,,ii ,calendar ,no4 #ebc #aaith ,,congress #b;d ,session ,s4 #cghh ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,february #e1 #bjbf,mr4 ,scott of ,florida 7for himself1 ,mrs4 ,gillibrand1 ,mr4 ,tuberville1 ,mrs4 ,britt1 ,mr4 ,johnson1 ,mrs4 ,moody1 ,mr4 ,lee1 ,mr4 ,cramer1 ,mr4 ,risch1 ,mr4 ,grassley1 ,mr4 ,ricketts1 ,ms4 ,ernst1 and ,mr4 ,armstrong7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,july #bg1 #bjbf,reported by ,mr4 ,cassidy1 with an amendment,strike out all after the enacting clause and insert the part printed in italic ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to require drug labeling to include original manufacturer and supply chain information4 #a4 ,short title ,this ,act may be cited as the ,consumer ,labeling for ,enhanced ,,api ,reporting and ,legitimate ,accountability for ,base ,entity ,listings ,act or the ,,clear ,,labels ,act4 #b4 ,require drug labeling to include original manufacturer and supply chain information ,section #ejb7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7;b77 is amended-- 7#a7 by striking containing 7#a7 the name and place of business of the manufacturer1 packer1 or distributor and inserting the following3 8containing-- 7,a7 the name1 place of business1 and unique facility identifier of the manufacturer1 packer1 or distributor or a link1 barcode1 ,,qr code1 or other means to access a searchable electronic portal containing such information 2 7#b7 in clause 7,a7 7as so designated71 by striking 7#b7 an accurate and inserting the following3 7,b7 an accurate 2 7#c7 in clause 7,b7 7as so designated71 by striking count3 ,provided1 ,that under clause 7#b7 of this paragraph reasonable variations and inserting count1 provided that under this clause1 reasonable variations2 7#d7 by striking 7b7 ,if in a package form and inserting the following3 7b7 7#a7 ,if it is a finished drug product in a package form 2 and 7#e7 by adding at the end the following3 7#b7 ,if it is an active pharmaceutical ingredient1 unless any accompanying label and certificate of analysis contains the name1 place of business1 and unique facility identifier of the original manufacturer4 7#c7 7,a7 ,if it is a finished drug product1 unless its labeling contains the name1 place of business1 and unique facility identifier of-- 7i7 the original manufacturer of each active pharmaceutical ingredient2 7ii7 the original manufacturer of the finished drug product2 and 7iii7 the packer or distributor1 if any1 or a link1 barcode1 ,,qr code1 or other means to access a searchable electronic portal containing such information4 7,b7 ,in the case of a finished drug product for which there are multiple potential different manufacturers of the active pharmaceutical ingredient1 the requirements of this subparagraph shall be satisfied if all such manufacturers of active pharmaceutical ingredients for the drug product are identified in the labeling or the searchable electronic portal4 7#d7 ,a manufacturer1 packer1 or distributor required to furnish information under paragraphs 7#a71 7#b71 and 7#c71 in addition to making such information available electronically1 as applicable1 shall make such information available through a package insert1 or in paper copy to any individual who requests such a copy4 7#e7 ,for purposes of this subsection1 the term original manufacturer1 means the single last establishment to conduct substantial manufacturing activities prior to introduction of the active pharmaceutical ingredient or finished drug product into interstate commerce4 7#f7 ,the ,secretary shall issue regulations to implement subparagraphs 7#b7 and 7#c7 and may provide for reasonable variations in the implementation of1 or an alternative placement for1 the labeling requirements under such subparagraphs1 including by electronic means4 ,such regulations shall take effect on a date determined by the ,secretary and not earlier than #a year after the date of publication of the final regulations1 and shall apply with respect to drugs manufactured on or after the effective date of such regulations4 4 #c4 ,exemption from customs country of origin marking requirement ,section #cjd of the ,tariff ,act of #aicj 7#ai ,u4,s4,c4 #acjd7 is amended by adding at the end the following3 7m7 ,marking of certain finished drug products ,the marking requirements of subsections 7a7 and 7b7 shall not apply to articles that are finished drug products and are marked in accordance with the requirements of section #ejb7;b77#b77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7;b77#b77;,a774 4 #a4 ,short title ,this ,act may be cited as the ,consumer ,labeling for ,enhanced ,,api ,reporting and ,legitimate ,accountability for ,base ,entity ,listings ,act or the ,,clear ,,labels ,act4 #b4 ,require drug labels to include original manufacturer and supply chain information ,section #ejc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7 is amended by adding at the end the following -- 7i7 ,original ,manufacturer and ,supply ,chain ,information 7#a7 ,in general ,no person shall introduce or deliver for introduction into interstate commerce any drug-- 7,a7 if it is an active pharmaceutical ingredient1 unless the label and certificate of analysis contain the name and place of business of the original manufacturer2 or 7,b7 if it is a finished drug product in a package form1 unless the label includes1 either printed directly or made available through electronic means1 the name and place of business of-- 7i7 the original manufacturer of each active pharmaceutical ingredient2 7ii7 the original manufacturer of the finished drug product2 and 7iii7 the packer or distributor1 if any4 7#b7 ,multiple original manufacturers ,in the case of a finished drug product for which there are multiple different original manufacturers of an active pharmaceutical ingredient1 the requirements of paragraph 7#a77;,b77i7 shall be satisfied if the label includes1 either printed directly or made available through electronic means1 the name and place of business of each applicable original manufacturer of the active pharmaceutical ingredient for the applicable drug product lot4 7#c7 ,effect of noncompliance ,in the case of noncompliance with the requirements of paragraph 7#a71 the ,secretary shall have discretion to determine that such noncompliance constitutes misbranding and to assess a civil monetary penalty1 as described in section #cjc7;f77#aj71 except that the ,secretary may not treat a violation of this subsection as a criminal violation4 7#d7 ,definition of original manufacturer ,for purposes of this subsection1 the term original manufacturer means the establishment that conducts the majority of the significant phases of manufacturing 7chemical1 physical1 or biological manipulation7 to produce the active pharmaceutical ingredient or the finished dosage form4 4 #c4 ,penalties 7a7 ,in general ,section #cjc7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7;f77 is amended by adding at the end the following3 7#aj7 7,a7 ,any person who fails to comply with the requirements of section #ejc7;i7 shall be subject to a civil monetary penalty in an amount not to exceed #be percent of the total value of the drug product lot or lots involved4 7,b7 ,in determining whether to assess a penalty under this paragraph against a person1 and the amount of such a penalty1 the ,secretary shall consider-- 7i7 the size of the business of such person and the gravity of the violation2 7ii7 whether such person received written notice of the noncompliance in advance of such proceeding and was provided an opportunity by the ,secretary to correct the violation following such notice2 and 7iii7 whether such person acted in good faith to correct the violation following any such notice4 4 7b7 ,conforming amendments ,section #cjc7;f77#e77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7;f77#e77;,a77 is amended by striking 7#a71 7#b71 7#c71 7#d71 or 7#i7 and inserting 7#a71 7#b71 7#c71 7#d71 7#i71 or 7#aj74 #d4 ,agency coordination regarding ,,fda and customs country of origin requirements ,in carrying out the amendments made by this ,act1 the ,commissioner of ,food and ,drugs shall coordinate with the ,commissioner of ,u4,s4 ,customs and ,border ,protection on efforts to address the potential administrative burden on manufacturers of active pharmaceutical ingredients and finished drug products related to any potential overlap with1 or duplication or conflict between1 the requirements of such amendments and section #cjd of the ,tariff ,act of #aicj 7#ai ,u4,s4,c4 #acjd74 ,such coordination may include the establishment of mechanisms to facilitate the sharing of relevant information between the ,food and ,drug ,administration and ,u4,s4 ,customs and ,border ,protection to ensure compliance with such amendments and such section #cjd1 and joint rulemaking1 if determined by such commissioners to be appropriate4 #e4 ,confidentiality ,nothing in the amendments made by this ,act shall be construed as authorizing the ,secretary of ,health and ,human ,services to disclose any information that is a trade secret or confidential information subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 #f4 ,effective date ,the amendments made by this ,act shall apply to active pharmaceutical ingredients and finished drug products that are manufactured and packaged on or after the date that is #e years after the date of enactment of this ,act4 ,july #bg1 #bjbf,reported with an amendment