Chief drug inspector; staff inspectors; duties; violation corrections or prosecution; duties of board; adulterated or misbranded drugs; destruction at owner's expense; seal of drugs and devices under control of licensee when license suspended or revoked; complimentary drug samples; optometric supplies.

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(A) There must be an administrator of the Board of Pharmacy who must be a pharmacist licensed in the State of South Carolina and who must be the chief drug inspector. When a vacancy occurs, the position of administrator of the Board of Pharmacy shall be filled in accordance with Section 40-1-50.

(B) The Board of Pharmacy shall have its own staff of inspectors who must be pharmacists licensed in South Carolina and shall conduct all pharmacy inspections and investigations and shall report to and be supervised by the administrator of the Board of Pharmacy.

(C) The chief drug inspector, or his designee, shall visit biennially all permitted facilities in this State and inspect them to see that the laws relating to the licensing of pharmacists are obeyed and to see that all of the provisions of this chapter are obeyed and carried out by the permitted facilities and pharmacists of this State. If a violation of this chapter is discovered, the inspector either shall require the pharmacist or permit holder of the permitted facility in default immediately to correct the violation or shall prosecute the offender under the law, using his discretion after consulting with the board if considered necessary. The inspector or his designee may swear out warrants for offenders who violate the provisions of this chapter.

(D) The board shall:

(1) regulate the practice of pharmacy;

(2) regulate the sale and dispensing of drugs, poisons, and devices;

(3) regulate the supervision and training of pharmacy interns and technicians in pharmacies;

(4) investigate alleged violations of this chapter or any other law in the State pertaining to, or in connection with, persons licensed by the board or otherwise authorized by state laws to manufacture, sell, distribute, dispense, or possess drugs, medicines, poisons, or devices, or as related to misbranded or counterfeit drugs, or any regulations promulgated by the board under this chapter; conduct hearings when, in its discretion, it appears to be necessary; and bring violations to the notice of the prosecuting attorney of the court of competent jurisdiction in which a violation takes place or to the notice of the Attorney General;

(5) establish the minimum specifications for the physical facilities, technical equipment, environment, supplies, personnel, and procedures for the storage, compounding or dispensing, or both, of drugs or devices, and for the monitoring of drug therapy;

(6) confine at any time to prescription order only the dispensing of a drug found to be potentially dangerous to public safety if dispensed without prescription;

(7) seize any drugs and devices found by the board to constitute an imminent danger to the public health and welfare;

(8) promulgate regulations which the board, in its judgment, considers necessary for the carrying out of the purposes of this chapter;

(9) license in accordance with this chapter pharmacists who shall practice in this State and permit all facilities which possess or dispense drugs in this State, except as provided in subsections (H) and (I) of this section, and as otherwise provided for in this chapter and except as to those entities and persons authorized to obtain and possess drugs pursuant to Section 47-3-420(A)(1)(i) and to suspend, revoke, or cancel a license or permit in accordance with law;

(10) adopt rules of professional conduct for pharmacists which must be appropriate to the establishment and maintenance of a high standard of integrity and dignity in the profession; and

(11) to have such powers and authority as may be necessary and proper to accomplish the foregoing or as may be prescribed by law.

(E) The board may:

(1) join professional organizations and associations organized exclusively to promote the improvement of the standards of the practice of pharmacy for the protection of the health and welfare of the public or whose activities assist and facilitate the work of the board, or both;

(2) establish a bill of rights for patients concerning the health care services a patient may expect in regard to pharmacy care.

(F) Notwithstanding anything in this chapter to the contrary, whenever a duly authorized representative of the board finds, or has probable cause to believe, that a drug or device is adulterated or misbranded within the meaning of the Federal Food and Drug Act, the duly authorized representative of the board shall affix to the drug or device a tag or other appropriate marking giving notice that the drug or device is or is suspected of being adulterated or misbranded, has been detained or embargoed, and warning all persons not to remove or dispose of the drug or device by sale or otherwise until provision for removal or disposal is given by the board, its agent, or the court. No person shall remove or dispose of the embargoed drug or device by sale or otherwise without permission of the board or its agent or, after summary proceedings have been instituted, without permission from the court.

