S*130 Session 112 (1997-1998)
S*0130(Rat #0343, Act #0366 of 1998) General Bill, By Giese
A BILL TO AMEND CHAPTER 43, TITLE 40, AS AMENDED, CODE OF LAWS OF SOUTH
CAROLINA, 1976, RELATING TO PHARMACISTS, SO AS TO REVISE THE PRACTICE AND
REGULATION OF PHARMACY INCLUDING, BUT NOT LIMITED TO FURTHER DEFINING
"PHARMACEUTICAL DEVICES" AND FURTHER PROVIDING FOR THEIR REGULATION, REVISING
THE ROLE OF PHARMACISTS IN DRUG THERAPY MANAGEMENT, REQUIRING PHARMACISTS TO
COUNSEL PATIENTS ON NEW MEDICATION, AUTHORIZING PHARMACISTS TO SUPERVISE TWO,
RATHER THAN ONE, PHARMACY TECHNICIAN, FURTHER PROVIDING FOR THE REQUIREMENTS
FOR COMPOUNDING PRESCRIPTION DRUGS, PROVIDING FOR THE TRANSFER OF
PRESCRIPTIONS BETWEEN PHARMACIES UNDER CERTAIN CONDITIONS, AND REVISING
PROCEDURES FOR THE DISCLOSURE OF CONFIDENTIAL PRESCRIPTION
INFORMATION.-AMENDED TITLE
01/14/97 Senate Introduced and read first time SJ-134
01/14/97 Senate Referred to Committee on Medical Affairs SJ-134
02/12/98 Senate Committee report: Favorable with amendment
Medical Affairs SJ-9
02/17/98 Senate Amended SJ-18
02/17/98 Senate Read second time SJ-18
02/17/98 Senate Ordered to third reading with notice of
amendments SJ-18
02/19/98 Senate Read third time and sent to House SJ-13
02/24/98 House Introduced and read first time HJ-21
02/24/98 House Referred to Committee on Medical, Military,
Public and Municipal Affairs HJ-21
04/15/98 House Committee report: Favorable with amendment
Medical, Military, Public and Municipal Affairs HJ-3
04/21/98 House Amended HJ-46
04/21/98 House Read second time HJ-48
04/22/98 House Requests for debate-Rep(s). Tripp HJ-11
04/22/98 House Debate adjourned until Wednesday, April 29, 1998 HJ-11
04/29/98 House Debate adjourned HJ-14
04/29/98 House Requests for debate removed-Rep(s). Tripp HJ-30
04/29/98 House Debate adjourned until Thursday, April 30, 1998 HJ-35
04/30/98 House Read third time and returned to Senate with
amendments HJ-8
05/06/98 Senate Concurred in House amendment and enrolled SJ-7
05/21/98 Ratified R 343
05/27/98 Signed By Governor
05/27/98 Effective date 05/27/98
06/23/98 Copies available
06/30/98 Act No. 366
(A366, R343, S130)
AN ACT TO AMEND CHAPTER 43, TITLE 40, AS AMENDED,
CODE OF LAWS OF SOUTH CAROLINA, 1976, RELATING TO
PHARMACISTS, SO AS TO REVISE THE PRACTICE AND
REGULATION OF PHARMACY INCLUDING, BUT NOT LIMITED
TO, FURTHER DEFINING PHARMACEUTICAL DEVICES AND
FURTHER PROVIDING FOR THEIR REGULATION, REVISING THE
ROLE OF PHARMACISTS IN DRUG THERAPY MANAGEMENT,
REQUIRING PHARMACISTS TO COUNSEL PATIENTS ON NEW
MEDICATION, AUTHORIZING PHARMACISTS TO SUPERVISE
TWO, RATHER THAN ONE, PHARMACY TECHNICIAN, FURTHER
PROVIDING FOR THE REQUIREMENTS FOR COMPOUNDING
PRESCRIPTION DRUGS, PROVIDING FOR THE TRANSFER OF
PRESCRIPTIONS BETWEEN PHARMACIES UNDER CERTAIN
CONDITIONS, AND REVISING PROCEDURES FOR THE
DISCLOSURE OF CONFIDENTIAL PRESCRIPTION
INFORMATION.
Be it enacted by the General Assembly of the State of South Carolina:
Chapter revised
SECTION 1. Chapter 43, Title 40 of the 1976 Code is amended to
read:
"CHAPTER 43
Pharmacists
Section 40-43-10. This chapter may be cited as the 'South Carolina
Pharmacy Practice Act'. The purpose of this chapter is to promote,
preserve, and protect the public health, safety, and welfare by and through
the effective control and regulation of the practice of pharmacy; the
licensure of pharmacists; the licensure, permitting, control, and regulation
of all sites or persons, in or out of this State, that distribute, manufacture,
possess, or sell drugs or devices within this State, as may be used in the
diagnosis, treatment, and prevention of injury, illness, and disease of a
patient or other individual.
The practice of pharmacy shall center around the provision of
pharmacy care services and assisting the patient to achieve optimal
therapeutic outcomes.
If a provision of this chapter is declared unconstitutional or illegal, or
the applicability of this chapter to a person, pharmacy, or circumstance is
held invalid by a court of competent jurisdiction, the constitutionality or
legality of the remaining provisions of this chapter and the application of
this chapter to other persons, pharmacies, and circumstances are not
affected and shall remain in full force and effect without the invalid
provision or application.
Section 40-43-20. Except as otherwise provided in this chapter, it is
unlawful for an individual to engage in the practice of pharmacy unless
currently licensed pursuant to this chapter.
Section 40-43-30. For purposes of this chapter:
(1) 'Administer' means the direct application of a drug or device
pursuant to a lawful order of a practitioner to the body of a patient by
injection, inhalation, ingestion, topical application, or any other means.
(2) 'Biological safety cabinet' means a containment unit suitable
for the preparation of low-to-moderate risk agents where there is a need
for protection of the product, personnel, and environment, according to
National Sanitation Foundation Standard 49.
(3) 'Board' or 'Board of Pharmacy' means the State Board of
Pharmacy.
(4) 'Brand name' means the proprietary or trade name placed upon
a drug, its container, label, or wrapping at the time of packaging.
(5) 'Chart order' means a lawful order from a practitioner for a
drug or device for patients of a hospital or extended care facility, or such
an order prepared by another person and signed by a practitioner either
immediately or at another time, issued for a legitimate medical purpose
within the practitioner's course of legitimate practice and including orders
derived on behalf of a practitioner from a practitioner approved drug
therapy management.
(6) 'Class 100 environment' means an atmospheric environment
which contains less than one hundred particles 0.5 microns in diameter
per cubic foot of air.
(7) 'Compounding' means the preparation, propagation,
conversion, or processing of a drug or device, either directly or indirectly,
by extraction from substances of natural origin or independently by means
of chemical or biological synthesis, or the preparation, mixing,
assembling, packaging, or labeling of a drug or device as the result of a
practitioner's prescription drug order or initiative based on the
practitioner/patient/pharmacist relationship in the course of professional
practice, or for the purpose of, or as an incident to, research, teaching, or
chemical analysis and not for sale or dispensing. Compounding also
includes the preparation of drugs or devices in anticipation of prescription
drug orders based on routine, regularly observed prescribing patterns.
The term compounding does not include mixing, reconstituting, or other
such acts that are performed in accordance with directions contained in
approved labeling provided by the product's manufacturer and other
manufacturer directions consistent with that labeling.
(8) 'Confidential information' means information maintained in a
patient's records or which is communicated to a patient as part of patient
counseling, which is privileged and may be released only to the patient,
to those practitioners and pharmacists where, in the pharmacist's
professional judgment, release is necessary to protect the patient's health
and well being, and to other persons or governmental agencies authorized
by law to receive such confidential information.
(9) 'Cytotoxic agent' means a drug that has the capability of killing
living cells.
(10) 'Deliver' or 'delivery' means the actual, constructive, or
attempted transfer of a drug or device from one person to another, whether
or not for consideration.
(11) 'Designated agent' means a person employed by an authorized
practitioner to transmit, either orally or electronically, a prescription drug
order on behalf of the authorized practitioner to the pharmacist. The
authorized practitioner accepts the responsibility for the correct
transmission of the prescription drug order.
(12) 'Designated pharmacist' means an individual currently licensed
by the Board of Pharmacy in this State who certifies internship training.
(13) 'Device' means an instrument, apparatus, implement, machine,
contrivance, implant, or other similar or related article, including any
component part or accessory, which is required under federal law to bear
the label: 'Caution: Federal law restricts this device for sale by or on the
order of a ___________', the blank to be filled with the word
physician, dentist, veterinarian, or with the descriptive designation of any
other practitioner licensed by the law of the State in which he practices to
use or order the use of the device; or 'Federal law prohibits dispensing
without prescription'; or any products deemed to be a public health threat
after notice and public hearing as designated by the board.
(14) 'Dispense' means the transfer of possession of one or more
doses of a drug or device by a licensed pharmacist or person permitted by
law, to the ultimate consumer or his agent pursuant to a lawful order of a
practitioner in a suitable container appropriately labeled for subsequent
administration to, or use by, a patient. As an element of dispensing, the
dispenser shall, before the actual physical transfer, interpret and assess the
prescription order for potential adverse reactions or side effects,
interactions, allergies, dosage, and regimen the dispenser considers
appropriate in the exercise of his professional judgment, and the dispenser
shall determine that the drug or device called for by the prescription is
ready for dispensing. The dispenser shall also provide counseling on
proper drug usage, either orally or in writing, as provided in this chapter.
The actual sales transaction and delivery of a drug or device is not
considered dispensing and the administration is not considered
dispensing.
(15) 'Distribute' means the delivery of a drug or device other than
by administering or dispensing.
(16) 'Drug' or 'medicine' means:
(a) articles recognized as drugs in an official compendium, or
supplement to a compendium, including, but not limited to, USP/NF
designated from time to time by the board for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in humans or other
animals;
(b) articles intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in humans or other animals;
(c) articles, other than food, or nonprescription vitamins
intended to affect the structure or a function of the human body or other
animals; and
(d) articles intended for use as a component of any articles
specified in item (a), (b), or (c) of this subsection.
(17) 'Drug regimen review' includes, but is not limited to, the
following activities:
(a) evaluation of prescription drug orders and pharmacy patient
records for:
(i) known allergies;
(ii) rational therapy-contraindications;
(iii) reasonable dose and route of administration; and
(iv) reasonable directions for use.
(b) evaluation of prescription drug orders and pharmacy patient
records for duplication of therapy.
(c) evaluation of prescription drug orders and pharmacy patient
records for interactions:
(i) drug-drug;
(ii) drug-food;
(iii) drug-disease, if available; and
(iv) adverse drug reactions.
(d) evaluation of prescription drug orders and pharmacy patient
records for proper utilization, including over-utilization or
under-utilization, and optimum therapeutic outcomes.
(18) 'Drug therapy management' is that practice of pharmacy which
involves the expertise of the pharmacist in a collaborative effort with the
practitioner and other health care providers to ensure the highest quality
health care services for patients.
(19) 'Enteral' means within or by way of the intestine.
(20) 'Equivalent drug product' means a drug product which has the
same established name and active ingredients to meet the same compendia
or other applicable standards, but which may differ in characteristics such
as shape, scoring configuration, packaging, excipient (including colors,
flavors, preservatives), and expiration time. Pharmacists may utilize as a
basis for the determination of generic equivalency Approved Drug
Products with Therapeutic Equivalence Evaluations and current
supplements published by the Federal Food and Drug Administration,
within the limitations stipulated in that publication.
(21) 'Extern' means an individual currently enrolled in an approved
college or school of pharmacy who is on required rotations for obtaining
a degree in pharmacy.
(22) 'Generic names' mean the official compendia names or United
States Adopted Names (USAN).
(23) 'Health care provider' includes a pharmacist who provides
health care services within the pharmacist's scope of practice pursuant to
state law and regulation.
(24) 'Institutional facility' means an organization whose primary
purpose is to provide a physical environment for patients to obtain health
care services and shall not include those places where physicians, dentists,
veterinarians, or other practitioners, who are duly licensed, engage in
private practice.
(25) 'Institutional pharmacy' means the physical portion of an
institutional facility that is engaged in the compounding, dispensing, and
distribution of drugs, devices, and other materials, hereinafter referred to
as 'drugs', used in the diagnosis and treatment of injury, illness, and
disease and which is permitted by the State Board of Pharmacy.
(26) 'Institutional consultant pharmacist' means a pharmacist
licensed in this State who acts as a consultant for institutional facilities.
(27) 'Intern' means an individual who is currently registered by
certificate in this State to engage in the practice of pharmacy while under
the personal supervision of a pharmacist and is satisfactorily progressing
toward meeting the requirements for licensure as a pharmacist.
(28) 'Labeling' means the process of preparing and affixing a label
which includes all information required by federal and state law to a drug
container exclusive of the labeling by a manufacturer, packer, or
distributor of a nonprescription drug or commercially packaged legend
drug or device.
