ENROLLED
COMMITTEE SUBSTITUTE
FOR
H. B. 2451
(By Delegates Gallagher and Border)
[Passed March 11, 1995; in effect ninety days from passage.]
AN ACT to repeal sections twelve-a and sixteen-a, article five,
chapter thirty of the code of West Virginia, one thousand nine
hundred thirty-one, as amended; to amend and reenact sections
one, two, three, four, five, six, seven, eight, nine, ten,
eleven, twelve, twelve-b, thirteen, fourteen, fourteen-a,
fifteen, sixteen, nineteen, twenty-one and twenty-two of said
article; and to further amend said article five by adding
thereto nine new sections, designated sections one-a, one-b,
two-a, five-a, seven-a, seven-b, sixteen-b, sixteen-c and
twenty-two-a, all relating to the regulation of pharmacists,
licensed interns and pharmacist technicians; repealing
existing section twelve-a relating to drug and drug price
listing and posting requirements and penalties for
noncompliance; repealing existing section sixteen-a
authorizing the manufacture of laetrile; legislative findings
and statement of purpose; defining terms; filling of board
vacancies; board qualifications; increasing board compensation; meetings and business of the board; clarifying
public and closed meetings; records kept by the board;
providing for expungement of records; examination of records;
notice requirements; public information; making various
technical changes; permitting licensed interns and pharmacy
technicians to assist pharmacists; experience and training
qualifications for pharmacists, licensed interns and pharmacy
technicians; titles and terms; regulating pharmacy
technicians; reciprocity; disciplinary proceedings; grounds
for disciplinary action; fines and penalties; hearings and
notice; confidentiality of prescription records; reporting
criteria for professional malpractice, incompetence and
convictions; voluntary agreements relating to alcohol or
chemical dependency; confidentiality requirements; pharmacy
lists; fees; license renewals and display; prohibitions;
distribution of generic and brand-name drugs; prescription
requirements for "brand medically necessary" drugs; requiring
ownership of USP-DI reference manual; pharmacy registration;
pharmacists-in-charge; increasing fines for violations of
equipment requirements; manufacturing permits; authorizing
partial filling of schedule II medications under certain
circumstances; limitations on application of
article;increasing criminal and civil penalties; providing for
immunity from civil actions for board members; limiting
liability for professionals reporting to the board; required
reporting of litigation results to the board; and rule-making authority.
Be it enacted by the Legislature of West Virginia:
That sections twelve-a and sixteen-a, article five, chapter
thirty of the code of West Virginia, one thousand nine hundred
thirty-one, as amended, be repealed; that sections one, two, three,
four, five, six, seven, eight, nine, ten, eleven, twelve, twelve-b,
thirteen, fourteen, fourteen-a, fifteen, sixteen, nineteen,
twenty-one and twenty-two of said article be amended and reenacted;
and that said article five be further amended by adding thereto
nine new sections, designated sections one-a, one-b, two-a, five-a,
seven-a, seven-b, sixteen-b, sixteen-c and twenty-two-a, all to
read as follows:
ARTICLE 5. PHARMACISTS, PHARMACY TECHNICIANS, PHARMACY INTERNS
AND PHARMACIES.
§30-5-1. Legislative findings.
The Legislature hereby finds and declares that the practice
of pharmacy is a privilege and not a natural or fundamental right
of any individual. As a matter of public policy, it is necessary
to protect the public through the enactment of this article and
to regulate the granting of such privileges and their use. This
article shall be liberally construed to carry out these purposes.
§30-5-1a. Statement of purpose.
It is the purpose of this article to promote, preserve and
protect the public health, safety and welfare by the effective
regulation of the practice of pharmacy; the licensure of
pharmacists; the licensure, and regulation of all sites or persons who distribute, manufacture, or sell drugs or devices
used in the dispensing and administration of drugs or devices
within this state.
§30-5-1b. Definitions.
The following words and phrases, as used in this article,
shall have the following meanings, unless the context otherwise
requires:
(a) "Administer" means the direct application of a drug to
the body of a patient or research subject by injection,
inhalation, ingestion or any other means.
(b) "Board of pharmacy" or "board" means the West Virginia
state board of pharmacy.
(c) "Compounding" means:
(1) The preparation, mixing, assembling, packaging or
labeling of a drug or device:
(A) 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 for sale or
dispensing; or
(B) For the purpose of, or as an incident to, research,
teaching or chemical analysis and not for sale or dispensing;
(2) The preparation of drugs or devices in anticipation of
prescription drug orders based on routine, regularly observed
prescribing patterns.
(d) "Confidential information" means information maintained
by the pharmacist in the patient record or which is communicated to the patient as part of patient counseling, or which is
communicated by the patient to the pharmacist. This information
is privileged and may be released only to the patient or to other
members of the health care team and other pharmacists where, in
the pharmacist's professional judgment, such release is necessary
to the patient's health and well-being; to such other persons or
governmental agencies authorized by law to receive such
privileged information; as necessary for the limited purpose of
peer review and utilization review; as authorized by the patient
or required by court order.
(e) "Deliver" or "delivery" means the actual, constructive
or attempted transfer of a drug or device from one person to
another, whether or not for a consideration.
(f) "Device" means an instrument, apparatus, implement or
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
or state law requires dispensing by or on the order of a
physician."
(g) "Dispense" or "dispensing" means the preparation and
delivery of a drug or device in an appropriately labeled and
suitable container to a patient or patient's representative or
surrogate pursuant to a lawful order of a practitioner for
subsequent administration to, or use by, a patient.
(h) "Distribute" means the delivery of a drug or device
other than by administering or dispensing.
(i) "Drug" means:
(1) Articles recognized as drugs in the USP-DI, Facts and
Comparisons, Physicians Desk Reference or supplements thereto,
for use in the diagnosis, cure, mitigation, treatment or
prevention of disease in human or other animals;
(2) Articles, other than food, intended to affect the
structure or any function of the body of human or other animals;
and
(3) Articles intended for use as a component of any articles
specified in subsection (1) or (2) of this section.
(j) "Drug regimen review" includes, but is not limited to,
the following activities:
(1) Evaluation of the prescription drug orders and patient
records for:
(A) Known allergies;
(B) Rational therapy-contraindications;
(C) Reasonable dose and route of administration; and
(D) Reasonable directions for use.
(2) Evaluation of the prescription drug orders and patient
records for duplication of therapy.
(3) Evaluation of the prescription drug for interactions
and/or adverse effects which may include, but are not limited to,
any of the following:
(A) Drug-drug;
(B) Drug-food;
(C) Drug-disease; and
(D) Adverse drug reactions.
(4) Evaluation of the prescription drug orders and patient
records for proper utilization, including over utilization and
under utilization and optimum therapeutic outcomes.
(k) "Intern" means an individual who is:
(1) Currently registered by this state to engage in the
practice of pharmacy while under the supervision of a licensed
pharmacist and is satisfactorily progressing toward meeting the
requirements for licensure as a pharmacist; or
(2) A graduate of an approved college of pharmacy or a
graduate who has established educational equivalency by obtaining
a Foreign Pharmacy Graduate Examination Committee (FPGEC)
certificate, who is currently licensed by the board for the
purpose of obtaining practical experience as a requirement for
licensure as a pharmacist; or
(3) A qualified applicant awaiting examination for
licensure; or
(4) An individual participating in a residency or fellowship
program.
