c7 ,electronic database ,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 entity4 ,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 chain1 as appropriate4 ,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 database4 7,d7 ,returned prescription drug product ,beginning not later than #e years after the date of the enactment of the ,safeguarding ,america's ,pharmaceuticals ,act of #bjac1 upon receipt of a returned prescription drug product that the manufacturer intends to further distribute1 before further distributing such prescription drug product1 the manufacturer shall-- 7i7 verify the prescription drug product identifier for each sealed homogeneous case of such prescription drug product2 or 7ii7 if such prescription drug product is not in a sealed homogeneous case1 verify the prescription drug product identifier on each package4 7c7 ,wholesale distributor requirements 7#a7 ,prescription drug product tracing 7,a7 ,in general ,beginning not later than ,april #a1 #bjae1 a wholesale distributor shall-- 7i7 not accept ownership of a prescription drug product unless the previous owner prior to1 or at the time of1 the transaction provides the applicable transaction history and a transaction statement for the prescription drug product2 7ii7 prior to1 or at the time of1 each transaction in which the wholesale distributor transfers ownership of a prescription drug product-- 7,i7 in the case that the wholesale distributor purchased the prescription drug product directly from the manufacturer1 provide the subsequent owner with transaction history and a transaction statement for the prescription drug product2 or 7,,ii7 in the case that the wholesale distributor did not purchase the prescription drug product directly from the manufacturer1 the exclusive distributor of the manufacturer1 or a repackager that purchased directly from the manufacturer1 provide the subsequent owner with transaction history beginning with the wholesale distributor that did purchase the product directly from the manufacturer1 the exclusive distributor of the manufacturer1 or a repackager that purchased directly from the manufacturer2 7iii7 notwithstanding clause 7ii71 if the wholesale distributor purchased the prescription drug product directly from the manufacturer1 its exclusive distributor1 or a repackager that purchased directly from the manufacturer or its authorized distributor of record-- 7,i7 provide an initial purchase transaction statement on the invoice to the customer1 stating that the wholesale distributor purchased the prescription drug product package directly from the manufacturer1 exclusive distributor1 or repackager2 7,,ii7 make available to the immediate subsequent recipient of such prescription drug product the information required under clause 7ii7 through any combination of self-generated paper1 electronic data1 or manufacturer-provided information on the prescription drug product package2 and 7,,iii7 for purposes of subclauses 7,i7 and 7,,ii71 need not include any transactions occurring before the transfer of the prescription drug product to the wholesale distributor2 and 7iv7 maintain the transaction information for each transaction described in clauses 7i7 and 7ii7 for not less than #c years after the transaction4 7,b7 ,returns exception 7i7 ,saleable returns ,notwithstanding subparagraph 7,a71 a wholesale distributor may-- 7,i7 accept returned prescription drug product without a transaction history from a dispenser or repackager2 and 7,,ii7 distribute such returned prescription drug product with a transaction history that begins with the wholesale distributor that so accepted the returned product4 7ii7 ,nonsaleable returns ,a wholesale distributor may return a nonsaleable prescription drug to the manufacturer or repackager1 to the wholesale distributor from whom such prescription drug was purchased1 or to a person acting on behalf of such a person1 including a returns processor1 without providing the information required under subparagraph 7,a74 7,c7 ,requests for information ,upon a request by the ,secretary or other appropriate ,federal or ,state official1 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 shall1 not later than #b business days after receiving the request or in such other reasonable time as determined by the ,secretary1 provide the applicable transaction history and transaction statements for the prescription drug product4 7#b7 ,prescription drug product identifier ,beginning not later than #g years after the date of the enactment of the ,safeguarding ,america's ,pharmaceuticals ,act of #bjac1 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 identifier1 except as provided in subsection 7a77#d74 7#c7 ,authorized trading partners ,beginning not later than ,january #a1 #bjae1 a wholesale distributor shall ensure that each of its trading partners is authorized4 7#d7 ,verification ,beginning not later than ,april #a1 #bjae1 a wholesale distributor shall implement systems to enable the wholesale distributor to comply with the following requirements3 7,a7 ,suspect prescription drug product 7i7 ,in general ,upon making a determination that a prescription drug product in the possession or control of the wholesale distributor is a suspect prescription drug product1 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 product1 a wholesale distributor shall promptly conduct an investigation to determine whether the prescription drug product is an illegitimate prescription drug product4 ,beginning not later than #g years after the date of the enactment of the ,safeguarding ,america's ,pharmaceuticals ,act of #bjac1 such investigation shall include-- 7,i7 verifying a package of the prescription drug product2 7,,ii7 validating any applicable transaction history in the possession of the wholesale distributor2 and 7,,iii7 otherwise investigating to determine whether the prescription drug product is an illegitimate prescription drug product4 7ii7 ,cleared prescription drug product ,if the wholesale distributor determines that a suspect prescription drug product is not an illegitimate prescription drug product1 the wholesale distributor shall promptly notify the ,secretary of such determination and such prescription drug product may be further distributed4 7iii7 ,records ,a wholesale distributor shall keep records of its investigation of a suspect prescription drug product for not less than #c years after the conclusion of the investigation4 7,b7 ,illegitimate prescription drug product 7i7 ,in general ,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 product1 the wholesale distributor shall-- 7,i7 quarantine such prescription drug product within the possession or control of the wholesale distributor from prescription drug product intended for distribution2 and 7,,ii7 provide for the disposition of the illegitimate prescription drug product within the possession or control of the wholesale distributor4 7ii7 ,trading partner ,upon determining that a prescription drug product in the possession or control of a trading partner is an illegitimate prescription drug product1 the wholesale distributor shall take reasonable steps to assist a trading partner to provide for the disposition of the illegitimate prescription drug product4 7iii7 ,making a notification ,upon determining that a prescription drug product in the possession or control