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H. 3198
STATUS INFORMATION
General Bill
Sponsors: Rep. White
Document Path: l:\council\bills\nbd\11117ac07.doc
Introduced in the House on January 9, 2007
Currently residing in the House Committee on Ways and Means
Summary: Cancer Drug Donation Program Act
HISTORY OF LEGISLATIVE ACTIONS
Date Body Action Description with journal page number
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1/9/2007 House Introduced and read first time HJ-100
1/9/2007 House Referred to Committee on Ways and Means HJ-100
View the latest legislative information at the LPITS web site
VERSIONS OF THIS BILL
TO AMEND THE CODE OF LAWS OF SOUTH CAROLINA, 1976, BY ADDING ARTICLE 3 TO CHAPTER 35, TITLE 44, ENACTING THE "CANCER DRUG DONATION PROGRAM ACT" SO AS TO ESTABLISH THIS PROGRAM IN THE DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL FOR THE DONATION OF CANCER DRUGS TO CERTAIN PATIENTS WHO DO NOT QUALIFY FOR MEDICAID OR ANY STATE FUNDED PRESCRIPTION DRUG PROGRAM; TO ESTABLISH CERTAIN RESTRICTIONS ON DRUGS AND SUPPLIES THAT MAY BE DONATED TO THE PROGRAM; TO REQUIRE THE DEPARTMENT TO ESTABLISH PATIENT ELIGIBILITY CRITERIA, STANDARDS AND PROCEDURES FOR ACCEPTING, STORING, DISTRIBUTING, AND DISPENSING DONATED DRUGS, AND HANDLING FEES; TO REQUIRE THE DEPARTMENT TO ESTABLISH A PROGRAM PARTICIPANT REGISTRY; AND TO ESTABLISH IMMUNITY FROM CIVIL AND CRIMINAL LIABILITY AND FROM PROFESSIONAL DISCIPLINARY ACTION; AND TO DESIGNATE SECTIONS 44-35-5 THROUGH 44-35-100 AS ARTICLE 1, CHAPTER 35, TITLE 44 ENTITLED "SOUTH CAROLINA CENTRAL CANCER REGISTRY".
Be it enacted by the General Assembly of the State of South Carolina:
SECTION 1. Chapter 35, Title 44 of the 1976 Code is amended by adding:
Section 44-35-300. This article may be cited as the 'Cancer Drug Donation Program Act'.
Section 44-35-305. For purposes of this article:
(1) 'Cancer drug' means a prescription drug used to treat cancer or its side effects or used to treat the side effects of a prescription drug used to treat cancer or its side effects.
(2) 'Department' means the Department of Health and Environmental Control.
(3) 'Donor' means a person, health care facility, hospital, pharmacy, drug manufacturer, medical device manufacturer or supplier, wholesaler of drugs or supplies, or any other entity that donates cancer drugs, or supplies needed to administer cancer drugs, in accordance with this article.
(4) 'Health care facility' means a health care facility licensed in accordance with Article 3, Chapter 7.
(5) 'Health clinic' means a health care clinic licensed in accordance with Article 3, Chapter 7.
(6) 'Hospital' means a facility licensed in accordance with Article 3, Chapter 7.
(7) 'Participant' means a physician's office, pharmacy, hospital, hospice, or health clinic that has elected to participate in the program and that accepts donated cancer drugs and supplies under the regulations promulgated by the department of this program.
(8) 'Pharmacy' means an entity licensed pursuant to Chapter 43, Title 40.
(9) 'Physician's office' means the office of a person licensed to practice medicine and surgery or osteopathic medicine.
(10) 'Prescribing practitioner' means a health care practitioner licensed pursuant to Title 40 who is authorized to prescribe cancer drugs.
(11) 'Prescription drug' means a drug as defined in Section 40-43-30.
(12) 'Program' means the Cancer Drug Donation Program created by this article.
(13) 'Supplies' means any supplies used in the administration of a cancer drug.
Section 44-35-310. There is established the Cancer Drug Donation Program within, and to be administered by, the Department of Health and Environmental Control.
