| Printed Page 1927, Apr. 20 | Printed Page 1940, Apr. 20 |

/SECTION 61. Article 7, Chapter 1, Title 13 of the 1976 Code, as added by Act 181 of 1993, is amended to read:

Section 13-1-1110. The organization and objectives of the Division of Aeronautics, a division of the Department of Commerce are stated in Chapters 1 through 9 of Title 55."/.

Amend the bill further, as and if amended, page 79, beginning on line 2, in Section 13-1-1710, as contained in SECTION 62, by striking lines 2 through 5 in their entirety and inserting therein the following:

/Authority, the Chairman Director of the South Carolina Department of Revenue and Taxation, and the Chairman of the Small and Minority Business Expansion Council, and the Chairman of the South Carolina Research Authority. The Director of the Department/.

Amend the bill further, as and if amended, page 98, beginning on line 4, by striking SECTION 93 in its entirety and inserting therein the following:

/SECTION 93. Section 20-7-5420(A) of the 1976 Code, as last amended by Act 181 of 1993, is further amended to read:

"(A) The State Council on Maternal, Infant, and Child Health shall consist of the following members:

(1) the Director Commissioner of the South Carolina Department of Health and Environmental Control; the State Superintendent of Education or his designee; the State Director of Social Services; the Director of the South Carolina Department of Alcohol and Other Drug Abuse Services; the State Director of Mental Health; the State Director of the Department of Disabilities and Special Needs; the Director of the Department of Health and Human Services; and the Commissioner of the South Carolina Commission for the Blind; and the Chairman of the Statewide Health Coordinating Council; and

(2) a member of the Health Care Planning and Oversight Committee, to be appointed by the chairman; and a member of the Joint Legislative Committee on Children and Families, to be appointed by the chairman.

The Governor shall appoint one representative of each of the following organizations as a member of the council: South Carolina Medical Association; South Carolina Chapter of the American Academy of Pediatrics; South Carolina Chapter of the American College of Obstetrics

The Governor shall appoint one member from each of the six congressional districts of the State who represents business, civic, community, and religious groups.

The Governor may appoint other ex officio members to the council as are needed to provide information to assist in the work of the council."/.

Amend the bill further, as and if amended, page 98, beginning on line 40, by striking SECTION 94 in its entirety and inserting therein the following:

/SECTION 94. Section 20-7-5910(A) of the 1976 Code, as last amended by Act 502 of 1994, is further amended to read:

"(A) There is created a multi-disciplinary State Child Fatality Advisory Committee composed of:

(1) the Commissioner Director of the South Carolina Department of Social Services;

(2) the Commissioner of the South Carolina Department of Health and Environmental Control;

(3) the State Superintendent of Education;

(4) the Executive Director of the South Carolina Criminal Justice Academy Department of Public Safety;

(5) the Chief of the State Law Enforcement Division;

(6) the Commissioner Director of the South Carolina Commission on Department of Alcohol and Other Drug Abuse Services;

(7) the Commissioner Director of the State Department of Mental Health;

(8) the Commissioner Director of the State Department of Mental Retardation Disabilities and Special Needs;

(9) the Commissioner Director of the Department of Youth Services Juvenile Justice;

(10) an attorney with experience in prosecuting crimes against children;

(11) a county coroner or medical examiner;

(12) a pediatrician with experience in diagnosing and treating child abuse and neglect, appointed from recommendations submitted by the State Chapter of the American Academy of Pediatrics; and

(14) a forensic pathologist; and

(15) two members of the public at large, one of which must represent a private nonprofit organization that advocates children services."/.

Amend the bill further, as and if amended, page 108, beginning on line 13, by striking SECTION 111 in its entirety and inserting therein the following:

/SECTION 111. Section 31-13-30 of the 1976 Code, as redesignated by Act 410 of 1992, is amended to read:

"Section 31-13-30. The Governor shall appoint, with the advice and consent of the Senate, seven persons to be commissioners of the South Carolina State Housing Finance and Development Authority. The seven persons so appointed shall must have experience in the fields of mortgage finance, banking, real estate, and home building. The Governor shall appoint a chairman from among the seven commissioners.