of the wholesale distributor is an illegitimate prescription drug product1 the wholesale distributor shall notify the ,secretary of such determination not later than #bd hours after making such determination4 ,the ,secretary shall determine whether additional trading partner notification is appropriate4 7iv7 ,responding to a notification ,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 product1 a wholesale distributor shall-- 7,i7 identify all illegitimate prescription drug product subject to such notification that is in the possession or control of the wholesale distributor1 including any prescription drug product that is subsequently received2 and 7,,ii7 perform the activities described in clause 7i74 7v7 ,records ,a wholesale distributor shall keep records of the disposition of an illegitimate prescription drug product for not less than #c years after the conclusion of the disposition4 7,c7 ,electronic database ,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 entity4 ,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 chain1 as appropriate4 ,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 database4 7,d7 ,returned prescription drug product ,beginning not later than #g years after the date of the enactment of the ,safeguarding ,america's ,pharmaceuticals ,act of #bjac1 upon receipt of a returned prescription drug product that the wholesale distributor intends to further distribute1 before further distributing such prescription drug product1 the wholesale distributor shall-- 7i7 verify the prescription drug product identifier for each sealed homogeneous case of such prescription drug product2 or 7ii7 if such prescription drug product is not in a sealed homogeneous case1 verify the prescription drug product identifier on each package4 7d7 ,dispenser requirements 7#a7 ,prescription drug product tracing 7,a7 ,in general ,beginning not later than ,july #a1 #bjae1 a dispenser-- 7i7 shall not accept ownership of a prescription drug product1 unless the previous owner prior to1 or at the time of1 the transaction1 provides transaction history and a transaction statement2 7ii7 prior to1 or at the time of1 each transaction in which the dispenser transfers ownership of a prescription drug product 7but not including dispensing to a patient or returns7 shall provide the subsequent owner with transaction history and a transaction statement for the prescription drug product1 except that the requirements of this clause shall not apply to sales by a dispenser to another dispenser to fulfill a specific patient need2 and 7iii7 shall maintain transaction information for a period of not less than #c years after the date of the transaction4 7,b7 ,agreements with third parties ,a dispenser may enter into a written agreement with a third party1 including an authorized wholesale distributor1 under which the third party confidentially maintains the transaction information required to be maintained under this subsection on behalf of the dispenser4 ,if a dispenser enters into such an agreement1 the dispenser shall maintain a copy of the written agreement4 7,c7 ,returns exception 7i7 ,saleable returns ,notwithstanding subparagraph 7,a77ii71 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 subparagraph4 7ii7 ,nonsaleable returns ,notwithstanding subparagraph 7,a77ii71 a dispenser may return a nonsaleable prescription drug to the manufacturer or repackager1 to the wholesale distributor from whom such prescription drug was purchased1 to a returns processor1 or to a person acting on behalf of such persons without providing the information required under such subparagraph4 7,d7 ,requests for information ,upon a request by the ,secretary or other appropriate ,federal or ,state official1 in the event of a recall or for the purpose of investigating a suspect prescription drug product or an illegitimate prescription drug product1 a dispenser shall1 not later than #b business days after receiving the request or in another such reasonable time as determined by the ,secretary1 provide lot level transaction information4 7#b7 ,prescription drug product identifier ,beginning not later than #h years after the date of the enactment of the ,safeguarding ,america's ,pharmaceuticals ,act of #bjac1 a dispenser may engage in transactions involving a prescription drug product only if such prescription drug product is encoded with a prescription drug product identifier1 except as provided in subsection 7a77#d74 7#c7 ,authorized trading partners ,beginning not later than ,january #a1 #bjae1 a dispenser shall ensure that each of its trading partners is authorized4 7#d7 ,verification ,beginning not later than ,january #a1 #bjae1 a dispenser shall implement systems to enable the dispenser to comply with the following requirements3 7,a7 ,suspect prescription drug product 7i7 ,in general ,upon making a determination that a prescription drug product in the possession or control of the dispenser is a suspect prescription drug product1 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 product1 a dispenser shall promptly conduct an investigation to determine whether the prescription drug product is an illegitimate prescription drug product4 ,such investigation shall include-- 7,i7 verifying whether the lot number of a suspect prescription drug product corresponds with the lot number for such prescription drug product2 7,,ii7 beginning #h years after the date of the enactment of the ,safeguarding ,america's ,pharmaceuticals ,act of #bjac1 verifying that the product identifier of at least #c packages or #aj percent of such suspect prescription drug product1 whichever is greater1 or all packages1 if there are fewer than #c1 corresponds with the prescription drug product identifier for such product2 7,,iii7 validating any applicable transaction history in the possession of the dispenser2 and 7,,iv7 otherwise investigating to determine whether the prescription drug product is an illegitimate prescription drug product4 7ii7 ,cleared prescription drug product ,if the dispenser makes the determination that a suspect prescription drug product is not an illegitimate prescription drug product1 the dispenser shall promptly notify the ,secretary of such determination and such prescription drug product may be further dispensed4 7iii7 ,records ,a dispenser shall keep records of its investigation of a suspect prescription drug product for not less than #c years after the conclusion of the investigation4 7,b7 ,illegitimate prescription drug product 7i7 ,in general ,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 product1 the dispenser shall-- 7,i7 quarantine such prescription drug product within the possession or control of the dispenser from prescription drug product intended for distribution2 and 7,,ii7 provide for the disposition of the illegitimate prescription drug product within the possession or control of the dispenser4 7ii7 ,trading partners ,upon determining that a prescription drug product in the possession or control of a trading partner is an illegitimate prescription drug product1 the dispenser shall take reasonable steps to assist a trading partner to provide for the disposition of the illegitimate prescription drug product4 7iii7 ,making a notification ,upon determining that a prescription drug product in the possession or control of the dispenser is an illegitimate