(29) 'Manufacturing' of products means the production, preparation,
propagation, conversion, or processing of a drug or device, either directly
or indirectly, by extraction from substances of natural origin or
independently by means of chemical or biological synthesis, or from bulk
chemicals, and includes any packaging or repackaging of the substances
or labeling or relabeling of its container, if these actions are followed by
the promotion and marketing of the drugs or devices for resale to
pharmacies, practitioners, or other persons.
(30) 'Manufacturer' means a person engaged in the manufacture of
prescription drugs or devices.
(31) 'Medical order' means a lawful order of a practitioner which
may or may not include a prescription drug order.
(32) 'Nonprescription drug' means a drug which may be sold
without a prescription and which is labeled for use by the consumer in
accordance with the requirements of the laws of this State and the federal
government.
(33) 'Nonresident pharmacy' means a pharmacy located outside this
State.
(34) 'Parenteral' means a sterile preparation of drugs for injection
through one or more layers of the skin.
(35) 'Patient counseling' means the oral or written communication
by the pharmacist to a patient or caregiver providing information on the
proper use of drugs and devices.
(36) 'Permit consultant pharmacist' means a pharmacist licensed in
this State who acts as a consultant for a permit holder other than a
pharmacy or institution.
(37) 'Person' means an individual, sole-proprietorship, corporation,
partnership, association, or any other legal entity including government.
(38) 'Pharmacy care' is the direct provision of drug therapy and
other pharmacy patient care services through which pharmacists, in
cooperation with the patient and other health care providers, design,
implement, monitor, and manage therapeutic plans for the purpose of
improving a patient's quality of life. Objectives include cure of disease,
elimination or reduction of a patient's symptomatology, arresting or
slowing a disease process, or prevention of a disease or symptomatology.
The process includes three primary functions:
(a) identifying potential and actual drug-related problems;
(b) resolving actual drug-related problems; and
(c) preventing potential drug-related problems.
(39) 'Pharmacist' means an individual health care provider licensed
by this State to engage in the practice of pharmacy. A pharmacist is a
learned professional authorized to provide patient care services within the
scope of his knowledge and skills.
(40) 'Pharmacist-in-charge' means a pharmacist currently licensed
in this State who accepts responsibility for the operation of a pharmacy in
conformance with all laws pertinent to the practice of pharmacy and the
distribution of drugs and who is in full and actual charge of the pharmacy
and personnel.
(41) 'Pharmacy' means a location for which a pharmacy permit is
required and in which prescription drugs and devices are maintained,
compounded, and dispensed for patients by a pharmacist. This definition
includes a location where pharmacy-related services are provided by a
pharmacist.
(42) 'Pharmacy technician' means an individual other than an intern
or extern, who works 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.
(43) 'Poison' means:
(a) a drug, chemical, substance, or preparation which, according
to standard works on medicine, materia medica, or toxicology, is liable to
be destructive to adult human life in doses of sixty grains or less; or
(b) a substance recognized by standard authorities on medicine,
materia medica, or toxicology as poisonous; or
(c) any other item enumerated in this chapter; or
(d) a drug, chemical, substance, or preparation which is labeled
'Poison'.
(44) 'Practice of pharmacy' means the interpretation, evaluation, and
dispensing of prescription drug orders in the patient's best interest;
participation in drug and device selection, drug administration,
prospective drug reviews, and drug or drug-related research; provision of
patient counseling and the provision of those acts or services necessary to
provide pharmacy care and drug therapy management; and responsibility
for compounding and labeling of drugs and devices, (except labeling by
a manufacturer, repackager, or distributor or nonprescription drugs and
commercially packaged legend drugs and devices) proper and safe storage
of drugs and devices and maintenance of proper records for them; or the
offering or performing of those acts, services, operations, or transactions
necessary in the conduct, operation, education, management, and control
of pharmacy.
(45) 'Practitioner' means a physician, dentist, optometrist, podiatrist,
veterinarian, or other health care provider authorized by law to diagnose
and prescribe drugs and devices.
(46) 'Prescription drug' or 'legend drug' means:
(a) a drug which, under federal law, is required, prior to being
dispensed or delivered, to be labeled with either 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
(b) a drug which is required by any applicable federal or state
law to be dispensed pursuant only to a prescription drug order or is
restricted to use by practitioners only;
(c) any drug products considered to be a public health threat,
after notice and public hearing as designated by the board; or
(d) any prescribed compounded prescription is a prescription
drug within the meaning of this act.
(47) 'Prescription drug order' means a lawful order from a
practitioner for a drug or device for a specific patient, issued for a
legitimate medical purpose within the prescriber's course of legitimate
practice and including orders derived from collaborative pharmacy
practice.
(48) 'Prospective drug use review' means a review of the patient's
drug therapy and prescription drug order before dispensing the drug as
part of a drug regimen review.
(49) 'Significant adverse drug reaction' means a drug-related
incident that may result in serious harm, injury, or death to the patient.
(50) 'Sterile pharmaceutical' means a dosage form devoid of viable
micro-organisms.
(51) 'Therapeutically equivalent' means a drug product with the
same efficacy and toxicity when administered to an individual as the
originally prescribed drug as provided for in Section 39-24-40.
(52) 'Wholesale distributor' means a person engaged in wholesale
distribution of prescription drugs or devices including, but not limited to,
manufacturers; repackagers; own-label distributors; private-label
distributors; jobbers; brokers; warehouses including manufacturers' and
distributors' warehouses, chain drug warehouses, and wholesale drug
warehouses; independent wholesale drug traders; and retail pharmacies
that conduct wholesale distributions. 'Wholesale distributor' does not
include:
(a) intracompany sales, being defined as a transaction or
transfer between a division, subsidiary, parent, or affiliated or related
company under the common ownership and control of a corporate entity;
(b) the purchase or other acquisition by a hospital or other
health care entity that is a member of a group-purchasing organization of
a drug for its own use from the group-purchasing organization or from
other hospitals or health care entities that are members of such
organizations;
(c) the sale, purchase, or trade of a drug or an offer to sell,
purchase, or trade a drug by a charitable organization described in section
501(c)(3) of the Internal Revenue Code of 1986 to a nonprofit affiliate of
the organization to the extent otherwise permitted by law;
(d) the sale, purchase, or trade of a drug or an offer to sell,
purchase, or trade a drug among hospitals or other health care entities that
are under common control. For purposes of this section, 'common control'
means the power to direct or cause the direction of the management and
policies of a person or an organization, whether by ownership of stock,
voting rights, by contract, or otherwise;
(e) the sale, purchase, or trade of a drug or an offer to sell,
purchase, or trade a drug for emergency medical reasons. For purposes
of this section, 'emergency medical reasons' includes the transfer of legend
drugs by a licensed pharmacy to another licensed pharmacy or a
practitioner licensed to possess prescription drugs to alleviate a temporary
shortage, except that the gross dollar value of the transfers may not exceed
five percent of the total legend drug sales revenue of either the transferor
or the transferee pharmacy during a consecutive twelve-month period;
(f) the sale, purchase, or trade of a drug, an offer to sell,
purchase, or trade a drug, or the dispensing of a drug pursuant to a
prescription; or
(g) the sale, purchase, or trade of blood and blood components
intended for transfusion.
(53) 'Revocation' means the cancellation or withdrawal of a license,
permit, or other authorization issued by the board either permanently or
for a period specified by the board before the person shall be eligible to
apply anew. A person whose license, permit, or other authorization has
been permanently revoked by the board shall never again be eligible for
a license or permit of any kind from the board.
Section 40-43-40. (A) There is created the State Board of Pharmacy
to be composed of eight members, appointed by the Governor with advice
and consent of the Senate, one of whom must be a lay member from the
State at large, one of whom must be a pharmacist from the State at large,
and six of whom must be pharmacists representing each of the six
congressional districts. Provided, however, if no hospital pharmacist is
selected to represent any of the six congressional districts, the Governor
shall appoint a hospital pharmacist as the pharmacist at large.
(B) The pharmacist at large and the lay member shall serve
coterminously with the appointing Governor and until their successors are
appointed and qualify. The board shall conduct an election to nominate
three pharmacists from each congressional district to be submitted to the
Governor for consideration for appointment. The Governor shall appoint
one pharmacist to represent each congressional district from among the
nominees submitted for that district. The election shall provide for
participation by all pharmacists currently licensed and residing in the
congressional district for which the nomination is being made. The
pharmacists must be residents of the congressional district they represent,
licensed, in good standing to practice pharmacy in this State, and actively
engaged in the practice of pharmacy in this State. The members of the
board representing the six congressional districts shall serve terms of six
years and until their successors are appointed and qualify. No member
may serve more than two successive terms of office except that a member
serving an unexpired term may be reelected and reappointed for two
successive terms.
(C) Before December first in the year in which the term expires for
a member representing a congressional district, a qualified pharmacist
desiring to be a candidate for the board shall submit to the administrator
of the board a biography and a petition bearing the signatures of a
minimum of fifteen pharmacists practicing in that pharmacist's
congressional district. The administrator shall prepare ballots for mailing
to all pharmacists licensed and residing in the congressional district for
which the nomination is being made. The ballots must be in a form so as
to make tabulation quick and easy and shall contain the names of the
nominees in alphabetical order. Enclosures to accompany the ballots shall
include the envelope in which the ballot is to be sealed and an envelope
addressed to the secretary of the board. The addressed envelope shall
contain a statement headed 'information required' on which must be typed
or printed the name of the voter and a space for the voter's signature
certifying that the voter:
(1) is the person whose name appears on the statement;
(2) is eligible to vote in this election;
(3) has personally cast the ballot.
(D) All ballots must be mailed by the administrator before January
fifteenth to the last known mailing address of all pharmacists residing in
the congressional district for which the nomination is being made and
must be returned to the administrator postmarked before February
fifteenth and received by the office before February twenty-fifth. The
administrator of the board shall certify these ballots to be true and valid.
(E) Before March first, the board shall certify in writing to the
Governor the name of the three persons winning the election and the name
of the person the nominee replaces on the board, and the member, when
appointed by the Governor, takes office the first of July of that year.
(F) Notwithstanding subsection (B), if a nominee is judged unfit by
the Governor, the board must be informed and other nominees must be
submitted in like manner.
(G) Vacancies must be filled in the manner of the original
appointment for the unexpired portion of the term.
(H) The Governor may remove a member of the board who is guilty
of continued neglect of board duties or who is found to be incompetent,
unprofessional, or dishonorable. No member may be removed without
first giving the member an opportunity to refute the charges filed against
that member.
Section 40-43-50. (A) The board is styled the 'Board of Pharmacy'
and shall meet in the City of Columbia or any other place in the State
designated by the board at least three times a year. The board may meet
additionally for administrative purposes at the call of the chairman or of
two-thirds of its members.
(B) A simple majority of the appointed members of the board
constitutes a quorum for the transaction of business. The board shall elect
a chairman and a vice chairman.
Section 40-43-60. (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 shall dispense drugs
in this State 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) 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 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. Drugs or medicine dispensed must
comply with the labeling requirements of State and federal laws and
regulations.
(J) 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 within the meaning of this chapter.
(K) A physician may dispense noncontrolled prescription drugs at an
entity that provides free medical services 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) 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.
Section 40-43-80. To obtain a license to engage in the practice of
pharmacy, an applicant for licensure by examination shall:
(1) have submitted a written application in the form prescribed by
the Board of Pharmacy at least forty-five days before the advertised date
of the licensure examination;
(2) have received a Bachelor of Science in pharmacy or Doctor of
Pharmacy degree from an accredited college or school of pharmacy or
department of pharmacy of a university which is recognized by the board,
the recognition to be established by the board on the basis of uniform and
reasonable standards of educational requirements to be observed by a
school or college of pharmacy or department of pharmacy of a university
or have received the Foreign Pharmacy Graduate Equivalency
Certification. The accrediting agency may include, but is not limited to,
the American Council on Pharmaceutical Education. The school or
college of pharmacy or department of pharmacy of universities referred
to in this item must be examined and inspected by the Board of Pharmacy
of South Carolina or its accrediting agency and approved by the board
periodically to see that the school or college of pharmacy of the
universities comply with the standards of the board and its accrediting
agency as to the purpose of the college, the faculty, teaching load, size of
classes, curriculum, and degrees, admission requirements, attendance,
promotion and graduation, student load, instruction, library,
administration, finance, physical plant, extra curricular activities,
miscellaneous factors, and annual progress report.
(3) have completed an internship or other program that has been
approved by the Board of Pharmacy, or demonstrated to the board's
satisfaction experience in the practice of pharmacy which meets or
exceeds the minimum internship requirements of the board;
(4) have successfully passed an examination or examinations
given by the Board of Pharmacy attaining a score of not less than
seventy-five on the National Association of Boards of Pharmacy License
Examination (NABPLEX) and the Drug Law Examination;
(5) have paid all the appropriate fees.