(1) When a drug or device detained or embargoed under this subsection has been declared by a representative to be adulterated or misbranded, the board shall, as soon as is practical, petition the court in which jurisdiction the article is detained or embargoed for an order for condemnation of the article. If the court determines that the drug or device so detained or embargoed is not adulterated or misbranded, the board shall direct the immediate removal of the tag or other marking.

(2) If the court finds the detained or embargoed drug or device is adulterated or misbranded, the drug or device, after entry of the decree, must be destroyed at the expense of the owner under the supervision of a board representative and all costs and fees, storage, and other proper expense shall be borne by the owner of the drug or device. When the adulteration or misbranding can be corrected by proper labeling or processing of the drug or device, the court, after entry of the decree and after costs, fees, and expenses have been paid and a good and sufficient bond has been posted, may direct that drug or device be delivered to the owner for labeling or processing under the supervision of a board representative. Expense of the supervision shall be paid by the owner. The bond shall be returned to the owner of the drug or device on representation to the court by the board that the drug or device is no longer in violation of the embargo and the expense of supervision has been paid.

(3) It is the duty of the Attorney General to whom the board reports any violation of this subsection to cause appropriate proceedings to be instituted in the proper court without delay and to be prosecuted in the manner required by law. Nothing in this subitem shall be construed to require the board to report violations whenever the board believes the public's interest will be adequately served in the circumstances by a suitable written notice or warning.

(G) The board may place under seal all drugs or devices that are owned by or in the possession, custody, or control of a licensee at the time the license is suspended or revoked or at the time the board refuses to renew the license. Except as otherwise provided in this section, drugs or devices so sealed shall not be disposed of until appeal rights under the Administrative Procedures Act have expired, or an appeal filed pursuant to that act has been determined. The court involved in an appeal filed pursuant to the Administrative Procedures Act may order the board, during the tendency of the appeal, to sell drugs that are perishable. The proceeds of the sale must be deposited with that court.

(H) Nothing in this chapter shall be construed to require a permit of or to prevent a licensed practitioner as defined under Section 40-43-30(45) from possessing or administering drugs or devices, or compounding drugs used for administration in the regular course of professional practice.

(I) This chapter does not require a permit of or prevent a licensed practitioner, as defined under Section 40-43-30(45), from dispensing drugs or devices that are the lawful property of the practitioner or a partnership or corporate entity which is fully owned by licensed practitioners or from dispensing a free complimentary trial supply of drugs owned by a person or institution authorized to possess medication under state or federal law for indigent patients with guidelines equal to or equivalent to Section 340B of the Public Health Service Act. Drugs or medicine dispensed must comply with the labeling requirements of state and federal laws and regulations.

(J) The possession of complimentary drug samples intended for distribution, and stock bottles and legend devices intended for remuneration or demonstration by manufacturer's representatives as allowed by the federal Food and Drug Administration and the actual distribution of them to pharmacists licensed to dispense and to practitioners in this State who are legally authorized to prescribe does not require a permit within the meaning of this chapter.

(K) A physician may dispense noncontrolled prescription drugs at an entity that provides free medical services for indigent patients if no pharmacist is available. All such drugs must be labeled as required by this chapter.

(L) Nothing in this chapter prohibits an optometrist from purchasing, possessing, administering, selling, prescribing, or dispensing either directly or through a licensed manufacturer contact lenses, contact lens solutions, and topically applied dyes or applies to the practice of opticianry.

(M) Nothing in this chapter may be construed to prevent, restrict, or in any manner interfere with the sale by a retail merchant of nonnarcotic nonprescription drugs which may be lawfully sold without a prescription under the United States Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq. as now or hereafter amended) or the laws of this State.

HISTORY: 1998 Act No. 366, Section 1; 1999 Act No. 76, Section 3; 2000 Act No. 340, Sections 1, 7; 2002 Act No. 314, Section 3.

Editor's Note

Prior Laws:1925 (34) 32; 1932 Code Section 5182; 1942 Code Section 5182; 1952 Code Section 56-1326; 1962 Code Section 56-1326; 1976 Code Section 40-43-300.


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