prescription drug product1 the dispenser shall notify the ,secretary of such determination not later than #bd hours after making such determination4 ,the ,secretary shall determine whether additional trading partner notification is appropriate4 7iv7 ,responding to a notification ,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 product1 a dispenser shall-- 7,i7 identify all illegitimate prescription drug products that are subject to such notification and in the possession or control of the dispenser1 including any prescription drug product that is subsequently received2 and 7,,ii7 perform the activities described in clause 7i74 7v7 ,records ,a dispenser shall keep records of the disposition of an illegitimate prescription drug product for not less than #c years after the conclusion of the disposition4 7,c7 ,electronic database ,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 entity4 ,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 chain1 as appropriate4 ,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 database4 7e7 ,repackager requirements 7#a7 ,prescription drug product tracing 7,a7 ,in general ,beginning not later than ,april #a1 #bjae1 with respect to a prescription drug product received by a repackager from a wholesale distributor1 and beginning not later than ,january #a1 #bjae1 with respect to any other prescription drug product1 a repackager shall-- 7i7 not accept ownership of a prescription drug product unless the previous owner1 prior to1 or at the time of1 the transaction1 provides transaction history and a transaction statement for the prescription drug product2 7ii7 prior to1 or at the time of1 each transaction in which the repackager transfers ownership of a prescription drug product1 provide the subsequent owner with transaction history and a transaction statement2 7iii7 maintain the transaction information for each transaction described in clause 7i7 or 7ii7 for not less than #c years after the transaction2 and 7iv7 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 product4 7,b7 ,nonsaleable returns ,notwithstanding subparagraph 7,a77ii71 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 subparagraph4 7,c7 ,requests for information ,upon a request by the ,secretary or other appropriate ,federal or ,state official1 in the event of a recall or for the purpose of investigating a suspect prescription drug product or an illegitimate prescription drug product1 a repackager shall1 not later than #b business days after receiving the request or in such other reasonable time as determined by the ,secretary1 provide the applicable transaction history and transaction statement for the prescription drug product4 7#b7 ,prescription drug product identifier ,beginning not later than #f years after the date of the enactment of the ,safeguarding ,america's ,pharmaceuticals ,act of #bjac1 a repackager-- 7,a7 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 transaction2 7,b7 shall maintain the prescription drug product identifier for such prescription drug product for not less than #c years after the date of the transaction2 and 7,c7 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 7a77#d74 7#c7 ,authorized trading partners ,beginning on ,january #a1 #bjae1 a repackager shall ensure that each of its trading partners is authorized4 7#d7 ,verification ,beginning not later than ,january #a1 #bjae1 a repackager shall implement systems to enable the repackager to comply with the following requirements3 7,a7 ,suspect prescription drug product 7i7 ,in general ,upon making a determination that a prescription drug product in the possession or control of the repackager is a suspect prescription drug product1 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 product1 a repackager shall promptly conduct an investigation to determine whether the prescription drug product is an illegitimate prescription drug product1 including-- 7,i7 beginning not later than #f years after the date of the enactment of the ,safeguarding ,america's ,pharmaceuticals ,act of #bjac1 verifying the prescription drug product at the package level2 7,,ii7 validating any applicable transaction information in the possession of the repackager2 and 7,,iii7 otherwise investigating to determine whether the prescription drug product is an illegitimate prescription drug product4 7ii7 ,cleared prescription drug product ,if the repackager determines that a suspect prescription drug product is not an illegitimate prescription drug product1 the repackager shall promptly notify the ,secretary of such determination and such prescription drug product may be further distributed4 7iii7 ,records ,a repackager shall keep records of its investigation of a suspect prescription drug product for not less than #c years after the conclusion of the investigation4 7,b7 ,illegitimate prescription drug product 7i7 ,in general ,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 product1 the repackager shall-- 7,i7 quarantine such prescription drug product within the possession or control of the repackager from prescription drug product intended for distribution2 and 7,,ii7 provide for the disposition of the illegitimate prescription drug product within the possession or control of the repackager4 7ii7 ,trading partner ,upon determining that a prescription drug product in the possession or control of a trading partner is an illegitimate prescription drug product1 the repackagers shall take reasonable steps to assist the trading partner to provide for the disposition of the illegitimate prescription drug product4 7iii7 ,making a notification ,upon determining that a prescription drug product in the possession or control of the repackager is an illegitimate prescription drug product1 the repackager shall notify the ,secretary of such determination not later than #bd hours after making such determination4 ,the ,secretary shall determine whether additional trading partner notification is appropriate4 7iv7 ,responding to a notification ,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 product1 a repackager shall-- 7,i7 identify all illegitimate prescription drug products that are subject to such notification and in the possession or control of the repackager1 including any prescription drug product that is subsequently received2 and 7,,ii7 perform the activities described in clause 7i74 7v7 ,records ,a repackager shall keep records of the disposition of an illegitimate prescription drug product for not less than #c years after the conclusion of the disposition4 7,c7 ,electronic database ,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 entity4 ,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 chain1 as appropriate4 ,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 database4 7,d7 ,returned prescription drug product ,beginning not later than #f years after the date of the enactment of the ,safeguarding ,america's ,pharmaceuticals ,act of #bjac1 upon receipt of a returned prescription drug product that the repackager intends to further distribute1 before further distributing such prescription drug product1 the repackager shall-- 7i7 verify the prescription drug product identifier for each sealed homogeneous case of such prescription drug product2 or 7ii7 if such prescription drug product is not in a sealed homogeneous case1 verify the prescription drug product identifier