,,ii #aaith ,,congress #b;d ,session ,s4 #dfib ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #d1 #bjbf,mr4 ,tuberville 7for himself and ,mr4 ,lee7 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 with respect to homeopathic drug products1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,homeopathic ,drug ,product ,safety1 ,quality1 and ,transparency ,act4 #b4 ,findings ,congress finds the following3 7#a7 ,homeopathic drug products have a long history of use in the ,united ,states and are prepared according to methods different from other drugs regulated under the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 7#b7 ,federal regulatory oversight of homeopathic drug products has been implemented through mechanisms other than premarket approval1 reflecting the distinct characteristics1 methods of preparation1 risk profile1 and patterns of use of such products4 7#c7 ,a clear statutory framework consistent with the historical regulatory treatment of homeopathic drug products will promote safety1 quality1 and access1 ensure consistent regulation1 and reduce uncertainty4 #c4 ,regulation of homeopathic drug products 7a7 ,definitions ,section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 is amended-- 7#a7 in paragraph 7p71 by striking except a new animal drug or an animal feed bearing or containing a new animal drug each place it appears and inserting except a new animal drug1 an animal feed bearing or containing a new animal drug1 or a homeopathic drug product2 7#b7 in paragraph 7v71 by adding at the end the following3 ,a homeopathic drug product is not a new animal drug42 and 7#c7 by adding at the end the following3 7tt7 7#a7 ,the term homeopathic drug product means a drug that-- 7,a7 contains #a or more homeopathic ingredients2 and 7,b7 contains no other active ingredient4 7#b7 ,the term homeopathic ingredient means an ingredient-- 7,a7 listed in the ,homeopathic ,pharmacopoeia of the ,united ,states or a ,state homeopathic formulary2 or 7,b7 prepared pursuant to-- 7i7 homeopathic manufacturing methods and safety and quality standards described in the ,homeopathic ,pharmacopoeia of the ,united ,states or any other officially recognized homeopathic pharmacopoeia2 and 7ii7 other standards recognized by the ,secretary4 4 7b7 ,safety1 quality1 and labeling requirements for homeopathic drug products 7#a7 ,in general ,subchapter ,a of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #ejc;,d 7#ba ,u4,s4,c4 #cec;d7 the following3 #ejc;,e4 ,homeopathic drug products 7a7 ,in general ,homeopathic drug products constitute a distinct category of drugs and shall be regulated by the ,secretary in a manner that is appropriate to their characteristics1 methods of preparation1 distinct risk profile1 and patterns of use4 7b7 ,provisions applicable to homeopathic drug products ,the only sections of this chapter that shall apply to homeopathic drug products are this section and sections #eja1 #ejb1 and #eaj4 ,homeopathic drug products shall not be subject to section #eje and shall not be required to be the subject of an approved application under such section4 7c7 ,safety and quality standards ,the ,secretary shall regulate homeopathic drug products using standards appropriate to such products1 taking into account the ,homeopathic ,pharmacopoeia of the ,united ,states and other standards recognized by the ,secretary4 7d7 ,final rule establishing current good manufacturing practices and labeling requirements 7#a7 ,in general ,not later than #c years after the date of enactment of this section1 the ,secretary shall issue a final rule that establishes current good manufacturing practices and labeling requirements for homeopathic drug products4 7#b7 ,requirement ,in establishing current good manufacturing practices and labeling requirements pursuant to paragraph 7#a71 the ,secretary shall ensure that such requirements-- 7,a7 are appropriate2 7,b7 do not conflict with standards established under subsection 7c72 and 7,c7 do not impose standards for which there are no current and generally available analytical methodologies for homeopathic drug products4 7e7 ,final and intermediate product testing 7#a7 ,final product testing ,a finished homeopathic drug product shall be exempt from the requirement for a laboratory determination of identity and strength of each active ingredient described in section #baa4afe7;a7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulation71 but shall continue to be required to meet other final specifications1 such as testing for contaminants and defects of the finished product1 consistent with this section4 7#b7 ,intermediate testing for certain starting materials 7,a7 ,in general ,the manufacturer of a homeopathic drug product made from a starting material containing a substance which may present a substantial risk of illness or injury in its undiluted form shall ensure and document that the quantity of such substance in an intermediate level preparation used to make all further attenuations does not exceed a safe level1 as determined by the ,secretary4 7,b7 ,safe level defined ,in this paragraph1 the term safe level means-- 7i7 a level set by nationally recognized standards for safety1 such as the ,homeopathic ,pharmacopoeia of the ,united ,states or an accredited voluntary consensus standard for homeopathic drug products2 or 7ii7 in the absence of a standard described in clause 7i71 a level below an analytically detectable presence4 7f7 ,labeling2 intended use2 claims 7#a7 ,labeling requirements ,homeopathic drug products shall comply with labeling requirements under this ,act1 except that dosage units may be expressed in homeopathic attenuations and substantiation may include traditional