H. B. 2451
(By Delegates Gallagher and Border)
[Introduced February 10, 1995; referred to the
Committee on Health and Human Resources.]
A BILL to repeal section twelve-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, sixteen-a, nineteen, and twenty-two of
said article; and to further amend said article five by
adding thereto eight new sections, designated sections
one-a, one-b, two-a, five-a, five-b, seven-a, sixteen-b and
twenty-two-a, all relating to the regulation of pharmacists,
interns and pharmacist technicians; deleting the existing
definition section of the article; adding a declarations and
findings section primarily related to acknowledging the duty
to protect the public; adding a 'statement of purpose'
section; providing a new definitions section with new
definitions; amending existing law concerning board
vacancies, term limitation and the conduct of business by the board; adding new provisions involving records kept by
the board; providing for expungement of records, examination
notice requirements, public information and voluntary
agreements relating to alcohol or chemical dependency as
well as confidentiality requirements; changing numerous
references to 'registration' requirements to 'licensure'
requirements; regulating as pharmacist technician persons
who work with or under the supervision of pharmacists;
increasing criminal penalties; adding provisions related to
partial filling of prescriptions; adding additional grounds
to justify disciplinary action and protections for
confidentiality of prescription records; adding provisions
concerning enforcement of board orders involved in
disciplinary matters; adding reporting criteria involving
professional malpractice and incompetence and adding
additional sanctions including more severe civil and
criminal penalties; repealing existing section twelve-a
which relates to drug and drug price listing requirements
including the requirement of posting of same and the
penalties for noncompliance; deleting authorization to
manufacture laetrile; authorizing partial filling of
schedule II medications under certain circumstances;
changing existing law as it relates to generic and
brand-name drugs and the requirement that 'brand medically
necessary' be handwritten on the prescription order;
updating the descriptive name for the reference manual used
by pharmacists; and providing for immunity from civil
actions for board members, limited liability for
professionals reporting to the board and providing reporting
of litigation results to the board.
Be it enacted by the Legislature of West Virginia:
That section twelve-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, sixteen-a, nineteen, and
twenty-two of said article be amended and reenacted; and that
said article five be further amended by adding thereto eight new
sections, designated sections one-a, one-b, two-a, five-a,
five-b, seven-a, sixteen-b and twenty-two-a, all to read as
follows:
ARTICLE 5. PHARMACISTS, PHARMACY TECHNICIANS, PHARMACY INTERNS
AND PHARMACIES.
§30-5-1. 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 the preparation, mixing, assembling,
packaging or labeling of a drug or device:
(1) 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
(2) For the purpose of, or as an incident to, research,
teaching or chemical analysis and not for sale or dispensing;
(3) Compounding also includes 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) "Guidelines or protocol" means a written agreement
between a pharmacist clinician or group of pharmacist clinicians and a allopathic or osteopathic physician or group of same that
delegates prescriptive authority;
(l) "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.
(m) "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.
(n) "Mail order pharmacy" means a pharmacy, regardless of its location, which dispenses greater than ten percent
prescription drugs via the mail.
(o) "Manufacturer" means a person engaged in the manufacture
of drugs or devices.
(p) "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.
(q) "Monitor prescription drug therapy" means to review the
prescription drug therapy regimen of patients by a pharmacist
clinician for the purpose of evaluating and rendering advice to
the prescribing practitioner regarding adjustment of the regimen.
"Monitor prescription drug therapy" includes:
(1) Collecting and reviewing patient prescription drug
histories;
(2) Measuring and reviewing routine patient vital signs
including pulse, temperature, blood pressure and respiration; and
(3) Ordering and evaluating the results of laboratory tests relating to prescription drug therapy, including blood
chemistries and cell counts, controlled substance therapy levels,
blood, urine, tissue or other body fluids, culture and
sensitivity tests when performed in accordance with guidelines or
protocols applicable to the practice setting.
(r) "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.
(s) "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.
(t) "Person" means an individual, corporation, partnership,
association or any other legal entity including government.
(u) "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.
(v) "Pharmacist" or "registered pharmacist" means an
individual currently licensed by this state to engage in the
practice of pharmacy and pharmaceutical care.
(w) "Pharmacist clinician" means a pharmacist with
additional training required by regulations adopted by the board
in consultation with the West Virginia board of medicine who
exercises prescriptive authority in accordance with guidelines or
protocol. Additional training shall include at least sixty hours
of physical assessment.