on each package4 7f7 ,third-,party logistics provider requirements 7#a7 ,authorized trading partners ,beginning on ,january #a1 #bjae1 a third-party logistics provider shall ensure that each of its trading partners is authorized4 7#b7 ,verification ,beginning not later than ,january #a1 #bjae1 a third-party logistics provider shall implement systems to enable the third-party logistics provider to comply with the following requirements3 7,a7 ,suspect prescription drug product 7i7 ,in general ,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 product1 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 product4 7ii7 ,cleared 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 product1 such prescription drug product may be further distributed4 7iii7 ,records ,a third-party logistics provider shall keep records of the activities described in clauses 7i7 and 7ii7 with respect to a suspect prescription drug product for not less than #c years after the conclusion of the investigation4 7,b7 ,illegitimate prescription drug product 7i7 ,in general ,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 product1 the third-party logistics provider shall-- 7,i7 quarantine such prescription drug product within the possession or control of the third-party logistics provider from prescription drug product intended for distribution2 7,,ii7 promptly notify the owner of such prescription drug product of the need to provide for the disposition of such prescription drug product2 and 7,,iii7 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 product4 7ii7 ,making a notification ,upon determining that a prescription drug product in the possession or control of the third-party logistics provider is an illegitimate prescription drug product1 the third-party logistics provider shall notify the ,secretary not later than #bd hours after making such determination4 ,the ,secretary shall determine whether additional trading partner notification is appropriate4 7iii7 ,responding to a notification ,upon the receipt of a notification from the ,secretary1 a third-party logistics provider shall-- 7,i7 identify all illegitimate prescription drug product subject to such notification that is in the possession or control of the third-party logistics provider1 including any prescription drug product that is subsequently received2 and 7,,ii7 perform the activities described in clause 7i74 7iv7 ,records ,a third-party logistics provider shall keep records of the activities described in clauses 7i7 and 7ii7 with respect to an illegitimate prescription drug product for not less than #c years after the conclusion of the disposition4 7g7 ,drop shipments ,this section does not apply to any entity1 notwithstanding its status as a wholesale distributor or repackager1 or other status that is not involved in the physical handling1 distribution1 or storage of a prescription drug product4 ,for purposes of this subsection1 facilitating the distribution of a prescription drug product by providing various administrative services1 including processing of orders and payments1 shall not1 by itself1 be construed as being involved in the handling1 distribution1 or storage of a prescription drug product4 4 #c4 ,enhanced drug distribution security 7a7 ,pilot projects 7#a7 ,in general ,not later than #b years after the date of the enactment of this ,act1 the ,secretary shall establish one or more pilot projects in coordination with manufacturers1 repackagers1 wholesale distributors1 third-party logistics providers1 and dispensers to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain4 7#b7 ,content 7,a7 ,in general ,the ,secretary shall ensure that the pilot projects under paragraph 7#a7 collectively-- 7i7 reflect the diversity of the pharmaceutical distribution supply chain2 and 7ii7 include participants representative of every sector within the pharmaceutical distribution supply chain1 including participants representative of small businesses4 7,b7 ,project design ,the pilot projects shall be designed to-- 7i7 utilize the prescription drug product identifier for tracing of a prescription drug product1 which utilization may include-- 7,i7 verification of the prescription drug product identifier of a prescription drug product2 and 7,,ii7 the use of aggregation and inference2 7ii7 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 product2 and 7iii7 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 chain4 7b7 ,public meetings 7#a7 ,in general ,not later than #f months after the date of the enactment of this ,act1 and at least every #f months thereafter until the submission of the report required by subsection 7e77#b71 the ,secretary shall hold a public meeting to enhance the safety and security of the pharmaceutical distribution supply chain4 ,in conducting such meetings1 the ,secretary shall take all measures reasonable and practicable to ensure the protection of confidential commercial information and trade secrets4 7#b7 ,content ,in conducting meetings under this subsection1 the ,secretary shall seek to address1 in at least one such meeting1 each of the following topics3 7,a7 ,best practices in each of the sectors within the pharmaceutical distribution supply chain to implement the requirements of section #ehb of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #b4 7,b7 ,the costs and benefits of implementation of such section #ehb1 including the impact on each pharmaceutical distribution supply chain sector and on public health4 7,c7 ,whether additional electronic traceability requirements1 including tracing of prescription drug product at the package level1 are feasible1 cost effective1 overly burdensome on small businesses1 and needed to protect public health4 7,d7 ,the systems and processes needed to utilize the prescription drug product identifiers to enhance tracing of prescription drug product at the package level4 7,e7 ,the technical capabilities and legal authorities1 if any1 needed to establish an electronic system that provides for enhanced tracing of prescription drug product at the package level4 7,f7 ,the impact that the requirements1 systems1 processes1 capabilities1 and legal authorities referred to in subparagraphs 7,c71 7,d71 and 7,e7 would have on patient safety1 the drug supply1 cost and regulatory burden1 the timeliness of patient access to prescription drugs1 and small businesses4 7c7 ,study of the pharmaceutical distribution supply chain 7#a7 ,in general ,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 ,food1 ,drug1 and ,cosmetic ,act1 as added by section #b1 in order to inform the regulations promulgated under this section4 7#b7 ,consideration ,in conducting the study under this subsection1 the ,comptroller ,general shall provide for stakeholder input and shall consider the following3 7,a7 ,the implementation of the requirements established under such subchapter ,h with respect to-- 7i7 the ability of the health care system collectively to maintain patient access to medicines2 7ii7 the scalability of such requirements1 including with respect to prescription drug product lines2 and 7iii7 the capability of different sectors within the pharmaceutical distribution supply chain1 including small businesses1 to affix and utilize the prescription drug product identifier4 7,b7 ,the need for additional legal authorities and activities to address additional gaps