H. B. 2796
(By Delegates Border, Leach and
Perdue, (By Request))
[Introduced February 17, 1999; referred to the
Committee on Government Organization.]
A BILL to amend and reenact sections six-a, nine and fourteen,
article five, chapter thirty of the code of West Virginia,
one thousand nine hundred thirty-one, as amended; and to
amend and reenact section seven, article eight, chapter
sixty-a of said code, all relating to fees for licensing and
permits to operate for pharmacists, pharmacies, drugstores
and wholesale drug distributors payable to the West Virginia
Board of Pharmacy; establishing an initial fee and a renewal
fee for an application for a permit for mail-order
pharmacies and drugstores; increasing the renewal fees for
licensing and operation permits for pharmacists; and
increasing the licensing fee for wholesale drug
distributors.
Be it enacted by the Legislature of West Virginia:
That sections six-a, nine and fourteen, article five,
chapter thirty of the code of West Virginia, one thousand nine
hundred thirty-one, as amended, be amended and reenacted; and that section seven, article eight, chapter sixty-a of said code
be amended and reenacted, all to read as follows:
CHAPTER 30.
PROFESSIONS AND OCCUPATIONS.
ARTICLE 5. PHARMACISTS, PHARMACY TECHNICIANS, PHARMACY INTERNS
AND PHARMACIES.
§30-5-6a. Permits for mail-order houses.
(a) Every mail-order house which dispenses drugs or
medicines through the United States mail or otherwise from any
point in the state of West Virginia to any point outside of the
state of West Virginia shall be registered as a pharmacy or
drugstore pursuant to the provisions of section fourteen of this
article: Provided, That the provisions of this subsection do not
apply to any mail-order house which operates solely as a
wholesale distributor. Every initial application for a permit
shall be accompanied by a fee of five hundred dollars. The fee
for renewal of the permit or license shall be five hundred
dollars annually.
(b) Every mail-order house which dispenses drugs or
medicines through the United States mail or otherwise from any
point outside of the state of West Virginia to any point within
the state of West Virginia shall, as a condition precedent to
being qualified and authorized to transact such business in the
state of West Virginia, annually register with the board of
pharmacy to conduct such business in this state. Every initial
application for a permit shall be accompanied by a fee of five hundred dollars. The fee for renewal of the permit or license
shall be five hundred dollars annually. Every such business
shall be required to provide to the board of pharmacy
satisfactory evidence that it qualifies as a pharmacy or
drugstore and that such the business is licensed or registered as
a pharmacy or drugstore in the state where the business dispenses
prescriptions by mail order to residents of this state. The
board of pharmacy shall promulgate rules, in accordance with the
provisions of article three, chapter twenty-nine-a of this code,
for the procedures of registration pursuant to this subsection:
Provided, That the provisions of this subsection do not apply to
any mail-order house which operates solely as a wholesale
distributor.
§30-5-9. Fees.
The board of pharmacy shall charge and collect the
following fees, in addition to those provided in article one of
this chapter and in sections five, fourteen and sixteen of this
article: For renewing the licensure of a pharmacist, thirty
fifty dollars; to license an intern pharmacist, ten dollars plus
five dollars for each of the remaining periods of his or her
internship; to register a consultant pharmacist, twenty dollars
for the initial application and ten dollars for each additional
application; and to register a pharmacy technician, twenty-five
dollars and ten dollars for each renewal.
§30-5-14. Pharmacies to be registered; permit to operate; fees; pharmacist to conduct business.
(a) The board of pharmacy shall require and provide for the
annual registration of every pharmacy doing business in this
state. Any person, firm, corporation or partnership desiring to
operate, maintain, open or establish a pharmacy in this state
shall apply to the board of pharmacy for a permit to do so. The
application for such permit shall be made on a form prescribed
and furnished by the board of pharmacy, which, when properly
executed, shall indicate the owner, manager, trustee, lessee,
receiver, or other person or persons desiring such permit, as
well as the location of such pharmacy, including street and
number, and
such any
other information as the board of pharmacy
may require. If it is desired to operate, maintain, open or
establish more than one pharmacy, separate application shall be
made and separate permits or licenses shall be issued for each.
(b) Every initial application for a permit shall be
accompanied by the required fee of one hundred fifty dollars.
The fee for renewal of such permit or license shall be
seventy-five one hundred dollars annually.
(c) If an application is approved, the secretary of the
board of pharmacy shall issue to the applicant a permit or
license for each pharmacy for which application is made.
Permits or licenses issued under this section shall not be
transferable and shall expire on the thirtieth day of June of
each calendar year, and if application for renewal of permit or
license is not made on or before that date, or a new one granted on or before the first day of August, following, the old permit
or license shall lapse and become null and void and shall require
an inspection of the pharmacy and a fee of one hundred fifty
dollars plus one hundred fifty dollars for the inspection.
(d) Every such place of business so registered shall employ
a pharmacist in charge and operate in compliance with the general
provisions governing the practice of pharmacy and the operation
of a pharmacy.
(e) The provisions of this section shall have no application
to the sale of nonprescription drugs which are not required to
be dispensed pursuant to a practitioner's prescription.
CHAPTER 60A. UNIFORM CONTROLLED SUBSTANCES ACT.
ARTICLE 8. WHOLESALE DRUG DISTRIBUTION LICENSING ACT OF 1991.
§60A-8-7. Wholesale drug distributor licensing requirements.
