2015-2016 Bill 3160: Medications Containing Ephedrine, Pseudoephedrine, Or Phenylpropanolamine

1 South Carolina General Assembly 2 121st Session, 2015-2016 3 4 H. 3160 5 6 STATUS INFORMATION 7 8 General Bill 9 Sponsors: Rep. Spires 10 Document Path: l:\council\bills\bh\26199vr15.docx 11 12 Introduced in the House on January 13, 2015 13 Currently residing in the House Committee on Medical, Military, Public and Municipal Affairs 14 15 Summary: Medications containing ephedrine, pseudoephedrine, or phenylpropanolamine 16 17 18 HISTORY OF LEGISLATIVE ACTIONS 19 20 Date Body Action Description with journal page number 21 12/11/2014 House Prefiled 22 12/11/2014 House Referred to Committee on Medical, Military, Public and Municipal Affairs 23 1/13/2015 House Introduced and read first time ( House Journalpage 120) 24 1/13/2015 House Referred to Committee on Medical, Military, Public and Municipal Affairs 25 ( House Journalpage 120) 26 27 View the latest legislative information at the website 28 29 30 VERSIONS OF THIS BILL 31 32 12/11/2014 33 1 2 3 4 5 6 7 8 9 A BILL 10 11 TO AMEND SECTION 4453398, AS AMENDED, CODE OF 12 LAWS OF SOUTH CAROLINA, 1976, RELATING TO THE 13 SALE AND REGULATION OF PRODUCTS CONTAINING 14 EPHEDRINE, PSEUDOEPHEDRINE, OR 15 PHENYLPROPANOLAMINE, SO AS TO PROVIDE THAT 16 THESE MEDICATIONS ONLY MAY BE SOLD UPON THE 17 PRESCRIPTION OF A PHYSICIAN OR OTHER LICENSED 18 PERSON WHO HAS PRESCRIPTIVE AUTHORITY. 19 20 Be it enacted by the General Assembly of the State of South 21 Carolina: 22 23 SECTION 1. Section 4453398 of the 1976 Code, as last amended 24 by Act 242 of 2010, is further amended to read: 25 26 “Section 4453398. (A) Nonprescription products whose sole 27 active ingredient is Medications containing ephedrine, 28 pseudoephedrine, or phenylpropanolamine only may be offered for 29 retail sale only if sold in blister packaging upon the prescription of 30 a physician or a person licensed pursuant to Title 40 who has 31 prescriptive authority. The retailer shall ensure that such products 32 are not offered for retail sale by selfservice but only from behind a 33 counter or other barrier so that such products are not directly 34 accessible by the public but only by an employee or agent of the 35 retailer A pharmacist shall store and maintain these medications in 36 accordance with applicable state and federal law. 37 (B)(1) A retailer may not sell to an individual in any single day 38 a nonprescription product or a combination of nonprescription 39 products containing more than 3.6 grams of ephedrine, 40 pseudoephedrine, or phenylpropanolamine; and a retailer may not 41 sell to an individual in a thirtyday period a nonprescription product 42 or a combination of nonprescription products containing more than

[3160] 2 1 nine grams of ephedrine, pseudoephedrine, or 2 phenylpropanolamine. 3 (2) An individual may not purchase in any single day a 4 nonprescription product or a combination of nonprescription 5 products containing more than 3.6 grams of ephedrine, 6 pseudoephedrine, or phenylpropanolamine; and an individual may 7 not purchase in a thirtyday period a nonprescription product or a 8 combination of nonprescription products containing more than 9 nine grams of ephedrine, pseudoephedrine, or 10 phenylpropanolamine. 11 (C) It is unlawful for a retailer to purchase any product 12 containing ephedrine, pseudoephedrine, or phenylpropanolamine 13 from any person or entity other than a manufacturer or a wholesale 14 distributor registered by the United States Drug Enforcement 15 Administration. 16 (D)(1) A retailer selling nonprescription products pharmacist 17 selling a medication containing ephedrine, pseudoephedrine, or 18 phenylpropanolamine shall require the purchaser to produce a 19 government issued photo identification showing the date of birth 20 of the person and require the purchaser to sign an electronic log 21 showing the date and time of the transaction, the person’s name 22 and address, the type, issuing governmental entity, identification 23 number, and the amount of the compound, mixture, or preparation. 24 The retailer shall determine that the name entered in the log 25 corresponds to the name on the identification and that the date and 26 time entered are correct and shall enter in the log the name of the 27 product and the quantity sold. The retailer shall ensure that the 28 product is delivered directly into the custody of that purchaser. The 29 log must include a notice to purchasers that entering false 30 statements or misrepresentations in the log may subject the 31 purchaser to criminal penalties. 32 (2) Before completing a sale of a product regulated by this 33 section, the retailer electronically shall transmit the information 34 entered in the log to a data collection system provided by the 35 National Association of Drug Diversion Investigators, or a 36 successor or similar entity. The system must collect this data in 37 real time and generate a stop sale alert if the sale would result in a 38 violation of subsection (B) or a federal quantity restriction, which 39 must be assessed on the basis of sales or purchases made in any 40 state to the extent that information is available in the data 41 collection system. If the retailer receives a stop sale alert, the 42 retailer must not complete the sale unless the retailer, upon 43 notifying the purchaser the sale cannot be completed, reasonably