(l) "Labeling" means the process of preparing and affixing
a label to a drug container exclusive, however, of a labeling by
a manufacturer, packer or distributor of a nonprescription drug
or commercially packaged legend drug or device. Any such label
shall include all information required by federal law or
regulation and state law or rule.
(m) "Mail order pharmacy" means a pharmacy, regardless of its location, which dispenses greater than ten percent
prescription drugs via the mail.
(n) "Manufacturer" means a person engaged in the manufacture
of drugs or devices.
(o) "Manufacturing" means the production, preparation,
propagation 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 and
includes any packaging or repackaging of the substance(s) or
labeling or relabeling of its contents and the promotion and
marketing of such drugs or devices. Manufacturing also includes
the preparation and promotion of commercially available products
from bulk compounds for resale by pharmacies, practitioners or
other persons.
(p) "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 and
rules of this state and the federal government.
(q) "Patient counseling" means the oral communication by the
pharmacist of information, as defined in the rules of the board,
to the patient, to improve therapy by aiding in the proper use of
drugs and devices.
(r) "Person" means an individual, corporation, partnership,
association or any other legal entity, including government.
(s) "Pharmaceutical care" is the provision of drug therapy
and other pharmaceutical patient care services intended to achieve outcomes related to the cure or prevention of a disease,
elimination or reduction of a patient's symptoms or arresting or
slowing of a disease process as defined in the rules of the
board.
(t) "Pharmacist" or "registered pharmacist" means an
individual currently licensed by this state to engage in the
practice of pharmacy and pharmaceutical care.
(u) "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 and rules
pertinent to the practice of pharmacy and the distribution of
drugs and who is personally in full and actual charge of such
pharmacy and personnel.
(v) "Pharmacy" means any drugstore, apothecary or place
within this state where drugs are dispensed and sold at retail or
displayed for sale at retail and pharmaceutical care is provided;
and any place outside of this state where drugs are dispensed and
pharmaceutical care is provided to residents of this state.
(w) "Pharmacy technician" means registered supportive
personnel who work under the direct supervision of a pharmacist
who have passed an approved training program as described in this
article.
(x) "Practitioner" means an individual currently licensed,
registered or otherwise authorized by the jurisdiction in which
he or she practices to prescribe and administer drugs in the
course of professional practices, including allopathic and osteopathic physicians, dentists, physician's assistants,
optometrists, veterinarians, podiatrists and nurse practitioners
as allowed by law.
(y) "Preceptor" means an individual who is currently
licensed as a pharmacist by the board, meets the qualifications
as a preceptor under the rules of the board, and participates in
the instructional training of pharmacy interns.
(z) "Prescription drug" or "legend drug" means a drug which,
under federal law, is required, prior to being dispensed or
delivered, to be labeled with either of the following statements:
(1) "Caution: Federal law prohibits dispensing without
prescription";
(2) "Caution: Federal law restricts this drug to use by, or
on the order of, a licensed veterinarian"; or a drug which is
required by any applicable federal or state law or rule to be
dispensed pursuant only to a prescription drug order or is
restricted to use by practitioners only.
(aa) "Prescription drug order" means a lawful order of a
practitioner for a drug or device for a specific patient.
(bb) "Prospective drug use review" means a review of the
patient's drug therapy and prescription drug order, as defined in
the rules of the board, prior to dispensing the drug as part of
a drug regimen review.
(cc) "USP-DI" means the United States
Pharmacopedia-Dispensing Information.
(dd) "Wholesale distributor" means any person engaged in wholesale distribution of drugs, including, but not limited to,
manufacturers' and distributors' warehouses, chain drug
warehouses and wholesale drug warehouses; independent wholesale
drug trader; and retail pharmacies that conduct wholesale
distributions.
§30-5-2. Board of pharmacy; appointment, qualifications and
terms of members; compensation; powers and duties
generally; meetings and notices.
(a) There shall be a state board of pharmacy, known as the
"West Virginia board of pharmacy," which shall consist of five
practicing pharmacists and two public members, who shall be
appointed by the governor, by and with the advice and consent of
the Senate. Any vacancy which occurs in the membership of the
board for any reason, including expiration of term, removal,
resignation, death, disability or disqualification shall be
immediately filled by the governor as provided by this section.
Nothing in this section shall require the governor to change the
composition of the board prior to the usual expiration of any
member's term. The governor may consider the diversity of
pharmacy areas of practice when filling vacancies.
(b) Each pharmacist member of the board, at the time of his
appointment, shall be a resident of this state, licensed and in
good standing to engage in the practice of pharmacy in this state
for a period of at least five years prior to their appointment.
The public members shall be residents of this state who have
attained the age of eighteen years and may not be a past or present pharmacist, the spouse of a pharmacist, a person who
has ever had any material financial interest in providing
pharmacy services or who has engaged in any activity directly
related to the practice of pharmacy.
(c) Each member of the board shall receive two hundred
dollars for each day spent in attending to the duties of the
board or of its committees, and shall be reimbursed for all
actual and necessary expenses incurred in carrying out his or her
duties.
(d) The members of the board in office on the date this
section takes effect shall, unless sooner removed, continue to
serve until their respective terms expire and until their
successors have been appointed and have qualified. Board member
terms shall be for five years with at least one pharmacist
member's term expiring yearly. The governor may, with the advice
and consent of the Senate, reappoint any member for additional
consecutive terms. Members as of the first day of July, one
thousand nine hundred ninety-five, are eligible for reappointment
to additional terms regardless of the length of time they have
previously served on the board.
(e) The board, in addition to the authority, powers and
duties granted to the board by this chapter and chapter sixteen
of this code, shall have the authority to:
(1) Regulate the practice of pharmacy;
(2) Regulate the employment of licensed interns in
pharmacy;
(3) Appoint, within the limit of appropriations, inspectors
who shall be pharmacists, and investigators, to act as agents
of the board within the provisions of this chapter and chapter
sixteen of this code and rules as the board shall promulgate;
(4) Adopt rules of professional conduct; and
(5) Hire an attorney, as may be necessary.
(f) A majority of the membership of the board constitutes
a quorum for the transaction of business, and any motion is
approved by a majority vote of a quorum. All board members shall
be given advance notice of each board meeting.
(g) Meetings of the board shall be held in public session,
except that the board may hold closed sessions to prepare,
approve, grade or administer examinations. Disciplinary
proceedings, prior to a finding of probable cause, as provided in
section seven of this article shall be held in closed sessions,
unless the party subject to discipline requests that the hearing
be held in public sessions. All discussions or meetings of the
board concerning personnel matters shall be held in closed
session.
§30-5-2a. Records of board; expungement; examination notice;
public information.
(a) The board shall maintain a permanent record of the names
of all pharmacists, interns and pharmacy technicians lawfully
practicing in this state, and of all persons applying for
licensure to practice, along with an individual historical record
for each such individual containing reports and all other information furnished to the board concerning any applicant,
pharmacist, intern or pharmacy technician.
(b) Upon a determination by the board that any information
submitted to it is without merit, the report shall be expunged
from the individual's historical record.
