Journal of the Senate
of the First Session of the 111th General Assembly
of the State of South Carolina
being the Regular Session Beginning Tuesday, January 10, 1995

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| Printed Page 1930, Apr. 20 | Printed Page 1950, Apr. 20 |
Printed Page 1940 . . . . . Thursday, April 20, 1995
(b)(B)(1) A drug intended for use by man which (A) is a habit-forming drug to which Section 39-23-40(d)(4) applies; or (B) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such the drug; or (C) is limited by an effective application under Section 39-23-70 to use under the professional supervision of a practitioner licensed by law to administer such the drug, shall may be dispensed only:

(i)(a) upon a written prescription of a practitioner licensed by law to administer such the drug,; or

(ii)(b) upon an oral prescription of such the practitioner which is reduced promptly to writing and filed by the pharmacist,; or

(iii)(c) by refilling any such a written or oral prescription if such the refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist.

(2) The act of dispensing a drug contrary to the provisions of this paragraph shall be item (1) is deemed to be an act which results in the drug being misbranded while held for sale.

(2)(3) Any A drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such the drug shall be is exempt from the requirements of Section 39-23-40, except paragraphs (a) items (1), (i)(2) (9)(b) and (3)(c), (k)(11), and the packaging requirements of paragraphs (g) (7) and (h) (8), if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription or of its filling, the name of the prescriber, and if stated in the prescription the name of the patient, and the directions for use and cautionary statements, if any, contained in such the prescription. This exemption shall does not apply to any a drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail, or to a drug dispensed in violation of paragraph (1) of this subsection item (1).

(3)(4) The Commissioner Department of Health and Environmental Control may by regulation may remove drugs subject to Section

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39-23-40(d)(4) and Section 39-23-70 from the requirements of paragraph item (1) of this subsection when such the requirements are not necessary for the protection of the public health. Drugs removed from the prescription requirements of the federal act by regulations issued thereunder may under it also by regulations issued promulgated by the Commissioner Department of Health and Environmental Control, may be removed from the requirements of paragraph item (1) of this subsection.

(4)(5) A drug which is subject to paragraph item (1) of this subsection shall be is misbranded if at any time prior to before dispensing its label fails to bear the statement `Caution: Federal law prohibits dispensing without prescription.' A drug to which paragraph item (1) of this subsection does not apply shall be is deemed to be misbranded if at any time prior to before dispensing its label bears the caution statement quoted in the preceding sentence.

(5)(6) Nothing in this subsection shall be construed to relieve any relieves a person from any a requirement prescribed by or under authority of law with respect to drugs now included or which may hereafter be included within the classifications stated in Sections 44-49-10, 44-49-40, 44-49-50, and 44-53-110 to 44-53-580.

Section 39-23-55. (A) For purposes of this section, `sample' means a unit of a drug which is not intended by the manufacturer to be sold and which is intended to promote the sale of the drug.

(B) The department may not require the labeling of a prescription or nonprescription drug sample for which a physician does not require a federal or state controlled substance license to dispense, when the physician dispenses it to a patient for no charge. If the sample is not in the manufacturer's original package, the physician shall label it meeting all requirements of nonsample prescription medication. If adequate directions for usage are not provided on the manufacturer's package, the physician shall give adequate written directions.

(C) The labeling exemption established in this section does not apply when more than one hundred twenty dosage units or a thirty-day supply of a drug in solid form or eight ounces of a drug in liquid form is dispensed.

Section 39-23-60. In accordance with federal standards, the Commissioner Department of Health and Environmental Control shall promulgate regulations providing for the listing of coal-tar colors which are harmless and suitable for use in drugs for purposes of coloring only and for the certification of batches of such the colors, with or without harmless diluents.

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Section 39-23-70. (A) No person shall may introduce or deliver for introduction into intrastate commerce any a new drug unless an application filed pursuant to subsection (B) is effective with respect to such the drug, or an application with respect thereto to the drug has been approved and such the approval has not been withdrawn under Section 505 of the federal act.

