Senate Bill No. 147
(By Senators Tomblin, Mr. President, and Sprouse,
By Request of the Executive)
____________
[Introduced February 10, 2005; referred to the Committee
on Health and Human Resources; and the Committee on the
Judiciary.]
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A BILL to amend and reenact §60A-2-212 of the Code of West
Virginia, 1931, as amended; to amend and reenact §60A-3-302
and §60A-3-308 of said code; to amend and reenact §60A-4-401
of said code; to amend said code by adding thereto a new
section, designated §60A-4-411a; and to amend and reenact
§60A-9-3, §60A-9-4 and §60A-9-5 of said code, all relating to
limiting the purchase of substances used in the production of
methamphetamine; providing that certain substances containing
ephedrine, pseudoephedrine or phenylpropanolamine, their salts
or optical isomers, or salts of optical isomers are Schedule
V substances; limiting access to such substances; providing
procedures for purchasing such substances from pharmacists or
licensed pharmacy technicians; providing for the registration
of every wholesaler, manufacturer or distributor of certain drug products containing such substances; creating a central
repository regarding the reporting of information related to
such substances; and providing for penalties.
Be it enacted by the Legislature of West Virginia:
That §60A-2-212 of the Code of West Virginia, 1931, as
amended, be amended and reenacted; that §60A-3-302 and §60A-3-308
of said code be amended and reenacted; that §60A-4-401 of said code
be amended and reenacted; that said code be amended by adding
thereto a new section, designated §60A-4-411a; and that §60A-9-3,
§60A-9-4 and §60A-9-5 of said code be amended and reenacted, all to
read as follows:
ARTICLE 2. STANDARDS AND SCHEDULES.
§60A-2-212. Schedule V.
(a) Schedule V shall consist of the drugs and other
substances, by whatever official name, common or usual name,
chemical name or brand name designated, listed in this section.
(b)
Narcotic drugs. -- Unless specifically excepted or unless
listed in another schedule, any material, compound, mixture or
preparation containing any of the following narcotic drugs and
their salts, as set forth below:
(1) Buprenorphine.
(c) Narcotic drugs containing nonnarcotic active medicinal
ingredients. Any compound, mixture or preparation containing any
of the following narcotic drugs or their salts calculated as the free anhydrous base or alkaloid in limited quantities as set forth
below, which shall include one or more nonnarcotic active medicinal
ingredients in sufficient proportion to confer upon the compound,
mixture or preparation valuable medicinal qualities other than
those possessed by the narcotic drug alone:
(1) Not more than 200 milligrams of codeine per 100
milliliters or per 100 grams;
(2) Not more than 100 milligrams of dihydrocodeine per 100
milliliters or per 100 grams;
(3) Not more than 100 milligrams of ethylmorphine per 100
milliliters or per 100 grams;
(4) Not more than 2.5 milligrams of diphenoxylate and not less
than 25 micrograms of atropine sulfate per dosage unit;
(5) Not more than 100 milligrams of opium per 100 milliliters
or per 100 grams;
(6) Not more than 0.5 milligrams of difenoxin and not less
than 25 micrograms of atropine sulfate per dosage unit.
(d)
Stimulants. Unless specifically exempted or excluded or
unless listed in another schedule, any material, compound, mixture
or preparation which contains any quantity of the following
substances having a stimulant effect on the central nervous system,
including its salts, isomers and salts of isomers:
(1) Pyrovalerone;
(e) Any compound, mixture or preparation containing any detectable quantity of ephedrine, pseudoephedrine or
phenylpropanolamine, their salts or optical isomers, or salts of
optical isomers.
ARTICLE 3. REGULATION OF MANUFACTURE, DISTRIBUTION AND DISPENSING
OF CONTROLLED SUBSTANCES.
§60A-3-302. Registration required; effect of registration;
exemptions; waiver; inspections.
(a) Every person who manufactures, distributes or dispenses
any controlled substance within this state or who proposes to
engage in the manufacture, distribution or dispensing of any
controlled substance within this state, must obtain annually a
registration issued by the State Board of Pharmacy or the
appropriate department, board or agency, as the case may be, as
specified in section three hundred one, in accordance with its
rules.
Every wholesaler, manufacturer or distributor of any drug
product containing ephedrine, pseudoephedrine, or
phenylpropanolamine, or their salts or optical isomers, or salts of
optical isomers shall obtain a registration issued by the State
Board of Pharmacy in accordance with rules promulgated by the State
Board of Pharmacy.