Section 40-43-81. (A) In order for a pharmacist currently licensed
in another jurisdiction to obtain a license as a pharmacist by license
transfer in this State, an applicant shall:
(1) have submitted a written application in the form prescribed by
the Board of Pharmacy at least thirty days prior to the advertised date of
the Pharmacy Law Exam;
(2) have possessed at the time of initial licensure as a pharmacist
all qualifications necessary to have been eligible for licensure at that time
in this State;
(3) have presented to the board proof of initial licensure by
examination and proof that such license is in good standing;
(4) have presented to the board proof that any other license
granted to the applicant by any other state has not been suspended,
revoked, or otherwise restricted for any reason except nonrenewal or for
the failure to obtain the required continuing education credits in any state
where the applicant is currently licensed but not engaged in the practice
of pharmacy;
(5) have paid the fees specified by the board;
(6) all applicants for licensure by reciprocity shall have a law
exam review with members of the board.
(B) No applicant is eligible for license transfer unless the state in
which the applicant was initially licensed as a pharmacist also grants
licensure transfer to pharmacists duly licensed by examination in this
State, under like circumstances and conditions.
Section 40-43-82. (A) The Board of Pharmacy shall register
pharmacy technicians who are performing pharmacy functions under the
supervision of a pharmacist.
(B) Formal academic pharmacy technician training programs that
lead to a certificate, diploma, or higher degree may be approved by the
board if they include at a minimum:
(1) introduction to pharmacy and health care systems;
(2) pharmacy law and ethics;
(3) pharmacy calculations;
(4) pharmacology;
(a) anatomy and physiology;
(b) therapeutic agents;
(c) prescription drugs;
(d) nonprescription drugs;
(5) pharmacy operations;
(a) drug distribution systems;
(b) records management and inventory control;
(c) ambulatory and institutional practice;
(6) compounding;
(a) aseptic technique;
(b) nonsterile compounding;
(7) general education;
(a) medical terminology;
(b) interpersonal relations;
(c) communications;
(d) computers/keyboarding;
(8) problem solving/critical thinking;
(9) experiential training (practical experience).
(C) No pharmacist whose license has been denied, revoked,
suspended, or restricted for disciplinary purposes is eligible to be
registered as a pharmacy technician.
Section 40-43-83. (A) All facilities located within this State
engaging in the manufacture, production, sale, distribution, possession, or
dispensing of prescription drugs or devices and all facilities located
outside of this State whose primary business is mail order pharmacy
service engaging in the sale, distribution, or dispensing of prescription
drugs or devices in this State must be permitted by the Board of
Pharmacy, and annually shall renew the permit by June first. Where
operations are conducted at more than one location, each location must be
permitted by the Board of Pharmacy.
(B) Each permittee located outside of this State who ships, mails,
distributes, or delivers prescription drugs or devices in this State and
every pharmacy located outside of this State who ships, mails, distributes,
or delivers prescription drugs or devices in this State shall designate a
registered agent in this State for service of process. Any such permittee
or pharmacy who does not so designate a registered agent is deemed to
have designated the Secretary of State of this State to be its true and
lawful attorney, upon whom may be served all legal process in any action
or proceeding against such permittee growing out of or arising from such
delivery. A copy of any such service of process shall be mailed to such
permittee or pharmacy by the board by certified mail, return receipt
requested, postage prepaid, at the address such permittee has designated
on its application for licensure in this State. If any such person is not
permitted in this State, service on the Secretary of State only is sufficient
service.
(C) The board shall determine and promulgate the permit
classifications of all permits by regulation under this chapter and establish
minimum standards for such permits.
(D) Each pharmacy shall have a pharmacist-in-charge. Whenever an
applicable rule requires or prohibits action by a pharmacy, responsibility
is that of the permit holder and the pharmacist-in-charge of the pharmacy,
whether the ownership is a sole proprietor, partnership, association,
corporation, or otherwise.
(E) The board may enter into agreements with other states or with
third parties for the purpose of exchanging information concerning the
permitting and inspection of entities located in this jurisdiction and those
located outside this State.
(F) Permits issued under this section must be displayed in a
conspicuous place in the permitted facility for which it was issued in such
a manner that will enable an interested person to determine the name of
the permittee, permit number, and permit expiration date. The permits are
not transferable.
(G) This section must not be construed as precluding any person from
owning or being a permit holder if all of the dispensing, compounding,
and retailing of prescription drugs in it are under the supervision and
direction of a licensed pharmacist.
(H) The Board of Pharmacy may deny or refuse to renew a permit if
it determines that the granting or renewing of such permit would not be
in the public interest. If an application is refused, the board shall notify
the applicant in writing of its decision and the reasons for its decision.
(I) A permit is required for the sale, distribution, possession, 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, mail order vendors, and
manufacturers within this State.
(J) The board shall assess a civil penalty in the amount of fifty
dollars for failure to display a permit as required by this section.
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 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
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 may not represent himself as a pharmacist. The board
shall issue to an intern a certificate for purposes of identification and
verification of his role as an intern. 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 shall take, use, or exhibit the title of intern, or any other term of
similar like or import.
(C) An intern 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 during all professional
activities throughout the entire period of the internship. 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. A pharmacist
may not supervise more than one intern at any one time.
Pharmacy interns 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 hours toward licensure that
may have been accrued by the intern, and may, in the discretion of the
board, cause the board after sufficient notice to the pharmacy intern, 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 40-43-85. (1) An intern shall notify the Board of Pharmacy
within ten days after the beginning and again within ten days after ending
of each internship period, 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) 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.
(3) 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) A minimum of five hundred hours of practical experience must
be obtained in a retail or institutional pharmacy.
(5) 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. Hours earned must be certified by the college of
pharmacy, none of which may be used to fulfill the requirement in
subsection (4). 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) Students enrolled in an approved doctor of pharmacy program
consisting of six or more years of collegiate studies may receive
internship 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).
(7) A pharmacy, site, or program offering interns 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 desiring to obtain practical experience
in accordance with this chapter.
(8) No more than forty hours per week of internship training may
be allowed.
Section 40-43-86. (A) A pharmacy, at a minimum, shall:
(1) be of sufficient size to allow for the safe and proper storage of
prescription drugs and for the safe and proper compounding and
preparation of prescription drug orders;
(2) maintain an area designated for the provision of patient
counseling services. This area must be designed to provide a reasonable
expectation of privacy;
(3) maintain on file current drug reference materials. The
references should enable the user to find information using the brand
name, generic name, pharmacologic group, therapeutic group, and
synonym;
(4) update drug monographs monthly, 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:
(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:
(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;
(8) have a current copy of the South Carolina Pharmacy Practice
Act, South Carolina Controlled Substances Act and Regulations, South
Carolina Drug Act, and South Carolina Board of Pharmacy Newsletter;
(9) maintain patient-oriented reference material for guidance in
proper drug usage;
(10) maintain storage areas at temperatures which shall ensure the
integrity of the drugs prior to their dispensing as stipulated by the
USP/NF and/or the manufacturer's or distributor's labeling;
(11) have access to a sink with hot and cold running water that is
in the compounding area;
(12) have a pharmacist who, while on duty, is responsible for the
security of the pharmacy department including provision of effective
control against theft or diversion of drugs or devices, or both;
(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 is not present. The barrier must be approved by the Board of
Pharmacy before being put into use;
(14) display, when the pharmacy department is closed or in the
absence of the licensed pharmacist, a sign stating 'Pharmacy Department
Closed, Pharmacist Not On Duty' displayed during the absence of the
licensed pharmacist;
(15) carry, utilize, and maintain according to manufacturer's
specifications the equipment and supplies necessary to conduct a
pharmacy in a manner that is in the best interest of the patients served and
to comply with all state and federal laws;
(16) maintain the area and equipment in which prescriptions are
compounded and dispensed in a clean and orderly condition and:
(a) the prescription department must be kept dry and well
ventilated, free from obnoxious odors, and equipped with adequate
lighting facilities;
(b) drugs, pharmaceuticals, and chemicals must be arranged in
a neat, orderly manner, free from dust, insects, rodents, or any type of
contamination;
(c) all outdated, damaged, defaced, or unlabeled drugs,
pharmaceuticals, biologicals, and chemicals must be removed from active
stock;
(d) pharmaceuticals and biologicals requiring refrigeration must
be kept stored in a refrigerator at the specified temperature;
(e) all stocks and materials used in the compounding of
prescriptions must be labeled and conform in purity and strength as
required by law;
(f) the prescription counter area upon which prescriptions are
compounded must be used for no other purpose than for compounding
prescriptions;
(g) the prescription department shall maintain only such
instruments, equipment, materials, drugs, pharmaceuticals, biologicals,
chemicals, and medicines as are necessary in the compounding and
dispensing of prescriptions and pharmaceutical preparations;
(h) all instruments, articles, and containers used in the
compounding and dispensing of prescriptions and pharmaceutical
preparations must be clean and free from all foreign substances;
(i) the sink, with hot water connection, of the prescription
department must be used for no other purpose than for cleaning of
instruments and materials used in the compounding and dispensing of
prescriptions and medicines, or the cleansing of the hands of those
preparing and compounding;
(j) all pharmacists, before compounding prescriptions, and
supportive personnel assisting pharmacists, shall thoroughly cleanse their
fingernails and wash their hands;
(k) the storing of drugs, medicines, pharmaceuticals, or
consumable materials used in compounding and dispensing prescriptions
and pharmaceutical preparations in the washroom or toilet of a pharmacy
is prohibited.
(B)(1) No person may operate a pharmacy without a
pharmacist-in-charge. The pharmacist-in-charge of a pharmacy must be
designated in and sign the application for the pharmacy permit, and in
each renewal thereof. A pharmacist may not serve as
pharmacist-in-charge unless he is physically present in the pharmacy a
sufficient amount of time to provide supervision and control. A
pharmacist may not serve as pharmacist-in-charge for more than one
pharmacy at any one time without written permission from the board.
(2) Each institutional pharmacy shall be directed by a pharmacist,
hereinafter referred to as the pharmacist-in-charge who is licensed to
engage in the practice of pharmacy in this State.
(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) 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) making or filing any reports required by state or federal laws
and regulations;
(e) 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.
(5) The pharmacist-in-charge shall develop or implement, or both,
a procedure for proper management of drug recalls which may include,
where appropriate, contacting patients to whom the recalled drug products
have been dispensed.
(6) The pharmacist-in-charge shall establish or implement, or both,
written policies and procedures for provision of drugs and 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.
(a) In the absence of a pharmacist, only specifically authorized
personnel shall have access by key or combination to the night cabinets.
Such enclosures, which are to be located outside of the pharmacy, must
be sufficiently secure to prevent access by unauthorized persons.
(b) The pharmacist-in-charge, in conjunction with the
appropriate committee of the institutional facility, shall develop inventory
listings of those drugs to be included in the cabinet and determine who
may have access and ensure that:
(i) the drugs are properly labeled;
(ii) only prepackaged drugs are available, in amounts
sufficient for immediate therapeutic requirements;
(iii) whenever access to the cabinet occurs, written
practitioner's orders and proofs of use are provided;
(iv) all drugs therein are inventoried no less than once a week;
(v) a complete audit of all activity concerning the cabinet is
conducted no less than once a month; and
(vi) written policies and procedures are established to
implement the requirements of this section.
(c) If a drug is not available from floor supplies or night
cabinets, and the drug is required to treat the immediate needs of a patient
whose health would otherwise be jeopardized, the drug may be obtained
from the pharmacy only by authorized personnel. Removal of a drug
from the pharmacy must be recorded on a suitable form showing patient
name, room number, name of drug, strength, amount, date, time, and
signature of authorized personnel. The form must be left with the
container from which the drug was removed and must be reviewed by a
licensed pharmacist within seventy-two hours.
(d) For an institutional facility that does not have an
institutional pharmacy, drugs may be provided for use by authorized
personnel in emergency kits located at the facility. The kits must meet the
following requirements:
(i) emergency kit drugs must be those drugs which may be
required to meet the immediate therapeutic needs of patients and which
are not available from any other authorized source in sufficient time to
prevent risk of harm to patients by delay resulting from obtaining the
drugs from the other sources;
(ii) all emergency kit drugs must be provided and sealed by
a pharmacist;
(iii) the supplying pharmacist and the medical staff of the
institutional facility shall jointly determine the drugs, by identity and
quantity, to be included in emergency kits;
(iv) emergency kits must be stored in secured areas to prevent
unauthorized access, and to ensure a proper environment for preservation
of the drugs within them;
(v) the exterior of each emergency kit must be labeled to
clearly indicate that it is an emergency drug kit for use in emergencies
only. The label shall contain a listing of the drugs contained in the kit,
including name, strength, and quantity of the contents, and the name,
address, and telephone number of the supplying pharmacist;
(vi) drugs must be removed from emergency kits only
pursuant to a valid medical order;
(vii) whenever an emergency kit is opened, the supplying
pharmacist must be notified and the pharmacist shall restock and reseal
the kit within a reasonable time to prevent risk of harm to patients; and
(viii) the expiration date of an emergency kit is the earliest
date of expiration of a drug or device supplied in the kit. Upon the
occurrence of the expiration date, the supplying pharmacist shall replace
the expired drug or device.
(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.
