,i #aacth ,,congress #ast ,session ,h4 ,r4 #cjhi ,,in ,,the ,,house ,,of ,,representatives ,september #ab1 #bjac ,mr4 ,griffith of ,virginia 7for himself1 ,ms4 ,de,gette1 and ,mr4 ,gene ,green of ,texas7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend section #ejc;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act with respect to pharmacy compounding4 #a4 ,short title ,this ,act may be cited as the ,compounding ,clarity ,act of #bjac4 #b4 ,traditional pharmacy compounding ,section #ejc;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;a7 is amended to read as follows3 #ejc;,a4 ,traditional pharmacy compounding 7a7 ,in ,general ,sections #eja7;a77#b77;,b71 #ejb7;f77#a71 and #eje of this ,act and section #cea of the ,public ,health ,service ,act shall not apply to a drug product for human use if each of the following conditions is met3 7#a7 ,identified patient and receipt of prescription ,the drug product is compounded in accordance with one of the following3 7,a7 ,in general ,the drug product is compounded by a licensed pharmacist in a ,state-licensed pharmacy or a ,federal facility1 or by a licensed physician1 for an identified individual patient based on the receipt of a valid prescription4 7,b7 ,anticipatory compounding ,the drug product is compounded by a licensed pharmacist in a ,state-licensed pharmacy or a ,federal facility1 or by a licensed physician1 in limited quantities before the receipt of a valid prescription for an identified individual patient1 based on-- 7i7 historical demand for the drug product2 and 7ii7 a history of prescriptions for the drug product generated solely within an established relationship between the licensed pharmacist or licensed physician who is performing the compounding and-- 7,i7 the individual patient2 or 7,,ii7 the physician or other licensed practitioner who writes the prescription4 7,c7 ,compounding for office use ,the drug product is compounded by a licensed pharmacist in a ,state-licensed pharmacy or a ,federal facility1 or by a licensed physician1 pursuant to a non-patient-specific purchase order and-- 7i7 the drug product will be administered by a health care practitioner within a physician's office1 a hospital1 or another health care setting2 7ii7 valid patient-specific prescriptions or1 when a compounded drug product is administered within the same health system in which it was compounded1 valid patient names-- 7,i7 are submitted1 electronically or otherwise1 to the pharmacist or physician who performs the compounding1 not later than #g business days after the drug product is administered2 and 7,,ii7 will1 in the aggregate1 account for the total volume of drug product compounded pursuant to the non-patient-specific purchase order2 7iii7 during any #f-month period1 of the total drug products dispensed from the facility at which the drug product was compounded1 not more than #e percent are compounded sterile drug products that are-- 7,i7 dispensed pursuant to this subparagraph2 and 7,,ii7 shipped interstate2 7iv7 records of the compounding will be kept for not less than #c years2 and 7v7 the statement ,office ,use ,only and the statement ,not for resale appear on the compounded drug product4 ,compounding under this subparagraph shall not be considered to be in violation of clause 7ii7 because of the failure of a pharmacist or a physician to account for valid patient-specific prescriptions or valid patient names as required by such clause1 so long as the pharmacist or physician makes a good faith1 reasonable effort to account for the prescriptions or names1 as applicable1 and does not continue to compound drug products under this subparagraph for a health care practitioner or facility with a history of failing to submit such prescriptions or patient names4 7#b7 ,quality standards ,irrespective of whether a drug product is compounded under subparagraph 7,a71 7,b71 or 7,c7 of paragraph 7#a71 the drug product is compounded1 stored1 and dated in compliance with the ,united ,states ,pharmacopoeia chapters that are applicable to pharmaceutical compounding 7including the chapter on sterile preparations74 7#c7 ,bulk drug substances ,if the drug product is compounded using bulk drug substances 7as defined in regulations of the ,secretary published at section #bjg4c7;a77#d7 of title #ba of the ,code of ,federal ,regulations 7or any successor regulations77-- 7,a7 the bulk drug substances-- 7i7 if an applicable monograph exists under the ,united ,states ,pharmacopoeia1 the ,national ,formulary1 or another compendium or pharmacopeia recognized under ,federal law1 each comply with the monograph2 7ii7 if such a