,i #aacth ,,congress #ast ,session ,h4 ,r4 #cjai ,,in ,,the ,,house ,,of ,,representatives ,august #b1 #bjac ,ms4 ,de,lauro 7for herself1 ,mrs4 ,lowey1 ,mr4 ,conyers1 ,mr4 ,honda1 and ,mr4 ,ellison7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act to enhance the requirements for pharmacies that compound drug products4 #a4 ,short title ,this ,act may be cited as the ,supporting ,access to ,formulated and ,effective ,compounded ,drugs ,act of #bjac or the ,s4,a4,f4,e4 ,compounded ,drugs ,act of #bjac4 #b4 ,enhanced requirements for compounded drugs 7a7 ,in general ,section #ejc;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;a7 is amended-- 7#a7 in subsection 7a77#a77;,a71 by inserting that is registered with the ,secretary under subsection 7b77#f7 7or is subject to the exception under subsection 7b77#f77;,c77 after ,state licensed pharmacy2 7#b7 in subsection 7b7-- 7,a7 in paragraph 7#a77;,a71 by inserting 7meaning not more than #e percent of the total quantity of drugs products compounded by the pharmacist or physician in any #cj day period7 after limited quantities2 7,b7 in paragraph 7#a77;,c71 by striking and at the end2 7,c7 in paragraph 7#a77;,d71 by striking regularly or in inordinate amounts 7as defined by the ,secretary72 7,d7 by adding at the end of paragraph 7#a7 the following3 7,e7 does not compound a drug product that appears on the list promulgated by the ,secretary under subsection 7h72 and 7,f7 does not compound a drug product in violation of the minimum standards promulgated under subsection 7i74 2 and 7,e7 by adding at the end of the subsection the following3 7#d7 ,notification 7,a7 ,prescriber notification ,before providing a prescription order for a drug to be compounded under subsection 7a71 the physician or other licensed practitioner who will write such order shall-- 7i7 inform the individual patient for whom such order is being written that a compounded drug is being prescribed2 and 7ii7 provide such patient with a written document containing information concerning the availability1 safety1 and production of compounded drugs4 7,b7 ,confirmation by pharmacist ,except in the case of a compounded drug product used in a procedure described in subparagraph 7,c71 a licensed pharmacist or licensed physician who dispenses a compounded drug under subsection 7a7 shall1 at the time such drug is dispensed-- 7i7 confirm that the patient 7or the individual to whom the drug is delivered on behalf of the patient7 understands that the drug is a compounded drug2 and 7ii7 provide a written document containing the information described in subparagraph 7,a77ii74 7,c7 ,provider notification ,prior to providing a health care service that will be conducted by a health care provider in a health care setting 7such as a hospital or a physician's office7 and during which service a drug compounded under subsection 7a7 will be administered to a patient for purposes of treating such patient1 the health care provider shall-- 7i7 inform the patient that a compounded drug will be used during the procedure2 and 7ii7 provide such patient with a written document containing the information described in subparagraph 7,a77ii74 7#e7 ,labeling 7,a7 ,in general ,a drug product compounded under subsection 7a7 shall be clearly labeled as a non-,,fda approved compounded drug product4 7,b7 ,development of requirements ,in determining the requirements for the label under subparagraph 7,a71 the ,secretary-- 7i7 shall establish1 and consult with1 a temporary advisory committee on compounded drug product labeling requirements2 and 7ii7 may establish different labeling requirements for-- 7,i7 a compounded drug product intended for use by a health care provider in an office or treatment setting2 and 7,,ii7 a compounded drug product intended for any use not described in subclause 7,i74 7#f7 ,registration 7,a7 ,establishment of process ,the ,secretary1 in consultation with experts and representatives of stakeholders including pharmacies1 compounding pharmacies1 ,state regulators1 and health care providers1 shall establish a process for pharmacies described in subsection 7a77#a77;,a7 to register as a compounding pharmacy4 ,such registration shall be conducted through an electronic method4 7,b7 ,registration requirement ,except as provided in subparagraph 7,c71 in order to be registered with the ,secretary for purposes of subsection 7a77#a77;,a71 every person who owns or operates a pharmacy shall submit to the ,secretary1 in such time and manner as the ,secretary may require-- 7i7 contact information for the pharmacy2 7ii7 the ,state or ,states that the pharmacy is licensed in2 7iii7 the methods used by the