(x) "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.
(y) "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.
(z) "Pharmacy technician" means registered supportive
personnel who work under the supervision of a pharmacist who have
passed an approved training program as described in this article.
(aa) "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.
(bb) "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.
(cc) "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.
(dd) "Prescription drug order" means a lawful order of a
practitioner for a drug or device for a specific patient.
(ee) "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.
(ff) "USP-DI" means the United States
Pharmacopoedia-Dispensing Information.
(gg) "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; powers and duties generally.
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.
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. 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.
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.
The board, in addition to the authority, powers and duties
granted to the board by this chapter and chapter sixteen of the
code, shall have the authority to: (a) Regulate the practice of
the profession of pharmacy; (b) regulate the employment of
apprentices and licensed interns in pharmacy; (c) 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 code and such rules and regulations as the board
shall promulgate; and (d) adopt rules of professional conduct;
appropriate to the establishment and maintenance of high
standards of integrity and dignity in a profession and (e) hire
an attorney, as may be necessary.
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.
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;
voluntary agreements relating to
alcohol or chemical dependency; confidentiality of
same.
(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.
(e) (1) 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.
(2) 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:
(A) 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
(B) 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.
(3) 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.
(4) 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.
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.
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.
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.
§30-5-3. When licensed pharmacist required; person not licensed
pharmacist, or pharmacy technician or apprentice
not to compound prescriptions or dispense poisons
or narcotics; licensure of interns.
It shall be unlawful for any person 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. It shall be 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 section two,
three and six, article eight, chapter sixteen, of this code,
except that an apprentice registered a licensed intern with the
state board of pharmacy, may compound and dispense prescriptions
or prescription refills under the direct supervision of a
registered pharmacist and 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.
It shall be is the duty of registered a pharmacists
pharmacist or other employers employer, who take into their
employ employs an apprentice an 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 certificate to the apprentice intern
upon being properly certified licensure. 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 the internship; and if
such apprenticeship the internship is not registered with the board of pharmacy, then he or she shall receive no credit for
such experience in a pharmacy when he or she makes application
for examination for licensure as a registered pharmacist unless
an appeal is made and evidence produced showing experience was
obtained but not registered and that failure to register this
experience was not the fault of the intern. 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 state or
country where the internship was served.
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.
It shall be unlawful for any person not legally registered
licensed as a pharmacist, unless he or she has in his employ
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. And it shall be
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. 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 one thousand dollars.
§30-5-5. Qualifications for licensure as pharmacist;
certificates of licensure.
In order to be registered licensed as a pharmacist within
the meaning of this article, a person shall be not less than
eighteen years of age old or older, 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. In addition, thereto he or she shall have had complete
at least nine months of practical experience fifteen hundred hours of internship practical experience in a pharmacy or
drugstore under the instruction and supervision of a registered
pharmacist and shall pass satisfactorily an examination by or
under the direction of approved by the board of pharmacy.
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 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 licensure as a pharmacist
shall present to the board of pharmacy 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 drunkenness alcohol or the use of
controlled substances. 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. 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 for registration.
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.
In order to become registered as pharmacy technicians in
this state, individuals must be at least eighteen years old, a
high school graduate or its equivalent, be of good moral
character and not addicted to alcohol or controlled substances
and free of any felony convictions. The individual shall also
satisfactorily complete a board-approved pharmacy technician
training program to be provided by the supervising licensed
pharmacist. The program and its curriculum shall be designed to
train individuals to perform nonprofessional functions as
described in legislative rules promulgated pursuant to article
three, chapter twenty-nine-a of this code. 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 two pharmacy technicians per on-duty
pharmacist operating in retail, clinical or mail order pharmacies and of four pharmacy technicians per on-duty pharmacist operating
in institutional pharmacies shall be maintained.
§30-5-5b. Pharmacist clinician duties.
(a) A pharmacist clinician exercising prescriptive authority
in his or her practice shall have on file at his or her place of
practice written guidelines or protocol. The guidelines or
protocol shall authorize a pharmacist clinician to exercise
prescriptive authority and shall be established and approved by
a allopathic or osteopathic physician in accordance with rules
adopted by the board. A copy of the written guidelines or
protocol shall be on file with the board. The allopathic or
osteopathic physician who is a party to the guidelines or
protocol shall be in active practice and the prescriptive
authority that he or she grants to a pharmacist clinician shall
be within the scope of allopathic or osteopathic physician's
current practice.