(1) The consultant pharmacist must be consistent with the
accepted standards of professional conduct and practice and responsible
for compliance with all applicable laws and regulations including:
(a) establishing as applicable to the permit, policies, and
procedures for the procurement, storage, compounding, dispensing, and
distribution of drugs;
(b) establishing and supervising the recordkeeping system for
the purchase, sale, possession, storage, safekeeping, and return of drugs;
(c) facilitating drug recalls and the removal of outdated and
adulterated drugs;
(d) supervising all employees of the permit holder whose duties
relate to the procurement, compounding, sale, distribution, and storage of
drugs;
(e) acting as a drug information resource for the staff by
bringing new and current drug information to their attention and being
available by phone for questions;
(f) performing written monthly inspections that are readily
available.
(2) The outgoing consultant pharmacist and the permit holder shall
notify the board in writing within ten days of a change of consultant
pharmacist.
(3) No designation of an individual as a consultant pharmacist or
delegation of duties to a consultant pharmacist by a holder of a pharmacy
permit shall relieve the permit holder of any of the permit holder's duties
under state or federal laws or regulations.
(D) In addition to the duties and responsibilities contained in this
section, a consultant pharmacist for an institutional facility shall review
the record of each institutional resident receiving medication for potential
adverse reactions, allergies, interactions, and laboratory test modification
and advise the physician of any recommended changes in the medication
regimen. This review must be conducted monthly and documented on the
resident's medical record.
(E) A prescription drug order shall contain at a minimum, the:
(1) full name and address of the patient;
(2) name, address, telephone number, and degree classification of
the prescriber; license number, and Drug Enforcement Agency
registration number of the prescribing practitioner where required by law;
(3) date of issuance;
(4) name, strength, dosage form, and quantity of drug prescribed;
(5) directions for use;
(6) number of refills authorized. No prescription marked 'PRN' or
any other nonspecified number of refills may be refilled more than two
years beyond the date it was originally written. Nothing in this subsection
abridges the right of a pharmacist to refuse to fill or refill a prescription;
and
(7) a written order signed by the prescriber, which shall bear the
name of the patient; name, strength, and quantity of the drug or device
prescribed; directions for use; date of issue; and, either rubber stamped,
typed, printed by hand, or typeset, the name, address, telephone number,
and degree classification of the prescriber; and, if a controlled substance
is prescribed, the prescriber's federal registration number;
(8) only one drug and set of instructions for each blank, if
preprinted;
(9) a chart order is exempt from the requirements of this
subsection.
(F) A prescription drug order must be issued for a legitimate medical
purpose by a practitioner acting within the course of legitimate
professional practice. The prescription drug order must be received at the
pharmacy as it was originally transmitted. Each prescription drug order
becomes part of a permanent record and must be readily retrievable. The
institutional pharmacist must review the physician's drug order, or a direct
copy, prior to dispensing any drug (except for emergency use).
Electronically transmitted prescription drug orders shall meet these
requirements:
(1) must be sent only to a pharmacy of the patient's choice;
(2) must be received at the pharmacy as it was originally
transmitted by facsimile or computer and shall include the name and
address of the practitioner, the phone number for verbal confirmation, the
time and date of transmission, and the name of the pharmacy intended to
receive the transmission, as well as any other information required by
federal or state law;
(3) a pharmacist may dispense prescription drug orders transmitted
electronically only when transmitted by an authorized practitioner or his
designated agent;
(4) the pharmacist shall exercise professional judgment regarding
the accuracy or authenticity of the transmitted prescription drug order
consistent with existing federal or state laws and regulations;
(5) any alterations of electronic transfer of a prescription drug
order or information constitutes an unlawful act which will be prosecuted
by the Attorney General of this State;
(6) the prescribing practitioner may authorize his agent to transmit
a prescription drug order orally or electronically to the pharmacy provided
that the identity of the transmitting agent is included in the order.
(G)(1) The one-time transfer of original prescription information for
the purpose of dispensing one refill is permissible between pharmacies in
this State subject to these requirements:
(a) The transfer must be communicated directly between two
pharmacists and not by one pharmacist accessing an information file
containing data for several locations, unless all locations accessed are
under common ownership or accessed pursuant to contractual agreement
of the pharmacies;
(b) The transferring pharmacist shall reduce any remaining
refills by one and so mark the face of the prescription retained by the
transferring pharmacist or record information electronically;
(c) The transferring pharmacist shall record the name and
address of the pharmacy to which the prescription was transferred and the
name of the pharmacist receiving the prescription information on the
reverse side of the transferred prescription or record information
electronically.
(2) The transferring pharmacist shall record the date of the transfer
and the name of the pharmacist transferring the information.
(3) The transferring pharmacist shall record on the prescription
transferred or record information electronically that the receiving
pharmacist is authorized to dispense one refill based on the original
prescription, if such is the case.
(4) The pharmacist receiving the transferred prescription
information shall record in writing or electronically the following:
(a) the word 'transfer' on the face of the transferred prescription;
(b) any information required to be on a prescription, including:
(i) the date of issuance of the original prescription;
(ii) the date and time of transfer;
(iii) the pharmacy's name, address, and original prescription
number from which the prescription information was transferred;
(c) the name of the transferring pharmacist;
(d) the manufacturer or brand name of drug dispensed; and
(e) a statement that the receiving pharmacist shall dispense only
one refill based on the transferring pharmacist's certification under
subsection (G).
(5) The pharmacist receiving the transferred prescription shall
dispense only one refill. The transferring pharmacist shall retain the
original prescription and shall continue to dispense refills up to the
amount for the period authorized less one refill allocated to the receiving
pharmacist.
(6) The requirements of this section may be facilitated by use of
a computer, data, or facsimile.
(7) All records pertinent to this section must be readily available.
(8) A copy of a prescription issued for restricted drugs must be
given and marked for information only. The copy may not be dispensed
as a prescription. A physician must be contacted for authorization of the
dispensing. This authorization must be handled in the same manner as an
oral or telephone prescription, reduced to writing, and placed on the
prescription file.
(9) Both the original and transferred prescription drug order must
be maintained for a period of two years from the date of last refill.
(10) The transfer must be in compliance with current state and
federal laws on controlled substances.
(11) The transfer of prescription information for the purpose of
dispensing authorized refills is permissible between pharmacies where all
pharmacies are under common ownership and access prescription
information through a common computerized data system, subject to
subsection (G)(1)(c), (G)(2), (G)(6), (G)(7), (G)(8), (G)(9), and (G)(10).
(H)(1) Upon receiving a prescription for a brand name product, a
registered pharmacist may in his professional judgment substitute an
equivalent drug product as provided in this subsection.
(2) Every oral or written drug prescription shall provide an
authorization from the practitioner as to whether or not an equivalent drug
product may be substituted.
(3) A written prescription shall have two signature lines at
opposite ends on the bottom of the form. Under the line at the left side
shall be clearly printed the words 'Dispense As Written'. Under the line
at the right side shall be clearly printed the words 'Substitution Permitted'.
The practitioner shall communicate the instructions to the pharmacist by
signing on the appropriate line. No written prescription is valid without
the signature of the practitioner on one of these lines.
(4) An oral prescription from the practitioner shall instruct the
pharmacist as to whether or not an equivalent drug product may be
substituted. The pharmacist shall note the instructions on the file copy of
the prescription and retain the prescription form for the period as
prescribed by law.
(5) The pharmacist shall note the brand name or the manufacturer
of the substituted drug dispensed on the file copy of a written or oral
prescription or record this information electronically, or both. If
substitution occurs, the prescription label shall contain the generic name
of the drug and its manufacturer listed first, followed by the words
'substituted for', and the brand name prescribed drug in this information
must be affixed to the container or an auxiliary label, unless the
prescribing practitioner indicated that the name of the drug may not
appear upon the prescription label.
(6) Substitution may not occur unless the pharmacist advises the
patient or the patient's agent that the practitioner has authorized
substitution and the patient, or patient's agent, consents.
(I)(1) All drugs dispensed for use by inpatients of a hospital or other
health care facility, where the drug is not in the possession of the ultimate
user prior to administration, shall meet these requirements:
(a) The label of a single unit package of an individual-dose or
unit-dose system of packaging of drugs shall include:
(i) the nonproprietary or proprietary name of the drug;
(ii) the route of administration, if other than oral;
(iii) the strength and volume, where appropriate, expressed in
the metric system whenever possible;
(iv) the control number and expiration date;
(v) special storage conditions, if required.
(b) A log book must be maintained identifying the repackager,
the name of the drug, the lot number, the manufacturer, the facility control
number, the expiration date, the quantity, and the initials of the
pharmacist.
(c) When a multiple-dose drug distribution system is utilized,
including dispensing of single-unit packages, the drugs must be dispensed
in a container to which is affixed a label containing the:
(i) patient's name;
(ii) date of dispensing;
(iii) nonproprietary or proprietary name of the drug dispensed,
or both; and
(iv) strength, expressed in the metric system whenever
possible.
(2) All drugs dispensed to inpatients for self-administration shall
be labeled in accordance with item (4).
(3) If any drugs are added to parenteral solutions, these admixtures
shall bear a distinctive label indicating:
(a) name of solution and volume of solution;
(b) patient's name;
(c) infusion rate;
(d) bottle sequence number or other system control method;
(e) name and quantity of each additive;
(f) date of preparation;
(g) beyond-use date and time of parenteral admixture;
(h) ancillary precaution labels; and
(i) identity of preparer and checking pharmacist.
(4) All drugs dispensed to ambulatory or outpatients shall contain
a label affixed to the container in which the drug is dispensed including:
(a) the name and address of the pharmacy dispensing the drug;
(b) the name of the patient for whom the drug is prescribed;
(c) the name of the prescribing practitioner;
(d) such directions as may be stated on the prescription drug
order;
(e) the date of dispensing;
(f) any cautions which may be required by federal or state law;
(g) the serial number of the prescription drug order;
(h) the name or initials of the dispensing pharmacist;
(i) the proprietary or generic name of the drug dispensed and
its strength, if more than one strength of the drug is marketed;
(j) the brand name of the drug product dispensed or the generic
name of the drug product dispensed and its manufacturer or labeler, either
written in full or appropriately abbreviated;
(k) when dispensing a prescribed medication, if a pharmacist
selects an equivalent drug product for a name-brand prescribed drug, the
generic drug name must either be listed on the prescription label first
followed by the name-brand prescribed drug, or this information must be
affixed to the container on an auxiliary label.
(5) Drugs other than sample medication provided by a
manufacturer to a prescriber for patient use shall meet all requirements of
labeling.
(6) No radiopharmaceutical may be dispensed unless a label is
affixed to the immediate container bearing:
(a) the standard radiation symbol;
(b) the words 'Caution--Radioactive Material'; and
(c) the prescription number.
(7) No radiopharmaceutical may be dispensed unless a label is
affixed to the outer or delivery container bearing the:
(a) standard radiation symbol;
(b) words 'Caution--Radioactive Material';
(c) radionuclide and chemical form;
(d) activity and date and time of assay;
(e) volume if in liquid form;
(f) requested activity and the calibrated activity;
(g) prescription number;
(h) patient name or space for patient name. Where the patient's
name is not available at the time of dispensing, a seventy-two hour
exemption is allowed to obtain the name of the patient. No later than
seventy-two hours after dispensing the radiopharmaceutical, the patient's
name shall become a part of the prescription drug order to be retained for
two years;
(i) name and address of the nuclear pharmacy;
(j) name of the practitioner; and
(k) lot number of the prescription.
(8) A package prepared by a pharmacist containing two or more
drugs prescribed for a specific patient shall meet USP labeling
requirements.
(J)(1) A pharmacy patient record system must be maintained by all
pharmacies for patients for whom prescription drug orders are dispensed.
The pharmacy patient record system shall provide for the immediate
retrieval of information necessary for the dispensing pharmacist to
identify previously dispensed drugs at the time a prescription drug order
is presented for dispensing. The pharmacist shall make a reasonable effort
to obtain, record, and maintain the:
(a) full name of the patient for whom the drug is intended;
(b) address and telephone number of the patient;
(c) patient's age or date of birth;
(d) patient's gender;
(e) list of all prescription drug orders obtained by the patient
at the pharmacy during the two years immediately preceding the most
recent entry showing the prescription number, name, and strength of the
drug, the quantity and date received, the number of refills given, the date
of each refill, the identity and quantity of each refill if different from the
prescribed quantity, the identity of dispensing pharmacist and the name
of the practitioner; and
(f) pharmacist comments relevant to the individual's drug
therapy, including any other information peculiar to the specific patient
or drug.
(2) The pharmacist shall make a reasonable effort to obtain
information from the patient or the patient's agent regarding any known
allergies, drug reactions, idiosyncrasies, and chronic conditions or disease
states of the patient and the identity of any other drugs, including
over-the-counter drugs, or devices currently being used by the patient
which may relate to prospective drug review. This information shall be
recorded in the patient's record.
(3) A pharmacy patient record must be maintained for a period of
not less than two years from the date of the last entry in the profile record.
This record may be a hard copy or a computerized form.
(K) A pharmacist shall review the pharmacy patient record and each
prescription drug order presented for dispensing for purposes of
promoting therapeutic appropriateness by identifying:
(1) over-utilization or under-utilization;
(2) therapeutic duplication;
(3) drug-disease contraindications;
(4) drug-drug interactions;
(5) incorrect drug dosage or duration of drug treatment;
(6) drug-allergy interactions;
(7) clinical abuse/misuse.