monograph does not exist1 each are drug substances that are components of drug products approved or licensed by the ,secretary for human use2 or 7iii7 if such a monograph does not exist and the drug substance is not a component of a drug product so approved or licensed1 each appear on a list published by the ,secretary 7through regulations issued under subsection 7e772 7,b7 the bulk drug substances are each manufactured by an establishment that is registered under section #eaj 7including a foreign establishment that is registered under section #eaj7;i772 and 7,c7 the bulk drug substances are each accompanied by a valid certificate of analysis4 7#d7 ,ingredients 7other than bulk drug substances7 ,if any ingredients 7other than bulk drug substances7 are used in compounding the drug product1 such ingredients comply with the standards of an applicable ,united ,states ,pharmacopoeia or ,national ,formulary monograph4 7#e7 ,drug products withdrawn or removed because unsafe or not effective ,the drug product does not appear on a list published by the ,secretary of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective4 7#f7 ,essentially a copy of a marketed and approved drug product ,the licensed pharmacist or licensed physician does not compound any drug product that is essentially a copy of a marketed and approved drug product4 7#g7 ,drug products presenting demonstrable difficulties for compounding ,the drug product is not identified 7directly or as part of a category of drug products7 in a list published by the ,secretary 7through regulations issued under subsection 7e77 as a drug product that presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product4 7#h7 ,prohibition on wholesaling ,the drug product will not be sold by an entity other than the pharmacy or physician that compounded such drug product4 7b7 ,state regulation ,nothing in this section shall prevent a ,state from-- 7#a7 imposing restrictions on the type of compounding described in subparagraph 7,b7 or 7,c7 of subsection 7a77#a7 that are in addition to the restrictions applicable under this section2 or 7#b7 enforcing requirements or restrictions contained in the chapters or standards described in subsection 7a77#b74 7c7 ,notification system 7#a7 ,development and implementation ,the ,secretary shall develop and implement a system for receiving and reviewing submissions from ,state boards of pharmacy-- 7,a7 describing actions taken against compounding pharmacies2 or 7,b7 expressing concerns that a compounding pharmacy may be acting in violation of one or more requirements of this section4 7#b7 ,content of submissions from ,state boards of pharmacy ,an action referred to in paragraph 7#a77;,a7 is1 with respect to a pharmacy that compounds drug products1 any of the following3 7,a7 ,the issuance of a warning letter1 or the imposition of sanctions or penalties1 by a ,state for violations of a ,state's pharmacy regulations pertaining to compounding4 7,b7 ,the suspension or revocation of a ,state-issued pharmacy license or registration4 7,c7 ,the recall of compounded drug products due to concerns relating to the quality or purity of such products4 7#c7 ,consultation ,the ,secretary shall develop the system under paragraph 7#a7 in consultation with the ,national ,association of ,boards of ,pharmacy4 7#d7 ,review and determination by ,secretary ,the ,secretary shall review each submission received under paragraph 7#a7 and such other information as the ,secretary determines necessary 7including information collected through an inspection or maintained in the ,adverse ,event ,reporting ,system database7 and make a determination as to whether the pharmacy involved may be in violation of one or more requirements of this section4 7#e7 ,notifying ,state boards of pharmacy ,the system under paragraph 7#a7 shall be designed to immediately notify ,state boards of pharmacy when-- 7,a7 the ,secretary receives a submission under paragraph 7#a72 or 7,b7 the ,secretary makes a determination that a pharmacy may be in violation of one or more requirements of this section4 7#f7 ,timing ,not later than one year after the date of enactment of the ,compounding ,clarity ,act of #bjac1 the ,secretary shall begin implementation of the system under paragraph 7#a74 7d7 ,inspection authority ,in accordance with section #gjd7;a71 the ,secretary may inspect a pharmacy's records to determine whether the pharmacy is in violation of one or more requirements of this ,act if-- 7#a7 the inspection is conducted in coordination with the relevant ,state board or boards of pharmacy2 or 7#b7 the ,secretary has evidence that the pharmacy may be