[3160] 3 1 fears bodily harm if he denies the sale due to the stop sale alert. A 2 product regulated by this section may not be sold without being 3 reported to the data collection system unless the system is 4 experiencing temporary technical difficulties that prevent a retailer 5 from reporting the information to the system, and in that case, the 6 retailer shall enter the necessary information in a written log, 7 which must subsequently be entered into the electronic log within 8 three business days of each business day that the electronic log 9 was not operational. A retailer using a written log under these 10 circumstances is immune from liability during the time the system 11 is temporarily disabled. 12 (3) Any information entered in the electronic log that is 13 retained by a retailer, or information maintained by a retailer 14 pursuant to subsection (J)(2), is confidential and not a public 15 record as defined in Section 30420(C) of the Freedom of 16 Information Act. A retailer or an employee or agent of a retailer 17 who in good faith releases information in a log to federal, state, or 18 local law enforcement authorities is immune from civil liability for 19 the release unless the release constitutes gross negligence or 20 intentional, wanton, or wilful misrepresentation. 21 (E) Except as authorized by this section, it is unlawful for any 22 person to possess, have under his or her control, manufacture, 23 deliver, distribute, dispense, administer, purchase, sell, or possess 24 with intent to distribute, any substance containing any amount of 25 ephedrine, pseudoephedrine, or phenylpropanolamine or any of 26 their salts, optical isomers, or salts of optical isomers which have 27 been altered from their original condition so as to be powdered, 28 liquefied, dissolved, solvated, or crushed. This subsection does not 29 apply to any of the substances identified within this subsection 30 which are possessed or altered for a legitimate medical purpose as 31 directed by a person licensed under Title 40 and authorized to 32 prescribe legend drugs. 33 (F) It is unlawful for a person to enter false statements or 34 misrepresentations on the log required pursuant to subsection (D) 35 (1). 36 (G) This section preempts all local ordinances or regulations 37 governing the retail sale or purchase of nonprescription products 38 containing ephedrine, pseudoephedrine, or phenylpropanolamine 39 except such local ordinances or regulations that existed on or 40 before December 31, 2004. 41 (H)(1) Except as otherwise provided in this section, it is 42 unlawful for a retailer knowingly to violate subsection (A), (B)(1),