facility in compounding2 and 7iv7 any additional information required by the ,secretary1 which may include the quantity of product compounded at such pharmacy for the purpose of determining if a drug manufacturing facility is inappropriately registering as a compounding pharmacy4 7,c7 ,prohibition on dual registration ,an entity registered under this subsection shall not be required to submit a registration under section #eaj4 7,d7 ,exception ,a pharmacy shall be exempt from the requirement to register under subsection 7a77#a77;,a7 if the pharmacy-- 7i7 employs fewer than #bj full-time employees 7or #bj full-time equivalents72 and 7ii7 performs traditional compounding of drug products for use in a single ,state4 2 and 7#c7 by adding at the end of section #ejc;,a the following3 7g7 ,database 7#a7 ,in general ,the ,secretary shall establish and maintain a database of information on pharmacies compounding drug products under subsection 7a7 that are licensed in more than one ,state1 including-- 7,a7 the minimum standards for a compounding pharmacy license in each ,state2 7,b7 relevant information provided to the ,secretary by ,state agencies that regulate pharmacies2 7,c7 reliable1 timely1 and comprehensive data related to inspections of such pharmacies1 including the classification of actions indicated as a result of such inspections2 and 7,d7 other information determined relevant by the ,secretary4 7#b7 ,design ,the database under paragraph 7#a7-- 7,a7 shall be accessible1 as determined appropriate by the ,secretary1 to ,state agencies that regulate pharmacies that compound drug products2 7,b7 shall enable ,states and the ,secretary to share information to ensure appropriate oversight of pharmacies that compound drug products2 7,c7 shall be used by the ,secretary to inform the ,federal inspection and oversight of pharmacies that compound drug products to ensure that issues and pharmacies identified in the database receive appropriate oversight2 and 7,d7 shall be accessible1 as determined appropriate by the ,secretary1 to health care providers and consumers4 7h7 ,active ingredients and dosage forms that should not be compounded ,the ,secretary shall1 after consultation with appropriate stakeholders 7including pharmacists1 patient and public health advocacy groups1 manufacturers1 and health care professionals71 promulgate a list of active ingredients and dosage forms that should not be compounded1 because the compounding of such active ingredient or dosage form is reasonably likely to present a risk to public health4 7i7 ,minimum standards 7#a7 ,in general ,the ,secretary shall promulgate minimum standards for the safe production of compounded drug products under this section4 7#b7 ,contents ,the standards under paragraph 7#a7 shall each specify-- 7,a7 the type of compounded drug products to which they apply2 and 7,b7 the intended route of administration4 7j7 ,training ,the ,secretary shall conduct a series of regional training opportunities for ,state agencies that regulate pharmacies that compound drug products4 ,these training opportunities shall include information on the minimum standards under subsection 7i71 sample inspection protocol1 and recordkeeping to facilitate the inclusion of ,state findings and inspections into the database under subsection 7g74 4 7b7 ,deadlines and advisory committees 7#a7 ,deadline for issuance of regulations ,not later than #ah months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue regulations to implement-- 7,a7 paragraphs 7#d7 and 7#e7 of section #ejc;,a7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a72 and 7,b7 subsection 7g7 of section #ejc;,a of such ,act4 7#b7 ,labeling advisory committee 7,a7 ,establishment ,the ,secretary of ,health and ,human ,services shall establish an advisory committee on labeling 7as defined in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba77 of compounded drug products and shall consult such committee in the development of the regulations under paragraph 7#a77;,a74 7,b7 ,membership ,the advisory committee shall include representatives of patients or consumers1 health care providers1 compounding pharmacies1 ,state agencies that regulate compounding pharmacies1 and at least one member with expertise on clearly communicating information in such labeling of drugs4 7,c7 ,meetings ,the advisory committee shall hold an initial meeting not later than #f months after the date of enactment of this ,act4 7,d7 ,recommendations ,not later than #ab months after the date of enactment of this ,act1 the advisory committee shall submit to the ,secretary of ,health and ,human ,services recommendations on the regulations under