(b) Persons registered by said State Board of Pharmacy or said
appropriate department, board, or agency, as the case may be, under
this act to manufacture, distribute, dispense or conduct research
with controlled substances may possess, manufacture, distribute,
dispense or conduct research with those substances to the extent
authorized by their registration and in conformity with the other provisions of this article.
(c) (1) The following persons need not register and may
lawfully possess, deliver, or transport into this state controlled
substances under this act:
(A) An agent or employee of any registered manufacturer,
distributor, or dispenser of any controlled substance if he
or she
is acting in the usual course of his
or her business or employment;
(B) A common or contract carrier or warehouseman, or an
employee thereof, whose possession, delivery or transportation into
this state of any controlled substance is in the usual course of a
lawful business or employment;
(2) The following persons need not register and may lawfully
possess or transport into this state controlled substances under
this act: An ultimate user or a person in possession of any
controlled substance pursuant to a lawful order of a practitioner
or in lawful possession of a Schedule V substance.
(d) The said State Board of Pharmacy or said appropriate
department, board or agency, as the case may be, may waive by rule
the requirement for registration of certain manufacturers,
distributors or dispensers if it finds it consistent with the
public health and safety.
(e) A separate registration is required at each principal
place of business or professional practice where the applicant
manufactures, distributes or dispenses controlled substances.
(f) The said State Board of Pharmacy or said appropriate
department, board or agency, as the case may be, may inspect the establishment of a registrant or applicant for registration in
accordance with the rule of said State Board of Pharmacy or said
appropriate department, board, or agency, as the case may be.
§60A-3-308. Prescriptions and dispensing of controlled substances.
(a) Except when dispensed directly by a practitioner, other
than a pharmacy, to an ultimate user, no controlled substance in
Schedule II may be dispensed without the written prescription of a
practitioner.
(b) In emergency situations, as defined by rule of the said
appropriate department, board or agency, Schedule II drugs may be
dispensed upon oral prescription of a practitioner, reduced
promptly to writing and filed by the pharmacy. Prescription shall
be retained in conformity with the requirements of section 306. No
prescription for a Schedule II substance may be refilled.
(c) Except when dispensed directly by a practitioner, other
than a pharmacy, to an ultimate user, a controlled substance
included in Schedule III or IV, which is a prescription drug as
determined under appropriate state or federal statute, shall not be
dispensed without a written or oral prescription of a practitioner.
The prescription shall not be filled or refilled more than six
months after the date thereof or be refilled more than five times,
unless renewed by the practitioner.
(d)
(1) A controlled substance included in Schedule V shall
not be distributed or dispensed other than for a medicinal purpose:
Provided, That buprenorphine shall be dispensed only by
prescription pursuant to subsections (a), (b) and (c) of this section:
Provided, however, That the controlled substances
included in subsection (e), section two hundred twelve, article two
of this chapter shall be dispensed, sold or distributed only by a
physician or a pharmacy by a pharmacist or licensed pharmacy
technician.
(2) If the substance described in subsection (e), section two
hundred twelve, article two of this chapter is dispensed, sold or
distributed in a pharmacy:
(A) The substance shall be dispensed, sold or distributed only
by a pharmacist or a licensed pharmacist technician; and
(B) Any person purchasing, receiving or otherwise acquiring
any such substance shall:
(i) Produce a photo identification showing the date of birth
of such person; and
(ii) Sign a form as provided in section three, article nine of
this chapter showing: The date of the transaction; the name of the
person; and the name and the amount of the substance purchased,
received or otherwise acquired.
ARTICLE 4. OFFENSES AND PENALTIES.
§60A-4-401. Prohibited acts A; penalties.
(a) Except as authorized by this act, it is unlawful for any
person to manufacture, deliver or possess with intent to
manufacture or deliver, a controlled substance.
Any person who violates this subsection with respect to:
(i) A controlled substance classified in Schedule I or II
which is a narcotic drug, is guilty of a felony, and, upon conviction, may be imprisoned in
the penitentiary a correctional
facility for not less than one year nor more than fifteen years, or
fined not more than twenty-five thousand dollars, or both;
(ii) Any other controlled substance classified in Schedule I,
II or III, is guilty of a felony, and, upon conviction, may be
imprisoned in
the penitentiary a correctional facility for not less
than one year nor more than five years, or fined not more than
fifteen thousand dollars, or both;
(iii) A substance classified in Schedule IV, is guilty of a
felony, and, upon conviction, may be imprisoned in
the penitentiary
a correctional facility for not less than one year nor more than
three years, or fined not more than ten thousand dollars, or both;
(iv) A substance classified in Schedule V,
except for
substances classified in subsection (e), section two hundred
twelve, article two of this chapter, is guilty of a misdemeanor,
and, upon conviction, may be confined in
the county jail for not
less than six months nor more than one year, or fined not more than
five thousand dollars, or both.