(B) Any A person may file with the Commissioner of the Department of Health and Environmental Control an application with respect to any a drug subject to the provisions of subsection (A). Such The persons shall submit to the Commissioner of the Department of Health and Environmental Control as a part of the application:

(1) full reports of investigations which have been made to show whether or not such the drug is safe for use;

(2) a full list of the articles used as components of such the drug;

(3) a full statement of the composition of such the drug;

(4) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such the drug;

(5) such samples of such the drug and of the articles used as components thereof of the drug as the Commissioner of the Department of Health and Environmental Control may require; and

(6) specimens of the labeling proposed to be used for such the drug.

(C) An application provided for in subsection (B) shall become is effective on the one hundred eightieth day after the its filing thereof, except that if. However, the Commissioner of the Department of Health and Environmental Control, before the effective date of the application, shall issue an order refusing to permit the application to become effective if he finds, after due notice to the applicant and giving him an opportunity for a hearing,:

(1), that the drug is not safe or not effective for use under the conditions prescribed, recommended, or suggested in the its proposed labeling thereof; or

(2) the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such the drugs are inadequate to preserve its identity, strength, quality, and purity; or

(3) based on a fair evaluation of all material facts, such the labeling is false or misleading in any particular; he shall, prior to the effective date of the application, issue an order refusing to permit the application to become effective.

(D) If The Commissioner of the Department of Health and Environmental Control, before the effective date of the application, shall

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issue an order refusing to permit the application to become effective if he finds, after due notice to the applicant and giving him an opportunity for a hearing, that:

(1) the investigations, reports of which are required to be submitted to the Commissioner commissioner pursuant to subsection (B), do not include adequate tests by all methods reasonably applicable to show whether or not such the drug is safe for use under the conditions prescribed, recommended, or suggested in the its proposed labeling thereof;

(2) the results of such the tests show that such the drug is unsafe for use under such the conditions or do not show that such the drug is safe for use under such the conditions;

(3) the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such the drug are inadequate to preserve its identity, strength, quality, and purity; or

(4) upon the basis of the information submitted to him as part of the application or upon the basis of any other information before him with respect to such the drug, he has insufficient information to determine whether such the drug is safe for use under such the conditions, he shall, prior to the effective date of the application, issue an order refusing to permit the application to become effective.

(E) The effectiveness of an application with respect to any a drug shall, after due notice and opportunity for hearing to the applicant, by order of the Commissioner of the Department of Health and Environmental Control stating the findings upon which it is based, must be suspended if the Commissioner commissioner finds that:

(1) that clinical experience, tests by new methods, or tests by methods not deemed reasonably applicable when such the application became effective show that such the drug is unsafe for use under conditions of use upon the basis of which the application became effective,; or

(2) that the application contains any an untrue statement of a material fact. The order shall state the findings upon which it is based.

(F) An order refusing to permit an application with respect to any a drug to become effective shall must be revoked whenever the Commissioner of the Department of Health and Environmental Control finds that the facts so require.

(G) Orders of the Commissioner of the Department of Health and Environmental Control issued under this section shall must be served:

Printed Page 1944 . . . . . Thursday, April 20, 1995
(1) in person by an officer or employee of the Department of Health and Environmental Control designated by the Commissioner commissioner; or

(2) by mailing the order by registered mail addressed to the applicant or respondent at his last known address in the records of the Commissioner commissioner.

