,i #aafth ,,congress #b;d ,session ,h4 ,r4 #eegh ,,in ,,the ,,house ,,of ,,representatives ,january #aj1 #bjbj,ms4 ,de,lauro introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to provide for the mandatory recall of drugs regulated by the ,food and ,drug ,administration4 #a4 ,short title ,this ,act may be cited as the ,recall ,unsafe ,drugs ,act of #bjbj4 #b4 ,notification1 nondistribution1 and recall of adulterated or misbranded drugs 7a7 ,prohibited ,acts ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is amended by adding at the end the following3 7fff7 ,the failure to comply with-- 7#a7 the notification requirement under section #efi;,d7a72 7#b7 an order issued under paragraph 7#a7 of section #efi;,d7c71 following a hearing1 if requested1 under paragraph 7#b77;,c7 of such section2 7#c7 an order amended under paragraph 7#b7 or paragraph 7#c7 of section #efi;,d7c72 or 7#d7 an emergency order issued under section #efi;,d7d74 7ggg7 ,the failure to have in effect a recall plan under section #efi7;g74 4 7b7 ,nondistribution and ,recall of ,adulterated or ,misbranded drugs ,subchapter ,e of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb et seq47 is amended by adding at the end the following3 #efi;,e4 ,notification1 nondistribution1 and recall of certain adulterated or misbranded drugs 7a7 ,notification regarding certain adulterated or misbranded drugs 7#a7 ,in general ,any person required to register under section #eaj shall1 as soon as practicable1 notify the ,secretary of the identity and location of a drug1 if such person has reason to believe-- 7,a7 that such drug1 when introduced into or while in interstate commerce1 or while held for sale 7regardless of whether the first sale7 after shipment in interstate commerce1 is adulterated or misbranded2 and 7,b7 there is a reasonable probability that the use or consumption of1 or exposure to1 the drug 7or an ingredient or component used in any such drug7 will cause a threat of serious adverse health consequences or death to humans or animals4 7#b7 ,manner of notification ,notification under paragraph 7#a7 shall be made in such manner and by such means as the ,secretary may require by regulation or guidance4 7b7 ,voluntary recall ,the ,secretary may request that any person who distributes a drug that the ,secretary has reason to believe is adulterated1 misbranded1 or otherwise in violation of this ,act voluntarily-- 7#a7 recall such drug2 and 7#b7 provide for notice1 including to individuals as appropriate1 to persons who may be affected by the recall4 7c7 ,order ,to cease distribution and recall drug and related procedures 7#a7 ,issuance of order ,if the ,secretary has reason to believe that the use or consumption of1 or exposure to1 a drug 7or an ingredient or component used in any such drug7 may cause serious adverse health consequences or death to humans or animals1 the ,secretary shall have the authority to issue an order requiring any person who distributes such drug-- 7,a7 to immediately cease distribution of such drug2 and 7,b7 to provide for notice1 including to individuals as appropriate1 to persons who may be affected by such cessation of distribution4 7#b7 ,action following order 7,a7 ,cease distribution and notification ,any person who is subject to an order under paragraph 7#a7 shall immediately cease distribution of such drug and provide notification as required by such order4 7,b7 ,appeal ,any person who is subject to an order under paragraph 7#a7 may appeal within #bd hours of issuance such order to the ,secretary4 ,such appeal may include a request for an informal hearing and a description of any efforts to recall such drug undertaken voluntarily by the person1 including after a request under subsection 7b74 7,c7 ,informal hearing ,except as provided in subsection 7d71 if an appeal made under subparagraph 7,b7 contains a request for an informal hearing1 such hearing shall be held as soon as practicable1 but not later than #e calendar days1 or less as determined by the ,secretary1 after such an appeal is filed1 unless the parties jointly agree to an extension4 7,d7 ,determination ,after affording an opportunity for an informal hearing1 the ,secretary shall determine-- 7i7 whether-- 7,i7 the order under paragraph 7#a7 should be amended to require a recall of such drug2 or 7,,ii7 inadequate grounds exist to support the actions required by the order2 or 7ii7 that the order under paragraph 7#a7 was appropriate as issued4 7,e7 ,amendment or vacation of order 7i7 ,amendment ,in the case of a determination made under subparagraph 7,d77i77,i71 the ,secretary shall amend the order made under paragraph 7#a7 