(b) Except as authorized by this
chapter act, it is unlawful
for any person to create, deliver or possess with intent to
deliver, a counterfeit substance.
Any person who violates this subsection with respect to:
(i) A counterfeit substance classified in Schedule I or II
which is a narcotic drug, is guilty of a felony, and, upon
conviction, may be imprisoned in
the penitentiary a correctional
facility for not less than one year nor more than fifteen years, or fined not more than twenty-five thousand dollars, or both;
(ii) Any other counterfeit substance classified in Schedule I,
II, or III, is guilty of a felony, and, upon conviction, may be
imprisoned in
the penitentiary a correctional facility for not less
than one year nor more than five years, or fined not more than
fifteen thousand dollars, or both;
(iii) A counterfeit substance classified in Schedule IV, is
guilty of a felony, and, upon conviction, may be imprisoned in
the
penitentiary a correctional facility for not less than one year nor
more than three years, or fined not more than ten thousand dollars,
or both;
(iv) A counterfeit substance classified in Schedule V, is
guilty of a misdemeanor, and, upon conviction, may be confined in
the county jail for not less than six months nor more than one
year, or fined not more than five thousand dollars, or both.
(c) It is unlawful for any person knowingly or intentionally
to possess a controlled substance unless the substance was obtained
directly from, or pursuant to, a valid prescription or order of a
practitioner while acting in the course of his
or her professional
practice, or except as otherwise authorized by this act. Any person
who violates this subsection is guilty of a misdemeanor, and
disposition may be made under section 407, subject to the
limitations specified in said section 407, or upon conviction, such
person may be confined in
the county jail not less than ninety days
nor more than six months, or fined not more than one thousand
dollars, or both:
Provided, That notwithstanding any other provision of this act to the contrary, any first offense for
possession of less than 15 grams of marihuana shall be disposed of
under said section 407.
(d) It is unlawful for any person knowingly or intentionally:
(1) To create, distribute or deliver, or possess with intent
to distribute or deliver, an imitation controlled substance; or
(2) To create, possess or sell or otherwise transfer any
equipment with the intent that such equipment shall be used to
apply a trademark, trade name or other identifying mark, imprint,
number or device, or any likeness thereof, upon a counterfeit
substance, an imitation controlled substance, or the container or
label of a counterfeit substance or an imitation controlled
substance.
(3) Any person who violates this subsection is guilty of a
misdemeanor, and, upon conviction, may be imprisoned in
the county
jail for not less than six months nor more than one year, or fined
not more than five thousand dollars, or both. Any person being
eighteen years old or more, who violates subdivision (1) of this
subsection, and, in so doing distributes or delivers an imitation
controlled substance to a minor child who is at least three years
younger than such person, is guilty of a felony, and, upon
conviction, may be imprisoned in
the penitentiary a correctional
facility for not less than one year nor more than three years, or
fined not more than ten thousand dollars, or both.
(4) The provisions of subdivision (1) of this subsection shall
not apply to a practitioner who administers or dispenses a placebo.
§60A-4-411a. Purchase, receipt, acquisition and possession of
substances to be used as precursor to manufacture
of methamphetamine or another controlled
substance; presumption; exceptions; penalties.
(a) (1) No person may purchase, receive or otherwise acquire
drug products containing more than nine (9) grams of ephedrine,
pseudoephedrine or phenylpropanolamine, or their salts, optical
isomers, or salts of optical isomers within any thirty-day period
unless such drug products are prescribed by a physician.
(2) A violation of this subsection is a misdemeanor offense
and is punishable by incarceration in jail for a period not to
exceed one year and a fine of not more than twenty five thousand
dollars. A person convicted of a second or subsequent offense,
under this subsection, is guilty of a felony and, upon conviction,
may be imprisoned in a correctional facility of this state for not
less than one more than five years, or fined not nor more than ten
thousand dollars, or both.
