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Bill 726

Indicates Matter Stricken

Indicates New Matter

COMMITTEE REPORT

May 26, 1999

S. 726

S. Printed 5/26/99--H.

Read the first time May 4, 1999.

To whom was referred a Bill (S. 726), to amend Section 40-43-30, as amended, Code of Laws of South Carolina, 1976, relating to definitions in the South Carolina Pharmacy Practice Act, etc., respectfully

That they have duly and carefully considered the same, and recommend that the same do pass:

JOE E. BROWN, for Committee.

EXPLANATION OF IMPACT:

The Department of Labor, Licensing and Regulation has indicated this bill would not have any impact to the department or to the General Fund of the State nor federal and/or other funds because it would not affect program services.

Approved By:

Don Addy

Office of State Budget

TO AMEND SECTION 40-43-30, AS AMENDED, CODE OF LAWS OF SOUTH CAROLINA, 1976, RELATING TO DEFINITIONS IN THE SOUTH CAROLINA PHARMACY PRACTICE ACT, SO AS TO REVISE CERTAIN DEFINITIONS; TO AMEND SECTION 40-43-60, AS AMENDED, RELATING TO VARIOUS REQUIREMENTS FOR THE DISPENSING AND SALE OF DRUGS, SO AS TO CLARIFY CONDITIONS UNDER WHICH A PHYSICIAN MAY DISPENSE NONCONTROLLED DRUGS AT A CLINIC PROVIDING FREE MEDICAL SERVICES AND TO CLARIFY WHICH NONNARCOTIC NONPRESCRIPTION DRUGS MAY BE SOLD BY A RETAIL MERCHANT; TO AMEND SECTION 40-43-84, RELATING TO PHARMACY INTERNSHIPS, SO AS TO ALSO REFERENCE EXTERNSHIPS; TO AMEND SECTION 40-43-85 RELATING TO INTERNSHIP PROGRAMS AND PRACTICAL EXPERIENCE, SO AS TO REVISE REQUIREMENTS FOR PRACTICAL EXPERIENCE; TO AMEND SECTION 40-43-86, AS AMENDED, RELATING TO FACILITY REQUIREMENTS FOR PHARMACIES, DUTIES OF PHARMACISTS-IN-CHARGE AND CONSULTANT PHARMACISTS, AND TO THE SALE OF NONPRESCRIPTION DRUGS, SO AS TO REVISE CERTAIN RECORDKEEPING AND FACILITY REQUIREMENTS, TO REVISE AND CLARIFY THE PHARMACIST TO TECHNICIAN RATIO IN CERTAIN FACILITIES, TO REVISE SPECIFIED CONSULTANT PHARMACIST DUTIES, TO CLARIFY PROVISIONS RELATING TO THE SALE OF NONPRESCRIPTION DRUGS AND TO PROHIBIT REQUIRING SUCH DRUGS TO BE SOLD BY PHARMACISTS OR IN A PHARMACY, AND TO PROHIBIT THE POSSESSION, DISPENSING, OR DISTRIBUTION OF CERTAIN DRUGS WITHOUT A PRESCRIPTION OF A LICENSED PRACTITIONER; AND TO AMEND SECTION 40-43-170, RELATING TO DISPENSING OF MEDICATIONS IN A STATE OF EMERGENCY, SO AS TO CLARIFY THE CONDITIONS UNDER WHICH A ONETIME EMERGENCY REFILL MAY BE DISPENSED.

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

SECTION 1. Section 40-43-30(42) of the 1976 Code, as amended by Act 366 of 1998, is further amended to read:

"(42) 'Pharmacy technician' means an individual other than an intern or extern, who works assists in preparing, compounding, and dispensing medicines under the personal supervision of a licensed pharmacist or who handles legend drugs in a pharmacy department, or both, and who is required to register as a pharmacy technician."