(c) Any licensee or registrant of the board or authorized
representative thereof, has the right, upon request, to examine
his or her own individual historical record maintained by the
board pursuant to this article and to place into such record a
statement regarding the correctness or relevance of any
information in the historical record. These statements shall at
all times be appended to and accompany any request for review or
copies made of the portion of the record to which they refer.
(d) Orders of the board relating to disciplinary action
against a pharmacist, pharmacy technician, or other license or
registrant of the board are public information.
§30-5-3. When licensed pharmacist required; person not
licensed pharmacist, pharmacy technician or
licensed intern
not to compound prescriptions or
dispense poisons or narcotics; licensure of interns.
(a)
It is unlawful for any person not a pharmacist, or
who does not employ a pharmacist, to conduct any pharmacy, or
store for the purpose of retailing, compounding or dispensing
prescription drugs or prescription devices.
(b) It is unlawful for the proprietor of any store or
pharmacy to permit any person not a pharmacist to compound or dispense prescriptions or prescription refills, or to retail or
dispense the poisons and narcotic drugs named in sections two,
three and six, article eight, chapter sixteen of this code:
Provided, That a licensed intern may compound and dispense
prescriptions or prescription refills under the direct
supervision of a pharmacist:
Provided, however, That registered
pharmacy technicians may assist in the preparation and dispensing
of prescriptions or prescription refills including, but not
limited to, reconstitution of liquid medications, typing and
affixing labels under the direct supervision of a licensed
pharmacist.
(c) It is the duty of a pharmacist or employer who
employs an intern to license the intern with the board within
ninety days after employment. The board shall furnish proper
forms for this purpose and shall issue a certificates to the
intern upon licensure.
(d) The experience requirement for licensure as a
pharmacist shall be computed from the date certified by the
supervising pharmacist as the date of entering the internship.
If the internship is not registered with the board of pharmacy,
then the intern shall receive no credit for such experience
when he or she makes application for examination for licensure as
a pharmacist
: Provided, That credit may be given for such
unregistered experience if an appeal is made and evidence
produced showing experience was obtained but not registered and
that failure to register the internship experience was not the fault of the intern.
(e) An intern having served part or all of his or her
internship in a pharmacy in another state or foreign country
shall be given credit for the same when the affidavit of his or
her internship is signed by the pharmacist under whom he or she
served, and it shows the dates and number of hours served in
the internship and when the affidavit is attested by the
secretary of the state board of pharmacy of the state or country
where the internship was served.
(f) Up to one third of the experience requirement for
licensure as a pharmacist may be fulfilled by an internship in a
foreign country.
§30-5-4. Use of titles or terms; ; penalties and fines.
(a) It is unlawful for any person not legally licensed as
a pharmacist, unless he or she employs a licensed pharmacist,
to take, use or exhibit the title of pharmacist, or licensed or
registered pharmacist, or the title of druggist or apothecary, or
any other title or description of like import, or to label, mark,
or advertise his or her or any other place of business as a
pharmacy or drugstore or by the use of the words drug or
medicines or any other compound or derivative of the same, or by
any other word or sign indicating or intended to indicate that
drugs or pharmaceutical supplies are either sold or offered for
sale.
(b) It is unlawful for any person not legally registered as
a pharmacy technician to take, use or exhibit the title of pharmacy technician, or any title or description of like import.
(c) Any person violating this section shall, upon conviction,
be deemed guilty of a misdemeanor and fined not less than five
hundred nor more than one thousand dollars.
§30-5-5. Qualifications for licensure as pharmacist;
fees;
certificates of licensure; rules for licensure;
reciprocity; minimum standards.
(a) In order to be licensed as a pharmacist within the
meaning of this article, a person shall:
(1) Be eighteen years of age or older;
(2) Present to the board satisfactory evidence that he or she
is a graduate of a recognized school of pharmacy as defined by
the board of pharmacy;
(3) Present to the board satisfactory evidence that he or
she has completed at least fifteen hundred hours of internship
in a pharmacy under the instruction and supervision of a
pharmacist;
(4) Pass an examination approved by the board of pharmacy;
and
(5) Present to the board satisfactory evidence that he or she
is a person of good moral character, has not been convicted of a
felony involving controlled substances or violent crime, and is
not addicted to alcohol or the use of controlled substances.
(b) An applicant for examination shall pay to the board a
fee of one hundred twenty-five dollars with his or her
application.
(c) The board shall issue certificates of licensure to all
persons who successfully pass the required examination and are
otherwise qualified and to all those whose certificates or
licenses the board shall accept in lieu of an examination as
provided in section six of this article.
(d) The board shall by rule stipulate the forms to be used
for licensure application, the requirements for reciprocity and
the required minimum score for passing of the licensure
examination.
§30-5-5a. Legislative findings; registration of pharmacy
technicians; qualifications; training programs;
rules and restrictions.
(a) The Legislature finds that it is in the best interests
of the public health, safety and welfare that licensed
pharmacists in this state be assisted with or relieved of certain
tasks so that the pharmacist may counsel patients, improve
pharmaceutical care and therapeutic outcomes. To achieve this
aim, the board shall recognize and register pharmacy technicians.
(b) On or after the first day of July, one thousand nine
hundred ninety-six, any person practicing as a pharmacy
technician in this state shall be registered with the board of
pharmacy pursuant to the provisions of this section.
(c) In order to become registered as pharmacy technicians
in this state, individuals shall:
(1) Be at least eighteen years old;
(2) Be a high school graduate or its equivalent;
(3) Present to the board satisfactory evidence that he or
she is of good moral character, is not addicted to alcohol or
controlled substances and is free of any felony convictions; and
(4) Satisfactorily complete a board-approved pharmacy
technician training program.
(d) The pharmacy technician training program and its
curriculum shall be designed to train individuals to perform
nonprofessional functions as described in legislative rules
promulgated in accordance with the provisions of article three,
chapter twenty-nine-a of this code.
(e) Pharmacy technicians shall be identified by a name tag
and designation as pharmacy technician while working in a
pharmacy within this state. A ratio of no more than four
pharmacy technicians per on-duty pharmacist operating in any
outpatient, mail order or institutional pharmacy shall be
maintained.
§30-5-6.
Reciprocal licensure of pharmacists from other states
or countries.
(a) The board of pharmacy may by reciprocity license
pharmacists in this state who have been legally registered or
licensed pharmacists in another state:
Provided, That the
applicant for such licensure shall meet the requirements of the
rules for reciprocity promulgated by the board in accordance with
the provisions of chapter twenty-nine-a of this code:
Provided,
however, That reciprocity is not authorized for pharmacists from another state where that state does not permit reciprocity to
pharmacists licensed in West Virginia.
(b) The board may refuse reciprocity to pharmacists from
another country unless the applicant qualifies under such rules
as may be promulgated by the board for licensure of foreign
applicants.
(c) Applicants for licensure under this section shall,
with their application, forward to the secretary of the board of
pharmacy a fee of two hundred fifty dollars. In the event the
applicant desires to be examined other than at a regular meeting
of the board the applicant shall submit to the board an
additional fee of one hundred fifty dollars.
§30-5-7.
Grounds for suspension or revocation of license or
disciplinary proceedings; penalties and procedures; temporary
suspensions; reporting of disciplinary action.