[3160] 4 1 (C), (D)(1), or (D)(2), and it is unlawful for a person knowingly to 2 violate subsection (B)(2), (E), or (F). 3 (2) A retailer convicted of a violation of subsection (A) or 4 (B)(1) is guilty of a misdemeanor and, upon conviction for a first 5 offense, must be fined not more than five thousand dollars and, 6 upon conviction for a second or subsequent offense, must be fined 7 not more than ten thousand dollars. 8 (3) A retailer convicted of a violation of subsection (C) is 9 guilty of a misdemeanor and, upon conviction for a first offense, 10 must be imprisoned not more than one year or fined not more than 11 one thousand dollars, or both, and, upon conviction for a second or 12 subsequent offense, must be imprisoned not more than three years 13 or fined not more than five thousand dollars, or both. 14 (4) A retailer convicted of a violation of subsection (D)(1), 15 (D)(2), or (J)(2) is guilty of a misdemeanor and, upon conviction 16 for a first offense, must be fined not more than one thousand 17 dollars and not less than five hundred dollars. Upon conviction for 18 a second offense, a retailer must be fined not more than five 19 thousand dollars and not less than one thousand dollars. Upon 20 conviction for a third or subsequent offense, a person must be 21 fined not more than ten thousand dollars and not less than five 22 thousand dollars. 23 (5) A person convicted of a violation of subsection (B)(2) or 24 (E) is guilty of a felony and, upon conviction for a first offense, 25 must be imprisoned not more than five years and fined not more 26 than five thousand dollars. The court, upon approval from the 27 solicitor, may request as part of the sentence, that the offender 28 enter and successfully complete a drug treatment program. For a 29 second or subsequent offense, the offender is guilty of a felony 30 and, upon conviction, must be imprisoned not more than ten years 31 or fined not less than ten thousand dollars. 32 (6) A person convicted of a violation of subsection (F), upon 33 conviction for a first offense, is guilty of a misdemeanor and must 34 be fined not more than one thousand dollars and, upon conviction 35 for a second or subsequent offense, is guilty of a felony and must 36 be fined not more than five thousand dollars. 37 (7) It is an affirmative defense to a violation of subsection 38 (A), (C), or (D)(1) if a retailer provided the training, maintained 39 records, and obtained employee and agent statements of agreement 40 required by subsection (I) for all employees and agents at the retail 41 location where the violation occurred and at the time the violation 42 occurred.

[3160] 5 1 (8) It is an affirmative defense to completing a sale 2 following receipt of a stop sale alert received pursuant to 3 subsection (D)(2) if the retailer, upon notifying the purchaser the 4 sale cannot be completed, reasonably fears bodily harm if he 5 denies the sale due to the stop sale alert. 6 (I) A retailer shall provide training on the requirements of this 7 section to all agents and employees who are responsible for 8 delivering the products regulated by this section into the custody of 9 purchasers or who deal directly with purchasers by obtaining 10 payments for the products. A retailer shall obtain a signed, written 11 agreement from each employee or agent that the employee or agent 12 agrees to comply with the requirements of this section. The 13 retailer shall maintain records demonstrating that these employees 14 and agents have been provided this training and the documents 15 executed by the retailer’s employees and agents agreeing to 16 comply with this section. 17 (J)(1) The following are exempt from the electronic log 18 requirements of this section but shall maintain a written log 19 containing the information required to be entered in the electronic 20 log, as provided for in subsection (D)(1): 21 (a) a retailer that only sells single dose packages of 22 nonprescription ephedrine, pseudoephedrine, or 23 phenylpropanolamine; 24 (b) a pharmacy that does not have a compatible point of 25 sale system. 26 (2) A retailer who maintains a written log pursuant to this 27 subsection shall retain the written log for two years after which the 28 log may be destroyed. The log must be made available for 29 inspection within twentyfour hours of a request made by a local, 30 state, or federal law enforcement officer. 31 (3) A retailer who violates the requirements of maintaining a 32 written log as provided for in subsection (J)(2) is subject to the 33 penalties provided for in subsection (H)(4). 34 (K) The sheriff or chief of police shall monitor and determine if 35 retailers, other than licensed pharmacies, are in compliance with 36 the provisions of this section by ensuring that a retailer: 37 (1) is entering all sales of a product regulated by this section 38 in an electronic log as required by this section; 39 (2) if not maintaining an electronic log, is exempt as 40 provided for in subsection (J)(1), and is continuing to maintain the 41 written log as provided for in subsection (J); 42 (3) is not selling products regulated by this section. 43 (L) This section does not apply to:

[3160] 6 1 (1) pediatric products labeled pursuant to federal regulation 2 as primarily intended for administration to children under twelve 3 years of age according to label instructions; 4 (2) products that the Board of Pharmacy, upon application of 5 a manufacturer, exempts because the product is formulated in such 6 a way as to effectively prevent the conversion of the active 7 ingredient into methamphetamine or its salts or precursors; and 8 (3) a purchase of a single sales package containing not more 9 than sixty milligrams of pseudoephedrine. 10 (M) For purposes of this section ‘retailer’ means a retail 11 distributor, including a pharmacy, where ephedrine, 12 pseudoephedrine, or phenylpropanolamine products are available 13 for sale and does not include an employee or agent of a retailer.” 14 15 SECTION 2. This act takes effect upon approval by the 16 Governor. 17 XX 18

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