(H) An appeal may be taken by the applicant from an order of the Commissioner of the Department of Health and Environmental Control refusing to permit the application to become effective, or suspending the effectiveness of the application. Such The appeal shall must be taken by filing in the circuit court within any a circuit wherein such in which the applicant resides or has his principal place of business, within sixty days after the entry of such the order, a written petition praying that the order of the Commissioner commissioner be set aside. A copy of such the petition shall must be forthwith served immediately upon the Commissioner commissioner or upon any an officer designated by him for that purpose, and thereupon the Commissioner commissioner shall certify and file in the court a transcript of the record upon which the order complained of was entered. Upon the filing of such the transcript such the court shall have has exclusive jurisdiction to affirm or set aside such the order. No objection to the order of the Commissioner commissioner shall may be considered by the court unless such the objection shall have has been argued before the Commissioner commissioner or unless there were reasonable grounds for failure so to do. The findings of the Commissioner commissioner as to the facts, if supported by substantial evidence, shall be are conclusive. If any a person shall apply applies to the court for leave to adduce additional evidence, and shall show shows to the satisfaction of the court that such the additional evidence is material and that there were reasonable grounds for failure to adduce such the evidence in the proceeding before the Commissioner commissioner, the court may order such the additional evidence to be taken before the Commissioner commissioner and to be adduced upon the hearing in such a manner and upon such terms and conditions as the court may deem proper. The Commissioner commissioner may modify his findings as to the facts by reason of the additional evidence so taken, and he shall file with the court such the modified findings which, if supported by substantial evidence, shall be are conclusive, and his recommendation, if any, for the setting aside of the original order. The judgment and decree of the court affirming or setting aside any such an order of the Commissioner commissioner shall be is final, subject to review as provided by statute. The commencement of proceedings under this

Printed Page 1945 . . . . . Thursday, April 20, 1995
subsection shall not, unless specifically ordered by the court to the contrary, does not operate as a stay of the Commissioner's commissioner's orders.

(I) The Commissioner Department of Health and Environmental Control shall promulgate regulations for exempting from the operation of this section drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety of drugs.

Section 39-23-80. (A) It is unlawful to do or cause the following acts:

(1) introduction or delivery for introduction into commerce within the State of a drug or device that is adulterated or misbranded;

(2) adulteration or misbranding of a drug or device in intrastate commerce;

(3) receipt in intrastate commerce of a drug or device that is adulterated or misbranded, and the delivery or proffered delivery of a drug or device for pay or otherwise;

(4) manufacture of a drug or device within the State which is adulterated or misbranded;

(5) forging, counterfeiting, simulating, or falsely representing, or without proper authority using any a mark, stamp, tag, or label, or other identification device authorized or required by regulations promulgated under the provisions of this chapter or the federal act;

(6) alteration, mutilation, destruction, obliteration, or removal of the whole or any a part of the labeling of, or the doing of any other another act with respect to, a drug or device, if the act is done while the article is held for sale, (whether or not the first sale), after shipment in intrastate commerce and results in the article being adulterated or misbranded;

(7) using, on the label of a drug or in an advertisement relating to the drug, any a representation or suggestion that an application with respect to the drug is effective under Section 39-23-70, or that the drug complies with the provisions of that section.

(B)(1) A person who violates a provision of this section is guilty of a misdemeanor and, upon conviction, must be imprisoned not more than two years, or fined not more than five thousand dollars, or both for a first offense.

(2) A person convicted under this section for a second offense is guilty of a felony and, upon conviction, must be imprisoned not more than five years or fined not more than ten thousand dollars, or both.

(3) A violation with intent to defraud or mislead is a felony and, upon conviction, the person must be imprisoned not more than five years or fined not more than ten thousand dollars, or both.