in violation of such a requirement4 7e7 ,regulations 7#a7 ,in general ,the ,secretary shall issue regulations to implement this section4 7#b7 ,advisory committee on compounding ,before issuing regulations to implement subsections 7a77#c77;,a77iii7 and 7a77#g71 the ,secretary shall convene and consult an advisory committee on compounding4 ,the advisory committee shall include representatives from the ,national ,association of ,boards of ,pharmacy1 the ,united ,states ,pharmacopoeia1 pharmacists having current experience and expertise in compounding1 physicians having background and knowledge in compounding1 and consumer organizations with an expertise in compounding4 7#c7 ,interim lists ,before the date on which final regulations are issued to implement subsections 7a77#c77;,a77iii7 and 7a77#g71 if the ,secretary determines it is necessary to protect the public health1 the ,secretary may designate drug products or substances as described in such subsections1 by-- 7,a7 publishing a notice of such drug products or substances proposed for designation1 including the rationale for such designation1 in the ,federal ,register2 7,b7 providing a period of not less than #fj calendar days for comment on the notice2 and 7,c7 publishing a notice in the ,federal ,register designating such drug products or substances4 7#d7 ,updating lists ,the ,secretary shall update the regulations containing the lists of drug products and substances described in subsections 7a77#c77;,a77iii7 and 7a77#g7 regularly1 but not less than once every three years4 7#e7 ,sunset of notice ,any notice published under paragraph 7#c7 shall not be effective after the earlier of-- 7,a7 the date that is #c years after the date of ,compounding ,clarity ,act of #bjac2 and 7,b7 the effective date of the final regulations issued to implement subsections 7a77#c77;,a77iii7 and 7a77#g74 7f7 ,definitions ,in this section3 7#a7 ,the term compounding includes-- 7,a7 the combining1 admixing1 mixing1 diluting1 reconstituting1 or otherwise altering of a marketed drug product1 except when performed in accordance with specific directions for such acts contained in approved labeling provided by the product's manufacturer or otherwise provided by that manufacturer consistent with that labeling2 7,b7 the combining1 admixing1 mixing1 diluting1 reconstituting1 or otherwise altering a bulk drug substance to create a drug product2 and 7,c7 repackaging4 7#b7 ,the term essentially a copy of a marketed and approved drug product does not include-- 7,a7 a drug product in which there is a change1 made for an identified individual patient1 which produces for that patient a clinical difference1 as determined by the prescribing practitioner1 between the compounded drug product and the comparable marketed and approved drug product2 or 7,b7 a drug product that appears on the drug shortage list in effect under section #ejf;,e4 7#c7 ,the term licensed pharmacist includes any individual who compounds drug products under the supervision of a practitioner licensed to compound drug products under ,state law4 7#d7 ,the term marketed and approved drug product means a drug product that-- 7,a7 is currently marketed2 and 7,b7 is approved under section #eje of this ,act or licensed under section #cea of the ,public ,health ,service ,act4 7#e7 7,a7 ,the term repackaging means taking a drug approved under section #eje of this ,act or licensed under section #cea of the ,public ,health ,service ,act from the container in which the drug is distributed by the original manufacturer and placing such drug in a different container of the same or smaller size without further manipulating the drug 7such as by diluting it or mixing it with another1 different drug or drugs74 7,b7 ,such term does not include removing the drug from its original container for immediate administration to an identified individual patient1 such as withdrawing a drug into a syringe for immediate injection or removing the drug from its original container within a health care entity by a practitioner1 or other licensed individual under the supervision or direction of such practitioner1 for administration within the same day within such health care entity4 4 #c4 ,outsourcing facilities 7a7 ,in general ,subchapter ,a of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended-- 7#a7 by redesignating section #ejc;,b as section #ejc;,c2 and 7#b7 by inserting after section #ejc;,a 7#ba ,u4,s4,c4 #cec;a7 the following new section3 #ejc;,b4 ,outsourcing facilities 7a7 ,in general ,sections #ejb7;f77#a7 and #eje of this ,act and section #cea of the ,public ,health ,service ,act shall not apply to a