Upon recognizing any of the above, the pharmacist shall take
appropriate steps to avoid or resolve the problem which shall, as
appropriate, include consultation with the practitioner.
(L)(1) Upon receipt of a prescription drug order for a new medication
and following review of the patient's pharmacy record, the pharmacist
shall personally offer counseling to the patient or the patient's agent.
Using his best professional judgment, the pharmacist's counseling shall
include a discussion of those matters that the pharmacist considers
appropriate for the patient or patient's agent in that particular situation.
The discussion must be in person, whenever practicable, or by
telephone and shall include appropriate elements of patient counseling.
The elements may include:
(a) the name and description of the drug;
(b) the dosage form, dose, route of administration, and duration
of drug therapy;
(c) intended use of the drug and expected action;
(d) special directions and precautions for preparation,
administration, and use by the patient;
(e) potentially serious side effects or interactions and
therapeutic contraindications that may be encountered, including their
avoidance, and the action required if they occur;
(f) techniques for self-monitoring drug therapy;
(g) proper storage;
(h) prescription refill information;
(i) action to be taken in the event of a missed dose; and
(j) pharmacist comments relevant to the individual's drug
therapy, including any other information peculiar to the specific patient
or drug.
(2) Alternative forms of patient information may be used to
supplement patient counseling when appropriate including, but not limited
to, written information leaflets, pictogram labels, or video programs.
(3) Patient counseling is not required for inpatients or emergency
department patients of a hospital or institution where other licensed health
care professionals are authorized to administer the drug.
(4) A pharmacist is not required to counsel a patient or caregiver
when the patient or caregiver refuses the consultation.
(M) Significant adverse drug reactions must be reported to the
prescriber immediately upon discovery. Appropriate entry on the patient's
record also must be made.
(N) Records of dispensing, which are readily retrievable within
twenty-four hours, for all drugs or devices are to be made and kept by
pharmacies for two years and shall include, but are not limited to:
(1) quantity dispensed for original and refills, if different from
original;
(2) date of dispensing;
(3) serial number or equivalent if an institution;
(4) the identification of the pharmacist responsible for dispensing;
(5) name and manufacturer of drug dispensed if drug product
selection occurs; and
(6) records of refills to date.
(O)(1) An up-to-date policy and procedure manual must be
maintained by the pharmacist-in-charge that explains the operational
aspects of an automated system and shall:
(a) include examples of all required output documentation
provided by the automated system;
(b) outline steps to be followed when the automated system is
not operational due to scheduled or unscheduled system interruption;
(c) outline regular and routine backup file procedure and file
maintenance;
(d) outline audit procedures, personnel code assignments, and
personnel responsibilities;
(e) provide a quality assurance mechanism for data entry
validation.
(2) The automated system shall have the capability of producing
sight-readable information on all original and refill prescription drug
orders. The term 'sight-readable' means that an authorized individual must
be able to examine the record and read the information from the cathode
ray tube (CRT), microfiche, microfilm, printout, or other method
acceptable to the Board of Pharmacy.
The automated system shall provide on-line retrieval (via CRT display
or hard-copy printout) of original prescription drug order information.
The information shall include, but is not limited to, the prescription drug
order requirements and records of dispensing.
The automated system shall have the capability of producing a
printout of any prescription drug order data. The system shall provide a
refill-by-refill audit trail for any specified strength and dosage form of any
drug. The audit trail must be by printout and shall include the name of the
prescribing practitioner, name and location of the patient, quantity
dispensed on each refill, date of dispensing of each refill, name or
identification code of the dispensing pharmacist, and unique identifier of
the prescription drug order.
A facility maintaining centralized prescription records must be
capable of sending a requested printout to the pharmacy within
seventy-two hours.
(3) To maintain the confidentiality of patient records, the system
shall have adequate security and systems safeguards to prevent
unauthorized access, modification, or manipulation of pharmacy patient
records. Once the drug has been dispensed, any alterations in prescription
drug order data must be documented including the identification of the
pharmacist responsible for the alteration.
(4) In the event of an unscheduled system interruption, sufficient
patient data and prescription drug order data must be available to permit
reconstruction of such data within a two-hour time period for the
pharmacist to dispense drugs with sound professional judgment.
An auxiliary system shall be established for the documentation of
refills if the automated data processing system is inoperative for any
reason and to ensure that all refills are authorized by the original
prescription drug order and that the maximum number of refills is not
exceeded.
The auxiliary system shall be in place to provide for the maintenance
of all necessary patient drug information until the automated system
becomes operational. However, nothing in this subsection shall preclude
the pharmacist from using professional judgment for the benefit of a
patient's health and safety.
When the automated system is restored to operation, the information
regarding prescription drug orders dispensed and refilled during the
inoperative period must be entered into the automated system.
Routine backup systems and procedures (hard copy, copy, disc, etc.)
must be in place and operational to ensure against loss of patient data.
In the event that permanent dispensing information is lost due to
unscheduled system interruption, the Board of Pharmacy must be notified
within seventy-two hours of the loss or of the discovery of the loss.
(P) If a pharmacist receives a request for a prescription refill and the
pharmacist is unable to obtain refill authorization from the prescriber, the
pharmacist may dispense a one-time emergency refill of up to a
seventy-two hour supply of the prescribed medication if:
(1) the prescription is not for a controlled substance;
(2) the medication is essential to the maintenance of life or to the
continuation of therapy;
(3) in the pharmacist's professional judgment, continuing the
therapy for seventy-two hours will produce no undesirable health
consequences or cause physical or mental discomfort;
(4) the pharmacist properly records the dispensing; and
(5) the dispensing pharmacist notifies the prescriber of the
emergency dispensing within seventy-two hours after the one-time
emergency refill dispensing.
(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.
(R)(1) It is unlawful for a person, except a pharmacist licensed under
this chapter and pursuant to the regulations of the board of pharmacy to:
(a) take, use, or exhibit the title 'pharmacist', 'druggist',
'pharmacy', 'drugstore', 'drugs', 'prescriptions', or any other title, sign,
display, or declaration that tends to lead the public to believe that the
person is engaged in the business of selling, compounding, or dispensing
any prescription drugs; or
(b) have charge of, engage in, or carry on, for himself or
another, the dispensing, compounding, or sale of any prescription drugs
anywhere within this State.
(2) Except as prescribed by this chapter, it is unlawful for a person
to practice as a pharmacist or to advertise or represent himself by a title,
sign, display, declaration, or other item to be a pharmacist or to engage in,
conduct, carry on, or be employed in the dispensing, compounding, or
retailing of any prescription drugs within this State.
(3) Notwithstanding any other provision of law or regulation,
pharmacies and apothecaries are permitted to advertise the retail price of
all drugs sold by prescription.
(4) Those merchants selling varieties of health and beauty needs,
including that class of personal care products and nonprescription drugs
which do not require a prescription for sale at retail, may use and display
the term 'drug-sundries' in advertising, if these conditions are met:
(a) the word 'drug-sundries' is a hyphenated word;
(b) the word 'drug-sundries' must appear all on one line;
(c) the two parts of the word must be of equal size lettering, of
the same color, and the same style print or script; and
(d) no effort may be made to mislead the public that there is a
full drug and prescription service available.
(5) Nothing in this section authorizes the board to promulgate
regulations concerning the prices of goods or drugs sold by outlets, the
hours that the business may be operated, or the hours of work of the
employees of the businesses.
(S) Licensed pharmacists may sell pharmaceutical agents, other than
controlled substances as defined in Section 44-53-110, to optometrists
who are diagnostically certified by the South Carolina Board of
Examiners in Optometry for diagnostic purposes in the practice of
optometry in accordance with Section 40-37-105(A). For these purposes,
'pharmaceutical agent' means anesthetics, mydriatics, cyclopegics,
miotics, dyes, and over-the-counter drugs.
Licensed pharmacists may sell pharmaceutical agents, other than
Schedule I and Schedule II controlled substances as defined in Section
44-53-110, to optometrists who are therapeutically certified by the South
Carolina Board of Examiners in Optometry for diagnostic and therapeutic
purposes in the practice of optometry in accordance with Section
40-37-105(B).
(T) Duties that must be performed by a licensed pharmacist or a
pharmacy intern or extern within the practice of pharmacy, to exclude
Home Medical Equipment providers, include, but are not limited to:
(1) the interpretation and evaluation of medical orders;
(2) participation in drug and device selection;
(3) provision of patient counseling;
(4) performing drug regimen reviews;
(5) provision of pharmacy care; and
(6) receiving telephone or verbal medical orders from licensed
practitioners.
A licensed pharmacist shall supervise the activities of a pharmacy
technician to ensure all activities are performed completely, safely, and
without risk of harm to patients.
(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.
(V) A manufacturer or wholesaler shall supply insulin only to persons
or entities that can legally possess prescription drugs.
(W) The American Pharmaceutical Association Code of Ethics will
be adopted as the code of ethics for pharmacists in this State.
(X) Physicians who are in charge or who directly supervise the
operation of emergency rooms may dispense legend drugs in order to
meet the immediate needs of the patient. The amount dispensed may not
exceed an amount equal to a seventy-two hour supply. Records of drugs
dispensed must be maintained. A valid physician-patient relationship
shall exist between the emergency room physician and the patient before
dispensing legend drugs in the emergency room.
(Y) It is unlawful for a person to deliver prescription drugs to any
permitted facility, at any time when the facility is not open for business,
unless shipments are received by an authorized employee of the facility
or into a secure area, or both.
(Z) A current record showing disposition of all restricted
pharmaceutical preparations, such as federal legend drugs, exempt class
V, insulin, controlled substances, poisons and any other drugs so
designated by the board, dispensed or sold to physicians, dentists,
veterinarians, pharmacies, hospitals, or other persons authorized by law
to possess drugs restricted to sale on prescription only, must be
maintained for two years in the prescription files or in the records of the
permitted facility showing the name of the person to whom dispensed or
sold, the name, strength, and quantity dispensed or sold, and the date of
the transaction.
Every pharmacist or other person selling nonlegend poison must be
satisfied that the purchase is made for legitimate purposes and keep a
book on file in which must be recorded every sale of the following
articles: arsenic and its preparations, all metallic cyanides and cyanides of
potassium, tartar emetic, corrosive sublimate, aconite and alkaloids, and
their salts, and hydrocyanic acid. The record shall exhibit the name of the
person to whom the poison was sold and the purpose of purchase stated.
The book or file must be kept at all times subject to inspection of the
coroner of the county and the solicitor or inspector of the Board of
Pharmacy or any other person as either of them may designate.
These above-named poisons, and oxalic acid, chloroform, or any other
poisonous articles that may be added to the list by the board, must be
securely labeled 'Poison' when sold in the permitted facility.
Nothing in this section may be construed to apply to the filling of
prescriptions written by physicians.
(AA) No pharmacist or permit holder shall reuse, sell, or offer for
sale a prescription or other medication intended for internal or external
use which has been returned unless the pharmacist accepting the
medication determines in his best professional judgment that the strength,
potency, and stability of the medication have not been adversely affected
or contaminated.
(BB) The fees for a permit to open a new pharmacy and for the
annual renewal of a permit to operate a pharmacy must be promulgated
by the board in regulation in accordance with the Administrative
Procedures Act. The following fees are in effect until these fees are
promulgated in regulation:
(1) one hundred dollars for a permit to open a new pharmacy;
(2) fifty dollars for the annual renewal of a permit to operate a
pharmacy.
(CC)(1) The provisions of this subsection only apply to the
compounding of medication by pharmacies permitted in the State of South
Carolina.
(2) The following are the minimum current good compounding
practices for the preparation of medications by pharmacists licensed in the
State for dispensing or administering, or both, to humans or animals:
(a) Pharmacists engaged in the compounding of drugs shall
operate in conformance with applicable laws regulating the practice of
pharmacy;
(b) Based on the existence of a pharmacist/patient/practitioner
relationship and the presentation of a valid prescription, or in anticipation
of prescription medication orders based on routine, regularly observed
prescribing patterns, pharmacists may compound, for an individual patient
medications that are commercially available in the market place;
(c) Pharmacists shall receive, store, or use drug substances for
compounding that meet official compendia requirements, or of a chemical
grade in one of the following categories: chemically pure (CP), analytical
reagent (AR), American Chemical Society (ACS), or, if other than this,
drug substances that meet the accepted standard of the practice of
pharmacy;
(d) Pharmacists may compound drugs before receiving a valid
prescription based on a history of receiving valid prescriptions that have
been generated solely within an established
pharmacist/patient/practitioner relationship, for all such products
compounded at the pharmacy as required by the Board of Pharmacy;
(e) Pharmacists may not offer compounded medications to other
pharmacies for resale; however, pharmacists may compound products
based on an order from a practitioner for use by practitioners for patient
use in institutional or office settings. Compounding
pharmacies/pharmacists may advertise or otherwise promote the fact that
they provide prescription compounding services, e.g., chemicals, devices,
and information, when requested; however, they may not solicit business
by promoting to compound specific drug products, e.g., like a
manufacturer;
(f) The compounding of drugs in anticipation of receiving
prescriptions without a historical basis or the distribution of compounded
products without a patient/practitioner/pharmacist relationship is
considered manufacturing.
