,i #aafth ,,congress #ast ,session ,h4 ,r4 #hfc ,,in ,,the ,,house ,,of ,,representatives ,january #cj1 #bjai,ms4 ,matsui 7for herself and ,mr4 ,johnson of ,ohio7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to prevent the abuse of dextromethorphan1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,,dxm ,abuse ,prevention ,act of #bjai4 #b4 ,sales of over-the-counter drugs containing dextromethorphan 7a7 ,prohibited acts 7#a7 ,verification system ,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 7fff7 ,the failure of a retailer 7as defined in section #ejf;,h7 that offers for sale in interstate commerce covered drugs 7as defined in section #ejf;,h7 to have a verification system as required by section #ejf;,h 7relating to sales of over-the-counter drugs containing dextromethorphan74 4 7#b7 ,identifier for electronic point of sale system2 active ingredients ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca71 as amended by paragraph 7#a71 is further amended by adding at the end the following3 7ggg7 ,the introduction or delivery for introduction into interstate commerce of any covered drug 7as defined in section #ejf;,h7 whose labeling does not include-- 7#a7 a universal product code1 universal product number1 bar code1 or similar identifier to allow an electronic point of sale system to recognize that the sale of the covered drug is prohibited to those under the age of #ah2 and 7#b7 the established name of each active ingredient of the covered drug within the first panel of the drug facts labeling required by section #bja4ff7;c7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulations71 in no smaller than #f-point type4 4 7b7 ,verification system ,the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #ejf;,g of such ,act 7#ba ,u4,s4,c4 #cef;g7 the following3 #ejf;,h4 ,sales of over-the-counter drugs containing dextromethorphan 7a7 ,verification system ,any retailer selling or offering for sale in interstate commerce a covered drug shall have a verification system in accordance with this section that is intended to ensure that no individual who purchases a covered drug from the retailer is under #ah years of age4 ,such a system shall be set up to prompt a retailer to examine a purchaser's identification card4 7b7 ,means used ,to ensure compliance ,a verification system under subsection 7a7 may ensure compliance with this section by any of1 or any combination of1 the following means3 7#a7 ,an electronic point-of-sale system that is coded-- 7,a7 to prompt for verification of the age of purchasers of covered drugs2 and 7,b7 to deny sales of covered drugs to those under the age of #ah4 7#b7 ,training manuals1 materials1 or programs that instruct employees-- 7,a7 to verify the age of purchasers of covered drugs2 and 7,b7 to deny sales of covered drugs to those under the age of #ah4 7#c7 ,signage in and around the sales counter outlining the age restriction on sales of covered drugs4 7#d7 ,designating one on-duty employee to approve sales of covered drugs4 7#e7 ,any other verification measure adopted by a retailer that is designed to ensure that a purchaser of a covered drug is not under #ah years of age if1 based on an examination of the purchaser's identification card1 the retailer reasonably concludes the identification card is valid and indicates the purchaser is not under #ah years of age4 7c7 ,exceptions 7#a7 ,individuals over #bf ,a verification system under subsection 7a7 need not require verification of the age of any individual over the age of #bf4 7#b7 ,valid prescription ,a verification system under subsection 7a7 need not apply to any sale made by a retailer that is a pharmacy pursuant to a validly issued prescription4 7#c7 ,valid military identification card ,a verification system under subsection 7a7 need not apply to any sale to an individual who supplies proof at the time of such sale that such individual is actively enrolled in the military and presents a valid military identification card4 7d7 ,enforcement ,in carrying out this section1 the ,secretary shall coordinate with ,state entities that regulate retailers1 as designated by the ,state1 to perform activities to ensure compliance with this section1 including providing for appropriate investigation of complaints related to violations of this section4 7e7 ,compliance with ,state system ,if a ,state has a law under which a retailer in the ,state is required to have a system that ensures that no individual who purchases a covered drug from the retailer is under #ah years of age1 the ,secretary shall treat any such retailer in the ,state that is in compliance with such law as having a verification system as required by this section1 including for purposes of sections #cja7;fff7 and #cjc7;h74 7f7 ,definitions ,in this section3 7#a7 ,the term covered drug-- 7,a7 means a drug that-- 7i7 contains dextromethorphan2 and 7ii7 is not subject to section #ejc7;b77#a72 and 7,b7 excludes any drug that is packaged in packets or pouches and contains #b or fewer maximum adult doses of dextromethorphan as allowable under section #cda4gd of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 7#b7 ,the term identification card means an identification card that-- 7,a7 includes a photograph and the date of birth of the individual2 and 7,b7 is issued by a ,state or the ,federal ,government or is considered acceptable for purposes of sections #bgd;a4#b7;b77#a77v77,a7 and #bgd;a4#b7;b77#a77v77,b77#a7 of title #h1 ,code of ,federal ,regulations 7including any successor regulations74 7#c7 ,the term retailer means-- 7,a7 a grocery store1 general merchandise store1 drug store1 pharmacy1 convenience store1 or other entity whose activities as a