Bill 2536

                    Current Status

Bill Number:               2536
Ratification Number:       328
Act Number:                321
Introducing Body:          House
Subject:                   Relating to the powers of the Board of
                           Pharmaceutical Examiners

(A321, R328, H2536)

AN ACT TO AMEND SECTION 40-43-40, CODE OF LAWS OF SOUTH CAROLINA, 1976, RELATING TO THE POWERS OF THE BOARD OF PHARMACEUTICAL EXAMINERS, SO AS TO CHANGE THE NAME TO THE BOARD OF PHARMACY, TO DELETE OBSOLETE PROVISIONS, AND TO AUTHORIZE THE BOARD TO EXERCISE POWERS WITH RESPECT TO DRUG OUTLETS; TO AMEND SECTION 40-43-100, RELATING TO DISPENSING OF DRUGS ONLY BY LICENSED PHARMACISTS, SO AS TO REQUIRE EMERGENCY ROOM PHYSICIANS TO DISPENSE NOT MORE THAN A SEVENTY-TWO HOUR SUPPLY OF LEGEND DRUGS TO MEET IMMEDIATE NEEDS AND TO REQUIRE RECORDS OF DISPENSED DRUGS; TO AMEND SECTION 40-43-360, AS AMENDED, RELATING TO THE DEFINITION OF PHARMACY, SO AS TO DEFINE "DRUG OUTLET", "PHARMACY", AND "PRACTITIONER" AND TO PROVIDE THAT THIS SECTION DOES NOT SUPERSEDE THE NURSING DISPENSING ACT; TO AMEND SECTION 40-43-370, RELATING TO THE REQUIREMENT THAT A PERMIT MUST BE OBTAINED FROM THE BOARD TO OPERATE A PHARMACY, SO AS TO DELETE THE OBSOLETE REFERENCE TO THE EFFECTIVE DATE OF THE SECTION, TO CHANGE THE REFERENCES TO DRUG OUTLET AND BOARD OF PHARMACY, TO ALLOW THE BOARD TO ISSUE SPECIAL PERMITS FOR LIMITED MEDICAL CARE INSTITUTIONS AND TO PROVIDE THE CONDITIONS UNDER WHICH THE PERMITS MAY BE ISSUED, TO REQUIRE EACH REGIONAL HEALTH SERVICE DISTRICT TO HAVE ONLY ONE PERMIT AND TO PROVIDE THE RESPONSIBILITIES OF PHARMACISTS IN THE DISTRICTS, AND TO PROVIDE FOR DISPENSING IN HOSPITAL PHARMACIES; TO AMEND CHAPTER 43 OF TITLE 40, AS AMENDED, RELATING TO PHARMACISTS, BY ADDING SECTION 40-43-135, SO AS TO AUTHORIZE THE BOARD TO ENFORCE THE PROVISIONS OF THIS CHAPTER, TO PROVIDE THE BOARD'S DUTIES IN REGULATING THE PRACTICE OF PHARMACY AND THE OPERATION OF HOSPITAL INPATIENT PHARMACIES AND DRUG OUTLETS, TO AUTHORIZE THE BOARD TO ORDER PERSONS TO REFRAIN FROM VIOLATING THE PROVISIONS OF THIS CHAPTER AND TO APPLY FOR AN INJUNCTION TO RESTRAIN THE PERSONS, AND TO PROVIDE EXEMPTIONS FROM REGULATIONS OF THE BOARD; AND TO REPEAL SECTION 40-43-130, RELATING TO ADDITIONAL REGULATORY POWERS OF THE BOARD.

Be it enacted by the General Assembly of the State of South Carolina:

Powers of board

SECTION 1. Section 40-43-40 of the 1976 Code is amended to read:

"Section 40-43-40. The Board of Pharmacy alone possesses and shall exercise all the powers with respect to the licenses of pharmacists and permits for drug outlets."

Definitions

SECTION 2. Section 40-43-360 of the 1976 Code, as last amended by Act 663 of 1976, is further amended to read:

"Section 40-43-360. For the purposes of Sections 40-43-360 to 40-43-460, 'drug outlet' means any outlet for the sale, distribution, or dispensing of drugs bearing the legend 'Caution - federal law prohibits dispensing without a prescription', including, but not limited to, pharmacies (institutional or community, public or private), nursing homes, hospitals, convalescent homes, extended care facilities, family planning clinics, public or private health clinics, infirmaries, wholesalers, correctional institutions, industrial health clinics which possess legend drugs, mail order vendors, and manufacturers within this State.