(a) The board shall have the power to withhold, revoke or
suspend any license or any certificate issued under this article
or to penalize or discipline any pharmacist or pharmacy after
giving reasonable notice and an opportunity to be heard pursuant
to the provisions of section one, article five, chapter
twenty-nine-a of this code, any person who has:
(1) Become unfit or incompetent to practice pharmacy by
reason of: (A) Alcohol or substance abuse; (B) insanity; or
(C) any abnormal physical or mental condition which threatens the
safety of persons to whom such person might sell or dispense
prescriptions, drugs, or devices, or for whom he might manufacture, prepare or package, or supervise the manufacturing,
preparation, or packaging of prescriptions, drugs or devices;
(2) Been convicted in any of the courts of this state, the
United States of America, or any other state, of a felony or any
crime involving moral turpitude which bears a rational nexus to
the individual's ability to practice as a pharmacist or
pharmacist technician;
(3) Violated any of the provisions of this chapter or
chapter sixteen of this code;
(4) Failed to comply with the rules of professional conduct
adopted by the board pursuant to section two of this article;
(5) Knowledge or suspicion that a pharmacist, pharmacy
technician or pharmacy intern is incapable of engaging in the
practice of pharmacy with reasonable skill, competence and safety
and has failed to report this information to the board;
(6) Committed fraud as a licensee in connection with the
practice of pharmacy;
(7) Performed an act outside this state which would
constitute a violation within this state; or
(8) Agreed to participate in a legend drug product
conversion program promoted or offered by a manufacturer,
wholesaler or distributor of such product for which the
pharmacist or pharmacy received any form of financial
remuneration, or agreed to participate in a legend drug program
in which the pharmacist or pharmacy is promoted or offered as the
exclusive provider of legend drug products or whereby in any way the public is denied, limited or influenced in selecting
pharmaceutical service or counseling.
(b) Upon a finding of a violation of one or more of the
above grounds for discipline by a pharmacist, intern or pharmacy
technician, the board may impose one or more of the following
penalties:
(1) Suspension of the offender's license or registration for
a term to be determined by the board;
(2) Revocation of the offender's license or registration;
(3) Restriction of the offender's license or registration to
prohibit the offender from performing certain acts or from
engaging in the practice of pharmacy in a particular manner for
a term to be determined by the board;
(4) Imposition of a fine not to exceed one thousand dollars
for each offense;
(5) Refusal to renew the offender's license or registration;
(6) Placement of the offender on probation and supervision
by the board for a period to be determined by the board.
(c) All final decisions of the board shall be subject to
judicial review pursuant to the procedures of article five,
chapter twenty-nine-a of this code.
(d) In the case of a pharmacy or wholesale distributor, the
disciplinary order may be entered as to the corporate owner, if
any, as well as to the pharmacist, officer, owner or partner of
the pharmacy or wholesale distributor if it is found that such
person or entity had knowledge of or knowingly participated in one or more of the violations set forth in this article or of
article three, chapter sixty-a of this code.
(e) Notwithstanding the provisions of section eight,
article one, chapter thirty of this code, if the board determines
that the evidence in its possession indicates that a pharmacist's
continuation in practice or unrestricted practice constitutes an
immediate danger to the public, the board may, on a temporary
basis and without a hearing, take any of the actions provided for
in this section if proceedings for a hearing before the board are
initiated simultaneously with the temporary action and begin
within fifteen days of such action. The board shall render its
decision within five days of the conclusion of a hearing
conducted pursuant to the provisions of this section.
(f) In every disciplinary or licensure case considered by
the board pursuant to this article, whether initiated by the
board or upon complaint or information from any person or
organization, the board shall make a preliminary determination as
to whether probable cause exists to substantiate charges of
disqualification due to any reason set forth in this section. If
such probable cause is found to exist, all proceedings on such
charges shall be open to the public, who shall be entitled to all
reports, records and nondeliberative materials introduced at such
hearing, including the record of any final action taken:
Provided, That any medical records pertaining to a person who has
not expressly waived his or her right to the confidentiality of
such records shall not be open to the public.
(g) All disciplinary actions taken by the board shall be
reported to the national board of pharmacy, appropriate federal
agencies and to any other state boards with which the disciplined
licensee may also be registered or licensed.
§30-5-7a. Required reporting of information to board pertaining
to professional malpractice and convictions;
complaints of professional incompetence; reporting
forms.
(a) Every person, partnership, corporation, association,
insurance company, professional society or other organization
providing professional liability insurance to a pharmacist,
pharmacist technician or intern in this state shall submit to the
board the following information within thirty days from any
judgment, dismissal or settlement of a civil action or of any
claim involving the insured: The date of any judgment or
settlement; the amount of any settlement or judgment against the
insured; and such other information as the board may require.
(b) Within thirty days after a person known to be a
pharmacist, pharmacy intern, or pharmacy technician licensed or
otherwise lawfully practicing pharmacy in this state or applying
to be so licensed is convicted of any crime under the laws of
this state, or the laws of the United States which involves drugs
in any way, including any controlled substance under state or
federal law, the clerk of the court of record in which the
conviction was entered shall forward to the board a certified
true and correct abstract of record of the convicting court. The abstract shall include the name and address of such licensee, the
nature of the offense committed and the final judgment and
sentence of the court.
(c) Any person may report to the board relevant facts about
the conduct of a licensee of the board which in the opinion of
such person amounts to professional malpractice or professional
incompetence.
(d) The board shall provide forms for filing reports
pursuant to this section. Reports submitted in other forms shall
be accepted by the board.
§30-5-7b. Voluntary agreements relating to alcohol or chemical
dependency; confidentiality of same.
(a) In order to encourage voluntary reporting of alcohol or
other chemical dependency impairment and in recognition of the
fact that alcoholism and chemical dependency are illnesses, a
pharmacist or pharmacy technician or other licensee or registrant
or the board may enter into a voluntary agreement with the board
reporting his or her participation in an alcohol or chemical
dependency treatment program or reporting an alcohol or chemical
dependency impairment to the board and seek treatment for his or
her dependency. Pursuant to said agreement, the board shall
impose limitations on the practice of said pharmacist, pharmacy
technician or other licensee or registrant of the board.
(b) Any voluntary agreement entered into pursuant to this
subsection may not be considered a disciplinary action or order
by the board and shall not be public information if:
(1) Such voluntary agreement is the result of the pharmacist,
pharmacy technician, or other licensee or registrant of the board
reporting his or her participation in an alcohol or chemical
dependency treatment program or reporting to the board his or her
alcohol or chemical dependency impairment and requesting such an
agreement for the purpose of seeking treatment; and
(2) The board has not received nor filed any written
complaints regarding said pharmacist, pharmacy technician or
other licensee or registrant of the board relating to an alcohol
or chemical dependency impairment affecting the care and
treatment of patients or customers, nor received any reports
pursuant to section seven of this article relating to an alcohol
or chemical dependency impairment.
(c) If any pharmacist, pharmacy technician or other licensee
or registrant enters into a voluntary agreement with the board
pursuant to this subsection and then fails to comply with or
fulfill the terms of said agreement, the board shall initiate
disciplinary proceedings pursuant to section seven of this
article.