(b) The guidelines or protocol required by subsection (a) of
this section shall include:
(1) A statement identifying the allopathic or osteopathic
physician authorized to prescribe prescription drugs and the
pharmacist clinician who is a party to the guidelines or
protocol;
(2) A statement of the types of prescriptive authority
decisions that the pharmacist clinician is authorized to make which may include:
(A) A statement of the types of diseases, prescription drugs
or prescription drug categories involved and the type of
prescriptive authority authorized in each case; and
(B) A general statement of the procedures, decision criteria
or plan the pharmacist clinician is to follow when exercising
prescriptive authority.
(3) A statement of the activities the pharmacist clinician
is to follow in the course of exercising prescriptive authority,
including documentation of decisions made and a plan for
communication or feedback to the authorizing allopathic or
osteopathic physician concerning specific decisions made.
Documentation may occur on the prescriptive record, patient
profile, patient medical chart or in a separate log book; and
(4) A statement that describes appropriate mechanisms for
reporting to the allopathic or osteopathic physician monitoring
activities and results.
(C) The written guidelines or protocol shall be reviewed and
shall be revised every two years if necessary.
(D) A pharmacist clinician exercising prescriptive authority
in his or her practice shall be authorized to monitor
prescription drug therapy.
(E) The board shall adopt rules to carry out the provisions
of this article.
§30-5-6. Reciprocal licensure of pharmacists from other states
or countries.
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 pursuant to 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. 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. 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 applicant desires to
be examined other than at a regular meeting of the board. In
that case, there will be an additional fee of one hundred fifty
dollars.
§30-5-7. Grounds for discipline; penalties; recovery of costs;
summary suspension; probable cause.
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) (a) Become unfit or incompetent to practice pharmacy by
reason of: (a) Acts of gross immorality; (b) habitual
intoxication Alcohol or substance abuse; (c) habitual use of
narcotics or habit-forming drugs; (d) (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) (b) 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) (c) Violated any of the provisions of this chapter or
chapter sixteen of the code.
(4) (d) Failed to comply with the rules of professional
conduct adopted 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.
(e) Knowing or suspecting that a pharmacist, pharmacy
technician or pharmacy intern is incapable of engaging in the
practice of pharmacy with reasonable skill, competence and safety
and failing to report this information to the board.
(f) Fraud by a licensee in connection with the practice of
pharmacy.
(g) Performance of an act outside this state which would
constitute a violation within this state.
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.
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.
In the case of a pharmacy or wholesale distributor, the
order may be made 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 to have knowingly participated in one or more
of the violations set forth in this article or of article three,
chapter sixty-a of this code.
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 under
this section.
In every discipline or licensure case considered by the
board under 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.
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. Reporting of information to board pertaining to
professional malpractice and professional
incompetence required; summary sanctions; civil and
criminal immunity; probable cause determinations.
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.
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.
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.
The board shall provide forms for filing reports pursuant to
this section. Reports submitted in other forms shall be accepted
by the board.
§30-5-8. 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 registered assistant pharmacists registered pharmacy
technicians and registered 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 registrations, renewals, reported deaths, forfeiture of registration 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 for renewing
the registration of a pharmacy technician, thirty-five dollars.
§30-5-10. Annual renewal of license.
Every registered licensed pharmacist, intern or pharmacy
technician who desires to continue in the practice of pharmacy or
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 by certified mail, return receipt requested. If any
pharmacist or pharmacy technician fails for a period of thirty
ninety days after said first day of July to apply to the board
for a renewal of his or her license, his or her name shall be
erased from the register of registered pharmacists and pharmacy
technicians and such person, in order to again become licensed,
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 licensure or permit shall be exposed.
Every certificate of registration 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 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.
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.
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.
(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.
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" "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.
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." in the pharmacist's
judgment, generic substitution would be improper. The pharmacist
shall note the instructions on the file copy of the prescription
or chart order form.
(c) 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
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) A pharmacist may substitute a drug under subsection (b)
of this section only where there will be a savings to the buyer.
Where substitution is proper under subsection (b) of 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) 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) 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.
All drugs shall be labeled in accordance with the instructions of the practitioner.
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) 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) The West Virginia board of pharmacy shall establish by
rule 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) 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) 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) 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) The West Virginia board of pharmacy shall promulgate
rules and regulations setting standards for substituted drug
products, obtaining compliance with the provisions of this
section and enforcing the provisions of this section. 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.