SECTION 2. Section 40-43-30(46)(a) of the 1976 Code, as amended by Act 366 of 1998, is further amended to read:

"(a) a drug which, under federal law, is required, prior to being dispensed or delivered, to be labeled with either any of the following statements:

(i) 'Caution: Federal law prohibits dispensing without prescription';

(ii) 'Caution: Federal law restricts this drug to use by, or on the order of, a licensed veterinarian'; or

(iii) 'Rx only'; or"

SECTION 3. Section 40-43-60(K) and (M) of the 1976 Code, as amended by Act 366 of 1998, is further amended to read:

"(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.

(M) Unless otherwise expressly restricted by this act, nothing in this shall prevent, restrict, or otherwise interfere with the sale of non-narcotic, nonprescription drugs by a retail merchant 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."

SECTION 4. Section 40-43-84 of the 1976 Code, as added by Act 366 of 1998, is amended to read:

"Section 40-43-84. (A) All applicants for licensure by examination shall obtain one thousand five hundred hours of practical experience in the practice of pharmacy. The board shall establish certificate requirements for interns interns/externs and standards for internship, or any other experiential program necessary to qualify an applicant for licensure. The board shall issue an intern certificate to a qualified applicant. No intern intern\extern may receive credit for practical experience unless he has been issued a certificate by the board. Such certificate must be granted only to individuals who have been accepted by or graduated from an approved college of pharmacy, but no sooner than three months before beginning pharmacy school. No credit shall be given for internships worked for more than three months before beginning pharmacy school or if the student does not matriculate. A foreign pharmacy graduate may secure a certificate of registration as a pharmacy intern upon presenting to the board proof of graduation from a pharmacy school located in a foreign country and a statement of his intent to complete the requirements of the Foreign Pharmacy Graduate Equivalency Examination (FPGEE).

(B) An intern intern\extern may not represent himself as a pharmacist. The board shall issue to an intern intern\extern a certificate for purposes of identification and verification of his role as an intern intern\extern. The internship certificate must be displayed in the pharmacy or site in which the experience is being gained. No individual who has not been issued a certificate by the board as an intern intern\extern shall take, use, or exhibit the title of intern intern\extern, or any other term of similar like or import.

(C) An intern intern\extern may engage in the practice of pharmacy if such activities are under the direct supervision of a licensed pharmacist. A pharmacist must be in continuous personal eye and voice contact with, and actually giving instructions to, the intern intern\extern during all professional activities throughout the entire period of the internship internship/externship. The pharmacist shall physically review the prescription drug order and the dispensed product before the product is delivered to the patient or the patient's agent. The pharmacist is responsible for the work of the intern intern\extern. A pharmacist may not supervise more than one intern at any one time.

Pharmacy interns interns/externs shall not be left in sole charge of a prescription department or other approved site at any time. Violation of this may result in cancellation of any and all internship internship/externship hours toward licensure that may have been accrued by the intern intern\extern, and may, in the discretion of the board, cause the board after sufficient notice to the pharmacy intern intern\extern, to revoke or suspend the internship certificate as provided above. The supervising pharmacist or designated pharmacist may also be subject to disciplinary action by the board.

An applicant for licensure, who is guilty of compounding or dispensing a prescription of a practitioner or selling legend drugs or medicines while not under the supervision of a licensed pharmacist may be refused licensure.

(D) All interns shall notify the board of any change of employment or residence address within ten days.

(E) Credit for claims of practical experience required under the pharmacy laws will not be recognized by the board unless such claims are corroborated by records on file in the board office, showing the beginning and ending of the practical experience claimed as supplied by the applicant during the training period and by the pharmacist who supervised the practical experience during the training period.

(F) The pharmacy, site, or program in which practical experience is being obtained shall have a current, valid pharmacy permit, as required by this chapter, and the designated pharmacist shall hold a current, valid license to practice pharmacy."

SECTION 5. Section 40-43-85 of the 1976 Code, as added by Act 366 of 1998, is further amended to read:

"Section 40-43-85. (1)( A) An intern shall notify the Board of Pharmacy within ten days after the beginning and again within ten days after the ending of each internship period and every calendar year, if the intern is employed, and within ten days after the beginning of each new employment and within ten days after the ending of each employment, on forms provided by the board, of the identity of the internship site and of the designated pharmacist. This form must be certified by the designated pharmacist. The pharmacy intern is responsible for the submission of the appropriate forms within the time limits as set.