drug product compounded for human use by a licensed pharmacist in an outsourcing facility if each of the following conditions is met3 7#a7 ,registration and reporting ,the facility is in compliance with the registration and reporting requirements of subsection 7b74 7#b7 ,drug product and substance limitations ,the facility does not compound drug products in violation of paragraphs 7#c7 through 7#h7 of section #ejc;,a7a74 7#c7 ,fees ,the facility has paid all fees owed by such facility pursuant to section #gdd,k4 7#d7 ,standardized drug products from bulk ,the facility does not compound1 from bulk drug substances1 standardized dosages that are not otherwise commercially available of a marketed and approved drug product4 7#e7 ,labeling of drug products 7,a7 ,label ,the label of a drug product compounded by an outsourcing facility shall include-- 7i7 the statement ,this is a compounded drug4 or a reasonable comparable alternative statement 7as specified by the ,secretary7 that prominently identifies the drug as a compounded drug product2 7ii7 the name1 address1 and phone number of the applicable outsourcing facility2 and 7iii7 with respect to the compounded drug product-- 7,i7 the lot or batch number2 7,,ii7 the established name of the drug product2 7,,iii7 the dosage form and strength2 7,,iv7 the statement of quantity or volume1 as appropriate2 7,v7 the date that the drug product was compounded2 7,,vi7 the expiration date2 7,,vii7 storage and handling instructions2 7,,viii7 the ,national ,drug ,code number1 if available2 7,,ix7 the ,not for resale statement required under section #ejc;,a7a77#a77;,c77v72 and 7,x7 subject to subparagraph 7,b77i71 a list of active and inactive ingredients1 identified by established name and the quantity or proportion of each ingredient4 7,b7 ,container ,the container from which the individual units of a drug product compounded by an outsourcing facility are removed for dispensing or for administration 7such as a plastic bag containing individual product syringes7 shall include-- 7i7 the information described under subparagraph 7,a77iii77,x71 if there is not space on the label for such information2 7ii7 the following information to facilitate adverse event reporting3 www4fda4gov_/medwatch and #a-hjj-;,,fda-#ajhh2 and 7iii7 directions for use1 including1 as appropriate1 dosage and administration4 7,c7 ,additional information ,the label and labeling of a drug product compounded by an outsourcing facility shall include any other information as determined necessary and specified in regulations promulgated by the ,secretary 7b7 ,registration of outsourcing facilities and reporting of drug products 7#a7 ,registration of outsourcing facilities 7,a7 ,annual registration ,during the period beginning on ,october #a and ending on ,december #ca each year1 each outsourcing facility-- 7i7 shall register with the ,secretary its name1 place of business1 and unique facility identifier 7which shall conform to the requirements for the unique facility identifier established under section #eaj71 and a point of contact e-mail address2 and 7ii7 shall indicate whether the outsourcing facility intends to compound a drug product that appears on the list in effect under section #ejf;,e during the subsequent calendar year4 7,b7 ,new outsourcing facilities ,each outsourcing facility1 upon first engaging in compounding pursuant to this section1 shall immediately register with the ,secretary and provide the information described in paragraph 7#a77;,a74 ,the ,secretary shall establish a timeline for registration for the first calendar year following the effective date of the ,compounding ,clarity ,act of #bjac4 ,in no case may registration be required until at least #fj calendar days following publication of the timeline in the ,federal ,register4 7,c7 ,availability of registration for inspection2 list 7i7 ,registrations ,the ,secretary shall make available for inspection1 to any person so requesting1 any registration filed pursuant to this paragraph4 7ii7 ,list ,the ,secretary shall make available on the public ,internet ,web site of the ,food and ,drug ,administration a list of the name of each facility registered under this subsection as an outsourcing facility1 the ,state in which each such facility is located1 whether the facility compounds from bulk drug substances1 and whether any such compounding from bulk drug substances is for sterile or non-sterile drug products4 7#b7 ,drug product reporting by outsourcing facilities 7,a7 ,in general ,upon initially registering as an outsourcing facility1 once during the month of ,june of each year1 and once during the month