paragraph 7#a77;,a71 including recommendations on the type of information and language that should be included on the labels of drug products that are compounded pursuant to section #ejc;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7,e7 ,termination ,the advisory committee under this subparagraph shall terminate upon the submission of the recommendations under subparagraph 7,d74 7#c7 ,database advisory committee 7,a7 ,establishment ,the ,secretary of ,health and ,human ,services shall establish an advisory committee on the database described in section #ejc;,a7g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a71 and shall consult such committee in the development of the regulations under paragraph 7#a77;,b74 7,b7 ,membership ,the advisory committee shall include representatives of patients or consumers1 health care providers1 compounding pharmacies1 ,state agencies that regulate compounding pharmacies1 and information technology experts4 7,c7 ,meetings ,the advisory committee shall hold an initial meeting not later than #f months after the date of enactment of this ,act4 7,d7 ,recommendations ,not later than #ab months after the date of enactment of this ,act1 the advisory committee shall submit to the ,secretary of ,health and ,human ,services recommendations on the regulations under paragraph 7#a77;,b74 7,e7 ,termination ,the advisory committee under this subparagraph shall terminate upon the submission of the recommendations under subparagraph 7,d74 7#d7 ,permanent advisory committee on pharmacy compounding ,the ,secretary shall convene the ,advisory ,committee on ,pharmacy ,compounding as appropriate to consider issues related to the safety and availability of compounded drug products4 #c4 ,reports and studies 7a7 ,biannual reports ,not later than #f months after the date of enactment of this ,act1 and at the end of each succeeding #f-month period that ends before the #beth month after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall submit to the ,congress a report on the status of the implementation of the requirements of this ,act1 and the amendments made by this ,act4 7b7 ,third-,party ,accreditation ,not later than #ab months after the date of enactment of this ,act1 the ,secretary shall submit to the ,congress a report that contains-- 7#a7 a review of the standards used by organizations that provide accreditation to compounding pharmacies2 and 7#b7 an evaluation of the effectiveness of such standards in ensuring the production of safe and effective compounded drug products4 7c7 ,structure of ,state oversight ,not later than #ah months after the date of enactment of this ,act1 the ,secretary shall submit to the ,congress a report that contains-- 7#a7 a review of the models used by ,states to structure their oversight of pharmacies that compound drug products1 including the structure of the agency or office responsible for oversight and its relationship with the industry that it regulates2 and 7#b7 consideration of how the structure and relationship of ,state regulators may impact the development and enforcement of regulations to ensure safe compounded drug products4 7d7 ,,gao report ,the ,comptroller ,general of the ,united ,states shall review-- 7#a7 the extent to which ,federal health care programs 7as such term is defined in section #aabh;,b7f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;b77 ensure that compounded drug products which are paid for by such programs are compounded in facilities that comply with the requirements of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq472 7#b7 whether the reimbursement rates for compounded drug products under such ,federal health care programs are appropriate1 taking into consideration the cost of production of such compounded drug products2 and 7#c7 whether such ,federal health care programs encourage the use of compounded drug products in place of otherwise available lawfully marketed drug products4 #d4 ,prohibitions and penalties 7a7 ,prohibition of violations of section #ejc;,a ,section #cja7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7;d77 is amended by inserting #ejc;,a1 before #eje14 7b7 ,penalties ,section #cjc7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7;b77 is amended by adding at the end the following3 7#h7 ,notwithstanding subsection 7a71 any person who violates section #cja7;d7 with respect to any compounded drug product-- 7,a7 knowingly and intentionally to defraud or mislead2 or 7,b7 with conscious or reckless disregard of a risk of death or serious bodily injury1 shall be fined under title #ah1 ,united ,states ,code1 imprisoned for not more than #aj years1 or both4 4