(2)(B) An intern may gain practical experience toward licensure as a pharmacist in any of the following areas:

(a) retail pharmacy (community, independent or chain, out-patient clinic, and family practice) dispensing prescriptions;

(b) institutional pharmacy (hospital or nursing home);

(c) summer internship program sponsored by the National Pharmaceutical Council (NPC);

(d) pharmaceutical industry;

(e) nuclear pharmacy;

(f) Veterans Administration or other federal agency pharmacy or program;

(g) research project in the pharmaceutical sciences;

(h) graduate teaching assistant in college of pharmacy; or

(i) other site or program as approved by the board.

Approval of all experience gained is left to the discretion of the board after receiving a description of the experience by the intern and designated pharmacist accordance with this section and as may otherwise be required by this chapter.

(3)(C) Where practical experience is gained in a pharmacy, other site, or program located outside of the State, the board has the discretion to determine whether such experience meets the requirements of the board. The applicant shall submit from the secretary of the Board of Pharmacy of the state in which practical experience was gained certification of the validity of the supervising pharmacist's license and the pharmacy permit.

(4)(D) A minimum of five hundred hours of practical experience must be obtained in a retail or institutional pharmacy. Approval of all experience gained is left to the discretion of the board after receiving a description of the experience by the intern and the designated pharmacist.

(5)(E) A maximum of five hundred hours of internship credit may be given for participation in an externship program approved by a recognized college of pharmacy. Students enrolled in an approved program leading to a bachelor of science degree in pharmacy may receive practical experience credit for up to five hundred hours for participation in an externship program upon completion of the program. Hours earned must be certified by the college of pharmacy, none of which may be used to fulfill the requirement in subsection (4) (D). The pharmacy at which an intern is being trained shall provide an environment that is conducive to the learning of the practice of pharmacy by an intern. It is expected that the intern will be exposed to all facets of the practice of pharmacy in that setting including, but not limited to:

(a) evaluation of prescription drug orders;

(b) preparation and labeling of drugs;

(c) dispensing of drugs;

(d) patient profile update and review;

(e) drug use review;

(f) patient counseling; and

(g) proper and safe storage of drugs.

(6)(F) Students enrolled in an approved doctor of pharmacy program consisting of six or more years of collegiate studies may receive internship practical experience credit for up to one thousand hours for practice related experiences upon completion of such program, the number of hours certified by the college of pharmacy, none of which shall be used to fulfill the requirements in subsection (4)(D).

(7)(G) A pharmacy, site, or program offering interns interns\externs practical experience toward licensure as a pharmacist shall conform to the best traditions of pharmacy, shall have available all necessary reference books, in addition to the official standards and current professional journals and periodicals, and must be operated at all times under the supervision of a licensed pharmacist as required by law. The designated pharmacist must signify willingness to train interns interns/externs desiring to obtain practical experience in accordance with this chapter. The pharmacy at which an intern\extern is being trained shall provide an environment that is conducive to the learning of the practice of pharmacy by an intern\extern. It is expected that the intern\extern will be exposed to all facets of the practice of pharmacy in that setting including, but not limited to:

(a)(1) evaluation of prescription drug orders;

(b)(2) preparation and labeling of drugs;

(c)(3) dispensing of drugs;

(d)(4) patient profile update and review;

(e)(5) drug use review;

(f)(6) patient counseling; and

(g)(7) proper and safe storage of drugs.

(8)(H) No more than forty hours per week of internship training may be allowed.