seller of covered drugs containing dextromethorphan are limited almost exclusively to sales for personal use1 both in number and volume of sales1 including any sales made by the ,internet or other means2 and 7,b7 excludes any entity listed in subparagraph 7,a7 that does not sell any covered drug described in paragraph 7#a77;,a74 4 7c7 ,civil penalties ,section #cjc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 is amended by adding at the end the following3 7h7 ,a retailer that violates section #cja7;fff7 shall not be subject to subsection 7a7 or any civil monetary penalty under this ,act for such violation except as follows3 7#a7 ,if the ,secretary finds that a retailer fails to have a verification system in violation of section #cja7;fff7-- 7,a7 upon the first such finding1 the ,secretary shall issue a formal notice of violation and give the retailer a period of at least #cj days 7beginning on the receipt of such notice7 to correct the violation2 7,b7 upon the second such finding1 the retailer shall be subject to a civil penalty of not more than #a1jjj2 7,c7 upon the third such finding1 the retailer shall be subject to a civil penalty of not more than #b1jjj2 and 7,d7 upon the fourth and any subsequent such finding1 the retailer shall be subject to a civil penalty of not more than #e1jjj4 7#b7 ,in determining the amount of a civil penalty under this subsection for a retailer1 the ,secretary shall consider whether the retailer has taken appropriate steps to prevent subsequent violations1 such as the establishment and administration of a documented employee training program to ensure all employees are familiar with1 and abiding by1 the retailer's verification system established pursuant to section #ejf;,h1 where such program includes-- 7,a7 educating employees regarding covered drugs2 7,b7 instruction on the correct method of checking a purchaser's identification card2 and 7,c7 notifying employees of the civil penalties under this subsection4 7#c7 ,if a retailer transacts sales of covered drugs at more than one physical location1 for purposes of determining the number of violations by that retailer under this subsection1 each individual physical location operated by that retailer shall be considered a separate retailer4 7#d7 ,the ,secretary shall notify retailers found to have violated section #cja7;fff7 as soon as practicable after the ,secretary discovers such violation4 ,such notification shall include the date and time when the failure to have a verification system as required by such section was observed to occur4 7#e7 ,in this subsection1 the terms covered drug and retailer have the meanings given such terms in section #ejf;,h4 4 7d7 ,applicability ,the amendments made by subsections 7a71 7b71 and 7c7 shall apply with respect to drugs sold or offered for sale on or after the date that is one year after the date of enactment of this ,act4 7e7 ,sense of ,congress regarding communication by organizations nominated by manufacturers ,it is the sense of ,congress that organizations nominated by manufacturers of covered drugs 7as defined in section #ejf;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7c77 should make reasonable efforts to communicate to retailers 7as defined in such section #ejf;,h7 the requirements of such section #ejf;,h1 including by making available upon request materials 7which may include signage1 manuals1 materials1 or programs7 to assist with educating employees regarding such covered drugs4 #c4 ,restrictions on distribution of bulk dextromethorphan 7a7 ,in general ,the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended-- 7#a7 in section #cja 7#ba ,u4,s4,c4 #cca7 7as amended by section #b7;a77 by adding at the end the following3 7hhh7 ,the possession1 receipt1 or distribution of unfinished dextromethorphan in violation of section #ejf;,i4 2 7#b7 by inserting after section #ejf;,h 7as added by section #b7;b77 the following3 #ejf;,i4 ,restrictions on the distribution of bulk dextromethorphan 7a7 ,in general ,no person shall-- 7#a7 possess or receive unfinished dextromethorphan1 unless the person is registered under section #eaj or otherwise registered1 licensed1 or approved pursuant to ,federal or ,state law to engage in-- 7,a7 the practice of pharmacy2 or 7,b7 drug or drug ingredient discovery1 production1 manufacture1 or distribution2 or 7#b7 distribute unfinished dextromethorphan to any person other than a person described in paragraph 7#a74 7b7 ,exception for common carriers ,this section does not apply to a common carrier that possesses1 receives1 or distributes unfinished dextromethorphan for purposes of distributing such unfinished dextromethorphan between persons described in subsection 7a74 7c7 ,definitions ,in this section3 7#a7 ,the term common carrier means any person that holds itself out to the general public as a provider for hire of the transportation by water1 land1 or air of merchandise1 whether or not the person actually operates the vessel1 vehicle1 or aircraft by which the transportation is provided1 between a port or place and a port or place in the ,united ,states4 7#b7 ,the term unfinished dextromethorphan means dextromethorphan that is not contained in a drug that is in finished dosage form4 2 and 7#c7 by amending section #cjc1 as amended by section #b7;c71 by adding at the end the following3 7i7 ,a person that violates section #cja7;hhh7 shall not be subject to subsection 7a7 or any civil monetary penalty under this ,act for such violation except such person shall be subject to a civil penalty in an amount of not more than #ajj1jjj4 4 7b7 ,applicability ,the amendments made by this section apply beginning on the date of enactment of this ,act4