COMMITTEE SUBSTITUTE
FOR
H. B. 2451
(By Delegates Gallagher and Border)
(Originating in the Committee on Health and Human Resources)
[February 22, 1995]
A BILL 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 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; limitation of board terms; 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; 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 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, ASSISTANT PHARMACISTS AND DRUGSTORES
PHARMACY TECHNICIANS, PHARMACY INTERNS AND
PHARMACIES.
§30-5-1. Definitions.Legislative findings.
The following words and phrases as used in this article,
shall have the following meanings, unless the context otherwise
requires:
(1) The term "drug" means (a) articles in the official
United States Pharmacopoeia, or official National Formulary, or
any other supplement to either of them, which are intended for
use in the diagnosis, cure, mitigation, treatment or prevention
of disease in man or other animals, and (b) all other articles
intended for use in the diagnosis, cure, mitigation, treatment or
prevention of disease in man or other animals, and (c) articles, other than food, intended to affect the structure or any function
of the body of man or other animals and (d) articles intended for
use as a component of any articles specified in clause (a), (b)
or (c).
(2) The term "poisonous drug" means any drug likely to be
destructive to adult human life in quantities of five grains or
less.
(3) The term "deleterious drug" means any drug likely to be
destructive to adult human life in quantities of sixty grains or
less.
(4) The term "habit-forming drug" means any drug which has
been or may be designated as habit forming under the regulations
promulgated in accordance with section 502 (d) of the Federal
Food, Drug and Cosmetic Act of June twenty- fifth, one thousand
nine hundred thirty-eight.
(5) The term "pharmacy" or "drugstore" or "apothecary" shall
be held to mean and include every store or shop or other place
(a) where drugs are dispensed or sold at retail or displayed for
sale at retail; or (b) where physicians' prescriptions are
compounded; or (c) which has upon it or displayed within it, or
affixed to or used in connection with it, a sign bearing the word
or words "pharmacy," "pharmacists," "apothecary," "drugstore,"
"drugs," "druggists," "medicine," "medicine store," "drug
sundries," "remedies" or any word or words of similar or like
import; or (d) any store or shop or other place, with respect to
which any of the above words are used in any advertisement.
(6) The term "prescription" shall be held to mean an order
for drugs or medicines or combinations or mixtures thereof,
written or signed by a duly licensed 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, dentist,
optometrist, as authorized by section two, article eight of this
chapter, veterinarian or other medical practitioner licensed to
write prescriptions intended for the treatment or prevention of
disease of man or animals. Any prescription written or signed by
an authorized Type A physician assistant shall be imprinted with
the name of his or her supervising physician, the name of the
physician assistant, and a list of drugs approved under the Type
A physician assistant's job description, in accordance with the
provisions of section sixteen, article three of this chapter.
The term "prescription" shall also include orders for drugs or
medicines or combinations or mixtures thereof transmitted to the
pharmacist by word of mouth, telephone or other means of
communication by a duly licensed physician, an authorized Type A
physician assistant, dentist, optometrist, veterinarian or other
medical practitioner licensed to write prescriptions intended for
treatment or prevention of disease of man or animals, and such
prescriptions received by word of mouth, telephone or other means
of communication shall be recorded in writing by the pharmacist
and the record so made by the pharmacist shall constitute the
original prescription to be filed by the pharmacist. A pharmacist receiving a prescription by word of mouth, telephone
or other means of communication from an authorized Type A
physician assistant shall require a copy of the list of drugs
approved under the job description of such Type A physician
assistant prior to accepting such orders. All such prescriptions
shall be preserved on file for a period of five years, subject to
inspection by the proper officer of the law. The above shall
apply except for narcotic prescriptions, when all narcotic laws
and regulations must be complied with.
(7) The term "cosmetic," which shall be held to include
"dentifrice" and "toilet article," means (a) articles intended to
be rubbed, poured, sprinkled or sprayed on, introduced into, or
otherwise applied to the human body, or any part thereof for
cleansing, beautifying, promoting attractiveness, or altering the
appearance, and (b) articles intended for use as a component of
any such articles, except that such term shall not include soap.
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, practitioner 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 shall 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 citizen and registered pharmacist of this
state 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 majority eighteen years and may not be a past or present
member of the profession of pharmacy pharmacist, the spouse of a
member of the profession of pharmacy pharmacist, a person who has
ever had any material financial interest in the providing of
pharmacy service services or who has engaged in any activity
directly related to the practice of pharmacy.
(c) Each member of the board shall receive one hundred
fifty 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. On or before
the first day of July, one thousand nine hundred thirty-one, and
on or before the first day of July of each year thereafter, the
governor shall appoint one member to serve for a term of five
years, commencing on said first day of July, and any member shall
be eligible for reappointment. 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 one additional consecutive term.