(d) If the board has not instituted any disciplinary
proceedings as provided for in this article, any information
received, maintained or developed by the board relating to the
alcohol or chemical dependency impairment of any pharmacist or
pharmacy technician, other licensee or registrant of the board
and any voluntary agreement made pursuant to this subsection
shall be confidential and not available for public information, discovery or court subpoena nor for introduction into evidence in
any professional liability action or other action for damages
arising out of the provision of or failure to provide health care
services.
(e) In the board's annual report of its activities to the
Legislature required under section eight of this article, the
board shall include information regarding the success of the
voluntary agreement mechanism established therein:
Provided,
That in making such report the board shall not disclose any
personally identifiable information relating to any pharmacist or
other licensee or registrant of the board participating in a
voluntary agreement as provided herein.
(f) Notwithstanding any of the foregoing provisions, the
board may cooperate with and provide documentation of any
voluntary agreement entered into pursuant to this subsection to
licensing boards in other jurisdictions, as may be appropriate.
(g) Any restrictions on the disclosure of confidential
information does not apply to any investigation or proceeding by
the board or by a hospital governing board or committee with
respect to relevant medical records, while any of the aforesaid
are acting within the scope of their authority as stated in law
or in the hospital bylaws, rules, regulations or policies and
procedures:
Provided, That the disclosure of any information
pursuant to this provision shall not be considered a waiver of
any such privilege in any other proceeding.
§30-5-8. Reports by secretary of board to secretary of state; "list of pharmacists."
The secretary of the board of pharmacy shall provide the
secretary of state with a list of all pharmacists, pharmacy
technicians and pharmacy interns in this state, giving the name
of the person, his or her business address, and the date of his
or her licensure registration. On or before the fifteenth day of
September each year, the secretary of the board shall certify to
the secretary of state all changes in said list required by the
addition of new licensures, registrations, renewals, reported
deaths, forfeitures of licenses or registrations or for other
causes, occurring during the preceding year. The secretary of
state shall enter in an appropriate book, known as "List of
Pharmacists" the facts shown by such reports, which reports shall
be filed and preserved in his or her office.
§30-5-9. Fees.
The board of pharmacy shall charge and collect the
following fees, in addition to those provided in article one of
this chapter and in sections five, fourteen and sixteen of this
article: For renewing the licensure of a pharmacist, thirty
dollars; to license an intern pharmacist, ten dollars plus five
dollars for each of the remaining periods of his or her
internship; to register a consultant pharmacist, twenty dollars
for the initial application and ten dollars for each additional
application; and to register a pharmacy technician, twenty-five
dollars and ten dollars for each renewal.
§30-5-10. Annual renewal of license; fees and notices.
(a) Every licensed pharmacist, intern or pharmacy
technician who desires to renew his or her license shall on or
before the first day of July, one thousand nine hundred
ninety-one, and annually thereafter apply to the state board of
pharmacy for a renewal of his or her license, and shall transmit
with his or her application the fee prescribed in the preceding
section of this article. Notification of the annual renewal
shall be given by the board at least thirty days prior to said
first day of July. Such notification shall be mailed to the last
known address of each pharmacist or pharmacy technician as shown
on record with the board.
(b) If any pharmacist or pharmacy technician fails for a
period of sixty days after the first day of July of each year
to apply to the board for a renewal of his or her license, the
board shall send a second notification of the required annual
renewal to the last known address of the pharmacist or pharmacy
technician by certified mail, return receipt requested. If the
pharmacist or pharmacy technician fails to apply to the board for
a renewal of his or her license within thirty days after receipt
of the second notification, his or her name shall be erased from
the register of pharmacists and pharmacy technicians.
(c) In order for any pharmacist or pharmacy technician
whose name has been erased from the register of the board
pursuant to subsection (b) of this section to again become
licensed, such pharmacist or pharmacy technician shall appear
personally before the board, or an authorized committee of the board, to show cause for permitting the license to lapse. If
such person submits to the board satisfactory reasons for
allowing the license to lapse and satisfies the board as to his
or her qualifications to practice the profession, such person
shall be reinstated upon payment of a reinstatement fee of two
hundred fifty dollars plus the renewal fee of thirty dollars.
§30-5-11. Certificate of licensure or permit shall be displayed.
Every certificate of registration or licensure to practice
as a pharmacist, intern or pharmacy technician, and every
renewal of such certificate or permit, shall be conspicuously
displayed in the pharmacy or place of business of which the
pharmacist, intern or pharmacy technician or other person to
whom it is issued is the owner or manager, or in which he or she
is employed.
§30-5-12. Responsibility for quality of drugs dispensed;
exception; falsification of labels; deviation from
prescription.
(a) All persons, whether licensed pharmacists or not,
shall be responsible for the quality of all drugs, chemicals and
medicines they may sell or dispense, with the exception of those
sold in or dispensed unchanged from the original retail package
of the manufacturer, in which event the manufacturer shall be
responsible.
(b) Except as provided in section twelve-b of this article,
the following acts shall be prohibited: (1) The falsification of any label upon the immediate container, box and/or package
containing a drug; (2) the substitution or the dispensing of a
different drug in lieu of any drug prescribed in a prescription
without the approval of the practitioner authorizing the original
prescription:
Provided, That this shall not be construed to
interfere with the art of prescription compounding which does
not alter the therapeutic properties of the prescription or
appropriate generic substitute; (3) the filling or refilling of
any prescription for a greater quantity of any drug or drug
product than that prescribed in the original prescription without
a written order or an oral order reduced to writing, or the
refilling of a prescription without the verbal or written consent
of the practitioner authorizing the original prescription.
§30-5-12b. Definitions; selection of generic drug products;
exceptions; records; labels; manufacturing
standards; rules; notice of substitution;
complaints; notice and hearing; immunity.
(a) As used in this section:
(1) "Brand name" means the proprietary or trade name
selected by the manufacturer and placed upon a drug or drug
product, its container, label or wrapping at the time of
packaging.
(2) "Generic name" means the official title of a drug or
drug combination for which a new drug application, or an
abbreviated new drug application, has been approved by the United
States food and drug administration and is in effect.
(3) "Substitute" means to dispense without the prescriber's
express authorization a therapeutically equivalent generic drug
product in the place of the drug ordered or prescribed.
(4) "Equivalent" means drugs or drug products which are the
same amounts of identical active ingredients and same dosage
form, and which will provide the same therapeutic efficacy and
toxicity when administered to an individual and is approved by
the United States food and drug administration.
(5) "Practitioner" means a physician, an authorized Type A
physician assistant at the direction of his or her supervising
physician in accordance with the provisions of section sixteen,
article three of this chapter, osteopath, dentist, veterinarian,
podiatrist, optometrist or any other person duly licensed to
practice and to prescribe drugs under the laws of this state.
(b) A pharmacist who receives a prescription for a brand
name drug or drug product shall substitute a less expensive
equivalent generic name drug or drug product unless in the
exercise of his or her professional judgment the pharmacist
believes that the less expensive drug is not suitable for the
particular patient:
Provided, That no substitution may be made
by the pharmacist where the prescribing practitioner indicates
that, in his or her professional judgment, a specific brand name
drug is medically necessary for a particular patient.
