Introduced Version
Senate Bill 324 History
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Key: Green = existing Code. Red = new code to be enacted
Senate Bill No. 324
(By Senators Stollings and Beach)
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[Introduced February 20, 2013; referred to the Committee on
Government Organization; and then to the Committee on Finance .]
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A BILL to amend and reenact §30-5-1a and §30-5-16 of the Code of
West Virginia, 1931, as amended; and to amend and reenact
§60A-3-301 of said code, all relating to permits for
manufacture, distribution and dispensing of controlled
substances; and providing boards which license persons who
engage in manufacture, distribution or dispensing of
controlled substances with legislative rule-making authority
to set fees.
Be it enacted by the Legislature of West Virginia:
That §30-5-1a and §30-5-16 of the Code of West Virginia, 1931,
as amended, be amended and reenacted; and that §60A-3-301 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.
§30-5-1a. Statement of purpose.
(a) 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.
(b) A 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 are subject to this article.
§30-5-16. Permit for manufacture and packaging of drugs,
medicines, cosmetics; distribution of legend drugs;
regulations as to sanitation and equipment;
penalties; revocation of permit.
(a) No drugs, or medicines, or toilet articles, dentifrices,
or cosmetics shall be manufactured, made, produced, packed,
packaged or prepared within the state except under the personal
supervision of a pharmacist as defined by section one-b of this
article or such other person as may be approved by the Board of
Pharmacy after an investigation and determination by the board that
they are the person is qualified by scientific or technical training and/or experience to perform such the duties of
supervision as may be necessary to protect the public health and
safety.
(b) No person shall manufacture, make, produce, pack, package
or prepare any such articles without first obtaining a permit to do
so from the Board of Pharmacy. The permit shall be is subject to
such rules with respect to sanitation and/or equipment as the Board
of Pharmacy may from time to time adopt for the protection of the
public health and safety promulgate.
(c) Any person, firm, corporation, partnership, company,
cooperative society or organization who offers for sale, sells,
offers or exposes for sale through the method of distribution any
legend drugs shall be subject to this article.
(d) (c) The application for any a permit required by this
section shall be made on a form to be prescribed in legislative
rule, and furnished by the Board of Pharmacy and shall be
accompanied by the following fees: For a distributor, $150, for a
manufacturer, $500, which amounts shall also be are also paid as
the fees for each annual renewal of such the permits. Separate
applications shall be made and separate permits issued for each
separate place of manufacture, distribution, making, producing,
packing, packaging or preparation.
(d) On and after the effective date of the reenactment of this
section during the Regular Session of the Legislature in 2013, the Board of Pharmacy and each department, board or agency may
establish by legislative rule annual fees for a permit required in
subsection (c) of this section. The fees set forth in subsection
(c) of this section remain in effect until modified by a
legislative rule promulgated pursuant to this subsection.
_____(e) The following fees shall be charged for a permit to handle
controlled substances: For a hospital or clinic, $50; for extended
care facilities, $25; for a nursing home, $25; for a teaching
institution, $25; for a researcher, $25; for a medical examiner,
$25; and for a pharmacy or drugstore, $15, which amounts shall also
be paid for each annual renewal of such permits.
(f) (e) Permits issued under the provisions of pursuant to
this section shall be posted in a conspicuous place in the factory
or place for which issued. such permits shall not be Permits are
not transferable, and shall expire on June 30 following the day of
issue and shall be renewed annually. Nothing in this section shall
be construed to apply applies to those operating registered
pharmacies.
(g) (f) Any A 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 a permittee who violates a condition of this
permit or any of the rules adopted a rule promulgated by the Board
of Pharmacy, shall, upon conviction, be deemed shall be guilty of a misdemeanor and, upon conviction, be fined not more than $50 for
each offense and shall have his or her permit immediately revoked.
Each and every day such violation continues shall constitute a
separate and distinct offense. Upon conviction of a permittee, his
or her permit shall also immediately be revoked and become null and
void. Each day a violation continues constitutes a separate
offense.
_____(h) (g) Any A person, firm, corporation, partnership, company,
cooperative society, organization or any a permittee who is
convicted of two or more successive violations of the provisions of
this section or of the rules adopted promulgated by the Board of
Pharmacy shall, at the discretion of the Board of Pharmacy, have
such her or his permit permanently revoked and the Board of
Pharmacy shall refuse to issue further permits to such the person,
firm, corporation, partnership, company, cooperative society,
organization or permittee.
CHAPTER 60A. UNIFORM CONTROLLED SUBSTANCE ACT.
ARTICLE 3. REGULATION OF MANUFACTURE, DISTRIBUTION AND DISPENSING
OF CONTROLLED SUBSTANCES.
§60A-3-301. Rules; fees.
(a) The State Board of Pharmacy shall promulgate rules and
charge fees relating to the registration and control of the
manufacture and distribution of controlled substances within this
state. and Each department, board or agency of this state which licenses or registers practitioners authorized to dispense any a
controlled substance shall promulgate rules and charge fees
relating to the registration and control of the dispensing of
controlled substances within this state by those practitioners
licensed or registered by such the department, board or agency.
(b) The State Board of Pharmacy or the department, board or
agency shall collect the following annual registration fees from
persons who manufacture, distribute, dispense or conduct research
with controlled substances: For registration of a manufacturer,
$50; for registration of a wholesaler, $50; for registration of a
hospital or clinic, $50; for registration of a medical examiner,
$25; for registration of a teaching or research institution, $25;
for registration of nursing home or an extended care facility, $25;
and for registration of a retailer $15. for registration of a
hospital or clinic, $15; and for registration of a research
institution, $5. dispenser, $15.
_____(c) On and after the effective date of the reenactment of this
section during the Regular Session of the Legislature in 2013, the
Board of Pharmacy and each department, board or agency may
establish by legislative rule, annual fees for a registration as
set forth in this section. The fees set forth in subsection (b) of
this section remain in effect until modified by a legislative rule
promulgated pursuant to this subsection.
NOTE: The purpose of this bill is to remove fees for the
manufacture, distribution and dispensing of controlled substances
from code and to allow the boards which license persons who engage
in manufacture, distribution or dispensing to set appropriate fees
by legislative rule.
Strike-throughs indicate language that would be stricken from
the present law and underscoring indicates new language that would
be added.