(3) Pharmacists engaging in compounding shall maintain
proficiency through current awareness and training. Continuing education
shall include training in the art and science of compounding and the rules
and regulations of compounding.
Pharmacy technicians may assist the pharmacist in compounding. The
pharmacist is responsible for training and monitoring the pharmacy
technician. The pharmacy technician's duties must be consistent with the
training received.
Personnel engaged in the compounding of medications shall wear
clean clothing appropriate to the operation being performed. Protective
apparel, such as coats, jackets, aprons, gowns, hand or arm coverings, or
masks must be worn as necessary to protect personnel from chemical
exposure and medication or chemical contamination.
Only personnel authorized by the responsible pharmacist may be in
the immediate vicinity of the drug compounding operation. A person
shown at any time, either by medical examination or pharmacist
determination, to have an apparent illness or open lesions that may
adversely affect the safety or quality of a drug product being compounded
must be excluded from direct contact with components, medication
containers, closures, in-process materials, and medication products until
the condition is corrected or determined by competent medical personnel
not to jeopardize the safety or quality of the products being compounded.
All personnel who assist the pharmacists in compounding procedures
must be instructed to report to the pharmacist any health conditions that
may have an adverse effect on drug products.
(4) Pharmacists engaging in compounding shall have a specifically
designated and adequate area (space) for the orderly compounding of
prescriptions that is maintained in a good state of repair for the placement
of material and equipment. Sterile compounding must be performed in a
separate area in compliance with Section 40-43-88.
Bulk medications and other chemicals or materials used in the
compounding of medication must be stored in adequately labeled
containers in a clean, dry, and temperature-controlled area or, if required,
under proper refrigeration.
Adequate lighting and ventilation must be provided in all drug
compounding areas. Potable water must be supplied under continuous
positive pressure in a plumbing system free of defects that could
contribute contamination to a compounded drug product. Adequate
washing facilities, easily accessible to the compounding areas of the
pharmacy, must be provided. These facilities shall include, but are not
limited to, hot and cold water, soap or detergent, and air-dryers or
single-use towels.
The area used for the compounding of drugs must be maintained in a
clean and sanitary condition. It must be free of infestation by insects,
rodents, and other vermin. Trash must be held and disposed of in a timely
and sanitary manner. Sewage and other refuse in and from the pharmacy
and immediate medication compounding areas must be disposed of in a
safe and sanitary manner.
If sterile products are being compounded, the pharmacist shall comply
with Section 40-43-88 as applicable to the procedure.
If radiopharmaceuticals are being compounded, the pharmacist shall
comply with Section 40-43-87 as applicable to the procedure.
If drug products with special precautions for contamination, such as
penicillin, are involved in a compounding procedure, appropriate
measures, including either the dedication of equipment or meticulous
cleaning of contaminated equipment before its use for the preparation of
other drugs, must be utilized in order to prevent cross-contamination.
(5) Equipment and utensils used for compounding must be of
appropriate design and capacity and stored in a manner to protect from
contamination. In addition, all equipment and utensils must be cleaned
and sanitized before use to prevent contamination that would alter the
safety or quality of the drug product beyond that desired. The pharmacist
is responsible for determining suitability for use. In the case of sterile
compounding, the pharmacist shall comply with Section 40-43-88 as
applicable to equipment and utensils.
Automatic, mechanical, electronic, or other equipment used in
compounding must be routinely inspected, calibrated, if necessary, or
checked to ensure proper performance.
The pharmacist shall ensure that the proper container is selected to
dispense the finished compounded prescription, whether sterile or
nonsterile.
(6) The pharmacist shall ensure that there are formulas and logs
maintained either electronically or manually. Formulas must be
comprehensive and include ingredients, amounts, methodology, and
equipment, if needed, and special information regarding sterile
compounding.
The pharmacist shall ensure that components used in compounding are
accurately weighed, measured, or subdivided as appropriate at each stage
of the compounding procedure to conform to the formula being prepared.
Any chemical transferred to a container from the original container must
be labeled with the same information as on the original container and the
date of transfer placed on the label.
The pharmacist shall establish and conduct procedures so as to
monitor the output of compounded prescriptions, i.e., capsule weight
variation, adequacy of mixing, clarity, pH of solutions, and, where
appropriate, procedures to prevent microbial contamination of
medications purported to be sterile.
(7) The pharmacist shall label any excess compounded product so
as to reference it to the formula used and the assigned control number and
the estimated beyond-use date based on the pharmacist's professional
judgment, appropriate testing, or published data. The product must be
stored appropriately.
At the completion of compounding the prescription, the pharmacist
shall examine the prescription for correct labeling.
(8) The pharmacist shall keep records of all compounded products
for a period of time as other prescriptions as required by the Board of
Pharmacy. These records must be readily available for authorized
inspection during the retention period at the establishment. These records
are subject to duplication by photocopying or other means of reproduction
as part of the inspection.
(DD) Unprofessional conduct includes, but is not limited to, the
following acts by a pharmacist, permit holder, pharmacy technician, or the
owner of a permitted facility:
(1) publishing or circulating false, misleading, or otherwise
deceptive statements concerning the practice of pharmacy;
(2) attempting to circumvent the patient counseling requirements,
or discouraging the patient from receiving patient counseling concerning
their prescription drug orders;
(3) divulging or revealing to unauthorized persons patient
information or the nature of professional pharmacy services rendered
without the patient's express consent, or without order or direction of a
court. Authorized persons include:
(a) a patient, or patient's agent, or another pharmacist acting on
behalf of a patient;
(b) the practitioner who issued the prescription drug order;
(c) certified/licensed health care personnel who are responsible
for the care of the patient;
(d) an inspector, agent, or investigator of the Board of Pharmacy
or any federal, state, county, or municipal officer whose duty is to enforce
the laws of this State or the United States relating to drugs or devices and
who is engaged in a specific investigation involving a designated person
or drug;
(e) an agency of government charged with the responsibility of
providing medical care for the patient upon written request by an
authorized representative of the agency requesting the information;
(4) selling, giving away, or otherwise disposing of accessories,
chemicals, or drugs or devices found in illegal drug traffic when the
pharmacist knows or should have known of their intended use in illegal
activities;
(5) engaging in conduct likely to deceive, defraud, or harm the
public, or demonstrating a wilful or careless disregard for the health,
welfare, or safety of a patient, or engaging in conduct which substantially
departs from the standards of care ordinarily exercised by a pharmacist;
(6) selling a drug for which a prescription drug order from a
practitioner is required without having received a prescription drug order
for the drug;
(7) wilfully and knowingly failing to maintain complete and
accurate records of all drugs received, dispensed, or disposed of in
compliance with the federal laws and regulations and state laws and
regulations;
(8) obtaining any remuneration by fraud, misrepresentation, or
deception;
(9) using a system providing for the electronic transfer of
information that infringes on a patient's freedom of choice as to the
provider of pharmacy care.
Section 40-43-87. (A) Nuclear/radiologic pharmacy practice refers
to a patient-oriented service that embodies the scientific knowledge and
professional judgment required to improve and promote health through
the assurance of the safe and efficacious use of radiopharmaceuticals and
other drugs. Nuclear/radiologic pharmacies also shall adhere to the
regulations established by the Nuclear Regulatory Commission as they
pertain to the practice of nuclear pharmacy.
The pharmacist-in-charge of a nuclear pharmacy must be a qualified
nuclear pharmacist. All personnel performing tasks in the preparation and
distribution of radiopharmaceuticals and ancillary drugs must be under the
direct supervision of a qualified nuclear pharmacist.
(B) Revocation of the radioactive materials license from the
Department of Health and Environmental Control voids the pharmacy
permit immediately and the permit must be returned to the board within
ten days.
(C) Copies of all regulatory inspection reports must be made
available upon request for board inspection.
(D) The nuclear pharmacist-in-charge shall notify the Board of
Pharmacy by letter of the outcome of any hearings that are conducted
pursuant to citations for violations of state or federal laws or regulations
governing radioactive materials. Notification must be within thirty days
of the date of the hearing.
(E) Space and equipment must be adequate to the scope of services
required and provided. All nuclear pharmacy facilities shall have a
radiopharmaceutical preparations/dispensing area, a radioactive material
shipping/receiving area, and a radioactive waste decay area. Airflow
hoods must be certified annually for operational efficiency in accordance
with federal standards by a qualified technician and must be recertified
each time the hood is moved. Certification must be attached to the front
of the hood and shall state the date certification was granted. Prefilters
must be changed in accordance with manufacturer's specifications.
Changes must be documented by date and initials. Documentation must
be retained for two years.
(F) For purposes of this section, 'qualified nuclear pharmacist' means
a pharmacist who holds a current license issued by the South Carolina
Board of Pharmacy, and who is either certified as a nuclear pharmacist by
the Board of Pharmaceutical Specialties, or meets minimal standards of
training for status as an authorized user of radioactive material, as
specified by the Nuclear Regulatory Commission.
Section 40-43-88. (A) The purpose of this section is to provide
standards for the preparation, labeling, and distribution of sterile products
by pharmacies, pursuant to or in anticipation of a prescription drug order
for a patient in home health care.
(B) The pharmacy shall have a separate area designated for
placement of the Class 100 laminar airflow hood, which must:
(1) be constructed so as to allow visual observation;
(2) not be a thruway for traffic;
(3) have walls, floor, ceiling, and work surfaces constructed of
materials that are nonporous and do not produce particulate matter;
(4) be ventilated in a manner that will not interfere with the
outward flow of air from the hood;
(5) not be used for unpacking bulk supplies;
(6) not be used for storage of bulk supplies and materials; and
(7) have an eye wash station and sink readily accessible to the
area.
(C)(1) All sterile pharmaceuticals must be prepared within the airflow
hood work surface.
(2) Work surfaces of the airflow hood must be cleaned with seventy
percent isopropyl alcohol or an equivalent disinfectant every eight-hour
work shift and as needed for microbial, drug, and particulate matter
removal. This cleaning must be documented by date, time, and initials.
Documentation must be retained for two years.
(3) The airflow hood must be certified by a qualified technician
every twelve months and must be recertified each time the hood is moved
for operational efficiency in accordance with federal standards. The
certification must be attached to the front of the hood and shall state the
date the certification was performed. Certification documents must be
retained for two years.
(4) The sterile product preparation area must be cleaned and
disinfected weekly with appropriate agents according to written policy
and procedures. This must be documented by date and initials and
retained for two years.
(5) Prefilters must be changed in accordance with manufacturer's
specifications. Changes must be documented by date and initials and
documentation must be retained for two years.
(6) Work surfaces inside the airflow hood must be clear of drugs,
records, labels, and equipment unrelated to work in process.
(7) All solutions, additive and nonadditive, must be checked by a
pharmacist before dispensing. The checking pharmacist's initials must
appear on either the prescription or medical order, the patient's profile, a
compounding record, or label. Only one system must be used. Initials
may be computer produced or stamped for solutions containing
noncontrolled additives.
(8) Sterile pharmaceuticals returned by an outpatient or the
outpatient's agent must be destroyed. Supplies and equipment designed
by the manufacturer for one time use may not be reused. Returned sterile
pharmaceuticals containing controlled substances must be destroyed in
accordance with federal and state requirements.
(9) A sink with hot and cold running water readily accessible to
the sterile products preparation area with immediate availability of
germicidal skin cleanser and either a warm air blower or nonshedding
single-use towels for hand drying must be available to all personnel
preparing sterile pharmaceuticals.
(10) Adverse drug reactions sustained by patients must be
documented in the patient's profile. Significant untoward reactions must
be reported to the Food and Drug Administration and the manufacturer.
(D)(1) Compounding shall involve aseptic manipulations that are
properly and promptly executed.
(2) Closed system transfers must be used in compounding sterile
pharmaceuticals, except for initial withdrawals from ampules.
(a) All container closures shall remain intact throughout the
aseptic process, except for the penetration of sterile, pyrogen-free, and
particulate matter-free needles or cannulas through the designated stopper
or port.
(b) Ancillary devices used to facilitate the transfer, withdrawal,
or delivery of sterile solutions must be sterile, free of pyrogen and
particulate matter, and used in accordance with the manufacturer's labeled
instructions.
(3) Compounded sterile pharmaceuticals must be stored
immediately according to published and professional guidelines.
(4) Administration must be initiated in accordance with stability
standards.
(5) If products are prepared from nonsterile ingredients, these
products must be appropriately sterilized before dispensing.
(E) In addition to reference books currently required in a pharmacy,
at least one current reference on compatibility and stability of sterile
pharmaceuticals must be available.