(c) A written prescription order shall permit the pharmacist
to substitute an equivalent generic name drug or drug product
except where the prescribing practitioner has indicated in his or her own handwriting the words "Brand Medically Necessary." The
following sentence shall be printed on the prescription form:
"This prescription may be filled with a generically equivalent
drug product unless the words 'Brand Medically Necessary' are
written, in the practitioner's own handwriting, on this
prescription form.":
Provided, That "Brand Medically Necessary"
may be indicated on the prescription order other than in the
prescribing practitioner's own handwriting unless otherwise
required by federal mandate.
(d) A verbal prescription order shall permit the pharmacist
to substitute an equivalent generic name drug or drug product
except where the prescribing practitioner shall indicate to the
pharmacist that the prescription is "Brand Necessary" or "Brand
Medically Necessary." The pharmacist shall note the instructions
on the file copy of the prescription or chart order form.
(e) No person may by trade rule, work rule, contract, or in
any other way prohibit, restrict, limit or attempt to prohibit,
restrict or limit the making of a generic name substitution under
the provisions of this section. No employer or his or her agent
may use coercion or other means to interfere with the
professional judgment of the pharmacist in deciding which generic
name drugs or drug products shall be stocked or substituted:
Provided, That this section shall not be construed to permit the
pharmacist to generally refuse to substitute less expensive
therapeutically equivalent generic drugs for brand name drugs, and that any pharmacist so refusing shall be subject to the
penalties prescribed in section twenty-two, article five, chapter
thirty of this code.
(f) A pharmacist may substitute a drug pursuant to the
provisions of this section only where there will be a savings to
the buyer. Where substitution is proper pursuant to this
section, or where the practitioner prescribes the drug by generic
name, the pharmacist shall, consistent with his or her
professional judgment, dispense the lowest retail cost, effective
brand which is in stock.
(g) All savings in the retail price of the prescription
shall be passed on to the purchaser; these savings shall be equal
to the difference between the retail price of the brand name
product and the customary and usual price of the generic product
substituted therefor:
Provided, That in no event shall such
savings be less than the difference in acquisition cost of the
brand name product prescribed and the acquisition cost of the
substituted product.
(h) Each pharmacy shall maintain a record of any
substitution of an equivalent generic name drug product for a
prescribed brand name drug product on the file copy of a written
or verbal prescription or chart order. Such record shall include
the manufacturer and generic name of the drug product selected.
(i) All drugs shall be labeled in accordance with the
instructions of the practitioner.
(j) Unless the practitioner directs otherwise, the prescription label on all drugs dispensed by the pharmacist shall
indicate the generic name using abbreviations if necessary and
either the name of the manufacturer or packager, whichever is
applicable in the pharmacist's discretion. The same notation
will be made on the original prescription retained by the
pharmacist.
(k) A pharmacist may not dispense a product under the
provisions of this section unless the manufacturer has shown that
the drug has been manufactured with the following minimum good
manufacturing standards and practices by:
(1) Labeling products with the name of the original
manufacturer and control number;
(2) Maintaining quality control standards equal to or
greater than those of the United States Food and Drug
Administration;
(3) Marking products with identification code or monogram;
and
(4) Labeling products with an expiration date.
(l) The West Virginia board of pharmacy shall promulgate
rules in accordance with the provisions of chapter twenty-nine-a
of this code which establish a formulary of generic type and
brand name drug products which are determined by the board to
demonstrate significant biological or therapeutic inequivalence
and which, if substituted, would pose a threat to the health and
safety of patients receiving prescription medication. The
formulary shall be promulgated by the board within ninety days of the date of passage of this section, and may be amended in
accordance with the provisions of chapter twenty-nine-a of this
code.
(m) No pharmacist shall substitute a generic named
therapeutically equivalent drug product for a prescribed brand
name drug product if the brand name drug product or the generic
drug type is listed on the formulary established by the West
Virginia board of pharmacy pursuant to this article, or is found
to be in violation of the requirements of the United States Food
and Drug Administration.
(n) Any pharmacist who substitutes any drug shall, either
personally or through his or her agent, assistant or employee,
notify the person presenting the prescription of such
substitution. The person presenting the prescription shall have
the right to refuse the substitution. Upon request the
pharmacist shall relate the retail price difference between the
brand name and the drug substituted for it.
(o) Every pharmacy shall post in a prominent place that is
in clear and unobstructed public view, at or near the place where
prescriptions are dispensed, a sign which shall read: "West
Virginia law requires pharmacists to substitute a less expensive
generic named therapeutically equivalent drug for a brand name
drug, if available, unless you or your physician direct
otherwise." The sign shall be printed with lettering of at least
one and one-half inches in height with appropriate margins and
spacing as prescribed by the West Virginia board of pharmacy.
(p) The West Virginia board of pharmacy shall promulgate
rules in accordance with the provisions of chapter twenty-nine-a
of this code setting standards for substituted drug products,
obtaining compliance with the provisions of this section and
enforcing the provisions of this section.
(q) Any person shall have the right to file a complaint
with the West Virginia board of pharmacy regarding any violation
of the provisions of this article. Such complaints shall be
investigated by the board of pharmacy.
(r) Fifteen days after the board has notified, by
registered mail, a person, firm, corporation or copartnership
that such person, firm, corporation or copartnership is suspected
of being in violation of a provision of this section, the board
shall hold a hearing on the matter. If, as a result of the
hearing, the board determines that a person, firm, corporation or
copartnership is violating any of the provisions of this section,
it may, in addition to any penalties prescribed by section
twenty-two of this article, suspend or revoke the permit of any
person, firm, corporation or copartnership to operate a pharmacy.
(s) No pharmacist complying with the provisions of this
section shall be liable in any way for the dispensing of a
generic named therapeutically equivalent drug, substituted under
the provisions of this section, unless the generic named
therapeutically equivalent drug was incorrectly substituted.
(t) In no event where the pharmacist substitutes a drug
under the provisions of this section shall the prescribing physician be liable in any action for loss, damage, injury or
death of any person occasioned by or arising from the use of the
substitute drug unless the original drug was incorrectly
prescribed.
(u) Failure of a practitioner to specify that a specific
brand name is necessary for a particular patient shall not
constitute evidence of negligence unless the practitioner had
reasonable cause to believe that the health of the patient
required the use of a certain product and no other.
§30-5-13. Each pharmacy to have USP-DI.
Every pharmacy as defined in this article shall own and
have in the pharmacy at all times in text or electronic form, a
recent edition of the USP-DI and any supplements No license or
renewal shall be issued until a USP-DI is in the pharmacy.
§30-5-14. Pharmacies to be registered; permit to operate; fees;
pharmacist to conduct business.
(a) The board of pharmacy shall require and provide for the
annual registration of every pharmacy doing business in this
state. Any person, firm, corporation or partnership desiring to
operate, maintain, open or establish a pharmacy in this state
shall apply to the board of pharmacy for a permit to do so. The
application for such permit shall be made on a form prescribed
and furnished by the board of pharmacy, which, when properly
executed, shall indicate the owner, manager, trustee, lessee,
receiver, or other person or persons desiring such permit, as
well as the location of such pharmacy, including street and number, and such other information as the board of pharmacy may
require. If it is desired to operate, maintain, open or
establish more than one pharmacy, separate application shall be
made and separate permits or licenses shall be issued for each.