homeopathic evidence4 7#b7 ,intended use 7,a7 ,in general ,homeopathic drug products intended for retail sale shall contain-- 7i7 #a or more intended uses for #a or more self-limiting conditions2 and 7ii7 the following statement3 ,these intended uses have not been evaluated by the ,food and ,drug ,administration4 ,this product is intended for traditional homeopathic uses44 7,b7 ,exception ,a homeopathic drug product not intended for retail sale shall not be required to contain #a or more intended uses4 7#c7 ,claims ,any claim made with respect to a homeopathic drug product-- 7,a7 shall be supported by competent and reliable evidence appropriate to the nature and risk profile of the homeopathic drug product1 including traditional homeopathic principles1 pharmacopoeial standards1 and real-world evidence2 and 7,b7 that relates to a specific condition shall be preceded by the following3 ,traditionally used for4 7#d7 ,effect ,a homeopathic drug product that contains an intended use1 or for which a claim is made1 that is in compliance with this ,act may not be considered a false advertisement or an unfair or deceptive act or practice in or affecting commerce for purposes of section #e or #ab of the ,federal ,trade ,commission ,act4 7g7 ,homeopathic ,drug ,product ,advisory ,committee 7#a7 ,establishment ,the ,secretary shall establish a ,homeopathic ,drug ,product ,advisory ,committee 7in this subsection referred to as the ,committee7 to provide advice and recommendations regarding the regulation of homeopathic drug products4 7#b7 ,membership ,in appointing members of the ,committee1 the ,secretary shall ensure that the membership of the ,committee reflects a proper balance of perspectives from the homeopathic practitioner1 manufacturer1 education1 and consumer communities1 including large and small domestic manufacturers1 licensed and certified health care practitioners with not less than #c years of active homeopathic practices and representatives of homeopathic standards and consumer organizations4 7#c7 ,duties ,with respect to the regulation of homeopathic drug products under this ,act1 the ,committee-- 7,a7 shall-- 7i7 provide recommendations on safety1 quality1 and labeling standards2 7ii7 advise on appropriate regulatory approaches2 7iii7 review guidance and rulemaking2 and 7iv7 evaluate relevant scientific1 traditional1 and real-world evidence2 and 7,b7 may investigate any report of a homeopathic drug product to the ,food and ,drug ,administration ,adverse ,event ,monitoring ,system to assist in postmarket surveillance4 7#d7 ,triggered consultation ,the ,secretary shall consult with the ,committee prior-- 7,a7 to issuing or revising guidance regarding homeopathic drug products2 7,b7 to initiating or finalizing rulemaking regarding homeopathic drug products2 7,c7 to adopting or revising good manufacturing practice requirements applicable to homeopathic drug products2 or 7,d7 to undertaking any enforcement initiative of general applicability with respect to homeopathic drug products4 7#e7 ,administrative record ,the ,secretary shall include in the administrative record a written response to significant recommendations of the ,committee4 7#f7 ,limitation ,nothing in this subsection shall require the ,secretary to follow a recommendation of the ,committee4 7#g7 ,termination ,notwithstanding section #ajac of title #e1 ,united ,states ,code1 the ,committee shall terminate on the date that is #g years after the date on which the ,committee is established4 4 7#b7 ,misbranding 7,a7 ,dietary supplements ,section #djc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7 is amended by adding at the end the following3 7z7 ,if it is a dietary supplement and its labeling bears the term homeopathic1 homeopathy1 homeopath1 or such similar term as is determined by the ,secretary4 4 7,b7 ,drugs ,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 7hh7 ,if it is a drug that is not a homeopathic drug product1 and its labeling bears the term homeopathic1 homeopathy1 homeopath1 or such similar term as is determined by the ,secretary4 4 7,c7 ,cosmetics ,section #fjb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfb7 is amended by adding at the end the following3 7g7 ,if it is a cosmetic and its labeling bears the term homeopathic1 homeopathy1 homeopath1 or such similar term as is determined by the ,secretary4 4 7c7 ,conforming amendments 7#a7 ,pharmaceutical distribution supply chain ,section #eha7ac7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;eee7#ac77 is amended by striking homeopathic drugs marketed in accordance with applicable guidance under this ,act and inserting homeopathic drug products marketed in accordance with this ,act4 7#b7 ,serious adverse event reporting ,section #gfj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;aa7 is amended-- 7,a7 in the section heading1 by inserting and homeopathic drug products after nonprescription drugs2 7,b7 by inserting or homeopathic drug product after nonprescription drug each place it appears 7other than in subsection 7a77#b772 and 7,c7 by inserting or homeopathic drug products after nonprescription drugs each place it appears4 7#c7 ,exemption from regulation of biological products ,section #cea7;i77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i77#a77 is amended by adding at the end the following3 ,such term does not include a homeopathic drug product 7as defined in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act744 7d7 ,withdrawal of guidance ,the guidance of the ,food and ,drug ,administration entitled ,homeopathic ,drug ,products2 ,guidance for ,,fda ,staff and ,industry 7#hg ,fed4 ,reg4 #gejed 7,december #g1 #bjbb77 shall have no force or effect4