SECTION 6. Section 40-43-86(A)(4),(5),(6),(7), and (13) of the 1976 Code, as added by Act 366 of 1998, are amended to read:

"(4) update drug monographs monthly at least quarterly, which include the following prescribing information: actions, indications, contradictions, warning and precautions, drug interactions, adverse reactions, patient information, overdosage, administration, and dosage;

(5) update this product information monthly at least quarterly:

(a) products grouped by dosage or strength;

(b) identical brand name products;

(c) distributor name;

(d) package sizes for all dosage forms;

(e) product identification;

(f) whether prescription or nonprescription;

(g) controlled substance schedule;

(h) combination products comparison;

(i) products with identical formulations.

(6) update new development information monthly at least quarterly:

(a) significant recent drug therapy developments;

(b) information on investigational agents;

(c) recent new product information and product listing changes.

(7) maintain a copy of Equivalent Drug Product Evaluations or equivalent reference;

(13) have secured its pharmacy by either a physical barrier with suitable locks or an electronic barrier, or both, to detect entry at a time the pharmacist, or a person authorized by the pharmacist on duty or the pharmacist-in-charge, is not present. The barrier must be approved by the Board of Pharmacy before being put into use;"

SECTION 7. Section 40-43-86(B)(3) and (4) of the 1976 Code, as added by Act 366 of 1998, are amended to read:

"(3) The pharmacist-in-charge shall have the following responsibilities:

(a) establishing or implementing, or both, written policies and procedures for the provision of pharmacy services;

(b) assuring that all pharmacists, technicians, and interns employed at the pharmacy are currently licensed, certified, or registered and that interns and technicians wear proper identification while on duty;

(c)(b) notifying the Board of Pharmacy immediately of any of the following changes:

(i) change of employment or responsibility as the pharmacist-in-charge;

(ii) change of ownership of the pharmacy;

(iii) change of address of the pharmacy; or

(iv) permanent closing of the pharmacy.;

(d)(c) making or filing any reports required by state or federal laws and regulations;

(e)(d) responding to the Board of Pharmacy regarding any violations brought to the pharmacist-in-charge's attention.

(4) The pharmacist-in-charge must be assisted by a sufficient number of licensed pharmacists and registered pharmacy technicians as may be required to competently and safely provide pharmacy services:.

(a) The pharmacist-in-charge shall maintain and file with the Board of Pharmacy, on a form provided by the board, a current list of all pharmacy technicians assisting in the provision of pharmacy services.

(b) The pharmacist-in-charge shall develop and implement written policies and procedures to specify the duties to be performed by pharmacy technicians. The duties and responsibilities of these personnel shall be consistent with their training and experience. These policies and procedures shall, at a minimum, specify that pharmacy technicians are to be personally supervised by a licensed pharmacist who has the ability to control and who is responsible for the activities of pharmacy technicians and that pharmacy technicians are not assigned duties that may be performed only by a licensed pharmacist. One pharmacist may not supervise more than two pharmacy technicians at a time; however, the number of pharmacy technicians does not include personnel in the prescription area performing only clerical functions including data entry up to the point of dispensing as defined in Section 40-43-30(14). In pharmacy practice sites where other licensed health care professionals are authorized to administer drugs, the full-time pharmacist-to-technician ratio may not exceed a one-to-two employment ratio.

(c) For the purpose of dispensing by institutional pharmacies to institutional facility in-patients the pharmacist to technician ratio may not exceed a one to three employment ratio. The allowable employment ratio for a site is determined by comparing the number of pharmacists employed at the site to the number of pharmacy technicians employed at the site. The day to day operational pharmacist to technician personal supervision ratio is to be determined by the pharmacist-in-charge."

SECTION 8. That portion of Section 40-43-86(B)(6) preceding the lettered subitems in that item of the 1976 Code, as added by Act 366 of 1998, is amended to read:

"(6) The pharmacist-in-charge of an institutional pharmacy shall establish or implement, or both, written policies and procedures for provision of drugs and to the medical staff and other authorized personnel whenever a licensed pharmacist is not physically present in an institutional facility by use of night cabinets and/or by access to the pharmacy. A licensed pharmacist must be on call at all times."