(b) Every initial application for a permit shall be
accompanied by the required fee of one hundred fifty dollars.
The fee for renewal of such permit or license shall be
seventy-five dollars annually.
(c) If an application is approved, the secretary of the
board of pharmacy shall issue to the applicant a permit or
license for each pharmacy for which application is made.
Permits or licenses issued under this section shall not be
transferable and shall expire on the thirtieth day of June of
each calendar year, and if application for renewal of permit or
license is not made on or before that date, or a new one granted
on or before the first day of August, following, the old permit
or license shall lapse and become null and void and shall require
an inspection of the pharmacy and a fee of one hundred fifty
dollars plus one hundred fifty dollars for the inspection.
(d) Every such place of business so registered shall
employ a pharmacist in charge and operate in compliance with the
general provisions governing the practice of pharmacy and the
operation of a pharmacy.
(e) The provisions of this section shall have no
application to the sale of nonprescription drugs which are not
required to be dispensed pursuant to a practitioner's prescription.
§30-5-14a. Pharmacist-in-charge.
(a) Every pharmacy at all times shall be under the
direction and supervision of a licensed pharmacist who shall be
designated by the owner of the pharmacy as the
pharmacist-in-charge. This designation must be filed with the
board within thirty days of the designation.
(b) The pharmacist-in-charge is responsible for the
pharmacy's compliance with state and federal pharmacy laws and
regulations and for maintaining records and inventory.
(c) It is a violation of this section if the owner of a
pharmacy fails to designate a pharmacist-in-charge or permits the
practice of pharmacy without having designated a
pharmacist-in-charge, or fails to notify the board of pharmacy if
the designated pharmacist-in-charge leaves the employ of the
pharmacy.
(d) Before a permit is issued to operate a pharmacy, or
renewed, the application shall designate the
pharmacist-in-charge. The designated pharmacist-in-charge shall
be present when a new store is to be inspected.
(e) A pharmacist-in-charge shall not hold such designated
position at more than one pharmacy, whether within or without the
state of West Virginia. The board of pharmacy shall promulgate
rules in accordance with the provisions of chapter twenty-nine-a
of this code relative to pharmacies which are operated over forty
hours a week.
(f) An interim pharmacist-in-charge may be designated for
a period not to exceed sixty days. The request for an interim
pharmacist-in-charge shall detail the circumstances which warrant
such a change. This change in designation shall be filed with
the board within thirty days of the designation.
(g) The board of pharmacy shall furnish the form which
designates a change of the pharmacist-in-charge and every such
application shall be subject to a fee of ten dollars.
§30-5-15. Professional and technical equipment required for
pharmacy or drugstore; penalties and fines.
(a) Every pharmacy shall be equipped with proper
pharmaceutical utensils so that prescriptions can be properly
filled and compounded. The board of pharmacy shall by rule
prescribe the minimum equipment which a pharmacy shall
possess.
(b) Any person violating this section is guilty of a
misdemeanor and shall be fined not less than two hundred fifty
dollars nor more than one thousand dollars, and no permit shall
be issued or renewed for any pharmacy which has not complied
with the provisions of this section.
§30-5-16. Permit for manufacture and packaging of drugs,
medicines, cosmetics; distribution of legend drugs;
regulations as to sanitation and equipment;
penalties; revocation of permit
(a) No drugs or medicines, or toilet articles, dentifrices,
or cosmetics, shall be manufactured, made, produced, packed, packaged or prepared within the state, except under the personal
supervision of a pharmacist or such other person as may be
approved by the board of pharmacy, after an investigation and
determination by the board that they are qualified by scientific
or technical training and/or experience to perform such duties of
supervision as may be necessary to protect the public health and
safety.
(b) No person shall manufacture, make, produce, pack,
package or prepare any such articles without first obtaining a
permit to do so from the board of pharmacy. The permit shall be
subject to such rules with respect to sanitation and/or
equipment, as the board of pharmacy may from time to time adopt
for the protection of the public health and safety.
(c) Any person, firm, corporation, partnership, company,
cooperative society or organization who offers for sale, sells,
offers or exposes for sale through the method of distribution any
legend drugs shall be subject to this article.
(d) The application for any permit required by this
section shall be made on a form to be prescribed and furnished by
the board of pharmacy and shall be accompanied by the following
fees: For a distributor, one hundred fifty dollars, for a
manufacturer, five hundred dollars, which amounts shall also be
paid as the fees for each annual renewal of such permits.
Separate applications shall be made and separate permits issued
for each separate place of manufacture, distribution, making,
producing, packing, packaging or preparation.
(e) The following fees shall be charged for a permit to
handle controlled substances: For a hospital or clinic, fifty
dollars; for extended care facilities, twenty-five dollars; for
a nursing home, twenty-five dollars; for a teaching institution,
twenty-five dollars; for a researcher, twenty-five dollars; for
a medical examiner, twenty-five dollars; and for a pharmacy or
drugstore, fifteen dollars, which amounts shall also be paid for
each annual renewal of such permits.
(f) Permits issued under the provisions of this section
shall be posted in a conspicuous place in the factory or place
for which issued; such permits shall not be transferable, and
shall expire on the thirtieth day of June following the day of
issue and shall be renewed annually. Nothing in this section
shall be construed to apply to those operating registered
pharmacies.
(g) Any person, firm, corporation, partnership, company,
cooperative society or organization violating any of the
provisions of this section and any permittee hereunder who shall
violate any of the conditions of this permit or any of the rules
adopted by the board of pharmacy shall, upon conviction, be
deemed guilty of a misdemeanor and fined not more than fifty
dollars for each offense. Each and every day such violation
continues shall constitute a separate and distinct offense. Upon
conviction of a permittee, his permit shall also immediately be
revoked and become null and void.
(h) Any person, firm, corporation, partnership, company, cooperative society, organization or any permittee who is
convicted of two or more successive violations of the provisions
of this section or of the rules adopted by the board of pharmacy
shall at the discretion of the board of pharmacy have such permit
permanently revoked, and the board of pharmacy shall refuse to
issue further permits to such person, firm, corporation,
partnership, company, cooperative society, organization or
permittee.
§30-5-16b. Partial filling of prescriptions.
The partial filling of a prescription for a controlled
substance listed in Schedule II is permissible if the pharmacist
is unable to supply the full quantity called for in a written or
emergency oral prescription and he makes a notation of the
quantity supplied on the face of the written prescription or on
the written record of the emergency oral prescription. The
remaining portion of the prescription may be filled within
seventy-two hours of the first partial filling:
Provided, That
if the remaining portion is not or cannot be filled within the
seventy-two hour period, the pharmacist shall so notify the
prescribing individual practitioner. No further quantity may be
supplied beyond seventy-two hours without a new prescription.
§30-5-16c. Partial filling of prescriptions for long-term care
facility or terminally ill patients; requirements;
records; violations.
