,,ii #aaith ,,congress #ast ,session ,s4 #bffe ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,august #a1 #bjbe,ms4 ,klobuchar 7for herself1 ,ms4 ,collins1 ,ms4 ,warren1 ,ms4 ,murkowski1 ,ms4 ,smith1 and ,mr4 ,peters7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to provide for notification by manufacturers of critical drugs of increased demand1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,drug ,shortage ,prevention ,act of #bjbe4 #b4 ,improving notification procedures in case of increased demand for critical drugs 7a7 ,in general ,section #ejf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7 is amended-- 7#a7 in the section heading1 by striking ,discontinuance or interruption in the production of life-saving drugs and inserting ,notification of issues affecting domestic supply of critical drugs2 7#b7 by striking subsections 7a71 7b71 and 7c71 and inserting the following3 7a7 ,notification required 7#a7 ,in general ,a manufacturer of a covered drug shall notify the ,secretary1 in accordance with subsection 7b71 of-- 7,a7 7i7 a permanent discontinuance in the manufacture of the drug or an interruption of the manufacture of the drug that is likely to lead to a meaningful disruption in the supply of such drug in the ,united ,states2 7ii7 a permanent discontinuance in the manufacture of an active pharmaceutical ingredient of such drug1 or an interruption in the manufacture of an active pharmaceutical ingredient of such drug that is likely to lead to a meaningful disruption in the supply of the active pharmaceutical ingredient of such drug2 or 7iii7 any other circumstance1 such as an increase in demand or export restriction1 that is likely to leave the manufacturer unable to meet demand for the drug without a meaningful shortfall or delay2 and 7,b7 the reasons for such discontinuance1 interruption1 or other circumstance1 if known4 7#b7 ,contents ,notification under this subsection with respect to a covered drug shall include-- 7,a7 with respect to the reasons for the discontinuation1 interruption1 or other circumstance described in paragraph 7#a77;,a77iii71 if an active pharmaceutical ingredient is a reason for1 or risk factor in1 such discontinuation1 interruption1 or other circumstance1 the source of the active pharmaceutical ingredient and any alternative sources for the active pharmaceutical ingredient known to the manufacturer2 7,b7 whether any associated device used for preparation or administration included in the drug is a reason for1 or a risk factor in1 such discontinuation1 interruption1 or other circumstance described in paragraph 7#a77;,a77iii72 7,c7 the expected duration of the interruption2 and 7,d7 such other information as the ,secretary may require4 7b7 ,timing ,a notice required under subsection 7a7 shall be submitted to the ,secretary-- 7#a7 at least #f months prior to the date of the discontinuance or interruption2 7#b7 in the case of such a notice with respect to a circumstance described in subsection 7a77#a77;,a77iii71 as soon as practicable1 or not later than #aj business days after the onset of the circumstance2 or 7#c7 if compliance with paragraph 7#a7 or 7#b7 is not possible1 as soon as practicable4 7c7 ,distribution ,to the maximum extent practicable1 the ,secretary shall distribute1 through such means as the ,secretary determines appropriate1 information on the discontinuance or interruption of the manufacture of1 or other circumstance described in subsection 7a77#a77;,a77iii7 that is likely to lead to a shortage or meaningful disruption in the supply of1 covered drugs to appropriate organizations1 including physician1 health provider1 and patient organizations1 as described in section #ejf;,e4 2 7#c7 in subsection 7g71 in the matter preceding paragraph 7#a71 by striking drug described in subsection 7a7 and inserting covered drug2 and 7#d7 in subsection 7j71 by striking drug described in subsection 7a7 and inserting covered drug4 7b7 ,definitions ,paragraph 7#a7 of section #ejf;,c7h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7h77 is amended to read as follows3 7#a7 the term covered drug means a drug that is intended for human use and that-- 7,a7 is-- 7i7 life-supporting2 7ii7 life-sustaining2 or 7iii7 intended for use in the prevention or treatment of a debilitating disease or condition1 including any such drug used in emergency medical care or during surgery or any such drug that is critical to the public health during a public health emergency declared by the ,secretary under section #cai of the ,public ,health ,service ,act2 7,b7 is not a radio pharmaceutical drug product or any other product as designated by the ,secretary2 and 7,c7 is not a biological product 7as defined in section #cea7;i7 of the ,public ,health ,service ,act71 unless otherwise provided by the ,secretary in the regulations promulgated under subsection 7i72 4 #c4 ,reporting on supply chains ,section #eaj7;j77#c77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;j77#c77;,a77 is amended-- 7#a7 by striking annually to the ,secretary in the first sentence and inserting to the ,secretary1 once during the month of ,march each year and once during the month of ,september each year12 7#b7 by inserting 1 and the legal names of1 and any additional information the ,secretary may require1 regarding suppliers of active pharmaceutical ingredients and intermediate and in-process materials such person used for the manufacture1 preparation1 propagation1 compounding1 or processing of such drug1 and the amount of such drug manufactured1 prepared1 propagated1 compounded1 or processed using each such active pharmaceutical ingredient or intermediate or in-process material sourced from each such supplier before the period at the end of the first sentence2 and 7#c7 by inserting after the first sentence the following3 ,in addition to the reporting required under the preceding sentence1 each person who registers with the ,secretary under this section with regard to a drug may voluntarily report on the information described in the preceding sentence1 at such other times as the ,secretary may specify44