in the pharmaceutical distribution supply chain1 if any1 after the implementation of the requirements established under such subchapter ,h with respect to-- 7i7 the systems and processes needed to enhance tracing of prescription drug product at the package level2 7ii7 the impact1 feasibility1 and cost effectiveness that additional requirements pursuant to this section would have on each pharmaceutical distribution supply chain sector and the public health2 and 7iii7 the systems and processes needed to enhance interoperability among trading partners4 7,c7 ,risks to the security and privacy of data collected1 maintained1 or exchanged pursuant to the requirements established under such subchapter ,h4 7d7 ,small dispensers 7#a7 ,in general ,not later than #aj years after the date of the enactment of this ,act1 the ,secretary shall enter into a contract with a private1 independent consulting firm with relevant expertise to conduct a technology and software study on the feasibility of dispensers that have #be or fewer full-time employees conducting interoperable1 electronic tracing of prescription drug products at the package level4 7#b7 ,condition ,as a condition of the award of a contract under paragraph 7#a71 the private independent consulting firm awarded such contract shall agree to consult with dispensers that have #be or fewer full-time employees when conducting the study under such subparagraph4 7#c7 ,study content ,the study conducted under paragraph 7#a7 shall assess whether1 with respect to conducting interoperable1 electronic tracing of prescription drug products at the package level1 the necessary hardware and software-- 7,a7 is readily accessible to such dispensers2 7,b7 is not prohibitively expensive to obtain1 install1 and maintain for such dispensers2 and 7,c7 can be integrated into business practices1 such as interoperability with wholesale distributors1 for such dispensers4 7#d7 ,publication ,the ,secretary shall publish-- 7,a7 the statement of work for the study conducted under paragraph 7#a7 for public comment not later than #cj days before commencing the study2 and 7,b7 the final version of such study for public comment not later than #cj days after such study is completed4 7#e7 ,report to ,congress ,not later than #cj days after the date on which the study conducted under paragraph 7#a7 is completed1 the ,secretary shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 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 electronic1 interoperable tracing of prescription drug products at the package level4 7#f7 ,public meeting ,not later than #ahj days after the date on which the study conducted under paragraph 7#a7 is completed1 the ,secretary shall hold a public meeting at which members of the public1 including stakeholders1 may present their views on the study4 7e7 ,reports 7#a7 ,,gao report ,not later than #ab years after the date of the enactment of this ,act1 the ,comptroller ,general shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report on the results of the study conducted under subsection 7c74 7#b7 ,,fda report ,not later than #ab years after the date of the enactment of this ,act1 the ,secretary shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report on the results of the pilot program conducted under subsection 7a71 taking into consideration-- 7,a7 the comments received during the public meetings conducted under subsection 7b72 and 7,b7 the results of the study conducted1 and the public comments received during the public meeting held1 under subsection 7d74 7f7 ,establishment of additional requirements 7#a7 ,in general ,notwithstanding any other provision of this ,act1 including the amendments made by this ,act1 not earlier than ,january #a1 #bjbg1 and not later than ,march #a1 #bjbg1 the ,secretary shall issue proposed regulations that establish additional requirements to prevent a suspect product1 illegitimate product1 or a product that is counterfeit1 stolen1 diverted1 or otherwise unfit for distribution from entering into or being further distributed in the supply chain1 including-- 7,a7 requirements related to the use of interoperable electronic systems and technologies for enhanced tracing of prescription drug product at the package level1 which may include verification of the prescription drug product identifier of a package of prescription drug product and enhanced verification of saleable returns2 7,b7 requirements related to the use of additional prescription drug product identifiers or prescription drug product identifier technology that meet the standards developed under section #ehb7;a77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #b2 7,c7 requirements related to the use of aggregation1 inference1 and other methods1 if determined to be necessary components of the systems and technologies referred to in subparagraph 7,a72 and 7,d7 other data transmission and maintenance requirements and interoperability standards4 7#b7 ,flexibility ,the requirements described in paragraph 7#a7 shall provide for flexibility for a member of the pharmaceutical supply chain1 by-- 7,a7 with respect to dispensers1 allowing a dispenser to enter into a written agreement with a third party1 including an authorized wholesale distributor1 under which-- 7i7 the third party confidentially maintains any information required to be maintained under such requirements for the dispenser2 and 7ii7 the dispenser maintains a copy of the written agreement and is not relieved of the other obligations of the dispenser under such requirements2 7,b7 establishing a process by which an authorized manufacturer1 repackager1 wholesale distributor1 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 manufacturer1 wholesale distributor1 or dispenser2 7,c7 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 data2 and 7,d7 prescribing alternative methods of compliance for small businesses1 as specified in paragraph 7#d74 7#c7 ,considerations ,in issuing proposed regulations under paragraph 7#a71 the ,secretary shall consider-- 7,a7 the results of the pilot project conducted under subsection 7a72 7,b7 the public meetings held under subsection 7b72 7,c7 the studies conducted under subsections 7c7 and 7d72 7,d7 the reports submitted under subsection 7e72 7,e7 the public health benefits of such regulations compared with the cost of compliance with the requirements contained in such regulations1 including with respect to entities of varying sizes and capabilities2 and 7,f7 the diversity of the pharmaceutical distribution supply chain by providing appropriate flexibility for each sector in the supply chain1 including small businesses4 7#d7 ,small business protection ,the ,secretary1 taking into consideration the study conducted under paragraph 7d71 shall1 if the ,secretary determines that the requirements established pursuant to paragraph 7#a7 would result in an undue economic hardship on small businesses1 provide for alternative methods of compliance with any such requirement by small businesses1 including-- 7,a7 establishing timelines for such compliance 7including compliance by dispensers with #be or fewer full-time employees7 that do not impose undue economic hardship for small businesses1 including dispensers with respect to which the study concluded has insufficient hardware and software to conduct interoperable1 electronic tracing