Members as of the first day of July, one thousand nine hundred
ninety-five, are eligible for reappointment 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 the this code, shall have the authority to:
(a)(1) Regulate the practice of the profession of pharmacy;
(b)(2) Regulate the employment of apprentices and licensed
interns in pharmacy;
(c)(3) Appoint, within the limit of appropriations,
inspectors who shall be registered pharmacists, and
investigators, both intended to act as agents of the board within
the provisions of this chapter and chapter sixteen of the this
code and such rules and regulations as the board shall
promulgate; and
(d)(4) Adopt rules of professional conduct; appropriate to
the establishment and maintenance of high standards of integrity
and dignity in a profession. and
(4) 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 registered licensed pharmacist required; special
provision for certain villages; person not
registered licensed pharmacist, assistant
pharmacist or apprentice pharmacy technician or
licensed intern not to compound prescriptions or
dispense poisons or narcotics; registration of
apprentices.licensure of interns.
(a)
It shall be is unlawful for any person or not a
registered pharmacist within the meaning of this article, or who
does not employ a registered pharmacist within the meaning of
this article, to conduct any pharmacy, drugstore, or apothecary
shop or store for the purpose of retailing, compounding or
dispensing medicines, poisons or narcotic drugs: Provided, That
in any village of not more than five hundred inhabitants where
there is no registered pharmacist within less than two miles of
such village, the board of pharmacy may grant to any person who
is a registered assistant pharmacist a permit to conduct a
drugstore or pharmacy in such village, which permit shall not be
valid in any other village than the one for which it was granted,
and shall cease and determine when the population of the village
for which such permit was granted shall become greater than five
hundred drugs or devices.
(b) It shall be is unlawful for the proprietor of any store
or pharmacy to permit any person not a registered pharmacist or assistant 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: except that an apprentice
registered with the state board of pharmacy Provided, That a
licensed intern may compound and dispense prescriptions or
prescription refills under the direct supervision of a registered
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 shall be is the duty of registered a pharmacists or
other employers who take into their employs an apprentice intern,
for the purpose of his becoming a registered pharmacist, to
register license said apprentice the intern with the board within
ninety days thereafter after employment. with the board of
pharmacy The board shall furnish proper blanks forms for this
purpose and shall issue a certificates to the apprentice intern
upon being properly certified licensure.
(d) The experience requirement for licensure as a
registered pharmacist shall be computed from the date certified
by the supervising pharmacist as the date of entering said
apprenticeship; and the internship. If such apprenticeship the
internship is not registered with the board of pharmacy, then he
or she the intern shall receive no credit for such experience in a pharmacy when he or she makes application for examination for
licensure as a registered 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 apprentice intern having served part or all of his
or her apprenticeship internship in a pharmacy without the in
another state or foreign country shall be given credit for the
same when the affidavit of his or her said apprenticeship
internship is signed by the registered pharmacist under whom he
or she served, and it shows the exact time of such apprenticeship
dates and number of hours served in the internship served, and
when same the affidavit is attested by the secretary of the state
board of pharmacy of that 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 "pharmacist" or "assistant pharmacist,"
etc., or of terms; "drugstore," "drugs," etc.;
penalties and fines.
(a) It shall be is unlawful for any person not legally
registered licensed as a pharmacist, unless he or she has in his
employs a registered 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) And It shall be is unlawful for any person not legally
registered as an assistant pharmacist to take, use or exhibit the
title of assistant pharmacist, or any title or description of
like import 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 hundred thousand dollars.
§30-5-5. Qualifications for registration licensure as
pharmacist; fees; certificates of registration
licensure; rules for licensure; reciprocity; minimum
standards.
(a) In order to be registered licensed as a pharmacist within
the meaning of this article, a person shall:
(1) Be not less than eighteen years of age or older;
(2) shall Present to the board of pharmacy 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 In
addition thereto, he or she shall have had has completed at least
nine months of practical experience fifteen hundred hours of
internship in a pharmacy or drugstore under the instruction and
supervision of a registered pharmacist;
(4) and shall Pass satisfactorily an examination by or under
the direction of 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.
Provided, That any registered pharmacist who has renewed his or
her registration as such assistant pharmacist for each
consecutive year since his or her original registration with the
state board of pharmacy, may upon application to the board of
pharmacy, be registered as a pharmacist within the meaning of
this article.
(b) An applicant for examination shall forward to the
secretary pay to the board a fee of one hundred twenty-five
dollars with his or her application.
Every applicant for registration as a pharmacist shall present
to the board of pharmacy satisfactory evidence that he or she is
a person of good moral character, and not addicted to drunkenness
or the use of controlled substances.
(c) The board shall issue certificates of registration
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 finding; 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. Registration of Reciprocal licensure of pharmacists
from other states or countries.