(F) All sterile pharmaceuticals prepared for dispensing shall have an
adhesive label affixed which shall contain the following:
(1) name, address, and telephone number of pharmacy for
outpatients and name of facility for inpatients;
(2) if additive, the date solution was prepared. Nonadditive
solutions must be dated if the manufacturer's protective cover is removed
before dispensing;
(3) name of physician;
(4) name of patient;
(5) room number and bed of patient, if applicable;
(6) serial number of prescription or other identifying number;
(7) if additive solution, the name and amount of additive. If
additives are identified by their generic name, the manufacturer must be
identified on either the prescription, the patient's profile, or compounding
record;
(8) name of basic solution;
(9) name or initials of individual preparing sterile pharmaceutical
on either the prescription or medical order, the patient's profile,
compounding record, or label. For solutions containing noncontrolled
additives, the initials may be imprinted;
(10) expiration date and, if applicable, the expiration time of the
solution in accordance with the manufacturer's specifications or
research-supported standard of practice;
(11) frequency and rate of administration;
(12) precautionary statements, auxiliary labels, or warning labels
in keeping with current standards or practice;
(13) special handling or storage requirements, or both;
(G) There must be a system for a pharmacist to be available
twenty-four hours a day for a patient, nursing agency, or physician to
which the pharmacy is providing services.
(H) A profile or medical record must be maintained for each patient.
This profile must be maintained for two years after the last dispensing
activity. It shall contain at a minimum:
(1) patient's name, address, telephone number and, if applicable,
the patient's bed or room number;
(2) age or date of birth, weight, height, and sex of patient;
(3) identity of the health care agency, if applicable;
(4) itemization of sterile pharmaceuticals dispensed with
prescription number or other identifying number, including date dispensed
and the name and amount of additives;
(5) drug and food allergies;
(6) primary diagnosis;
(7) prescription and nonprescription drugs and home remedies the
patient is receiving; and
(8) documentation by a pharmacist of the resolution of other
potential drug related problems.
(I)(1) All cytotoxic solutions must be compounded in a Class II,
biological safety cabinet. No other products may be compounded in this
cabinet.
(2) Protective apparel must be worn by personnel compounding
cytotoxic agents including gloves, closed front gowns with tight cuffs,
and masks. Written procedures for handling spills of cytotoxic agents
must be developed.
(3) There must be immediate access to emergency spill supplies
wherever cytotoxic drugs are prepared.
(4) Prepared solutions must be identified with warning labels in
accordance with state and federal requirements.
(5) Prepared solutions must be packaged for handling and delivery
in a manner that minimizes the risk of rupture of the primary container
and ensures the stability and potency of the solution.
(6) Documentation that personnel have been trained in the
compounding, handling, and destruction of cytotoxic agents must be
available. This documentation must be obtained annually.
(7) Documentation that personnel have been informed of the
carcinogenic, mutagenic, and teratogenic nature of the cytotoxic agents
handled must be available. This documentation must be updated annually
by all personnel.
(8) Class II safety cabinets must be certified by a qualified
technician every twelve months and must be recertified each time the
hood is moved for operational efficiency. Earlier recertification may be
required if dictated by federal or state requirements or manufacturer's
specifications due to workload.
(J) All waste materials must be disposed of in accordance with
federal, state, and local requirements.
(K) A policy and procedure manual must be available in the
pharmacy. The manual shall include policies and procedures as
applicable for the following:
(1) quality control;
(2) sterile technique;
(3) destruction of returned solutions;
(4) labeling of injectable solutions;
(5) drug recall procedures;
(6) investigational drugs;
(7) handling and disposal of hazardous waste;
(8) cytotoxic agents;
(9) maintenance of patient profiles; and
(10) material safety data sheets.
(L) When sterile pharmaceuticals are provided to home care patients,
the dispensing pharmacy may supply a nurse with emergency drugs if a
physician has authorized the use of these drugs by a protocol or
prescription drug order for use in an emergency situation, e.g.,
anaphylactic shock.
(M) A licensed health care professional may possess noncontrolled
prescribed legend drugs or devices such as water for injection, normal
saline for IV, and heparin flush used in the administration of sterile
pharmaceuticals.
(N) If appropriate, the pharmacist shall demonstrate or document the
patient's training and competency in managing therapy provided by the
pharmacist to the patient in the home environment. A pharmacist must be
involved in the patient training process in any area that relates to drug
compounding, labeling, administration, storage, stability, compatibility,
or disposal. The pharmacist is responsible for seeing that the patient's
competency in the above areas is reassessed on an ongoing basis.
(O) There must be a documented, ongoing, quality assurance control
program that monitors patient care and pharmacy care outcomes,
including but not limited to:
(1) routine performance of prospective drug use review and patient
monitoring functions by a pharmacist;
(2) patient-monitoring plans that include written outcome
measures and systems for routine patient assessment including, but not
limited to, infection rates, rehospitalization rates, and the incidence of
adverse drug reactions;
(3) documentation of patient training as specified in subsection
(N);
(4) appropriate collaboration with other health care professionals.
Section 40-43-89. (A)(1) The following information must be
provided to the board with an application for a wholesale distributor
permit, and for any subsequent permit renewals:
(a) name, full business address, and telephone number of the
applicant;
(b) all trade or business names used by the applicant;
(c) addresses, telephone numbers, and the names of contact
persons for the facility used by the applicant for storage, handling, and
distribution of drugs;
(d) the type of ownership or operation, i.e., partnership,
corporation, or sole proprietorship; and
(e) name of the owner and/or operator of the applicant,
including:
(i) if a person, the name, address, and social security number
or date of birth, or both, of the person;
(ii) if a partnership, the name, address, and social security
number or date of birth, or both, of each partner, and the name of the
partnership;
(iii) if a corporation, the name, address, social security number
or date of birth, or both, and title of each corporate officer and director,
the corporate names, the name of the state of incorporation, and the name
of the parent company, if any; the name, address, and social security
number of each shareholder owning ten percent or more of the voting
stock of the corporation, including over-the-counter stock, unless the
stock is traded on a major stock exchange and not over-the-counter;
(iv) if a sole proprietorship, the full name, address, and social
security number or date of birth, or both, of the sole proprietor and the
name of the business entity.
(2) Changes in any information in this subsection must be
submitted to the Board of Pharmacy within thirty days of the change.
(3) Pursuant to Section 40-43-83(E) and Section 40-43-90, the
information required for initial permitting or renewal of a permit of a
wholesale distributor must be submitted on forms prepared by the Board
of Pharmacy or by the National Association of Boards of Pharmacy which
shall act as a clearinghouse of applications for the board and must be
submitted to the board or NABP accompanied by the applicable fee.
(4) The board may suspend, revoke, deny, or refuse to renew the
permit of wholesale drug distributors other than pharmacies dispensing or
distributing drugs or devices directly to patients.
(B) The licensed wholesale distributor shall employ adequate
personnel with the education and experience necessary to safely and
lawfully engage in the wholesale distribution of drugs.
(C) All facilities where drugs are stored, warehoused, handled, held,
offered, marketed, or displayed shall:
(1) be of suitable size and construction to facilitate cleaning,
maintenance, and proper operations;
(2) have storage areas big enough to provide adequate lighting,
ventilation, temperature, sanitation, humidity, space, equipment, and
security conditions;
(3) have a quarantine area for storage of drugs that are outdated,
damaged, deteriorated, misbranded, or adulterated, or that are in
immediate or sealed secondary containers that have been opened;
(4) be maintained in a clean and orderly condition; and
(5) be free from infestation by insects, rodents, birds, or vermin of
any kind.
(D)(1) All facilities used for wholesale drug distribution must be
secure from unauthorized entry, access from outside the premises must be
kept to a minimum and well controlled, the outside perimeter of the
premises must be well lighted, and entry into areas where prescription
drugs are held must be limited to authorized personnel.
(2) All facilities must be equipped with an alarm system to detect
entry after hours.
(3) All facilities must be equipped with a security system that
provides suitable protection against theft and diversion. When
appropriate, the security system shall provide protection against theft or
diversion that is facilitated or hidden by tampering with computers or
electronic records.
(E) All drugs must be stored at appropriate temperatures and under
appropriate conditions in accordance with requirements, if any, in the
labeling of such drugs, or with requirements in the current edition of an
official compendium.
If no storage requirements are established for a drug, the drug may be
held at 'controlled' room temperature, as defined in an official
compendium, to help ensure that its identity, strength, quality, and purity
are not adversely affected.
Temperature and humidity must be automatically documented by
electronic recording devices.
The recordkeeping requirements in subsection (I) must be followed for
all stored drugs.
(F) Upon receipt, each outside shipping container must be visually
examined for identity and to prevent the acceptance of contaminated
drugs or drugs that are otherwise unfit for distribution. This examination
must be adequate to reveal container damage that would suggest possible
contamination or other damage to the contents.
Each outgoing shipment must be carefully inspected for identity of the
drug products and to ensure that there is no delivery of drugs that has
been damaged in storage or held under improper conditions.
The recordkeeping requirements in subsection (I) must be complied
with for all incoming and outgoing drugs.
(G)(1) Drugs that are outdated, damaged, deteriorated, misbranded,
or adulterated must be quarantined and physically separated from other
drugs until they are destroyed or returned to their supplier.
(2) A drug whose immediate or sealed outer or sealed secondary
containers have been opened or used must be identified as such and must
be quarantined and physically separated from other drugs until they are
either destroyed or returned to the supplier.
(3) If the conditions under which a drug has been returned cast
doubt on the drug's safety, identity, strength, quality, or purity, the drug
must be destroyed or returned to the supplier unless examination, testing,
or other investigation proves that the drug meets appropriate standards of
safety, identity, strength, quality, and purity. In determining whether the
conditions under which a drug has been returned cast doubt on the drug's
safety, identity, strength, quality, or purity, the wholesale drug distributor
shall consider, among other things, the conditions under which the drug
has been held, stored, or shipped before or during its return and the
condition of the drug and its container, carton, or labeling, as a result of
storage or shipping.
(4) The recordkeeping requirements in subsection (I) must be
complied with for all outdated, damaged, deteriorated, misbranded, or
adulterated drugs.
(H)(1) Wholesale drug distributors shall establish and maintain
inventories and records of all transactions regarding the receipt and
distribution or other disposition of drugs. These records shall include:
(a) the source of the drugs, including the name and principal
address of the seller or transferor, and the address of the location from
which the drugs were shipped;
(b) the identity and quantity of the drugs received and
distributed or disposed of; and
(c) the dates of receipt and distribution or other disposition of
the drugs.
(2) Inventories and records must be made available for inspection
and photocopying by any authorized official of any governmental agency
charged with enforcement of this chapter for a period of two years
following disposition of the drugs.
(3) Records described in this subsection that are kept at the
inspection site or that can be immediately retrieved by computer or other
electronic means must be readily available for authorized inspection
during the retention period. Records kept at a central location apart from
the inspection site and not electronically retrievable must be available for
inspection within two working days of a request by an authorized official
of any governmental agency charged with enforcement of this chapter.
(I) Wholesale drug distributors shall establish, maintain, and adhere
to written policies and procedures which shall be followed for the receipt,
security, storage, inventory, and distribution of drugs, including policies
and procedures for identifying, recording, and reporting losses or thefts,
and for correcting all errors and inaccuracies in inventories. Wholesale
drug distributors shall include in their written policies and procedures:
(1) a procedure whereby the oldest approved stock of a drug
product is distributed first. The procedure may permit deviation from this
requirement if such deviation is temporary and appropriate;
(2) a procedure to be followed for handling recalls and
withdrawals of drugs. The procedure must be adequate to deal with
recalls and withdrawals due to:
(a) any action initiated at the request of the Food and Drug
Administration or other federal, state, or local law enforcement or other
government agency, including the Board of Pharmacy;
(b) any voluntary action by the manufacturer to remove
defective or potentially defective drugs from the market; or
(c) any action undertaken to promote public health and safety
by the replacing of existing merchandise with an improved product or
new package design;
(3) a procedure to ensure that wholesale drug distributors prepare
for, protect against, and handle any crisis that affects security or operation
of any facility in the event of a strike, fire, flood, or other natural disaster,
or other situations of local, state, or national emergency;
(4) a procedure to ensure that outdated drugs are segregated from
other drugs and either returned to the manufacturer or destroyed. This
procedure shall provide for written documentation of the disposition of
outdated drugs which must be maintained for two years after disposition
of the outdated drugs.
(J) Wholesale distributors shall establish and maintain a current list
of officers, directors, managers, and other individuals in charge of
wholesale drug distribution, storage, and handling, including a description
of their duties and a summary of their qualifications.
(K) Wholesale distributors shall permit the Board of Pharmacy and
authorized federal, state, and local law enforcement officials to enter and
inspect their premises and delivery vehicles, and to audit their records and
written operating procedures, at reasonable times and in a reasonable
manner, to the extent authorized by law.
Wholesale distributors that deal in controlled substances shall register
with the appropriate state-controlled substance authority and with the
Drug Enforcement Administration, and shall comply with all applicable
state, local, and DEA requirements.
(L) Wholesale distributors are subject to the provisions of any
applicable federal, state, or local laws or regulations that relate to drug
product salvaging or reprocessing.
(M) This chapter may not be construed to prevent licensed
pharmacists from filling, as otherwise provided by law, prescriptions
originating outside the boundaries of this State and official United States
government prescriptions issued by authorized governmental officials.
(N)(1) A facility located outside this State, whose primary business
is mail order prescription service, shall 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 facility shall report to the board:
(a) 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 of a change of
permit holder or pharmacist-in-charge;
(b) 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
facility shall have 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 facility 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;
(c) 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.
