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Bill Number: 1253 Ratification Number: 469 Act Number 406 Introducing Body: Senate Subject: Out-of-state pharmacies; regulation of mail order prescription services
(A406, R469, S1253)
AN ACT TO AMEND THE CODE OF LAWS OF SOUTH CAROLINA, 1976, BY ADDING SECTION 40-43-425 SO AS TO PROVIDE FOR THE REGULATION OF A PHARMACY LOCATED OUTSIDE THIS STATE WHOSE PRIMARY BUSINESS IS MAIL ORDER PRESCRIPTION SERVICE.
Be it enacted by the General Assembly of the State of South Carolina:
Out-of-state pharmacies; regulation of mail order prescription services
SECTION 1. Chapter 43, Title 40 of the 1976 Code is amended by adding:
"Section 40-43-425. (A) A pharmacy located outside this State, whose primary business is mail order prescription service, must have a permit issued by the board to ship, mail, or deliver a controlled substance or dangerous drug or device into this State pursuant to a prescription of a licensed practitioner. The pharmacy shall report to the board:
(1) information on the location, names, and titles of all principal corporate officers and pharmacists who are dispensing controlled substances or dangerous drugs or devices to residents of this State. The report must be updated annually and within thirty days after a change of permitholder or pharmacist-in-charge;
(2) that it complies with the applicable laws for operation in the state in which it is located and with the provisions of this section. The pharmacy shall maintain a valid unexpired license, permit, or registration in compliance with the laws of the state in which it is located and must be constantly under the personal and immediate supervision of a licensed pharmacist. The pharmacy shall submit to the board with its initial application and with each renewal application a copy of its most recent inspection report resulting from an inspection conducted by the regulatory or licensing agency of the state in which it is located. These inspections are deemed to meet all inspection requirements contained in this chapter;
(3) that it maintains its records of controlled substances or dangerous drugs or devices dispensed to patients in this State so that the records are readily retrievable.
(B) Nothing in this chapter requires that pharmacists employed by pharmacies located in other states and who are not engaged in the practice of pharmacy in this State be licensed in this State.
(C) If the state in which the pharmacy is located does not establish, by statute or regulation, a ratio describing the number of auxiliary personnel that a pharmacist may supervise, or otherwise define the role of the pharmacist in the compounding and dispensing of prescription drugs, then that pharmacy must not allow a pharmacist to supervise more than one supportive person at any one time in the compounding and dispensing of prescription drugs.
(D) A pharmacy, as described in this section, during its regular hours of operation but not less than six days nor forty hours a week, shall provide a toll-free telephone service to facilitate communication between patients in this State and a pharmacist at the pharmacy who has access to their records. This telephone number must be printed on a label affixed to the container for the substance, drug, or device.
(E) An application for a pharmacy permit under the provisions of this section must be made on a form furnished by the board, signed by a responsible person who has been designated as the permitholder, and accompanied by the required fee. The board may require information from the pharmacy reasonably necessary to carry out the purposes of this section. Each pharmacy shall apply individually and obtain a separate permit for each location. The permit is not transferable and expires annually. An application blank for a renewal permit must be mailed by the board to each permitholder before May second each year, and if application for renewal is not made before the following June second, the existing permit lapses on the date of its expiration, and no renewal permit may be granted except:
(1) upon evidence satisfactory to the board of good and sufficient grounds for the failure to file the application within the prescribed period;
(2) upon payment of the renewal fee and a penalty of fifty dollars.
(F) The board may deny, revoke, suspend, or otherwise take action against a pharmacy permit issued under the provisions of this section for:
(1) failure to comply with the requirements of:
(a) this section;
(b) Sections 40-43-150, 40-43-400, 40-43-410, and 40-43-420;
(c) board Regulations 99-2, 99-27, 99-33, and 99-38;
(d) Subchapter 1, Chapter 13, Title 21 of the U. S. Code, the Federal Controlled Substance Act; or
(e) Chapter 2, Title 21 of the Code of Federal Regulations, the Federal Controlled Substance Regulation;
(2) conduct which causes serious bodily or serious psychological injury to a resident of this State if the board has referred the matter to the regulatory or licensing agency under which the pharmacy operates in the state in which it is located and that agency fails to initiate an investigation within forty-five days of the referral. The board shall maintain a record of referrals pursuant to this item and action taken on them.
The board annually shall furnish each pharmacy permitholder with a current copy of the sections and regulations listed in item (1).
(G) A pharmacy required to obtain a permit pursuant to this section but not issued a permit, may not advertise its services in this State, nor may a resident of this State advertise the services for the pharmacy.
(H) A permit issued pursuant to this section is not evidence that the pharmacy is doing business within this State."
SECTION 2. This act takes effect upon approval by the Governor.
Approved the 10th day of April, 1990.