(a) The board of pharmacy may register by reciprocity
license and admit to practice as pharmacists in this state such
persons as who have been legally registered or licensed as
pharmacists in other states another state: Provided, That the
applicant for such registration licensure shall appear personally
before the board, at a regular meeting, and shall present
satisfactory evidence of qualification equal to that required of
applicants for registration in this state, and that he was
registered or licensed by examination in such other state, and
that the standard of competence required in such other state is not lower than that required in this state: Provided, however,
That the board is satisfied that such other state accords similar
recognition to registered licensed pharmacists of this state.
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 registration licensure under this
section shall, with their application, forward to the secretary
of the board of pharmacy a fee of two hundred fifty dollars.,
unless the In the event the applicant desires to be examined
other than at a regular meeting of the board. In that case,
there will be the applicant shall submit to the board an
additional fee of one hundred fifty dollars.
§30-5-7. Refusal to issue; suspension or revocation of
certificate of registration. Grounds for
suspension or revocation of license or
disciplinary proceedings; penalties and
procedures; temporary suspensions; reporting of
disciplinary action.
(a) The board of pharmacy 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, to any person who has:
(1) Become unfit or incompetent to practice pharmacy by
reason of: (a) Acts of gross immorality; (b) habitual
intoxication; (c) habitual use of narcotics or habit-forming
drugs; (d) (b) (A) alcohol or substance abuse; (B) insanity; or
(e) (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 the code;
(4) Failed to comply with the rules of professional conduct
adopted by the board pursuant to subparagraph (d) of section two
of this article;
(5) Promoted to the public in any manner any one drug which may only be dispensed pursuant to a prescription over any other
of such drugs.
(6) Solicited professional practice directly or indirectly
by promoting professional ability, experience, integrity, or
professional qualifications.
(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."
Within ninety days after this code takes effect, The
secretary of the board of pharmacy shall make a report to the
provide the secretary of state with a list of all registered
pharmacists, and registered assistant 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 be entitled to 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 registration licensure
of a pharmacist, thirty dollars; to register license an intern
pharmacist, ten dollars plus five dollars for each of the
remaining periods of his or her internship; and 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 registration license; fees and
notices.
(a) Every registered licensed pharmacist, intern or
pharmacy technician who desires to continue in the practice of pharmacy 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 thirty sixty days after said 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 registered
pharmacists and pharmacy technicians. and such person,
(c) In order to 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 be
required to 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 registration licensure or permit shall
be displayed exposed.
Every certificate of registration or licensure to practice
as a pharmacist, intern or assistant pharmacist pharmacy
technician, and every permit to an assistant pharmacist to
conduct a drugstore in a village of not more than five hundred
inhabitants, and every renewal of such certificate or permit,
shall be conspicuously exposed displayed in the pharmacy or
drugstore or place of business of which the pharmacist, intern or
assistant pharmacist 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 registered licensed pharmacists or
not, shall be held 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 held 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 as practiced
by the pharmacist in preparing more elegant preparations which do
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 essentially 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. Every drug
prescription order shall contain an instruction on whether or not
an equivalent generic name drug or drug product may be
substituted.
(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 Necessary" or
"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 Necessary" or 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 practitioners 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 or his or her agent
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.
(c)(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 subsection (b) 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.
(d) (f) A pharmacist may substitute a drug pursuant to the
provisions under subsection (b) of this section only where there
will be a savings to the buyer. Where substitution is proper
under subsection (b) of 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.
(e) (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.
(f)(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.
(g)(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.
(h) (l) The West Virginia board of pharmacy shall establish
by rule 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.
(i)(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.
(j)(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.
(k)(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.
(l)(p) The West Virginia board of pharmacy shall promulgate
rules in accordance with the provisions of chapter twenty-nine-a
of this code and regulations 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.
or drugstore.
(m)(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 United States Pharmacopoeia and
National Formulary USP-DI.
Every pharmacy or drugstore as defined, in this article,
shall own and have on file in the pharmacy at all times in text
or electronic form, a recent edition of the United States
Pharmacopoeia and a recent edition of the National Formulary USP-
DI and any supplements to any of them or some other publication embodying their texts in full, and no. No license or renewal
shall be issued until there is a compliance with this section a
USP-DI is in the pharmacy.
§30-5-14. Pharmacies or drugstores to be registered; permit to
operate; fees; registered pharmacist to conduct
business.
(a) The board of pharmacy shall require and provide for the
annual registration of every pharmacy or drugstore, as defined,
doing business in this state. Any person, firm, corporation or
partnership desiring to operate, maintain, open or establish a
pharmacy, or drugstore, as defined, in this state shall apply to
the board of pharmacy for a permit to do so. The application for
such permit or license 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, or drugstore, 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, or drugstore, 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 found satisfactory approved, the
secretary of the board of pharmacy shall issue to the applicant
a permit or license for each pharmacy or drugstore 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 be in
direct charge of a registered pharmacist employ a pharmacist in
charge and operate in compliance with the general provisions
governing the practice of pharmacy and the operation of a
drugstore or pharmacy.