of prescription drug products at the package level2 and 7,b7 establishing a process by which a dispenser may request a waiver from any such requirement4 7#e7 ,regulations ,in issuing regulations to carry out this subsection1 the ,secretary shall-- 7,a7 issue a notice of proposed rulemaking that includes a copy of the proposed rule2 7,b7 provide for a period of not less than #fj days for comments on the proposed rule2 and 7,c7 provide for an effective date of the final rule that is #b years after the date on which such final rule is published4 7#f7 ,sunset ,the requirements regarding the provision and receipt of transaction history and transaction statements under section #ehb of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #b1 shall cease to be effective on the date on which the regulations issued under this section are fully implemented4 7g7 ,definitions ,in this section3 7#a7 ,the terms defined in section #eha of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #b1 shall have the same meanings in this section as such terms are given in such section #eha4 7#b7 ,the term ,secretary means the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs4 #d4 ,national standards for wholesale distributors 7a7 ,standards ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended-- 7#a7 in section #ejc 7#ba ,u4,s4,c4 #cec71 by striking 7e77#a77;,a7 and all that follows through 7#c7 ,for the purposes of this subsection and subsection 7d7-- and inserting the following3 7e7 ,for purposes of subsection 7d7-- 2 7#b7 in section #ejc7;e7 7#ba ,u4,s4,c4 #cec7;e771 by redesignating subparagraphs 7,a7 and 7,b7 as paragraphs 7#a7 and 7#b71 respectively2 and 7#c7 in subchapter ,h1 as added by section #b1 by adding at the end the following3 #ehc4 ,national standards for wholesale distributors 7a7 ,standards 7#a7 ,in general ,the ,secretary shall establish1 by regulation1 standards for the licensing of persons that make wholesale distributions4 7#b7 ,requirements ,the standards under paragraph 7#a7 shall1 with respect to wholesale distributions1 include requirements for-- 7,a7 the storage and handling of drugs subject to section #ejc7;b77#a71 including facility requirements2 7,b7 the establishment and maintenance of records of the distributions of such drugs2 7,c7 the furnishing of a bond or other equivalent means of security in accordance with paragraph 7#c72 7,d7 mandatory background checks and fingerprinting of facility managers or designated representatives2 7,e7 the establishment and implementation of qualifications for key personnel2 7,f7 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 distributor2 and 7,g7 in accordance with paragraph 7#e71 the prohibition of certain persons from engaging in wholesale distribution4 7#c7 ,bond or other security ,the requirements under paragraph 7#b77;,c7 shall provide for the following3 7,a7 ,an applicant that is not a government-owned-and-operated wholesale distributor1 for the issuance or renewal of a wholesale distributor license1 shall submit a surety bond of #ajj1jjj or other equivalent means of security acceptable to the applicable licensing authority4 7,b7 ,for purposes of subparagraph 7,a71 the applicable licensing authority may accept a surety bond less than #ajj1jjj if the annual gross receipts of the previous tax year for the wholesale distributor is #aj1jjj1jjj or less1 in which case the surety bond may not be less than #be1jjj4 7,c7 ,if a wholesale distributor can provide evidence that it possesses the required bond in a ,state1 the requirement for a bond in another ,state is waived4 7#d7 ,inspections ,to satisfy the inspection requirement under paragraph 7#b77;,f71 the ,secretary may conduct the inspection1 or may accept an inspection by-- 7,a7 the government of the ,state in which the facility is located2 or 7,b7 a third-party accreditation or inspection service approved by the ,secretary4 7#e7 ,prohibited persons ,the requirements under paragraph 7#b7 shall include requirements to prohibit a person from receiving or maintaining licensure for wholesale distribution if the person-- 7,a7 has been convicted of any felony for conduct relating to wholesale distribution2 any felony violation of section #cja7;i7 or #cja7k72 or any felony violation of section #acfe of title #ah1 ,united ,states ,code1 relating to prescription drug product tampering2 or 7,b7 has engaged in a pattern of violating the requirements of this section that presents a threat of serious adverse health consequences or death to humans4 7b7 ,reporting by licensed wholesale distributors 7#a7 ,annual report ,beginning not later than #a year after the date of the enactment of this section1 each person engaged in wholesale distribution in interstate commerce shall submit on an annual basis1 and update as necessary1 a report to the ,secretary including-- 7,a7 the wholesale distributor's name2 7,b7 the wholesale distributor's address2 7,c7 a listing of each ,state in which the wholesale distributor is licensed for wholesale distribution2 and 7,d7 any disciplinary actions taken by a ,state1 the ,federal ,government1 or a foreign government during the reporting period against the wholesale distributor4 7#b7 ,posting on ,internet ,the ,secretary shall post on the public ,internet ,website of the ,food and ,drug ,administration the name of each wholesale distributor1 and the ,state in which each such distributor is licensed1 based on reports under paragraph 7#a74 7c7 ,preservation of ,state authority ,this subchapter does not prohibit a ,state from-- 7#a7 licensing wholesale distributors for the conduct of wholesale distribution activities in the ,state in accordance with this subchapter2 and 7#b7 collecting fees from wholesale distributors in connection with such licensing1 so long as the ,state does not require such licensure to the extent to which an entity is engaged in third-party logistics provider activities4 7d7 ,definition ,in this section1 the term wholesale distribution means the distribution of a drug subject to section #ejc7;b77#a7 to a person other than a consumer or patient1 but does not include-- 7#a7 intracompany distribution of any drug between members of an affiliated group 7as defined in section #aejd7;a7 of the ,internal ,revenue ,code of #aihf72 7#b7 the distribution of a drug1 or an offer to distribute a drug among hospitals or other health care entities which are under common control2 7#c7 the distribution of a drug or an offer to distribute a drug for emergency medical reasons1 including a public health emergency declaration pursuant to section #cai of the ,public ,health ,service ,act1 except that a drug shortage not caused by a public health emergency shall not constitute such an emergency medical reason2 7#d7 dispensing of a drug pursuant to a valid prescription executed in accordance with subsection #ejc7;b77#a72 7#e7 the distribution of minimal quantities of drug by a licensed retail pharmacy to a licensed practitioner for office use2 7#f7 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 law2 7#g7 the purchase or other acquisition by a dispenser1 hospital1 or other health care entity of a drug for use by such dispenser1 hospital1 or other health care entity2 7#h7 the distribution of a drug by the manufacturer of such drug2 7#i7 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 drug2 7#aj7 the transport of a