Printed Page 1946 . . . . . Thursday, April 20, 1995
Section 39-23-100. (A) Any A drug or device that is adulterated or misbranded when introduced into or while in intrastate commerce or while held for sale, (whether or not the first sale), after shipment in intrastate commerce, or which may not, under the provisions of Section 39-23-50, may not be introduced into intrastate commerce, shall be is liable to be proceeded against while in intrastate commerce or at any after that time thereafter, on libel of information and condemned in any a circuit court of the State within the jurisdiction of which the article is found; provided,. However, that no libel for condemnation shall may be instituted under this chapter, for any alleged misbranding if there is pending in any a court a libel for condemnation proceeding under this chapter based upon the same alleged misbranding, and. Not more than one such libel for condemnation proceeding shall may be instituted if no such proceeding is so pending, except that such the limitations shall do not apply (1) when such misbranding has been the basis of a prior judgment in favor of the State, in a criminal injunction, or libel for condemnation proceeding under this chapter, or (2) when the Commissioner of the Department of Health and Environmental Control has probable cause to believe from facts found, without hearings, by him or any an officer or employee of the Department of Health and Environmental Control that the misbranding is dangerous to health, or that the labeling of the misbranded article is fraudulent, or would be in a material respect misleading to injury or damage of the purchaser or consumer. In any case Where the number of libel for condemnation proceedings is limited as above provided in this subsection, the proceeding pending or instituted shall, on application of the claimant, reasonably made, must be removed for trial to any a circuit agreed upon by stipulation between the parties, or, in case of for failure to so stipulate within a reasonable time, the claimant may apply to the court of the circuit in which the seizure has been made, and such the court, (after giving the Attorney General or other attorney for the Department of Health and Environmental Control reasonable notice and opportunity to be heard), shall by order, unless good cause to the contrary is shown, by order shall specify a circuit of reasonable proximity to the claimant's principal place of business to which the case shall must be removed for trial.

(B) The article shall be is liable to seizure by process pursuant to the libel, and the procedure in cases under this section shall conform, as nearly as may be, to the procedure in admiralty; except that. However, on demand of either party, any an issue of fact joined in any such a case shall must be tried by jury. When libel for condemnation proceedings under this section, involving the same claimant and the same issues of adulteration or misbranding, are pending in two or more jurisdictions,

Printed Page 1947 . . . . . Thursday, April 20, 1995
such the pending proceedings, upon application of the claimant reasonably made to the court of one such jurisdiction of the jurisdictions, shall must be consolidated for trial by order of such that court, and tried in (1) any a circuit selected by the claimant where one of such the proceedings is pending; or (2) a circuit agreed upon by stipulation between the parties. If no order for consolidation is so made within a reasonable time, the claimant may apply to the court of one such jurisdiction of the jurisdictions, and such that court, (after giving the Attorney General or other attorney for the Department of Health and Environmental Control reasonable notice and opportunity to be heard) shall by order, unless good cause to the contrary is shown, by order shall specify a circuit of reasonable proximity to the claimant's principal place of business, in which all pending proceedings shall must be consolidated for trial and tried. Such The order of consolidation shall may not apply so as to require the removal of any a case the date for trial of which has been fixed. The court granting such the order shall give prompt notification thereof of the order to the other courts having jurisdiction of the cases covered thereby by the order.

(C) The court at any time after seizure up to a reasonable time before trial shall by order shall allow any a party to a condemnation proceeding, his attorney or agent, to obtain a representative sample of the article seized.

(D) Any A drug or device condemned under this section shall, after entry of the decree, must be disposed of by destruction or sale as the court may, in accordance with the provisions of this section, may direct and the proceeds thereof, if sold, less the legal costs and charges, shall must be paid into to the Treasury of the State of South Carolina; but such Treasurer. However, the article shall must not be sold under such the decree contrary to the provisions of this chapter or the laws of the jurisdiction in which sold; provided, that. After entry of the decree and upon the payment of the costs of such proceedings and the execution of a good and sufficient bond conditioned that such the article shall must not be sold or disposed of contrary to the provisions of this chapter or the laws of any a state or territory in which sold, the court may by order may direct that such the article be delivered to the its owner thereof to be destroyed or brought into compliance with the provisions of this chapter under the supervision of an officer or employee duly designated by the Commissioner of the Department of Health and Environmental Control, and. The expenses of such the supervision shall must be paid by the person obtaining release of the article under bond. Any An article condemned by reason of its being an article which may not, under Section

Printed Page 1948 . . . . . Thursday, April 20, 1995
39-23-70, may not be introduced into intrastate commerce, shall must be disposed of by destruction.