All wholesale distributors and pharmacy distributors shall
be subject to the following requirements:
(a) No person or distribution outlet may act as a wholesale
drug distributor without first obtaining a license to do so from
the board of pharmacy and paying any reasonable fee required by
the board of pharmacy, such fee not to exceed two four hundred
dollars per year.
(b) The board of pharmacy may grant a temporary license when
a wholesale drug distributor first applies for a license to
operate within this state and such the
temporary license shall
remain valid until the board of pharmacy finds that the applicant meets or fails to meet the requirements for regular licensure,
except that no such temporary license shall be valid for more
than ninety days from the date of issuance. Any temporary
license issued pursuant to this subdivision shall be renewable
for a similar period of time not to exceed ninety days pursuant
to policies and procedures to be prescribed by the board of
pharmacy.
(c) No license may be issued or renewed for a wholesale drug
distributor to operate unless the distributor operates in a
manner prescribed by law and according to the rules promulgated
by the board of pharmacy with respect thereto.
(d) The board of pharmacy may require a separate license for
each facility directly or indirectly owned or operated by the
same business entity within this state, or for a parent entity
with divisions, subsidiaries, or affiliate companies within this
state when operations are conducted at more than one location and
there exists joint ownership and control among all the entities.
(e) (1) As a condition for receiving and retaining any
wholesale drug distributor license issued pursuant to this
article, each applicant shall satisfy the board of pharmacy that
it has and will continuously maintain:
(A) Acceptable storage and handling conditions plus
facilities standards;
(B) Minimum liability and other insurance as may be required
under any applicable federal or state law;
(C) A security system which includes after hours central alarm or comparable entry detection capability, restricted
premises access, adequate outside perimeter lighting,
comprehensive employment applicant screening and safeguards
against employee theft;
(D) An electronic, manual or any other reasonable system of
records describing all wholesale distributor activities governed
by this article for the two-year period following disposition of
each product and being reasonably accessible as defined by board
of pharmacy regulations during any inspection authorized by the
board of pharmacy;
(E) Officers, directors, managers and other persons in
charge of wholesale drug distribution, storage and handling, who
must at all times demonstrate and maintain their capability of
conducting business according to sound financial practices as
well as state and federal law;
(F) Complete, updated information to be provided the board
of pharmacy as a condition for obtaining and retaining a license
about each wholesale distributor to be licensed under this
article including all pertinent licensee ownership and other key
personnel and facilities information deemed determined necessary
for enforcement of this article, with any changes in such the
information to be submitted at the time of license renewal or
within twelve months from the date of such the
change, whichever
occurs first;
(G) Written policies and procedures which assure reasonable
wholesale distributor preparation for protection against and handling of any facility security or operation problems,
including, but not limited to, those caused by natural disaster
or government emergency, inventory inaccuracies or product
shipping and receiving, outdated product or other unauthorized
product control, appropriate disposition of returned goods and
product recalls;
(H) Sufficient inspection procedures for all incoming and
outgoing product shipments; and
(I) Operations in compliance with all federal legal
requirements applicable to wholesale drug distribution.
(2) The board of pharmacy shall consider, at a minimum, the
following factors in reviewing the qualifications of persons who
engage in wholesale distribution of prescription drugs with this
state:
(A) Any conviction of the applicant under any federal, state
or local laws relating to drug samples, wholesale or retail drug
distribution or distribution of controlled substances;
(B) Any felony convictions of the applicant under federal,
state or local laws;
(C) The applicant's past experience in the manufacture or
distribution of prescription drugs, including controlled
substances;
(D) The furnishing by the applicant of false or fraudulent
material in any application made in connection with drug
manufacturing or distribution;
(E) Suspension or revocation by federal, state or local government of any license currently or previously held by the
applicant for the manufacture or distribution of any drug,
including controlled substances;
(F) Compliance with licensing requirements under previously
granted licenses, if any;
(G) Compliance with requirements to maintain and /or make
available to the board of pharmacy or to federal, state or local
law-enforcement officials those records required by this article;
and
(H) Any other factors or qualifications the board of
pharmacy considers relevant to and consistent with the public
health and safety, including whether the granting of the license
would not be in the public interest.
(3) All requirements set forth in this subsection shall
conform to wholesale drug distributor licensing guidelines
formally adopted by the United States food and drug
administration (FDA); and in case of conflict between any
wholesale drug distributor licensing requirement imposed by the
board of pharmacy pursuant to this subsection and any food and
drug administration wholesale drug distributor licensing
guideline, the latter shall control.
(f) An agent or employee of any licensed wholesale drug
distributor need not seek licensure under this section and may
lawfully possess pharmaceutical drugs when such the
agent or
employee is acting in the usual course of business or employment.
(g) The issuance of a license pursuant to this article does not change or affect tax liability imposed by this state's
department of tax and revenue on any wholesale drug distributor.
(h) The board of pharmacy may adopt rules pursuant to
section nine of this article which permit out-of-state wholesale
drug distributors to obtain any license required by this article
on the basis of reciprocity to the extent that: (i) An
out-of-state wholesale drug distributor possesses a valid license
granted by another state pursuant to legal standards comparable
to those which must be met by a wholesale drug distributor of
this state as prerequisites for obtaining a license under the
laws of this state; and (ii) such other state would extend
reciprocal treatment under its own laws to a wholesale drug
distributor of this state.
Strike-throughs indicate language that would be stricken
from the present law, and underscoring indicates new language
that would be added.