(a) As used in this section, "long-term care facility" or
"LTCF" means any nursing home, personal care home, or residential board and care home as defined in section two, article five-c,
chapter sixteen of this code which provides extended health care
to resident patients:
Provided, That the care or treatment in a
household, whether for compensation or not, of any person related
by blood or marriage, within the degree of consanguinity of
second cousin to the head of the household, or his or her spouse,
may not be deemed to constitute a nursing home, personal care
home or residential board and care home within the meaning of
this article. This section shall not apply to:
(1) Hospitals, as defined under section one, article five-b,
chapter sixteen of this article or to extended care facilities
operated in conjunction with a hospital;
(2) State institutions as defined in section six, article
one, chapter twenty-seven or in section three, article one,
chapter twenty-five, all of this code;
(3) Nursing homes operated by the federal government;
(4) Facilities owned or operated by the state government;
(5) Institutions operated for the treatment and care of
alcoholic patients;
(6) Offices of physicians; or
(7) Hotels, boarding homes or other similar places that
furnish to their guests only a room and board.
(b) As used in this section, "terminally ill" means that an
individual has a medical prognosis that his life expectancy is
six months or less.
(c) Schedule II prescriptions for patients in a LTCF and for terminally ill patients shall be valid for a period of sixty days
from the date of issue unless terminated within a shorter period
by the discontinuance of the medication.
(d) A prescription for a Schedule II controlled substance
written for a patient in a LTCF or for a terminally ill patient
may be filled in partial quantities, including, but not limited
to, individual dosage units. The total quantity of Schedule II
controlled substances dispensed in all partial filling shall not
exceed the total quantity prescribed.
(1) If there is any question whether a patient may be
classified as having a terminal illness, the pharmacist shall
contact the prescribing practitioner prior to partially filling
the prescription.
(2) Both the pharmacist and the prescribing practitioner
have a corresponding responsibility to assure that the controlled
substance is for a terminally ill patient.
(e) The pharmacist shall record on the prescription that the
patient is "terminally ill" or a "LTCF patient". A prescription
that is partially filled and does not contain the notation
"terminally ill" or "LTCF patient" shall be deemed to have been
filled in violation of section three hundred eight, article
three, chapter sixty-a of this code.
(f) For each partial filling, the dispensing pharmacist
shall record on the back of the prescription, or on another
appropriate record which is readily retrievable, the following
information:
(1) The date of the partial filling;
(2) The quantity dispensed;
(3) The remaining quantity authorized to be dispensed; and
(4) The identification of the dispensing pharmacist.
(g) Information pertaining to current Schedule II
prescriptions for terminally ill and LTCF patients may be
maintained in a computerized system if such a system has the
capability to permit either by display or printout, for each
patient and each medication, all of the information required by
this section as well as the patient's name and address, the name
of each medication, original prescription number, date of issue,
and prescribing practitioner information. The system shall also
allow immediate updating of the prescription record each time a
partial filling of the prescription is performed and immediate
retrieval of all information required under this section.
§30-5-19.
Rules of board of pharmacy; revocation of permits;
employment of field agents, chemists, clerical and
other qualified personnel.
(a) The board of pharmacy shall promulgate rules in
accordance with the provisions of chapter twenty-nine-a of this
code not inconsistent with law, as are necessary to carry out the
purposes and enforce the provisions of this article. The board
may revoke any permit or license issued under the provisions of
this article at any time when examination or inspection of the
pharmacy discloses that such place of business is not being
conducted according to law.
(b) The board of pharmacy shall have the power and authority
to employ field agents, chemists, clerical help, hearing
examiners and other qualified personnel as may be necessary to
carry out the purposes and enforce the provisions of this
article.
§30-5-21. Limitations of article.
(a) Nothing in this article shall be construed to prevent,
restrict or in any manner interfere with the sale of non-narcotic
nonprescription drugs which may be lawfully sold without a
prescription in accordance with the United States food, drug, and
cosmetic act, or the laws of this state, nor shall any rule be
adopted by the board which shall require the sale of
nonprescription drugs by a licensed pharmacist or in a pharmacy,
or which shall prevent, restrict, or otherwise interfere with the
sale or distribution of such drugs by any retail merchant. The
sale or distribution of nonprescription drugs shall not be deemed
to be improperly engaging in the practice of pharmacy.
(b) Nothing in this article shall be construed to interfere
with any legally qualified practitioner of medicine, dentistry or
veterinary medicine, who is not the proprietor of the store for
the dispensing or retailing of drugs, and who is not in the
employ of such proprietor, in the compounding of his own
prescriptions, or to prevent him from supplying to his patients
such medicines as he may deem proper, if such supply is not made
as a sale.
§30-5-22. Offenses; penalties.
(a) Any person who violates any of the provisions of
section three of this article is guilty of a misdemeanor, and,
upon conviction, shall, for each offense, be fined not less than
two hundred fifty dollars nor more than one thousand dollars, or
confined in the county jail not to exceed six months, or both
fined and imprisoned, in the discretion of the court, and each
day such violation shall continue shall be deemed a separate
offense.
(b) Any person who violates any of the provisions of
section twelve is guilty of a misdemeanor, and, upon conviction,
shall be punished by a fine of not less than fifty nor more than
one hundred fifty dollars for each offense.
(c) Any person, except for the board of pharmacy or board
member acting within the scope of his or her responsibilities or
duties as such member, who violates any of the provisions of
section twelve-b is guilty of a misdemeanor, and, upon
conviction, shall be punished by a fine of not less than fifty
nor more than one thousand dollars for each offense.
(d) Any person, firm, partnership or corporation who
violates any of the provisions of section fourteen is guilty of
a misdemeanor, and, upon conviction, , for the first offense
shall be fined not to exceed one hundred dollars, or shall be
imprisoned in the county jail not to exceed six months, or both
fined and imprisoned, in the discretion of the court.Each and
every day that the violation continues shall constitute a separate offense.
(e) Any person, firm, partnership or corporation who
violates any of the provisions of section eighteen is guilty of
a misdemeanor, and, upon conviction, shall be fined not to
exceed fifty dollars for the first offense, and upon conviction
of a second offense shall be fined not less than fifty nor more
than five hundred dollars, or shall be imprisoned in the county
jail not to exceed thirty days, or both fined and imprisoned,
Each and every day that the violation continues shall
constitute a separate offense.
§30-5-22a. Civil immunity for board members; liability
limitations of professionals reporting to board;
reporting results of litigation to the board;
rules.
(a) The members of the board when acting in good faith and
without malice shall enjoy immunity from individual civil
liability while acting within the scope of their duties as board
members.
(b) Any licensee of this board who reports or otherwise
provides evidence of the negligence, impairment or incompetence
of another member of this profession to the board or to any
peer review organization, shall not be liable to any person for
making such a report if such report is made without actual malice
and in the reasonable belief that such report is warranted by the
facts known to him or her at the time.
(c) Within thirty days of the dismissal, settlement, adjudication or other termination of any claim or cause of action
asserted against any professional reporting under the provisions
of this article the person or persons filing such claim or cause
of actions shall submit to the board the following information:
(1) The names of the parties involved;
(2) The name of the court in which the action was filed, if
applicable;
(3) The basis and nature of the claim or cause of action;
and
(4) The results of such claim or cause of action, including
dismissal, settlement, court or jury verdict or other means of
termination.
(d) The board shall promulgate legislative rules in
accordance with the provisions of chapter twenty-nine-a of this
code establishing procedures for imposing sanctions and penalties
against any licensee who fails to submit to the board the
information required by this section.