SECTION 9. That portion of Section 40-43-86(C) preceding the numbered items in that subsection of the 1976 Code, as added by Act 366 of 1998, is amended to read:

"(C) Except for a pharmacy, wholesaler, or a permitted facility that supplies only oxygen, every holder of a permit from the board shall designate a pharmacist duly licensed by the Board of Pharmacy as a consultant pharmacist to be responsible for the duties as stated in this chapter at the permit holder's location. The consultant pharmacist shall sign a new or renewal application along with the permit holder and agree in writing to assume the responsibilities of consultant pharmacist. Every holder of a permit from the board shall designate a pharmacist duly licensed by the Board of Pharmacy as a consultant pharmacist to be responsible for the duties as stated in this chapter at the permit holder's location. The consultant pharmacist shall sign a new or renewal application along with the permit holder and agree in writing to assume the responsibilities of consultant pharmacist."

SECTION 10. Section 40-43-86(Q) of the 1976 Code, as added by Act 366 of 1998, is amended to read:

"(Q) Machines used in the prescription drug distribution process must be under the control of and are the responsibility of a licensed pharmacist.

The pharmacist-in-charge shall establish or implement, or both, written procedures for the safe and efficient distribution of drugs and for the provision of pharmacy care. An annual updated copy of these procedures shall be on hand for inspection by the Board of Pharmacy.

Drugs brought into an institutional facility by a patient may not be administered unless they can be identified. If such drugs cannot be administered, then according to pharmacy procedures specified in writing, the drugs must be turned into the pharmacy which shall package and seal them and return them to an adult member of the patient's immediate family, or store and return them to the patient upon discharge.

Investigational drugs which are used within an institutional facility must be stored in and dispensed from the pharmacy only. All information with respect to investigational drugs must be maintained in the pharmacy.

All drug storage areas must be routinely inspected by pharmacy personnel to ensure that no outdated or unusable items are present, and that all stock items are properly labeled and stored.

A written stop-order policy or other system must be established by the institutional pharmacists-in-charge to ensure that drug orders are not inappropriately continued.

There must be a written policy and procedure for providing pharmacy services in the event of a disaster. This shall be reviewed annually by all pharmacy staff members and so documented."

SECTION 11. Section 40-43-86(U) of the 1976 Code, as added by Act 366 of 1998, is amended to read:

"(U) Nonprescription drugs which can be sold by all retailers in the manufacturer's original package, also may be dispensed and profiled by pharmacists. When dispensed in this manner by a pharmacist, the drug must be treated in all respects as a prescription drug and all prescription drug counseling and labeling requirements apply may be sold by any retailer in their original, unbroken prepackaged containers and no rule or regulation shall be adopted by the Board of Pharmacy which shall require the sale of nonprescription drugs by a licensed pharmacist or in a pharmacy. However, nonprescription drugs may also be dispensed and profiled by pharmacists pursuant to a practitioner's prescription, and when dispensed in this manner by a pharmacist, the drug must be treated in all respects as a prescription drug and all prescription drug counseling and labeling requirements shall apply."

SECTION 12. Section 40-43-86 of the 1976 Code, as added by Act 366 of 1998, is amended by adding at the end:

"(EE) Except as provided in subsection (S), it is unlawful for a person to possess, dispense, or distribute in this State, except on a prescription of a licensed practitioner, any drug or device, as defined in Section 39-23-20, bearing on its manufacturer's or distributor's original commercial container the legend, 'Caution: Federal law prohibits dispensing without prescription', 'Rx Only', 'Caution: Federal law restricts this drug to use by, or on the order of, a licensed veterinarian', or 'Caution: Federal law restricts device for sale by or on the order of a ____________'."

SECTION 13. That portion of Section 40-43-170(A)(1) preceding the lettered subitems in that item, of the 1976 Code, as added by Act 366 of 1998, is amended to read:

"(1) A pharmacist may work in the affected county and may dispense a one-time emergency refill of up to a fifteen-day supply of a prescribed medication if:"

SECTION 14. This act takes effect upon approval by the Governor.

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