The commissioners must be appointed for terms of four years, except that all vacancies must be filled for the unexpired term. A commissioner shall hold office until his successor has been appointed and qualifies qualified. A certificate of the appointment or reappointment of any commissioner must be filed in the office of the Secretary of State and in the office of the authority, and the certificate is conclusive evidence of the due and proper appointment of the commissioner. The Governor or his designee and the State Commissioner of the Department of Health and Environmental Control or his designee from his administrative staff shall serve ex officio as commissioners of the authority with the same powers as the other commissioners."/.

Amend the bill further, as and if amended, page 114, line 4, by striking SECTION 122 in its entirety and inserting therein the following:

/SECTION 122. Chapter 23, Title 39 of the 1976 Code is amended to read:

Section 39-23-10. This chapter may be cited as the South Carolina Drug Act.

Section 39-23-20. For the purposes of this chapter:

(a)(1) The `Commissioner of the Department of Health and Environmental Control' means the Commissioner of the Department of Health and Environmental Control or his designated agent.

(b)(1)(2)(a) The term `Drug' means:

(B) (ii) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and

(C) (iii) articles, (other than food), intended to affect the structure or any function of the body of man or other animals; and

(D) (iv) articles intended for use as a component of any articles an article specified in clause (A) subsubitem (i), (B) ii, or (C); but (iii).

(b) `Drug' does not include devices or their components, parts, or accessories.

(2)(c) The term `Counterfeit drug' means a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof of it, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such the drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such the other drug manufacturer, processor, packer, or distributor.

(c)(3) The term `Device' means instruments, apparatus, and contrivances, including their components, parts, and accessories, intended:

(1)(a) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or

(2)(b) to affect the structure or any function of the body of man or other animals.

(d)(4) The term `Official compendium' means the official United States Pharmacopoeia, Official Homeopathic Pharmacopoeia of the United States, Official National Formulary, or any a supplement to any of them.

(e)(5) The term `Label' means a display of written, printed, or graphic matter upon the immediate container of any an article; and. A requirement made by or under authority of this chapter that any a word, a statement, or other information appear on the label shall is not be considered to be complied with unless such the word, statement, or other information also appears on the outside container or wrapper, if any there be one, of the retail package of such the article, or is easily legible through the outside container or wrapper.

(f)(6) The term `Labeling' means all labels and other written, printed, or graphic matter (1) upon any an article or any of its containers or wrappers, or (2) accompanying such the article. If an article is alleged to be misbranded because the labeling is misleading, or if an advertisement is alleged to be false because it is misleading, then in determining whether

(g)(7) The term `New drug' means:

(1)(a) Any a drug, (except a new animal drug or an animal feed bearing or containing a new animal drug), the composition of which is such that such the drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such of the drug. However, a drug not so recognized shall is not be deemed to be a `new drug' if at any time prior to before July 17, 1972, it was subject to the Federal Food and Drug Act of June 30, 1906, as amended, and if at such the time its labeling contained the same representations concerning the conditions of its use; or

(2)(b) Any a drug, except a new animal drug or an animal feed bearing or containing a new animal drug, the composition of which is such that such the drug, as a result of investigations to determine its safety and effectiveness for use under such the conditions, has become so recognized, but which has not, otherwise than in such these investigations, been used to a material extent or for a material time under such the conditions.

(h)(8) The term `Color' includes black, white, and intermediate grays.