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) 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.
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.
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 or drugstore as defined, 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 to be registered; permit to operate; fees;
pharmacist to conduct business.
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. 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. 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. 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.
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.
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.
The pharmacist-in-charge is responsible for the pharmacy's
compliance with state and federal pharmacy laws and regulations.
The pharmacist-in-charge is responsible for maintaining
records and inventory.
It is a violation of this section if the owner of a pharmacy
fails to designate a pharmacist-in-charge or permit 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.
Before a permit is issued to operate a pharmacy, or renewed,
the application must designate the pharmacist-in-charge. The
designated pharmacist-in-charge must be present when a new store
is to be inspected.
A pharmacist-in-charge cannot hold the designated position
at more than one pharmacy, whether within or without the state of
West Virginia. The board of pharmacy shall promulgate rules
relative to pharmacies which are operated over forty hours a
week.
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 must be filed with the
board within thirty days of the designation.
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.
Every registered drugstore or pharmacy must 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.
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, 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.
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
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 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.
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.
The application for such permits 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.
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.
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
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.
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 refuse the issuance of further permits to
such person, firm, corporation, partnership, company, cooperative
society, organization or permittee.
§30-5-16a. 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
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.
§30-5-16b. Partial filling of prescriptions for long-term care
facility or terminally ill patients.
(a) As used in this section, "long-term care facility"
(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 must
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 must record on the prescription that the
patient is "terminally ill" or a "LTCF patient". A prescription that is partially filed 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 must 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 of board of pharmacy; revocation of permits;
employment of field agents, chemists, clerical and
other qualified personnel.
The board of pharmacy shall make such rules, and regulations
not inconsistent with law, as necessary to carry out the purposes
and enforce the provisions of this article and is hereby
authorized to 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.
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.
Any person who shall violate 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.
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.
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.
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 such fine and imprisonment, in the
discretion of the court, and each and every day that such the
violation continues shall constitute a separate offense.
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.
(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) In the event a claim or cause of action is asserted
against a reporting pharmacist, intern or pharmacy technician or
licensed entity as a result of the filing of a report pursuant to
the provisions of this chapter, or the rules of the board or
pursuant to rules, regulations or by-laws of any peer review
organization, and such claim or cause of action is subsequently dismissed, settled or adjudicated in favor of the person or
entity making the required report, the person or persons who
initiated the claim or action shall be liable for all attorneys
fees, costs and expenses incurred by the reporting professional.
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.
The board shall promulgate legislative rules pursuant to the
provisions of chapter twenty-nine-a establishing procedures for
imposing sanctions and penalties against any licensee who fails
to submit to the board the information required by this section.
NOTE: The purpose of this bill is to make substantial
changes to the entire article that regulates the profession of
pharmacology. The bill: Deletes the entire existing definition
section of the article; adds a declarations and findings section primarily related to acknowledging the duty to protect the
public; adds a "statement of purpose" section; provides a new
definitions section with expanded definitions; amends existing
law concerning board vacancies and the conduct of business by the
board; adds new provisions involving records kept by the board
and provides for expungement of certain records; provides for
regulation of pharmacist technicians; modifies notice
requirements, public information and provides for voluntary
agreements relating to alcohol or chemical dependency as well as
confidentiality requirements; changes numerous references from
"registration" requirements to "licensure" requirements;
increases fees and criminal penalty provisions; adds additional
grounds to justify disciplinary action; adds provisions
concerning enforcement of board orders involved in disciplinary
matters; adds reporting criteria involving professional
malpractice and incompetence while adding additional sanctions
including more severe civil and criminal penalties; repeals
existing section twelve-a which relates to drug and drug price
listing requirements including the requirement of posting of same
and the penalties for noncompliance; changes existing law as it
relates to generic and brand-name drugs; updates the descriptive
name for the reference manual used by pharmacists; provides for
immunity from civil actions for board members, while limiting
liability of professionals who report to the board; deletes
authorization to manufacture laetrile; authorizes partial
filling of Schedule II medications in certain circumstances;
and provides for the reporting of litigation results to the
board.
Strike-throughs indicate language that would be stricken
from the present law, and underscoring indicates new language
that would be added.
Sections one-a, one-b, two-a, five-a, five-b, seven-a,
sixteen-b and twenty-two-a are new; and sixteen-a has been
completely rewritten; therefore, strike-throughs and underscoring
have been omitted.