,i #aacth ,,congress #ast ,session ,h4 ,r4 #aieh ,,in ,,the ,,house ,,of ,,representatives ,may #ad1 #bjac ,mr4 ,cummings introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to prohibit wholesalers from purchasing prescription drugs from pharmacies1 and to enhance information and transparency regarding drug wholesalers engaged in interstate commerce4 #a4 ,short title ,this ,act may be cited as the ,gray ,market ,drug ,reform and ,transparency ,act of #bjac4 #b4 ,prohibition against wholesale distributors purchasing prescription drugs from pharmacies 7a7 ,prohibited act ,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 7ccc7 ,the purchase or receipt by any person required to report under section #eaj7;b77#d7 7relating to wholesale distributors of prescription drugs7 of any drug subject to section #ejc7;b77#a7 from a pharmacy or pharmacist1 except that this paragraph does not apply to the return of a drug to the wholesale distributor from which the particular drug was purchased4 4 7b7 ,misbranding ,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 7bb7 ,if it is purchased or received in violation of section #cja7;aaa7 7prohibiting the purchase or receipt of prescription drugs by wholesale distributors from pharmacists74 4 #c4 ,reporting by wholesale distributors of prescription drugs 7a7 ,reporting requirement 7#a7 ,in general ,section #eaj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7 is amended-- 7,a7 in subsection 7b71 by adding at the end the following3 7#d7 ,on or before ,december #ca of each year1 every person engaged in the wholesale distribution in interstate commerce of drugs subject to section #ejc7;b77#a7 shall report to the ,secretary such person's name1 contact information for such person's principal officer 7or the designee thereof71 such person's places of business1 such person's licensing information 7including the type of license and expiration date7 for each ,state in which such person is so engaged1 and such other information as the ,secretary deems appropriate4 2 7,b7 in subsection 7c7-- 7i7 by striking the second period at the end2 and 7ii7 by adding at the end the following3 ,every person upon first engaging in the wholesale distribution in interstate commerce of drugs subject to section #ejc7;b77#a7 shall immediately report to the ,secretary the information described in subsection 7b77#d74 7,c7 in subsection 7d71 by adding at the end the following3 ,every person duly reporting in accordance with the foregoing subsections shall immediately report to the ,secretary with respect to any additional establishment which the person owns or operates in any ,state and in which the person begins the wholesale distribution in interstate commerce of drugs subject to section #ejc7;b77#a744 7#b7 ,reporting number ,subsection 7e7 of section #eaj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7 is amended-- 7,a7 by striking registration number and inserting registration or reporting number2 and 7,b7 by inserting or reporting in accordance with subsections 7b77#d71 7c71 or 7d7 after registered in accordance with this section4 7#c7 ,public availability2 database ,subsection 7f7 of section #eaj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7 is amended-- 7,a7 by striking 7f7 and inserting 7f77#a72 and 7,b7 by adding at the end the following3 7#b7 7,a7 ,the ,secretary1 acting directly or by entering into a contract with a private entity1 shall establish and maintain a database including all information reported under subsection 7b77#d71 the second sentence of subsection 7c71 and the second sentence of subsection 7d74 7,b7 ,subject to subparagraph 7,c71 the ,secretary shall make the information in such database publicly available1 including on the public ,website of the ,food and ,drug ,administration4 7,c7 ,the ,secretary may choose to restrict the ,secretary's disclosure of any information reported under subsection 7b77#d71 7c71 or 7d7-- 7i7 that relates to a storage facility2 and 7ii7 whose disclosure would1 as determined by the ,secretary1 compromise the security of such facility4 4 7#d7 ,conforming amendments 7,a7 ,section #cja7p7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7p77 is amended by inserting the failure to report in accordance with subsection 7b77#d71 7c71 or 7d7 of section #eaj1 after ,the failure to register in accordance with section #eaj or #ije14 7,b7 ,section #ejb7o7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7o77 is amended by inserting if it was distributed in interstate commerce by a person in violation of the reporting requirements of subsection 7b77#d71 7c71 or 7d7 of section #eaj1 before if it was not included4 7,c7 ,section #eaj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7 is amended-- 7i7 in subsection 7g7-- 7,i7 in paragraph 7#c71 by adding or at the end2 7,,ii7 by striking paragraph 7#d72 7,,iii7 by redesignating paragraph 7#e7 as paragraph 7#d72 7,,iv7 in paragraph 7#d7 7as so redesignated71 by inserting or reporting1 as applicable1 after registration2 and 7,v7 by striking the matter following paragraph 7#d7 7as so redesignated72 7ii7 in subsection 7h71 by adding at the end the following3 7#g7 ,wholesale distributors ,every establishment in any ,state used by a person required to report under subsection 7b77#d71 7c71 or 7d7 for the wholesale distribution in interstate commerce of drugs subject to section #ejc7;b77#a7 shall