drug by a common carrier1 provided that the common carrier does not take ownership of the drug2 7#aa7 the distribution of a drug1 or an offer to distribute a drug1 by an authorized repackager that has taken ownership of the drug and repacked it in accordance with section #ehb7;e72 7#ab7 saleable drug returns when conducted by a dispenser in accordance with section #bjc4bc of title #ba1 ,code of ,federal ,regulations 7or any successor regulation72 7#ac7 the distribution of a combination prescription drug product described in section #eha7bj77;,b77xiii72 7#ad7 the distribution of a medical convenience kit described in section #eha7ba77;,b77xiv72 7#ae7 the distribution of an intravenous drug that1 by its formulation1 is intended for the replenishment of fluids and electrolytes 7such as sodium1 chloride1 and potassium7 or calories 7such as dextrose and amino acids72 7#af7 the distribution of an intravenous drug used to maintain the equilibrium of water and minerals in the body1 such as dialysis solutions2 7#ag7 the distribution of a drug that is intended for irrigation or reconstitution1 or sterile water1 whether intended for such purposes or for injection2 7#ah7 the distribution of compressed medical gas 7as defined in section #eha7ba77;,c772 7#ai7 facilitating the distribution of a prescription drug product by providing administrative services1 such as processing of orders and payments1 without physical handling1 distribution1 or storage of a prescription drug product2 or 7#bj7 7,a7 the distribution of a product by a dispenser1 or a wholesale distributor acting at the direction of the dispenser1 to a repackager registered under section #eaj 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 control1 so long as the dispenser retains ownership of the prescription drug product2 and 7,b7 the saleable or nonsaleable return by such repackager of such prescription drug product4 7e7 ,effective date ,the standards required by subsection 7a7 shall take effect not later than #b years after the date of the enactment of this section4 ,the ,secretary shall issue the regulations required by subsection 7a7 not later than #a year after the date of the enactment of this ,act4 4 7b7 ,conforming amendment ,section #hjd7;a77#e77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chd7;a77#e77;,a77 is amended by striking #ejc7;e77#b77;,a7 and inserting #ehc7;a74 #e4 ,national licensure standards for third-party logistics providers ,subchapter ,h of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as amended by section #d1 is further amended by adding at the end the following3 #ehd4 ,national licensure standards for third-party logistics providers 7a7 ,license requirement ,no facility may engage in the activities of a third-party logistics provider in any ,state unless-- 7#a7 the facility is licensed-- 7,a7 by the ,state from which the drug is distributed by the third-party logistics provider in accordance with a qualified licensing program1 if the ,state has such a program2 or 7,b7 by the ,secretary under this section1 if the ,state from which the drug is distributed does not have such a program2 and 7#b7 if the drug is distributed interstate and the facility is not licensed by the ,secretary under paragraph 7#a77;,b71 registers with the ,state into which the drug is distributed if such ,state requires such registration4 7b7 ,reporting by licensed third-,party logistics providers 7#a7 ,annual report ,beginning not later than #a year after the date of the enactment of this section1 each facility engaged in the activities of a third-party logistics provider shall submit on an annual basis1 and update as necessary1 a report to the ,secretary including-- 7,a7 the facility's name2 7,b7 the facility's address2 7,c7 a listing of each jurisdiction 7whether ,state or ,federal7 in which the facility is licensed for third-party logistics provider activities2 and 7,d7 any disciplinary actions taken by a ,state or ,federal licensing authority during the reporting period against the facility4 7#b7 ,posting on ,internet ,the ,secretary shall post on the public ,internet ,website of the ,food and ,drug ,administration the name of each third-party logistics provider1 and each jurisdiction 7whether ,state or ,federal7 in which the provider is licensed1 based on reports under paragraph 7#a74 7c7 ,preservation of ,state authority ,this subchapter does not prohibit a ,state from-- 7#a7 licensing third-party logistic providers for the conduct of third-party logistics provider activities in the ,state in accordance with this subchapter2 and 7#b7 collecting fees from third-party logistics providers in connection with such licensing1 so long as the ,state does not require such licensure to the extent to which an entity is engaged in wholesale distribution4 7d7 ,costs 7#a7 ,authorized licensure fees ,in the case of a facility engaging in the activities of a third-party logistics provider licensed by the ,secretary under this section1 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 established1 and conducting period inspections1 under this section4 7#b7 ,adjustment ,the ,secretary shall adjust the amount of the fee under paragraph 7#a7 on an annual basis1 if necessary1 to generate an amount of revenue equal to the costs referred to in such paragraph4 7#c7 ,availability ,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 ,acts4 ,such fees shall remain available until expended4 7e7 ,license regulations 7#a7 ,in general ,the ,secretary shall establish1 by regulation1 standards1 terms1 and conditions for licensing persons to engage in third-party logistics provider activities4 7#b7 ,content ,the regulations under paragraph 7#a7 shall-- 7,a7 include standards relating to eligibility for1 and revocation and reissuance of1 licenses2 7,b7 establish a process by which the applicable licensing authority will1 upon request by a third-party logistics provider that is accredited by a third-party accreditation program approved by the ,secretary1 issue a license to the provider2 7,c7 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 program2 7,d7 require that the third-party logistics provider comply with storage practices1 as determined by the ,secretary1 at the provider's facilities1 including-- 7i7 maintaining access to warehouse space of suitable size to facilitate safe operations1 including a suitable area to quarantine suspect prescription drug product2 7ii7 maintaining adequate security2 and 7iii7 having written policies and procedures to-- 7,i7 address receipt1 security1 storage1 inventory1 shipment1 and distribution of a prescription drug product2 7,,ii7 identify1 record1 and report confirmed losses or thefts in the ,united ,states2 7,,iii7 correct errors and inaccuracies in inventories2 7,,iv7 provide support for manufacturer recalls2 7,v7 prepare for1 protect against1 and address any reasonably foreseeable crisis that affects security or operation at the facility1 such as a strike1 fire1 or flood2 7,,vi7 ensure that any expired prescription drug product is segregated from other prescription drug products and returned to the manufacturer or repackager or destroyed2 7,,vii7 maintain the capability to electronically trace the receipt and outbound distribution of a prescription drug product1 and supplies and records of inventory2 and 7,,viii7 quarantine or destroy a suspect prescription