South Carolina General Assembly
117th Session, 2007-2008

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S. 1043

STATUS INFORMATION

General Bill
Sponsors: Senator Elliott
Document Path: l:\council\bills\ggs\22044ab08.doc

Introduced in the Senate on January 30, 2008
Currently residing in the Senate Committee on Medical Affairs

Summary: Phenylpropanolamine products

HISTORY OF LEGISLATIVE ACTIONS

     Date      Body   Action Description with journal page number
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   1/30/2008  Senate  Introduced and read first time SJ-8
   1/30/2008  Senate  Referred to Committee on Medical Affairs SJ-8

View the latest legislative information at the LPITS web site

VERSIONS OF THIS BILL

1/30/2008

(Text matches printed bills. Document has been reformatted to meet World Wide Web specifications.)

A BILL

TO AMEND THE CODE OF LAWS OF SOUTH CAROLINA, 1976, BY ADDING ARTICLE 14 TO CHAPTER 3, TITLE 23 SO AS TO CREATE THE STATE REAL-TIME ELECTRONIC LOGBOOK FOR PHARMACEUTICALS; TO AMEND SECTION 44-53-398, RELATING TO THE SALE OF PRODUCTS CONTAINING EPHEDRINE OR PSEUDOEPHEDRINE, SO AS TO ADD PHENYLPROPANOLAMINE TO THE PRODUCTS GOVERNED BY THE SECTION, TO REQUIRE A RETAILER SELLING A PRODUCT CONTAINING THESE PRODUCTS TO ENTER THE TRANSACTION IN THE STATE REAL-TIME ELECTRONIC LOGBOOK FOR PHARMACEUTICALS, AND TO SPECIFY THE INFORMATION THAT MUST BE ENTERED.

Be it enacted by the General Assembly of the State of South Carolina:

SECTION    1.    Chapter 3, Title 23 of the 1976 Code is amended by adding:

"Article 14

Real-Time Electronic Logbook For Pharmaceuticals

Section 23-3-1100.    (A)(1)    There is established in the South Carolina Law Enforcement Division (SLED) the State Real-Time Electronic Logbook for Pharmaceuticals. SLED shall provide pharmacies in the State access to the real-time electronic logbook for the purpose of entering in the logbook a transaction required to be reported pursuant to Section 44-53-398.

(2)    The real-time electronic logbook must be:

(a)    capable of checking compliance with all applicable local, state, and federal laws;

(b)    maintained for a period of two years from the date of entry unless the transaction record is being used in an ongoing criminal investigation or criminal proceeding, in which case the records must be maintained until the conclusion of the investigation or proceeding, whichever occurs later;

(c)    subject to random and warrantless inspection by city, county, state, or federal law enforcement officers; and

(d)    capable of calculating state and federal ephedrine, pseudoephedrine, or phenylpropanolamine purchase limitations.

(B)    SLED may contract with a private vendor to implement this section.

Section 23-3-1110.    (A)    Information entered into the real-time electronic logbook is confidential and not subject to the South Carolina Freedom of Information Act.

(B)    Except as provided in Section 23-3-1120 or as otherwise provided by law, SLED may not disclose information entered, collected, recorded, transmitted, or maintained in the real-time electronic logbook.

Section 23-3-1120.    SLED shall provide access to the real-time electronic logbook to:

(1)    a person authorized to prescribe or dispense products containing ephedrine, pseudoephedrine, or phenylpropanolamine for the purpose of providing medical care or pharmaceutical care;

(2)    a local, state, or federal law enforcement official or prosecutor;

(3)    a local, state, or federal official who requests access for the purpose of facilitating a product recall necessary to protect public health and safety; and

(4)    the State Board of Pharmacy for the purpose of investigating a suspicious transaction.

Section 23-3-1130.    SLED shall promulgate regulations necessary to:

(1)    implement the provisions of this section;

(2)    ensure the real-time electronic logbook enables a pharmacy to monitor the sale of ephedrine, pseudoephedrine, or phenylpropanolamine occurring at that pharmacy; and

(3)    allow a pharmacy to determine whether it will access information concerning a sale of ephedrine, pseudoephedrine, or phenylpropanolamine at another pharmacy in this State.

Section 23-3-1140.    A pharmacy in this State is not liable civilly for a sale of ephedrine, pseudoephedrine, or phenylpropanolamine that occurs at another pharmacy in this State."