(2) Nothing in this chapter requires that pharmacists employed by
facilities located in other states and who are not engaged in the practice
of pharmacy in this State be licensed in this State.
(3) If the state in which the facility 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 facility may not allow a pharmacist to supervise more than two
pharmacy technicians at any time in the compounding and dispensing of
prescription drugs.
(4) A pharmacy, as described in this section, during its regular
hours of operation but not less than six days or 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.
(5) 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 permit holder, and
accompanied by the required fee. The board may require information from
the facility reasonably necessary to carry out the purposes of this section.
Each facility shall apply individually and obtain a separate permit for each
location. The permit is not transferable and expires annually. A renewal
application must be mailed to the board postmarked no later than June
second or the existing permit lapses on the date of its expiration, and no
renewal permit may be granted except:
(a) upon evidence satisfactory to the board of good and
sufficient grounds for the failure to file the application within the
prescribed period;
(b) upon payment of the renewal fee and a penalty of fifty
dollars.
(6) The board may deny, revoke, suspend, or otherwise take action
against a facility permit issued under the provisions of this section for:
(a) failure to comply with the requirements of:
(i) this section;
(ii) subsection (C), dealing with prescription drug orders,
drug product selection, labeling, patient records, drug review, drug
dispensing, patient counseling, emergency refills, and advertisements;
(iii) subchapter 1, Chapter 13, Title 21 (Federal Controlled
Substance Act);
(iv) Chapter 2, Title 21 of the Code of Federal Regulations
(Federal Controlled Substance Regulation);
(b) 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.
(7) A facility required to obtain a permit pursuant to this
subsection but which has not been issued a permit, may not advertise its
services in this State, nor may a resident of this State advertise the
services for the facility.
(8) A permit issued pursuant to this section is not evidence that the
pharmacy is doing business within this State.
Section 40-43-90. (A) To obtain a permit, an applicant shall:
(1) submit a written application in the form prescribed by the
Board of Pharmacy at least forty-five days before the opening date of the
facility;
(2) pass an inspection conducted by inspectors of the Board of
Pharmacy; and
(3) pay all appropriate fees.
(B) Applicants for permits to distribute, manufacture, sell, purchase,
or produce drugs or devices within this State shall file with the Board of
Pharmacy a verified application containing such information as the board
requires of the applicant relative to the qualifications for a permit holder.
(C) Permits issued by the board pursuant to this chapter are not
transferable or assignable.
Section 40-43-91. (A) All permit holders shall report to the Board
of Pharmacy within three working days of the discovery of the occurrence
of:
(1) theft or loss of drugs or devices;
(2) conviction of any employee of any state or federal drug laws.
(B) All permit holders shall report to the Board of Pharmacy within
ten working days of the discovery of the occurrence of any of the
following:
(1) permanent closing;
(2) change of ownership, management, location, consultant
pharmacists, or pharmacist-in-charge of a pharmacy;
(3) change in employment of pharmacists or pharmacy technicians
within a pharmacy permitted by the board;
(4) disasters, accidents, destruction, or loss of records required to
be maintained by state or federal law.
(C) Upon permanent closing a permittee shall return the permit to the
board within thirty days.
(D) The board may assess a civil penalty of not more than one
hundred dollars upon any individual who fails to comply with the rules as
provided in this section.
(E) Any currently licensed pharmacist or pharmacy technician who
changes his mailing address must notify the board in writing within ten
days listing his name, license or registration number, and new mailing
address.
(F) When a licensed pharmacist in the employ of or in charge of the
pharmacy duties of a permitted facility within this State leaves the employ
of or ceases to have charge of the pharmacy duties of the permitted
facility, he shall notify the board in writing within ten days of the change,
giving the name and address of the permitted facility at which he was last
employed. When a licensed pharmacist or registered pharmacy technician
within this State makes any change in employment from one permitted
facility to another, he shall notify the board of the change within ten days,
listing the name and address of the permitted facility at which he was last
employed and of the facility to which he expects to move.
Section 40-43-100. The examination for licensure required under
Section 40-43-80 must be given by the board at least two times during
each year. The examination must be prepared to measure the competency
of an applicant to engage in the practice of pharmacy.
Section 40-43-110. (A) For permits not renewed by the expiration
date specified on the permit, the board may charge late penalties as
follows:
(1) ten dollars a day if renewed during the first thirty days
following expiration;
(2) failure to renew by the end of thirty days following expiration
shall result in automatic cancellation of the permit and application for a
new permit is required.
(B) Upon the occurrence of any of the following, an existing permit
is void and a new permit must be applied for:
(1) change of ownership:
(a) any change of ownership in the case of a sole proprietorship;
(b) a gain or loss of a partner in the case of a partnership;
(c) a change of ownership of fifty percent or more of stock in
the case of a corporation.
(2) change of name; or
(3) change of location.
A change in location of a permit within the same city requires an
inspection and the payment of a relocation fee.
(C) The board may, upon application and payment of the applicable
renewal fee, issue an inactive status license to a licensed pharmacist who
is not actively engaged in the practice of pharmacy in this State, pursuant
to this chapter. The pharmacist's license renewal certificate must be
prominently marked as an inactive license, and the holder may not
practice pharmacy under any conditions in this State. If the pharmacist
wishes to reactivate the license, he shall complete the required continuing
education for license renewal, plus an additional fifteen hours which must
have been obtained during the calendar year immediately preceding the
reactivation.
(D)(1) After May first, a license which has not been renewed is
considered a lapsed license. A person who practices pharmacy with a
license that has lapsed is considered practicing without a license.
Reinstatement of a lapsed license may be granted upon evidence
satisfactory to the board of good and sufficient grounds for the failure to
renew the license within the prescribed period and payment of the renewal
fee and a penalty of fifty dollars.
(2) A pharmacist whose license has lapsed for less than three years
may reactivate his license by applying to the board, submitting proof of
completion of 1.5 CEU's for each year the license has lapsed, and paying
the reactivation fee.
(3) A pharmacist whose license has lapsed for three years but less
than five years may reactivate his license by applying to the board,
demonstrating to the board evidence of no less than one thousand hours
of practice under the on-site supervision of a pharmacist licensed in this
State, and paying the reactivation fee.
(4) A pharmacist whose license has lapsed for ten years or more
may reactivate his license by applying to the board, demonstrating to the
board evidence of no less than one thousand hours of practice under the
on-site supervision of a pharmacist licensed in this State, successfully
passing an examination administered or approved by the board, and
paying the reactivation fee.
(5)(a) A pharmacist whose license has lapsed for less than three
years and who has active status outside of South Carolina may reinstate
his license by submitting proof of completion of 1.5 CEU's for each year
the license has lapsed, official verification of a current license, and paying
the reactivation fee.
(b) A pharmacist whose license has lapsed for three years or
more and who has active status outside of South Carolina may reinstate
his license by submitting evidence of no less than one thousand hours of
out-of-state employment within the last five years, official verification of
a current license, and paying the reactivation fee.
(E)(1) Each licensed pharmacist shall apply for renewal of his license
annually no later than April first. A licensed pharmacist who desires to
continue in the practice of pharmacy in this State shall file with the board
an application in such form and containing data as the board requires for
renewal of the license. If the board finds that the applicant has been
licensed, and that the license has not been revoked or suspended or
otherwise disciplined, that the applicant has paid the renewal fee and has
completed all pharmacy education requirements for continuing education
in accordance with this chapter, the board shall issue a license to the
applicant.
(2) If a pharmacist fails to make application to the Board of
Pharmacy for renewal of his license within a period of three years from
the expiration of his license, he must pass the Pharmacy Law Examination
for license renewal; except that a person who has been licensed under the
laws of this State and after the expiration of his license has continually
practiced pharmacy in another state under a license issued by the authority
of such state, may renew his license upon payment of the designated fee
and proof of completion of thirty hours of continuing education on a form
approved by the board.
(3) Those assistant pharmacists currently licensed have all the
rights and privileges of a licensed pharmacist.
(F) No temporary license may be issued.
Section 40-43-130. (A) Topics and formats of study for continuing
education shall include subject matter designed to maintain the
professional competence of pharmacists licensed to practice and to
improve their professional skills in order to protect the public health and
safety.
(B) Each licensed pharmacist, as a condition of an active status
license renewal, shall complete fifteen hours (1.5 CEU's) of American
Council on Pharmaceutical Education (ACPE) accredited continuing
pharmacy education or continuing medical education (CME), Category
I, or both, each license year. Of the fifteen hours, a minimum of six hours
must be obtained through attendance at lectures, seminars, or workshops.
At least fifty percent of the total number of hours required must be in drug
therapy or patient management.
(C) All hours completed in any license year in excess of the
requirement may be carried forward for credit in the next license year but
may not be carried forward for more than one license year.
(D) Upon licensure in this State by examination or by license
transfer, pharmacists are exempt from continuing education requirements
for the first renewal period.
(E) A copy of the original certificates of completion of the required
continuing education shall be submitted to the board upon completion.
(F) An exemption may be granted by the board for pharmacists
enrolled in an approved pharmacy postgraduate degree program.
Application must be made to the board and grade reports must be
submitted to the board.
Section 40-43-140. (A)(1) The board may suspend, revoke, deny,
or refuse to renew the permit of a permittee or impose disciplinary action
authorized by this chapter for:
(a) violations of any of the provisions of this chapter or any
regulations promulgated pursuant to this chapter;
(b) retaining as an employee a person who wilfully or habitually
violates any of the state or federal laws applicable to a permitted facility
or its operation.
(2) A person who distributes or delivers drugs or devices to a
person not permitted in accordance with this chapter is subject to a fine
to be imposed by the board not to exceed one thousand dollars for each
offense in addition to such other disciplinary action the board may take
under this chapter. Each violation constitutes a misdemeanor punishable
by a fine not to exceed five thousand dollars or imprisonment not to
exceed one year, or both.
(3) Facilities requiring permits may not operate unless a permit has
been issued by the board.
(4) Except where otherwise allowed by law, it is unlawful for a
manufacturer or a wholesale distributor to distribute or deliver drugs or
devices to any person in this State not permitted under this chapter.
(a) conviction for a violation of any federal, state, or local law
relating to the practice of pharmacy, drug samples, wholesale or retail
drug or device distribution, or illegal use of or distribution of controlled
substances;
(b) the furnishing of false or fraudulent material in any
application made in connection with drug or device manufacturing or
distribution;
(c) suspension or revocation by federal, state, or local
government of any permit or license currently or previously held by the
applicant for the manufacture or distribution of any drugs or devices,
including controlled substances;
(d) obtaining remuneration by fraud, misrepresentation, or
deception;
(e) dealing with drugs or devices that they know or should have
known are stolen drugs or devices.
Section 40-43-150. (A) Investigations and hearings must be
conducted in accordance with the provisions of Section 40-1-80.
(B) Restraining orders and cease and desist orders shall be issued in
accordance with the provisions of Section 40-1-100.
(C) Upon determination by the board that one or more of the grounds
for disciplining a licensee or permittee exists, as provided for in Section
40-1-110, the board may, in addition to the actions provided for in Section
40-1-120, impose a fine not to exceed an amount set by the board in
regulation.
(D) A licensee or permittee who is under investigation for any of the
grounds provided for in Section 40-36-110 for which the board may take
disciplinary action must voluntarily surrender his license or permit to the
board in accordance with Section 40-1-150.
(E) A person aggrieved by an action of the board may seek review
of the decision in accordance with Section 40-1-160.
Section 40-43-160. (A) An individual who, after a hearing, shall be
found by the board to have unlawfully engaged in the practice of
pharmacy is subject to a fine to be imposed by the board not to exceed an
amount set by the board in regulation for each offense.
(B) Each violation of this chapter or the regulations promulgated
under this chapter pertaining to unlawfully engaging in the practice of
pharmacy shall also constitute a misdemeanor and, upon conviction, is
punishable as provided in Section 40-1-210.
Section 40-43-170. (A) When the Governor issues a 'State of
Emergency':
(1) A pharmacist in the affected county may dispense a one-time
emergency refill of up to a fifteen-day supply of a prescribed medication
if:
(a) the pharmacist has all prescription information necessary in
order to accurately refill the prescription and;
(b) in the pharmacist's professional opinion the medication is
essential to the maintenance of life or to the continuation of therapy and;
(c) the pharmacist reduces the information to a written
prescription marked 'Emergency Refill', files the prescription as required
by law and notifies the prescribing physician within fifteen days of the
emergency refill and;
(d) the prescription is not for a controlled substance.
(2) A pharmacist not licensed in South Carolina but currently
licensed in another state, may in a state of emergency dispense
prescription medications in those affected counties without being licensed
in South Carolina during the time that a state of emergency exists if:
(a) the pharmacist has some type of identification to verify current
licensure in another state and;
(b) the pharmacist is engaged in a legitimate relief effort during an
emergency situation.
(B) This disaster preparedness ends with the state of emergency.
Section 40-43-180. Nothing in this chapter may be construed to
require a health maintenance organization, a self-funded plan, an accident
and health insurer, or any other third party payor to provide services or to
pay for services provided for in this chapter."
Time effective
SECTION 2. This act takes effect upon the approval of the Governor.
Approved the 27th day of May, 1998. |