drug product if directed to do so by the respective manufacturer1 wholesale distributor1 dispenser1 or an authorized government agency2 7,e7 provide for periodic inspection1 as determined by the ,secretary1 of such facility warehouse space to ensure compliance with this section2 7,f7 prohibit a facility from having as a manager or designated representative anyone convicted of any felony violation of section #cja7;i7 or #cja7k7 or any felony violation of section #acfe of title #ah1 ,united ,states ,code1 relating to prescription drug product tampering2 7,g7 perform mandatory background checks of the provider's facility managers or designated representatives of such managers2 7,h7 require a third-party logistics provider to provide to the applicable licensing authority1 upon the authority's request1 a list of all prescription drug product manufacturers1 wholesale distributors1 and dispensers for whom the third-party logistics provider provides services at the provider's facilities2 and 7,i7 include procedures under which any third-party logistics provider license-- 7i7 will expire on the date that is #c years after issuance of the license2 and 7ii7 may be renewed for additional #c-year periods4 7f7 ,validity of license ,a license issued under this section shall remain valid as long as such third-party logistics provider remains accredited by the ,secretary1 subject to renewal under subsection 7d74 ,if the ,secretary finds that the third-party accreditation program demonstrates that all applicable requirements for licensure under this section are met1 the ,secretary shall issue a license under this section to a third-party logistics provider receiving accreditation4 7g7 ,qualified licensing program defined ,in this section1 the term qualified licensing program means a program meeting the requirements of this section and the regulations thereunder4 7h7 ,effective date ,the requirements of this section shall take effect not later than #a year after the date of the enactment of this section4 ,the ,secretary shall issue the regulations required by subsection 7d7 not later than #ahj days after the date of the enactment of this section4 4 #f4 ,penalties 7a7 ,prohibited acts ,section #cja7t7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7t77 is amended by striking or the distribution of drugs in violation of section #ejc7;e7 or the failure to otherwise comply with the requirements of section #ejc7;e7 and inserting the failure to comply with any requirement of section #ehb1 engaging in the wholesale distribution of a drug in violation of section #ehc or the failure to otherwise comply with the requirements of section #ehc1 or engaging in the activities of a third-party logistics provider in violation of section #ehd or the failure to otherwise comply with the requirements of section #ehd4 7b7 ,enhanced penalty for knowing unlicensed activities ,section #cjc7;b77#a77;,d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7;b77#a77;,d77 is amended by striking #ejc7;e77#b77;,a7 and inserting #ehc or #ehd4 7c7 ,misbranding ,section #ejb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is amended by adding at the end the following3 7bb7 ,if it is a drug and it fails to bear a prescription drug product identifier as required by section #ehb4 4 #g4 ,uniform national policy ,subchapter ,h of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as amended by section #e1 is further amended by adding at the end the following3 #ehe4 ,uniform national policy 7a7 ,preemption of ,state prescription drug product tracing and other requirements ,beginning on the date of the enactment of the ,safeguarding ,america's ,pharmaceuticals ,act of #bjac1 no ,state or political subdivision of a ,state may establish or continue in effect any requirements for tracing drugs through the distribution system 7including any requirements with respect to paper or electronic pedigrees1 track and trace1 statements of distribution history1 transaction history1 or transaction statements1 or verification1 investigation1 disposition1 alerts1 or recordkeeping relating to the pharmaceutical distribution supply chain system7 that-- 7#a7 are inconsistent with1 more stringent than1 or in addition to any requirements applicable under this ,act2 or 7#b7 are inconsistent with any applicable waiver1 exception1 or exemption issued by the ,secretary under section #ehb7;a74 7b7 ,standards or licensure 7#a7 ,in general ,beginning on the date of the enactment of ,safeguarding ,america's ,pharmaceuticals ,act of #bjac1 no ,state or political subdivision of a ,state may establish or continue any standards1 requirements1 or regulations with respect to wholesale drug distributor or third-party logistics provider licensure which are inconsistent with1 less stringent than1 in addition to1 or more stringent than1 the standards and requirements under this ,act4 7#b7 ,licensing fees ,paragraph 7#a7 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 #ehc or #ehd pursuant to a licensing program meeting the requirements of such sections4 7#c7 ,enforcement1 suspension1 and revocation of licenses ,notwithstanding paragraph 7#a71 a ,state-- 7,a7 may take administrative action1 including fines1 to enforce a licensure requirement promulgated by the ,state in accordance with this ,act2 7,b7 may provide for the suspension or revocation of licenses issued by the ,state for violations of the laws of such ,state2 7,c7 upon conviction of a person for a violation of ,federal1 ,state1 or local controlled substance laws or regulations1 may provide for fines1 imprisonment1 or civil penalties2 and 7,d7 may regulate activities of entities licensed pursuant to section #ehc or #ehd in a manner that is consistent with the provisions of this subchapter4 4 #h ,electronic labeling 7a7 ,in general ,section #ejb7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7;f77 is amended by adding at the end the following new sentence3 ,required labeling 7other than immediate container or carton labels7 that is intended for use by a physician1 a pharmacist1 or another health care professional1 and that provides directions for human use of a drug subject to section #ejc7;b77#a71 may 7except as necessary to mitigate a safety risk1 as specified by the ,secretary in regulation7 be made available by electronic means instead of paper form1 provided that such labeling complies with all applicable requirements of law1 the manufacturer or distributor1 as applicable1 affords health care professionals and authorized dispensers 7as defined in section #eha7 the opportunity to request the labeling in paper form1 and after such a request the manufacturer or distributor promptly provides the requested information without additional cost44 7b7 ,regulations ,the ,secretary of ,health and ,human ,services shall promulgate regulations implementing the amendment made by subsection 7a74 7c7 ,application ,the last sentence of section #ejb7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7;f771 as added by subsection 7a71 shall apply beginning on the earlier of-- 7#a7 the effective date of final regulations promulgated under subsection 7b72 or 7#b7 the day that is #ahj days after the date of enactment of this ,act4 ,june #c1 #bjac ,reported with an amendment1 committed to the ,committee of the ,whole ,house on the ,state of the ,union1 and ordered to be printed