Section 44-35-315. A person or entity may donate cancer drugs to the program. Cancer drugs may be donated at a physician's office, pharmacy, hospital, hospice, or health clinic that elects to participate in the program and meets criteria established by the department in regulation. Cancer drugs must not be donated to a specific cancer patient. No donated drugs or supplies may be resold by the program.
Section 44-35-320. Cancer drugs or supplies donated to the program must be prescribed by a practitioner for use by an eligible individual and dispensed by a pharmacist.
Section 44-35-325. (A) A cancer drug or supplies only may be accepted or dispensed under this program if the drug is in its original, unopened, sealed, and tamper-evident unit dose packaging, except that a cancer drug packaged in single unit doses may be accepted and dispensed if the outside packaging is opened but the single-unit-dose packaging is unopened.
(B) A cancer drug must not be accepted or dispensed under this program if the expiration date of the drug falls outside the timeframe established by the department in regulation.
(C) A cancer drug must not be accepted or dispensed under this program if the drug is adulterated or misbranded as determined in subsection (D).
(D) Before dispensing to a patient, a cancer drug or supplies donated under this program must be inspected by a pharmacist to determine that the drug or supplies are not adulterated or misbranded.
(E) A dispenser of donated products may not submit a claim or otherwise seek reimbursement from any public or private third party payer for donated drugs dispensed to a patient in accordance with this program, and a public or private third party payer must not be required to provide reimbursement for donated drugs dispensed to any patient under this program.
Section 44-35-330. (A) A physician's office, pharmacy, hospital, hospice, or health clinic that accepts donated cancer drugs under this program shall comply with all applicable provisions of state and federal law relating to the storage, distribution, and dispensing of these drugs.
(B) A physician's office, pharmacy, hospital, hospice, or health clinic who participates in this program may charge a nominal handling fee for distributing or dispensing cancer drugs under this program. The fee must be established in regulations promulgated by the department.
Section 44-35-335. An individual who is eligible to receive drugs under the state Medicaid Program or under any other prescription drug program funded in whole or in part by the State is not eligible to participate in this program.
Section 44-35-340. The department, upon consultation with the Board of Pharmacy, shall promulgate regulations to carry out the provisions of this article. These regulations must include, but are not limited to:
(1) eligibility criteria, including a method to determine priority of recipients under this program;
(2) standards and procedures for participants that accept, store, distribute, or dispense donated cancer drugs or supplies;
(3) necessary forms for administration of the program including, but not limited to, forms for use by persons or entities that donate, accept, distribute, or dispense cancer drugs or supplies under the program;
(4) categories of cancer drugs and supplies that the program will accept for dispensing;
(5) categories of cancer drugs and supplies that the program may not accept for dispensing and the reason that these drugs and supplies must not be accepted;
(6) the maximum handling fee that may be charged by a participant that accepts and distributes or dispenses donated cancer drugs or supplies;
(7) maintenance and distribution of the program participant registry established in Section 44-35-345.
Section 44-35-345. The department shall establish and maintain a program participant registry. The registry must include the participant's name, address, and telephone number and must identify whether the participant is a physician's office, a pharmacy, a hospital, a hospice, or a health clinic. The department shall make the registry available to any person or entity wishing to donate cancer drugs to the program.
Section 44-35-350. A donor of a cancer drug or supplies, or a participant in the program, who exercises reasonable care in donating, accepting, distributing, or dispensing cancer drugs or supplies under this article and the regulations promulgated pursuant to this article are immune from civil or criminal liability and from professional disciplinary action of any kind for any injury, death, or loss to person or property relating to donating, accepting, distributing, or dispensing cancer drugs or supplies pursuant to this article.
Section 44-35-355. A pharmaceutical manufacturer is not liable for any claim or injury arising from the transfer of any prescription drug pursuant to the provisions of this article including, but not limited to, liability for failure to transfer or communicate product or consumer information regarding the transferred drug, as well as the expiration date of the transferred drug."
SECTION 2. 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 article, 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 3. Sections 44-35-5 through 44-35-100 of the 1976 Code are designated as Article 1 of Chapter 35, Title 44 and entitled "South Carolina Central Cancer Registry".
SECTION 4. This act takes effect July 1, 2007.
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