Section 39-23-30. A drug or device shall be is deemed to be adulterated if it:

(a)(1)(a) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or

(2)(A)(b)(i) if it has been prepared, packed, or held under insanitary conditions whereby where it may have been contaminated with filth, or whereby where it may have been rendered injurious to health; or

(B)(ii) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such the drug meets the requirements of the Federal Food, Drug, and Cosmetic Act, as amended,

(3)(c) if it is a drug and its container is composed, in whole or in part, of any a poisonous or deleterious substance which may render the contents injurious to health; or

(4) if

(A)(d)(i) it is a drug which bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of Section 706(a) of the Federal Food, Drug, and Cosmetic Act, as amended,;

(B) (ii) it is a color additive the intended use of which in or on drugs is for purposes of coloring only and is unsafe within the meaning of Section 706(a) of the Federal Food, Drug, and Cosmetic Act, as amended; or

(5)(e) if it is a new animal drug which is unsafe within the meaning of Section 512 of the Federal Food, Drug, and Cosmetic Act, as amended; or

(6)(f) if it is an animal feed bearing or containing a new animal drug, and such the animal feed is unsafe within the meaning of Section 512 of the Federal Food, Drug, and Cosmetic Act, as amended.

(b)(2) If it purports or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from or its quality or purity falls below the standard set forth in such the compendium. Such The determination as to strength, quality, or purity shall must be made in accordance with the tests or methods of assay set forth in such the compendium, except that whenever. However, when tests or methods of assay have not been prescribed in such the compendium, or those prescribed under authority of the federal act, or such the tests or methods of assay as are prescribed are, in the judgment of the Commissioner of the Department of Health and Environmental Control, insufficient for the making of such the determination, the Commissioner commissioner shall bring such that fact to the attention of the appropriate body charged with the revision of such the compendium, and. If such the body fails within a reasonable time to prescribe tests or methods of assay, which, in the judgment of the Commissioner commissioner, are sufficient for purposes of this paragraph, then the Commissioner Department of Health and Environmental Control shall promulgate regulations prescribing appropriate tests or methods of assay in accordance with which such the determination as to strength, quality, or purity shall must be made. No drug defined in an official compendium shall may be deemed to be adulterated under this paragraph because it

(c)(3) If it is not subject to the provisions of paragraph (b) of this section, item (2) and its strength differs from, or its purity or quality falls below that which it purports or is represented to possess.;

(d)(4) If it is a drug and any a substance has been (1) mixed or packed therewith with the drug so as to reduce its quality of strength or (2) substituted wholly or in part therefor.

Section 39-23-40. A drug or device shall be is deemed to be misbranded:

(a)(1) if its label is false or misleading in any particular.;

(b)(2) if in a package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; provided. However, that reasonable variations shall be are permitted under regulations issued promulgated by the Commissioner Department of Health and Environmental Control or issued under the federal act. Provided, further, that in the case of any For a drug subject to Section 39-23-50(B)(1), the label shall must contain the name and place of business of the manufacturer of the finished dosage form and, if different, the name and place of business of the packer or distributor. For the purpose of this paragraph item, the finished dosage form of a drug is that form of the drug which is, or is intended to be, dispensed or administered to the ultimate user upon prescription or as otherwise dispensed by the pharmacist.;

(c)(3) if any a word, a statement, or other information required by or under the authority of this chapter or the Federal Food, Drug, and Cosmetic Act to appear on the label or labeling is not prominently placed thereon prominently on the label or labeling with such conspicuousness, as compared with other words, statements, designs, or devices, in the labeling, and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.;

(e)(1)(5)(a) if it is a drug, unless:

(A) (i) its label bears, to the exclusion of any other another nonproprietary name, (except the applicable systematic chemical name or the chemical formula), (i)(A) the established name, (as defined in subparagraph (2)) subitem (b), of the drug, if such there be is, and, (ii) in case (B) if it is fabricated from two or more ingredients, the established name and quantity of each active ingredient, including the quantity, kind, and proportion of any alcohol, and also including whether active or not, the established name and quantity or proportion of any bromides, ether, chloroform, acetanilide, acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any a derivative or preparation of any such these substances, contained therein; provided, that in them. However, the requirement for stating the quantity of the active ingredients, other than the quantity of those specifically named in this paragraph sub-subitem, shall apply applies only to prescription drugs; and

(B) (ii) for any a prescription drug, the established name of such the drug or ingredient, as the case may be, on such the label, (and on any the labeling on which a name for such the drug or ingredient is used), is printed prominently and in type at least half as large as that used thereon on the label or labeling for any a proprietary name or designation for such the drug or ingredient; and provided, that. However, to the extent that compliance with the requirements of clause (A)(ii) sub-subitem (i)(B) or clause (B) of this subparagraph sub-subitem is impracticable, exemptions shall must be established by regulations promulgated by the Commissioner Department of Health and Environmental Control or under the federal act.