SECTION    2.    Section 44-53-398 of the 1976 Code, as added by Act 275 of 2006, is amended to read:

"Section 44-53-398.    (A)    Products A product whose sole active ingredient is ephedrine, or pseudoephedrine, or phenylpropanolamine may be offered for retail sale only if sold in blister packaging. The retailer shall ensure that such products are not offered for retail sale by self-service, but only from behind a counter or other barrier so that such products are not directly accessible by the public but only by an employee or agent of the retailer.

(B)    A retailer may not in any a single over-the-counter sale sell more than three packages of any a product containing ephedrine, or pseudoephedrine, or phenylpropanolamine as the sole active ingredient or in combination with other active ingredients or any number of packages that contain a combined total of more than nine grams of ephedrine, or pseudoephedrine, or phenylpropanolamine base and shall ensure that the product is delivered directly into the custody of the purchaser.

(C)    It is unlawful for a retailer to purchase any a product containing ephedrine, or pseudoephedrine, or phenylpropanolamine from any a person or entity other than a manufacturer or a wholesale distributor registered by the United States Drug Enforcement Administration.

(D)(1)    A retailer selling products a product containing ephedrine, or pseudoephedrine, or phenylpropanolamine pursuant to subsection (A) shall require the purchaser to produce a government issued photo identification showing the date of birth of the person and require the purchaser to sign a written or electronic log showing the date and time of the transaction, the person's name and address, and the amount of the compound, mixture, or preparation. The retailer shall determine that the name entered in the log corresponds to the name on the identification and that the date and time entered are correct and shall enter in the log the name of the product and the quantity sold. The log must include a notice to purchasers that entering a false statements statement or misrepresentations misrepresentation in the logbook may subject the purchaser to a criminal penalties penalty. The retailer shall retain this log for two years after which the log may be destroyed. The log must be made available for inspection within twenty-four hours of a request made by a local, state, or federal law enforcement officer.

(2)    A retailer selling a product containing ephedrine, pseudoephedrine, or phenylpropanolamine pursuant to subsection (A) shall enter a transaction required to be maintained in this section into the State Real-Time Electronic Logbook. The transaction information must include the:

(a)    transaction date;

(b)    name, date of birth, and residential street address of the person making the purchase;

(c)    type of identification provided by the purchaser, identification number, and issuing state or agency; and

(d)    amount and name of the compound, mixture, or preparation being purchased.

(3)    A log retained by a retailer is confidential and not a public record as defined in Section 30-4-20(C) of the Freedom of Information Act. A retailer or an employee or agent of a retailer who in good faith releases information in a log to federal, state, or local law enforcement authorities is immune from civil liability for the release unless the release constitutes gross negligence or intentional, wanton, or wilful misrepresentation.

(E)    Except as authorized by this section, it is unlawful for any a person to possess, have under his or her control, manufacture, deliver, distribute, dispense, administer, purchase, sell, or possess with intent to distribute, any a substance containing any an amount of ephedrine, pseudoephedrine, phenylpropanolamine, or any of its salts, optical isomers, or salts of optical isomers which have been altered from their original condition so as to be powdered, liquefied, dissolved, solvated, or crushed. This subsection does not apply to any of the substances identified within this subsection which that are possessed or altered for a legitimate medical purpose as directed by a person licensed under Title 40 and authorized to prescribe legend drugs.

(F)    It is unlawful for a person to enter a false statements statement or misrepresentations misrepresentation on the log required pursuant to subsection (D)(1).

(G)    This section preempts all local ordinances or regulations governing the retail sale of over- the- counter products containing ephedrine, or pseudoephedrine, or phenylpropanolamine by a retailer except such local ordinances or regulations that existed on or before December 31, 2004.

(H)(1)    Except as otherwise provided in this section, it is unlawful for a retailer knowingly to violate subsection (A), (B), (C), or (D)(1), and it is unlawful for a person knowingly to violate subsection (E) or (F).

(2)    A retailer convicted of a violation of subsection (A) or (B) is guilty of a misdemeanor and, upon conviction for a first offense, must be fined not more than five thousand dollars and, upon conviction for a second or subsequent offense, must be fined not more than ten thousand dollars.