of ,december of each year1 each outsourcing facility that registers with the ,secretary under paragraph 7#a7 shall submit to the ,secretary a report-- 7i7 identifying the drug products compounded by such outsourcing facility during the previous #f-month period2 and 7ii7 with respect to each drug product identified under clause 7i71 providing the active ingredient2 the source of such active ingredient2 the ,national ,drug ,code number1 if available1 of the source drug product or bulk active ingredient2 the strength of the active ingredient per unit2 the dosage form and route of administration2 the package description2 the number of individual units produced2 and the ,national ,drug ,code number of the final product1 if assigned4 7,b7 ,form ,each report under subparagraph 7,a7 shall be prepared in such form and manner as the ,secretary may prescribe by regulation or guidance4 7,c7 ,confidentiality ,reports submitted under this paragraph shall be exempt from inspection under paragraph 7#a77;,c71 unless the ,secretary finds that such an exemption would be inconsistent with the protection of the public health4 7#c7 ,electronic registration and reporting ,registrations and drug product reporting under this subsection 7including the submission of updated information7 shall be submitted to the ,secretary by electronic means unless the ,secretary grants a request for waiver of such requirement because use of electronic means is not reasonable for the person requesting waiver4 7#d7 ,risk-based inspection frequency 7,a7 ,in general ,outsourcing facilities-- 7i7 shall be subject to inspection pursuant to section #gjd2 and 7ii7 shall not be eligible for the exemption under section #gjd7;a77#b77;,a74 7,b7 ,risk-based schedule ,the ,secretary1 acting through one or more officers or employees duly designated by the ,secretary1 shall inspect outsourcing facilities in accordance with a risk-based schedule established by the ,secretary4 7,c7 ,risk factors ,in establishing the risk-based schedule1 the ,secretary shall inspect outsourcing facilities according to the known safety risks of such outsourcing facilities1 which shall be based on the following factors3 7i7 ,the compliance history of the outsourcing facility4 7ii7 ,the record1 history1 and nature of recalls linked to the outsourcing facility4 7iii7 ,the inherent risk of the drug products compounded at the outsourcing facility4 7iv7 ,the inspection frequency and history of the outsourcing facility1 including whether the outsourcing facility has been inspected pursuant to section #gjd within the last #d years4 7v7 ,whether the outsourcing facility has registered under this paragraph as an entity that intends to compound a drug product that appears on the list in effect under section #ejf;,e4 7vi7 ,any other criteria deemed necessary and appropriate by the ,secretary for purposes of allocating inspection resources4 7#e7 ,adverse event reporting ,outsourcing facilities shall be required to submit adverse event reports to the ,secretary in accordance with the content and format requirements established through guidance or regulation under section #caj4cje of title #ba1 ,code of ,federal ,regulations 7or any successor regulations7 or section #fjj4hj of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 7c7 ,definitions ,in this section3 7#a7 ,outsourcing facility ,the term outsourcing facility means a facility at one geographic location or address that compounds sterile drug products for office use in excess of the limitation set forth in section #ejc;,a7a77#a77;,c77iii74 7#b7 ,other definitions ,the terms compounding1 essentially a copy of a marketed and approved drug product1 licensed pharmacist1 and marketed and approved drug product have the meanings given such terms in section #ejc;,a7f74 4 7b7 ,fees ,subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;f et seq47 is amended by adding at the end the following3 #i ,fees relating to outsourcing facilities #gdd;,j4 ,definitions ,in this part3 7#a7 ,the term affiliate has the meaning given such term in section #gce7aa74 7#b7 ,the term gross annual sales means the total worldwide gross annual sales1 in ,united ,states dollars1 for an outsourcing facility1 including the sales of all the affiliates of the outsourcing facility4 7#c7 ,the term outsourcing facility has the meaning given to such term in section #ejc;,b7c74 7#d7 ,the term reinspection means1 with respect to an outsourcing facility1 one or more inspections conducted under section #gjd subsequent to an inspection conducted under such provision which identified noncompliance materially related to an applicable