be subject to inspection pursuant to section #gjd4 2 and 7iii7 in subsection 7j71 by adding at the end the following3 7#e7 ,the provisions of this subsection shall apply with respect to a person required to report under subsection 7b77#d71 7c71 or 7d7 for the wholesale distribution in interstate commerce of drugs subject to section #ejc7;b77#a7 to the same extent and in the same manner as such provisions apply to persons required to register under subsection 7b71 7c71 7d71 or 7i71 except that-- 7,a7 any reference to manufacturing shall be treated as a reference to wholesale distribution2 and 7,b7 any reference to a drug shall be treated as a reference to a drug subject to section #ejc7;b77#a74 2 and 7,d7 in subsection 7p77#a71 by striking ,registrations and listings under this section and inserting ,registrations and listings under this section1 and reports under subsection 7b77#d71 7c71 and 7d7 before shall be submitted4 7b7 ,information on ,state actions against wholesale distributors of prescription drugs ,paragraph 7#b7 of section #eaj7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;f771 as added by subsection 7a77#c77;,b7 of this section1 is amended-- 7#a7 in subparagraph 7,a71 by adding at the end of the subparagraph the following3 ,such database shall also include information on actions 7such as suspension or revocation of licensing7 taken by ,states against persons engaged in wholesale distribution of drugs subject to section #ejc7;b77#a742 and 7#b7 by adding at the end the following3 7,d7 ,the ,secretary shall encourage ,states to report the type of information described in the second sentence of subparagraph 7,a7 to the ,food and ,drug ,administration-- 7i7 in a consistent manner2 and 7ii7 on a voluntary basis4 4 7c7 ,fees for reporting ,subchapter ,c of chapter ,,vii 7#ba ,u4,s4,c4 #cgi;f et seq47 is amended by adding at the end the following3 #i ,fees relating to wholesale distributors of prescription drugs #gdd,k4 ,authority to assess and collect fees 7a7 ,in general ,for fiscal year #bjac and each subsequent fiscal year1 the ,secretary shall assess and collect fees under this section from each person that reports under section #eaj7;b77#d7 to engage in the wholesale distribution in interstate commerce of drugs subject to section #ejc7;b77#a74 7b7 ,establishment of amount 7#a7 ,in general ,not later than #a year after the date of the enactment of the ,gray ,market ,drug ,reform and ,transparency ,act of #bjac1 the ,secretary shall promulgate a final regulation establishing the amount of fees under this section for the period of fiscal years #bjad through #bjah so as to generate a total revenue amount not exceeding the ,secretary's estimate of #ajj percent of the costs described in subsection 7c7 during such period4 7#b7 ,consideration ,in establishing the amount of fees under this section1 the ,secretary shall take into consideration the amount of annual revenues of a person to be assessed such fees in comparison with the amount of annual revenues of other persons to be assessed such fees4 7c7 ,costs ,to be funded through fees ,the fees authorized by this section shall only be collected and available to pay the costs incurred by the ,food and ,drug ,administration in-- 7#a7 implementing the reporting requirement under section #eaj7;b77#d72 and 7#b7 establishing and maintaining an up-to-date database of the information collected pursuant to such requirement4 7d7 ,crediting and availability fees ,fees authorized under subsection 7a7 shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriation ,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 costs described in subsection 7c74 7e7 ,authorization of appropriations ,for each of the fiscal years #bjad through #bjah1 there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection 7b7 for the fiscal year4 7f7 ,offset ,if the sum of the cumulative amount of fees collected under this section for the fiscal years #bjad through #bjaf and the amount of fees estimated to be collected under this section for fiscal year #bjag exceeds the cumulative amount appropriated pursuant to subsection 7e7 for the fiscal years #bjad through #bjag1 the excess shall be credited to the appropriation account of the ,food and ,drug ,administration as provided in subsection 7d71 and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation ,acts for fiscal year #bjah4 4 #d4 ,identification of sales price for drugs in shortage 7a7 ,identification of sales price for drugs in shortage ,paragraph 7#a7 of section #ejc7;e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;e77 is amended-- 7#a7 in subparagraph 7,a71 by inserting before the period at the end the following3 1 the amount paid for such drug by the person receiving it if such drug is in shortage at the time of the sale1 and the amount paid for such drug for any prior sale that occurred at a time when such drug was in shortage2 and 7#b7 by adding at the end the following new subparagraph3 7,c7 ,in this paragraph1 the term in shortage means listed on the public ,website of the ,food and ,drug ,administration1 at the time of the sale to be identified in the statement required by subparagraph 7,a71 as being in shortage4 4 7b7 ,applicability ,the amendment made by subsection 7a7 applies only with respect to sales of a drug occurring on or after the date that is #a year after the date of the enactment of this ,act4