(3)    A retailer convicted of a violation of subsection (C), upon conviction for a first offense, is guilty of a misdemeanor and must be imprisoned not more than one year or fined not more than one thousand dollars, or both; and upon conviction for a second or subsequent offense, is guilty of a misdemeanor and must be imprisoned not more than three years or fined not more than five thousand dollars, or both.

(4)    A retailer convicted of a violation of subsection (D)(1) is guilty of a misdemeanor and, upon conviction for a first offense, must be fined not more than one thousand dollars and not less than five hundred dollars. Upon conviction for a second offense, a retailer must be fined not more than five thousand dollars and not less than one thousand dollars. Upon conviction for a third or subsequent offense, a person retailer must be fined not more than ten thousand dollars and not less than five thousand dollars.

(5)    A person convicted of a violation of subsection (E) is guilty of a felony and, upon conviction for a first offense, must be imprisoned not more than five years and fined not more than five thousand dollars. The court, upon approval from the solicitor, may request as part of the sentence, that the offender enter and successfully complete a drug treatment program. For a second or subsequent offense, the offender is guilty of a felony and, upon conviction, must be imprisoned not more than ten years or fined not less than ten thousand dollars.

(6)    A person convicted of a violation of subsection (F), upon conviction for a first offense, is guilty of a misdemeanor and must be fined not more than one thousand dollars and, upon conviction for a second or subsequent offense, is guilty of a felony and must be fined not more than five thousand dollars.

(7)    It is an affirmative defense to a violation of subsection (A), (C), or (D)(1) if a retailer provided the training, maintained records, and obtained employee and agent statements of agreement required by subsection (I) for all employees and agents at the retail location where the violation occurred and at the time the violation occurred.

(I)    A retailer shall provide training on the requirements of this section to all agents and employees who are responsible for delivering the products regulated by this section into the custody of purchasers or who deal directly with purchasers by obtaining payments for the products. A retailer shall obtain a signed, written agreement from each employee or agent that the employee or agent agrees to comply with the requirements of this section.

The retailer shall maintain records demonstrating that these employees and agents have been provided this training and the documents executed by the retailer's employees and agents agreeing to comply with this section.

(J)    This section does not apply to:

(1)    pediatric products labeled pursuant to federal regulation as primarily intended for administration to children under twelve years of age according to label instructions; and

(2)    products that the Board of Pharmacy, upon application of a manufacturer, exempts because the product is formulated in such a way as to effectively prevent the conversion of the active ingredient into methamphetamine or its salts or precursors;

(3)    a purchase of a single sales package containing not more than sixty milligrams of pseudoephedrine.

(K)    For purposes of this section 'retailer' means a retail distributor, including a pharmacy, where pseudoephedrine products are available for sale and does not include an employee or agent of a retailer."

SECTION    3.    Implementation of the provisions of Article 14, Chapter 3, Title 23 of the 1976 Code as contained in Section 1, and the provisions of subsection (D)(2) of Section 44-53-398 as added by Section 2, are contingent upon annual appropriation of sufficient funding to SLED to implement these provisions.

SECTION    4.    The repeal or amendment by this act of any law, whether temporary or permanent or civil or criminal, does not affect pending actions, rights, duties, or liabilities founded thereon, or alter, discharge, release or extinguish any penalty, forfeiture, or liability incurred under the repealed or amended law, unless the repealed or amended provision shall so expressly provide. After the effective date of this act, all laws repealed or amended by this act must be taken and treated as remaining in full force and effect for the purpose of sustaining any pending or vested right, civil action, special proceeding, criminal prosecution, or appeal existing as of the effective date of this act, and for the enforcement of rights, duties, penalties, forfeitures, and liabilities as they stood under the repealed or amended laws.

SECTION    5.    If any section, subsection, paragraph, subparagraph, sentence, clause, phrase, or word of this act is for any reason held to be unconstitutional or invalid, such holding shall not affect the constitutionality or validity of the remaining portions of this act, the General Assembly hereby declaring that it would have passed this act, and each and every section, subsection, paragraph, subparagraph, sentence, clause, phrase, and word thereof, irrespective of the fact that any one or more other sections, subsections, paragraphs, subparagraphs, sentences, clauses, phrases, or words hereof may be declared to be unconstitutional, invalid, or otherwise ineffective.

SECTION    6.    Sections 3, 4, 5, and this section take effect upon approval by the Governor. Sections 1 and 2 take effect six months after approval by the Governor.

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