,,ii ,calendar ,no4 #ebd #aaith ,,congress #b;d ,session ,s4 #cgid ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,february #e1 #bjbf,mr4 ,banks 7for himself and ,mr4 ,heinrich7 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 further regulate compounding pharmacies and outsourcing facilities1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,safeguarding ,americans from ,fraudulent and ,experimental ,drugs ,act of #bjbf or the ,,safe ,drugs ,act of #bjbf4 #b4 ,definitions relating to compounding of drug products ,section #ejc;,a7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;a7b77 is amended-- 7#a7 by amending paragraph 7#a77;,d7 to read as follows3 7,d7 does not1 more than #bj times in a single month1 compound any drug product that is essentially a copy of a commercially available drug product4 2 and 7#b7 by amending paragraph 7#b7 to read as follows3 7#b7 ,definitions 7,a7 ,for purposes of paragraph 7#a77;,d71 the term essentially a copy of a commercially available drug product means any drug product-- 7i7 that contains any active ingredient found in a commercially available drug product2 and 7ii7 in which there is no change1 made for an identified individual patient1 which produces for that patient a significant difference1 as determined by the prescribing practitioner1 between the compounded drug product and the comparable commercially available drug product4 7,b7 ,for purposes of subparagraph 7,a71 the term commercially available drug product includes any drug product that-- 7i7 is sold in the commercial marketplace in the ,united ,states and manufactured in one or more facilities required to comply with section #eja7;a77#b77;,b72 and 7ii7 is not included in the discontinued section of the list of products described in section #eje7;j77#g77;,a74 4 #c4 ,reporting requirement ,section #ejc;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;a7 is amended-- 7#a7 by redesignating subsections 7d7 and 7e7 as subsections 7e7 and 7f71 respectively2 and 7#b7 by inserting after subsection 7c7 the following3 7d7 ,reporting requirement 7#a7 ,in general ,for calendar year #bjbe and each calendar year thereafter1 if a pharmacy1 facility1 or physician compounds1 more than #bj times in a single month for patients who reside outside the ,state in which the compounding occurs1 any drug product that contains any active ingredient found in a commercially available drug product 7as defined in subsection 7b77#b77;,b771 such pharmacy1 facility1 or physician shall submit a report to the ,secretary4 7#b7 ,contents ,each report under paragraph 7#a7 shall identify-- 7,a7 each type of drug product described in paragraph 7#a7 that is compounded for a patient described in such paragraph2 and 7,b7 for each month1 the total number of times each such type is so compounded4 7#c7 ,timing ,for any calendar year for which paragraph 7#a7 applies1 the pharmacy1 facility1 or physician shall submit the report under such paragraph not later than the end of such calendar year4 7#d7 ,form and manner ,a pharmacy1 facility1 or physician shall submit each report under paragraph 7#a7 in such form and manner as the ,secretary may prescribe4 7#e7 ,hospital pharmacy exclusion ,this subsection does not apply to the compounding of any drug products for hospital patients by a pharmacy located on the premises of the hospital4 4 #d4 ,large-scale outsourcing facilities 7a7 ,inspections ,section #ejc;,b7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;b7b77 is amended by adding at the end the following3 7#f7 ,inspections of large-scale outsourcing facilities 7,a7 ,in general ,in the case of a large-scale outsourcing facility1 the risk-based inspections under paragraph 7#d7 shall include-- 7i7 an inspection prior to such facility compounding any drug product for the first time2 and 7ii7 the reinspection of such facility not less than biennially4 7,b7 ,large-scale outsourcing facility defined ,for purposes of this paragraph1 the term large-scale outsourcing facility means any outsourcing facility that compounds1 more than #ajj times in a single calendar year1 any drug product4 4 7b7 ,registration and reporting requirement ,section #eaj7;g77#a7 of such ,act 7#ba ,u4,s4,c4 #cfj7;g77#a77 is amended by inserting before the semicolon at the end the following3 1 except that the exemption in this paragraph shall not apply to any outsourcing facility 7as defined in section #ejc;,b7d77#d774 7c7 ,delayed applicability ,the amendments made by subsections 7a7 and 7b7 apply beginning #f months after the date of enactment of this ,act4 #e4 ,base establishment fee ,section #gdd,k7c77#a77;,a77i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#fb7;c77#a77;,a77i77 is amended by striking #ae1jjj and inserting a base amount deemed appropriate by the ,secretary to fund activities to ensure the safety of compounded drug products4 #a4 ,short title ,this ,act may be cited as the ,safeguarding ,americans from ,fraudulent and ,experimental ,drugs ,act of #bjbf or the ,,safe ,drugs ,act of #bjbf4 #b4 ,reporting requirement ,section #ejc;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;a7 is amended-- 7#a7 by redesignating subsections 7d7 and 7e7 as subsections 7e7 and 7f71 respectively2 and 7#b7 by inserting after subsection 7c7 the following3 7d7 ,reporting 7#a7 ,serious adverse events ,each licensed pharmacist or licensed physician who compounds drug products under this section and sends such drug products1 or causes such drug products to be sent1 out of the ,state in which the compounding occurs shall submit any report received by such licensed pharmacist or licensed physician of a serious adverse event associated with a compounded drug product1 in accordance with the content and format requirements established through guidance or under section #caj4cje of title #ba1 ,code of ,federal ,regulations 7or any successor regulations71 to-- 7,a7 the ,secretary2 7,b7 the ,state in which the compounding occurs2 and 7,c7 each ,state to which such drugs are sent4 7#b7 ,interstate dispensing 7,a7 ,in general ,beginning with the first calendar year that begins after the date of enactment of the ,,safe ,drugs ,act of #bjbf1 not later than ,january #ae of each calendar year1 each licensed pharmacist or licensed physician who compounds drug products under this section and sends1 or causes to be sent1 out of the ,state in which the compounding occurs1 more than #e percent of the total annual amount of drug products compounded by such licensed pharmacist or licensed physician shall annually submit a report containing the information described in subparagraph 7,b7 to the ,secretary and the ,state to which such drug products are sent4 7,b7 ,contents ,each report under subparagraph 7,a7 shall identify-- 7i7 the name1 address1 license number1 and ,state of license of the licensed pharmacist or licensed physician who compounded the drug product2 and 7ii7 the total number of units of compounded drug products1 by type of product1 and by month1 sent or caused to be sent to each applicable ,state4 7,c7 ,form and manner ,a licensed pharmacist or licensed physician shall submit each report under subparagraph 7,a7 in such form and manner as the ,secretary may prescribe4 7,d7 ,information sharing ,the ,secretary shall use an information sharing system for purposes of facilitating the transmission of reports under subparagraph 7,a7 from a licensed pharmacist or licensed physician to the ,secretary and each applicable ,state in a manner that reduces unnecessary administrative burden4 7,e7 ,exclusion ,this subsection shall not apply to the compounding of any drug products for hospital patients by a pharmacy located on the premises of the hospital4 7#c7 ,rule of construction ,nothing in this section shall be construed to preempt any requirement of a ,state or political subdivision of a ,state that requires additional1 more stringent1 or supplementary reporting with respect to a drug product compounded under this section4 4 #c4 ,labeling ,section #ejc;,a7b77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;a7b77#c77 is amended-- 7#a7 in subparagraph 7,a71 by striking 2 and and inserting a semicolon2 7#b7 in subparagraph 7,b77ii71 by striking the period and inserting 2 and2 and 7#c7 by inserting after subparagraph 7,b7 the following3 7,c7 the label of such drug product includes-- 7i7 the statement3 ,this medication has been compounded for dispensing to an individual patients and has not been approved by the ,food and ,drug ,administration42 7ii7 the following information to facilitate adverse event reporting3 www4fda4gov_/medwatch1 and #a-hjj-;,,fda-#ajhh 7or any successor website or telephone number72 and 7iii7 such other information as the ,secretary may prescribe by order1 which may include information to facilitate adverse event reporting4 4 ,july #bg1 #bjbf,reported with an amendment