(2)(b) As used in this paragraph (e) item, the term `established name', with respect to a drug or ingredient thereof of the drug, means:

(B) (ii) if there is no such official name and such the drug, or such the ingredient, is an article recognized in an official compendium, then the official title thereof in such the compendium,; or

(C) (iii) if neither clause (A) sub-subitem (i) nor clause (B) of this subparagraph sub-subitem (ii) applies, then the common or usual name, if any, of such the drug or of such the ingredient; provided, further, that. Where clause (B) of this paragraph sub-subitem (ii) applies to an article recognized in the United States Pharmacopoeia and in the Homeopathic Pharmacopoeia under different official titles, the official title used in the United States Pharmacopoeia shall apply applies unless it is labeled and offered for sale as a homeopathic drug, in which case. If it is labeled and offered for sale as a homeopathic drug, the official title used in the Homeopathic Pharmacopoeia shall apply. applies;

(f)(6)(a) unless its labeling bears adequate:

(1) (i) adequate directions for use; and

(2) (ii) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such a manner and form, as are necessary for the protection of users;

(b) provided, that where any a requirement of clause (1) of this paragraph sub-subitem (i), as applied to any a drug or device, is not necessary for the protection of the public health, the Commissioner Department of Health and Environmental Control shall promulgate regulations exempting such the drug or device from such the requirement; provided, further, that. Articles exempted under regulations issued under Section 502(f) of the federal act shall also be are exempt.;

(g)(7) if it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and labeled as prescribed therein; provided, that. However, the method of packing may be modified with the consent of the Commissioner of the Department of Health and Environmental Control or if consent is obtained under the federal act. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it shall be is subject to the requirements of the United States Pharmacopoeia with respect to packaging, and labeling unless it is labeled and offered for sale as a homeopathic drug, in which case. If it is labeled and offered for sale as a homeopathic drug, it shall be is subject to the provisions of the Homeopathic Pharmacopoeia of the United States, and not to those of the

(h)(8) if it has been found by the Commissioner of the Department of Health and Environmental Control or under the federal act to be a drug liable to deterioration, unless it is packaged in such a form and manner, and its label bears a statement of such the precautions, as the Commissioner Department of Health and Environmental Control or under the federal act shall by regulations require requires as necessary for the protection of the public health. No such regulation shall may be established for any a drug recognized in an official compendium until the Commissioner of the Department of Health and Environmental Control shall have informed informs the appropriate body charged with the revision of such the compendium of the need for such the packaging or labeling requirements and such the body shall have failed fails within a reasonable time to prescribe such the requirements.;

(i)(1)(9)(a) if it is a drug and its container is so made, formed, or filled as to be misleading; or

(2)(b) if it is an imitation of another drug; or

(3)(c) if it is offered for sale under the name of another drug.;

(j)(10) if it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.;

(k)(11) In the case of any for a prescription drug distributed or offered for sale in any state, unless the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that drug a true statement of:

(1)(a) the established name as defined in Section 39-23-40(e) item (5), printed prominently and in type at least half as large as that used for any a trade or brand name thereof,;

(2)(b) the formula showing quantitatively each ingredient of such the drug to the extent required for labels under Section 39-23-40(e), and (3) such item (e);
(c) other information in brief summary relating to side effects, contraindications, and effectiveness as shall be required in regulations which shall be issued under the federal act.

Section 39-23-50. (a)(A) The Commissioner Department of Health and Environmental Control is hereby directed to shall promulgate regulations

| Printed Page 1927, Apr. 20 | Printed Page 1940, Apr. 20 |

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