requirement of this ,act1 specifically to determine whether compliance has been achieved to the ,secretary's satisfaction4 #gdd,k4 ,authority to assess and use outsourcing facility fees 7a7 ,establishment and reinspection fees -- 7#a7 ,in general ,for fiscal year #bjae and each subsequent fiscal year1 the ,secretary shall1 in accordance with this subsection1 assess and collect-- 7,a7 an annual establishment fee from each outsourcing facility2 and 7,b7 a reinspection fee from each outsourcing facility subject to a reinspection in such fiscal year4 7#b7 ,multiple reinspections ,an outsourcing facility subject to multiple reinspections in a fiscal year shall be subject to a reinspection fee for each reinspection4 7b7 ,establishment and reinspection fee setting ,the ,secretary shall-- 7#a7 establish the amount of the establishment and reinspection fee to be collected under this section for each fiscal year based on the methodology described in subsection 7c72 and 7#b7 publish such fee amounts in a ,federal ,register notice not later than #fj calendar days before the start of each such year4 7c7 ,amount of establishment fee and reinspection fee 7#a7 ,in general ,for each outsourcing facility in a fiscal year-- 7,a7 except as provided in paragraph 7#d71 the amount of the annual establishment fee under subsection 7b7 shall be equal to the sum of-- 7i7 #ae1jjj1 multiplied by the inflation adjustment factor described in paragraph 7#b72 plus 7ii7 the small business adjustment factor described in paragraph 7#c72 and 7,b7 the amount of any reinspection fee 7if applicable7 under subsection 7b7 shall be equal to #ae1jjj1 multiplied by the inflation adjustment factor described in paragraph 7#c74 7#b7 ,inflation adjustment factor 7,a7 ,in general ,for fiscal year #bjae and subsequent fiscal years1 the fee amounts established in paragraph 7#a7 shall be adjusted by the ,secretary by notice1 published in the ,federal ,register1 for a fiscal year by the amount equal to the sum of-- 7i7 one2 7ii7 the average annual percent change in the cost1 per full-time equivalent position of the ,food and ,drug ,administration1 of all personnel compensation and benefits paid with respect to such positions for the first #c years of the preceding #d fiscal years1 multiplied by the proportion of personnel compensation and benefits costs to total costs of an average full-time equivalent position of the ,food and ,drug ,administration for the first #c years of the preceding #d fiscal years2 and 7iii7 the average annual percent change that occurred in the ,consumer ,price ,index for urban consumers 7,u4,s4 ,city ,average2 ,not ,seasonally ,adjusted2 ,all items2 ,annual ,index7 for the first #c years of the preceding #d years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of an average full-time equivalent position of the ,food and ,drug ,administration for the first #c years of the preceding #d fiscal years4 7,b7 ,compounded basis ,the adjustment made each fiscal year under subparagraph 7,a7 shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year #bjad under subparagraph 7,a74 7#c7 ,small business adjustment factor ,the small business adjustment factor referred to in paragraph 7#a77;,a77ii7 shall be an amount established by the ,secretary for each fiscal year based on the ,secretary's estimate of-- 7,a7 the number of small businesses that will pay a reduced establishment fee for such fiscal year2 and 7,b7 the adjustment to the establishment fee necessary to achieve total fees equaling the total fees that the ,secretary would have collected if no entity qualified for the small business exception in paragraph 7#d74 7#d7 ,exception for small businesses 7,a7 ,in general ,in the case of an outsourcing facility with gross annual sales of #a1jjj1jjj or less in the #ab months ending ,april #a of the fiscal year immediately preceding the fiscal year in which the fees under this section are assessed1 the amount of the establishment fee under subsection 7b7 for a fiscal year shall be equal to #a_/c of the amount calculated under paragraph 7#a77;,a77i7 for such fiscal year4 7,b7 ,application ,to qualify for the exception under this paragraph1 a small business shall submit to the ,secretary a written request for such exception1 in a format specified by the ,secretary in guidance1 certifying its gross annual sales for the #ab months ending ,april #a of the fiscal year immediately preceding the fiscal year in which fees under this subsection are assessed4 ,any such application shall be submitted to the ,secretary not later than ,april #cj of such immediately preceding fiscal year4 7#e7 ,crediting of fees ,in