For the purposes of this section, medical practitioners dispensing drugs in the treatment of their patients and pharmacists are not considered drug outlets. The distribution of complimentary drug samples by manufacturer's representatives to pharmacists licensed to dispense and to practitioners in this State who are legally authorized to prescribe does not require a permit for a drug outlet within the meaning of this chapter.

'Pharmacy' means any outlet dispensing drugs on the order of a practitioner licensed to prescribe drugs. 'Practitioner' means a physician, dentist, osteopath, podiatrist, or veterinarian licensed by any state or territory (other than pharmacists engaged in the practice of pharmacy) to prescribe with regard to drugs or devices in the course of professional practice or research. Nothing in this section shall supersede the Nursing Dispensing Act."

Permit may be issued

SECTION 3. Section 40-43-370 of the 1976 Code is amended to read:

"Section 40-43-370. It is unlawful for any person to operate any drug outlet within this State without having obtained a permit so to do from the Board of Pharmacy.

The board may issue a special permit for a limited medical care institution which must be based on special conditions of use imposed by the board. A policy and procedure manual detailing the type and method of operation, hours of operation, and the method of documentation of continuing pharmacist control shall accompany the application for this permit. The issuance and continuation of these permits are subject to compliance with the conditions set forth by the board.

The application for all permits must be made on a form to be prescribed by the board and accompanied by the required fee.

If it is desired to operate more than one drug outlet, separate applications must be made and separate permits issued for each.

Regional health services districts operated by the South Carolina Department of Health and Environmental Control are required to have only one permit for each district. A pharmacist may supervise no more than two adjacent districts and has full responsibility for drug distribution and dispensing in those districts.

Hospital pharmacies must be directed by a pharmacist who is knowledgeable in the specialized functions of institutional pharmacy. For the purposes of dispensing to hospital inpatients, a licensed pharmacist may supervise a number of ancillary pharmacy personnel to be determined by the pharmacist in charge and the hospital administrator."

Enforcement

SECTION 4. Chapter 43 of Title 40 of the 1976 Code is amended by adding:

"Section 40-43-135. The responsibility for the enforcement of the provisions of this chapter is vested in the Board of Pharmacy. The board has all of the duties, powers, and authority granted by and necessary to the enforcement of this chapter. The board shall regulate the practice of pharmacy. Its duties include, but are not limited to, determining the ethical and professional competence, on a continuing basis, of pharmacists and for disciplining them and the compounding, dispensing, and sale of drugs and the required recordkeeping for the sale of drugs. However, the Board of Pharmacy's inspection authority over the inpatient pharmacy of a hospital will only apply to recordkeeping activities of drugs dispensed by the pharmacy. Further, the responsibility for inspections of the hospital inpatient pharmacy is delegated to the Department of Health and Environmental Control as part of its licensing process; provided, that these DHEC inspections must be conducted by a licensed pharmacist.

The board shall regulate the operation of drug outlets including, but not limited to, the compounding, manufacturing, sale, and distribution of drugs bearing the legend 'Caution - federal law prohibits dispensing without a prescription'. In so doing, the board shall make, publish, supervise, and enforce regulations for the operation of drug outlets, including the operation of pharmacies, the inspection of weights and measures used in the prescription departments of pharmacies, the compounding, dispensing and sale of drugs, medicines, poisons, and prescriptions, and the necessary recordkeeping. It shall prescribe minimum standards for technical equipment, sanitation, reference materials, and the currently dated inventory of drugs in all drug outlets.

When the board has reason to believe that any person is violating or intends to violate any provisions of this chapter it may, in addition to all other remedies, order the person to immediately refrain from the conduct. The board may apply to the court of common pleas for an injunction restraining the person from the conduct. The court may issue a temporary injunction ex parte and upon notice and full hearing may issue any other order in the matter it considers proper. No bond is required from the board by the court as a condition to the issuance of any injunction or other action contemplated by the provisions of this section.

Nothing in this section authorizes the board to make regulations concerning the prices of goods or drugs sold by outlets, the hours that the businesses may be operated, or the hours of work of the employees of the businesses."

Dispensing of drugs

SECTION 5. Section 40-43-100 of the 1976 Code is amended by adding at the end of the paragraph:

"Physicians who are in charge or who directly supervise the operation of emergency rooms shall dispense legend drugs in order to meet the immediate needs of the patient. The amount dispensed shall not exceed an amount equal to a seventy-two hour supply. Records of drugs dispensed shall be maintained."

Repeal

SECTION 6. Section 40-43-130 of the 1976 Code is repealed.

Time effective

SECTION 7. This act shall take effect upon approval by the Governor.