(e) The provisions of this section shall have no
application to the sale of patent or proprietary medicines which
are not poisonous, deleterious or habit-forming nor to such
ordinary drugs in original retail packages when such are not
poisonous, deleterious or habit-forming nor to flavoring extracts
or dyestuffs as are usually sold in a country store required to
be dispensed pursuant to a practitioner's prescription.
§30-5-14a. Pharmacist-in-charge.
(a) Every pharmacy or drugstore, at all times, shall be under the jurisdiction 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
The pharmacist-in-charge is responsible
(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 must shall designate the
pharmacist-in-charge. The designated pharmacist-in-charge must
shall be present when a new store is to be inspected.
(e) A pharmacist-in-charge cannot shall not hold the 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 registered drugstore or pharmacy must shall be
equipped with proper pharmaceutical utensils so that
prescriptions can be properly filled and United States
Pharmacopoeia and National Formulary preparations properly
compounded. The board of pharmacy shall by rule prescribe the
minimum of such professional and technical equipment which a
pharmacy or drugstore shall at all times possess.
(b) Any person violating this section shall, upon
conviction, be deemed is guilty of a misdemeanor and shall be
fined not less than two hundred fifty dollars nor more than more
than fifty one thousand dollars, and no permit shall be issued or
continued renewed for the conducting of a any pharmacy or
drugstore which has not complied with the provisions of this
section.
§30-5-16. Permit for manufacture, and packaging, etc., of drugs,
medicines, cosmetics; distribution of legend
drugs;, etc.; regulations as to sanitation and equipment; penalties; revocation of permit; for
permits, including permit to handle controlled
substances.
and immediate supervision of a registered pharmacist or such
other person as may be approved by the board of pharmacy, after
an investigation and determination by said 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; and
(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. Such The permit
shall be subject to such rules and regulations 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 such any permits 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
drug store, 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. or drugstores
(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
and regulations adopted by the board of pharmacy in pursuance of the power hereby conferred shall, upon conviction, be deemed
guilty of a misdemeanor and fined not more than fifty dollars for
each offense., and Each and every day such violation continues
shall constitute a separate and distinct offense., and Upon
conviction of a permittee, his permit shall also forthwith
immediately be revoked and become null and void.
(h) Any person, firm, corporation, partnership, company,
cooperative society, organization or any permittee hereunder who
shall have been is convicted of two or more successive violations
of the provisions of this section or of the rules and regulations
adopted by the board of pharmacy in pursuance of the powers
hereby conferred shall at the discretion of the board of pharmacy
have such permit permanently revoked, and the board of pharmacy
is hereby authorized to shall refuse the issuance of to issue
further permits to such person, firm, corporation, partnership,
company, cooperative society, organization or permittee.
§30-5-16b. Partial filing 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 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 filing of the prescription is performed and immediate
retrieval of all information required under this section.
§30-5-19. Rules and regulations of board of pharmacy;
revocation of permits; employment of field
agents, chemists, clerical and other qualified personnel.
(a) The board of pharmacy shall make such rules, and
regulations, 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. and is hereby authorized to 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 or drugstore shall disclose discloses
that such place of business is not being conducted according to
law.
(c) 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.
§30-5-22. Offenses; penalties.
(a) Any person who shall violates any of the provisions of
section three of this article shall be is guilty of a
misdemeanor, and, upon conviction, thereof, shall, for each
offense, be fined not less than two hundred fifty dollars nor
more than exceeding two hundred 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 shall be deemed is guilty of a misdemeanor, and,
upon conviction, thereof, shall be punished by a fine of not less
than fifty nor more than one hundred fifty dollars for each such
offense.
(c) Any person, except for the board of pharmacy or board
member thereof acting within the scope of his or her
responsibilities or duties as such member, who violates any of
the provisions of section twelve-b shall be deemed is guilty of
a misdemeanor, and, upon conviction, thereof, shall be punished
by a fine of not less than fifty nor more than one thousand
dollars for each such offense.
(d) Any person, firm, partnership or corporation who shall
violate violates any of the provisions of section fourteen shall
be deemed is guilty of a misdemeanor, and, upon conviction,
thereof, 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 imprisonment, imprisoned, in
the discretion of the court., and Each and every day that such
the violation continues shall constitute a separate offense.
(e) Any person, firm, partnership or corporation who shall
violate violates any of the provisions of section eighteen shall
be deemed is guilty of a misdemeanor, and, upon conviction,
thereof 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 such fine fined and imprisonment imprisoned, in the
discretion of the court. and Each and every day that such 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 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.
(e) 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.