establishing the small business adjustment factor under paragraph 7#c7 for a fiscal year1 the ,secretary shall-- 7,a7 provide for the crediting of fees from the previous year to the next year if the ,secretary overestimated the amount of the small business adjustment factor for such previous fiscal year2 and 7,b7 consider the need to account for any adjustment of fees and such other factors as the ,secretary determines appropriate4 7d7 ,use of fees ,the ,secretary shall make all of the fees collected pursuant to subparagraphs 7,a7 and 7,b7 of subsection 7a77#a7 available solely to pay for the costs of oversight of outsourcing facilities4 7e7 ,supplement not supplant ,funds received by the ,secretary pursuant to this section shall be used to supplement and not supplant any other ,federal funds available to carry out the activities described in this section4 7f7 ,crediting and availability of fees ,fees authorized under this section shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations ,acts4 ,such fees are authorized to remain available until expended4 ,such sums as may be necessary may be transferred from the ,food and ,drug ,administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation4 ,the sums transferred shall be available solely for the purpose of paying the costs of oversight of outsourcing facilities4 7g7 ,collection of fees 7#a7 ,establishment fee ,an outsourcing facility shall remit the establishment fee due under this section in a fiscal year when submitting a registration pursuant to section #ejc;,b7b7 for such fiscal year4 7#b7 ,reinspection fee ,the ,secretary shall specify in the ,federal ,register notice described in subsection 7b77#b7 the manner in which reinspection fees assessed under this section shall be collected and the timeline for payment of such fees4 ,such a fee shall be collected after the ,secretary has conducted a reinspection of the outsourcing facility involved4 7#c7 ,effect of failure to pay fees 7,a7 ,registration ,an outsourcing facility shall not be considered registered under section #ejc;,b7b7 in a fiscal year until the date that the outsourcing facility remits the establishment fee under this subsection for such fiscal year4 7,b7 ,misbranding ,all drug products manufactured1 prepared1 propagated1 compounded1 or processed by an outsourcing facility for which any establishment fee or reinspection fee has not been paid1 as required by this section1 shall be deemed misbranded under section #ejb until the fees owed for such outsourcing facility under this section have been paid4 7#d7 ,collection of unpaid fees ,in any case where the ,secretary does not receive payment of a fee assessed under this section within #cj calendar days after it is due1 such fee shall be treated as a claim of the ,united ,states ,government subject to provisions of subchapter ,,ii of chapter #cg of title #ca1 ,united ,states ,code4 7h7 ,annual report to ,congress ,not later than #abj calendar days after each fiscal year in which fees are assessed and collected under this section1 the ,secretary shall submit a report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 to include a description of fees assessed and collected for such year1 a summary description of entities paying the fees1 a description of the hiring and placement of new staff1 a description of the use of fee resources to support inspecting outsourcing facilities1 and the number of inspections and reinspections of such facilities performed each year4 7i7 ,authorization of appropriations ,for fiscal year #bjae and each subsequent fiscal year1 there is authorized to be appropriated for fees under this subsection an amount equivalent to the total amount of fees assessed for such fiscal year under this section4 4 #d4 ,prohibited acts 7a7 ,intentional falsification of prescription order for compounded drug product ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is amended by inserting after paragraph 7bbb7 the following3 7ccc7 ,with respect to a drug product to be compounded under section #ejc;,a or #ejc;,b1 the intentional falsification of a prescription1 a purchase order1 or patient name required under section #ejc;,a or #ejc;,b4 4 7b7 ,intentional failure of outsourcing facility ,to register ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca71 as amended by subsection 7a71 is further amended by inserting after paragraph 7ccc7 7as added by such subsection71 the following3 7ddd7 ,with respect to any year in which an outsourcing facility is required to register with the ,secretary under section #ejc;,b7b71 the intentional failure of the outsourcing facility to so register4 4