accordingly4 7ii7 ,vacation ,in the case of a determination made under subparagraph 7,d77i77,,ii71 the ,secretary shall vacate the order made under paragraph 7#a74 7#c7 ,order to ,recall 7,a7 ,amendment ,except as provided under subsection 7d71 if after providing an opportunity for an informal hearing under paragraph 7#b77;,c71 the ,secretary determines that the order should be amended to include a recall of the drug with respect to which the order was issued1 the ,secretary shall amend the order to require a recall4 7,b7 ,contents ,an amended order under subparagraph 7,a7 shall-- 7i7 specify a timetable in which the recall will occur2 7ii7 require periodic reports to the ,secretary describing the progress of the recall2 and 7iii7 provide for notice1 including to individuals as appropriate1 to persons who may be affected by the recall4 ,in providing for such notice1 the ,secretary may allow for the assistance of health professionals1 ,state or local officials1 or other individuals designated by the ,secretary4 7,c7 ,nondelegation ,an amended order under this paragraph shall be ordered by the ,secretary or an official designated by the ,secretary4 ,an official may not be so designated unless the official is the director of the district under this ,act in which the drug involved is located1 or is an official senior to such director4 7d7 ,emergency ,recall ,order 7#a7 ,in general ,if the ,secretary has credible evidence or information that a drug subject to an order under subsection 7c77#a7 presents an imminent threat of serious adverse health consequences or death to humans or animals1 the ,secretary may issue an order requiring any person who distributes such drug-- 7,a7 to immediately recall such drug2 and 7,b7 to provide for notice1 including to individuals as appropriate1 to persons who may be affected by the recall4 7#b7 ,action following order 7,a7 ,recall and notification ,any person who is subject to an emergency recall order under this subsection shall immediately recall such drug and provide notification as required by such order4 7,b7 ,appeal 7i7 ,timing ,any person who is subject to an emergency recall order under this subsection may appeal within #bd hours after issuance such order to the ,secretary4 7ii7 ,continuation of recall ,the person subject to an emergency recall order shall conduct the recall notwithstanding the pendency of any appeal of such order4 7,c7 ,informal hearing ,an informal hearing shall be held as soon as practicable but not later than #e calendar days1 or less as determined by the ,secretary1 after an appeal under subparagraph 7,b7 is filed1 unless the parties jointly agree to an extension4 7,d7 ,determination ,after affording an opportunity for an informal hearing1 the ,secretary shall determine-- 7i7 whether-- 7,i7 the order under paragraph 7#a7 should be amended to require a recall of such drug2 or 7,,ii7 inadequate grounds exist to support the actions required by the order2 or 7ii7 that the order under paragraph 7#a7 was appropriate as issued4 7,e7 ,amendment or vacation of order 7i7 ,amendment ,in the case of a determination made under subparagraph 7,d77i77,i71 the ,secretary shall amend the order made under paragraph 7#a7 accordingly4 7ii7 ,vacation ,in the case of a determination made under subparagraph 7,d77i77,,ii71 the ,secretary shall vacate the order made under paragraph 7#a74 7#c7 ,nondelegation ,an order under this subsection shall be issued by the ,commissioner of ,food and ,drugs1 the ,principal ,deputy ,commissioner1 or the ,associate ,commissioner for ,regulatory ,affairs of the ,food and ,drug ,administration4 7e7 ,notice to ,consumers and ,health ,officials ,the ,secretary shall1 as the ,secretary determines to be necessary1 provide notice of a recall order under this section to consumers to whom the drug was1 or may have been1 distributed and to appropriate ,state and local health officials4 7f7 ,savings ,clause ,nothing contained in this section shall be construed as limiting-- 7#a7 the authority of the ,secretary to issue an order to cease distribution of1 or to recall1 a drug under any other provision of this ,act or the ,public ,health ,service ,act2 or 7#b7 the ability of the ,secretary to request any person to perform a voluntary activity related to any drug subject to this ,act or the ,public ,health ,service ,act4 7g7 ,recall plan ,any person required to register under section #eaj shall have in effect a recall plan consistent with the requirements of this section4 4 7c7 ,delayed applicability ,the amendments made by this section apply beginning on the date that is one year after the date of the enactment of this ,act4