(E) When a decree of condemnation is entered against the article, court costs of fees, and storage and other proper expenses, shall must be awarded against the person, if any, intervening as claimant of the article.

(F) In the case of For removal for trial of any a case as provided by subsection (A) or (B):

(1) The clerk of the court from which removal is made shall promptly shall transmit to the court in which the case is to be tried all records in the case necessary in order that such so the court may exercise jurisdiction.

(2) The court to which such the case was removed shall have has the powers and be is subject to the duties, for purposes of such the case, which the court from which removal was made would have had, or to which such the court would have been subject, if such the case had not been removed.

Section 39-23-110. Before any a violation of this chapter is reported by the Commissioner of the Department of Health and Environmental Control to the Attorney General for institution of a criminal proceeding, the person against whom such the proceeding is contemplated shall must be given appropriate notice and an opportunity to present his views, either orally or in writing, with regard to such the contemplated proceeding.

Section 39-23-120. Nothing in this chapter shall may be construed as requiring the Commissioner of the Department of Health and Environmental Control to report for prosecution, or for the institution of libel or injunction proceedings, minor violations of this chapter whenever he believes that the public interest will be adequately served adequately by a suitable written notice or warning.

Section 39-23-130. The Commissioner of the Department of Health and Environmental Control may, upon service of written notice, may embargo any a drug, or device, or other substance for a period not to exceed more than fifteen days if such the drug, device, or substance is suspected of being adulterated or misbranded,. The purpose of such the embargo being is to prevent the removal of such the drug, device, or substance from the jurisdiction of the Commissioner of the Department of Health and Environmental Control until an investigation of such the suspected adulteration or misbranding may be conducted."/.

Amend the bill further, as and if amended, page 147, beginning on line 14, in Section 41-16-20(3), as contained in SECTION 153, by striking lines 14 through 16 and inserting therein the following:

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/"(3) `Department Division' means the South Carolina Division of Labor of the Department of Labor, Licensing, and Regulation./.

Amend the bill further, as and if amended, beginning on page 172, line 24, by striking SECTION 202 in its entirety.

Amend the bill further, as and if amended, page 174, beginning on line 20, in Section 43-21-130(A), as contained in SECTION 203, by striking /Department of Juvenile Justice,/.

Amend the bill further, as and if amended, page 174, beginning on line 26, in Section 43-21-130, as contained in SECTION 203, by striking /Department of Corrections,/.

Amend the bill further, as and if amended, page 176, beginning on line 26, by striking SECTION 204 in its entirety.

Amend the bill further, as and if amended, page 177, beginning on line 1, by striking SECTION 205 in its entirety and inserting therein the following:

/SECTION 205. Section 43-35-310 (A)(2) of the 1976 Code, as added by Act 110 of 1993, is amended to read:

"(2) these members who shall serve ex officio:

(a) Attorney General or a designee;

(b) Board of Long Term Health Care Administrators, Executive Director, or a designee;

(c) State Board of Nursing for South Carolina, Executive Director, or a designee;

(d) Commission Division on Aging in the Office of the Governor, Executive Director, or a designee;

(e) Criminal Justice Academy, Executive Department of Public Safety Director, or a designee;

(f) South Carolina Department of Health and Environmental Control, Commissioner, or a designee;

(g) State Department of Mental Health, Commissioner Director, or a designee;

(h) South Carolina Department of Mental Retardation Disabilities and Special Needs, Commissioner Director, or a designee;

(i) Adult Protective Services Program, Director, or a designee;

(j) Department of Health and Human Services Finance Commission, Executive Director, or a designee;

(k) Joint Legislative Committee on Aging, Chair, or a designee;

(l) Police Chiefs' Association, President, or a designee;

(m) Prosecution Coordination Commission, Executive Director, or a designee;

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