(b) (1) Except as authorized by this chapter it shall be
unlawful for a person to knowingly possess the following
substances:
(A) A substance containing ephedrine, pseudoephedrine or
phenylpropanolamine, or their salts, optical isomers or salts of
optical isomers with intent to use the product as a precursor to
manufacture methamphetamine or another controlled substance;
(B) A substance containing ephedrine, pseudoephedrine or
phenylpropanolamine, or their salts, optical isomers or salts of optical isomers in a pure form or a state of form which is, or has
been, altered or converted from the state or form in which these
chemicals are, or were, commercially distributed.
(2) Except as provided in this subsection, possession of a
drug product containing more than nine (9) grams of ephedrine,
pseudoephedrine or phenylpropanolamine, or their salts, optical
isomers or salts of optical isomers shall constitute a rebuttable
presumption of the intent to use the product as a precursor to
methamphetamine or another controlled substance. The rebuttable
presumption established by this subsection does not apply to the
following persons who are lawfully possessing drug products:
(A) A retail distributor of drug products or wholesaler;
(B) A wholesale drug distributor, or its agents, licensed by
the Board of Pharmacy;
(C) A manufacturer of drug products, or its agents, licensed
by the Board of Pharmacy;
(D) A pharmacist or licensed pharmacist technician;
(E) A licensed healthcare professional possessing the drug
products in the course of carrying out his or her profession; and
(F) A person who possesses the drug product with a
prescription from a physician.
(3) Any person who violates this subsection is guilty of a
felony and, upon conviction, may be imprisoned in a correctional
facility of this state for not less than two nor more than ten
years, or fined not more than twenty-five thousand dollars, or
both.
(c) (1) Any wholesaler, manufacturer, or distributor of drug
products containing ephedrine, pseudoephedrine or
phenylpropanolamine, or their salts or optical isomers, or salts of
optical isomers shall obtain a registration annually from the State
Board of Pharmacy. Any such wholesaler, manufacturer, or
distributor shall keep complete records of all transactions
involving such drug products including the names of all parties
involved in the transaction and amount of the drug products
involved. The records shall be kept readily retrievable and
separate from all other invoices or records of transactions not
involving such drug products, and shall be maintained for not less
than three years.
(2) Any substances possessed without a registration as
provided in this section are subject to forfeiture upon conviction
for a violation of this section.
(3) In addition to any administrative penalties provided by
law, any violation of this subsection is a misdemeanor, punishable
upon conviction by a fine in an amount not more than ten thousand
dollars.
(4) As used in this section:
(A) "Manufacturer" means any person within this state who
produces, compounds packages, or in any manner initially prepares
for sale or use any drug product described in subsection (e),
section two-hundred twelve, article two of this chapter, or any
such person in another state if they cause the products to be
compounded, packaged or transported into this state;
(B) "Wholesaler" means any person within this state or another
state, other than a manufacturer, who sells, transfers or in any
manner furnishes a drug product described in subsection (e),
section two hundred twelve, article two of this chapter to any
other person in this state for the purpose of being resold;
(C) "Distributor" means any person within this state or
another state, other than a manufacturer or wholesaler, who sells,
delivers, transfers or in any manner furnishes a drug product
described in subsection (e), section two hundred twelve, article
two of this chapter to any person who is not the ultimate user or
consumer of the product; and
(D) "Readily retrievable" means available for inspection
without prior notice at the registration address if that address is
within West Virginia. If the registration address is in a state
other than West Virginia, it means records must be furnished within
three working days by courier, facsimile, mail or electronic mail.
ARTICLE 9. CONTROLLED SUBSTANCES MONITORING.
§60A-9-3. Reporting system requirements; implementation; central
repository requirement.
(a) On or before the first day of September, two thousand two,
the Board of Pharmacy shall implement a program wherein a central
repository is established and maintained which shall contain such
information as is required by the provisions of this article
regarding Schedule II, III and IV controlled substance
prescriptions written or filled in this state. In implementing
this program, the Board of Pharmacy shall consult with the West Virginia State Police, the licensing boards of practitioners
affected by this article and affected practitioners.
(b) On or before the first day of July, two thousand five, the
Board of Pharmacy shall implement a program wherein a central
repository is established and maintained which shall contain such
information as is required by the provisions of this article
regarding the substances contained in subsection (e), section
two-hundred twelve, article two of this chapter.
(b) (c) The
program programs authorized by
subsection
subsections (a)
and (b) of this section shall be designed to
minimize inconvenience to patients, prescribing practitioners and
pharmacists while effectuating the collection and storage of the
required information. The State Board of Pharmacy shall allow
reporting of the required information by electronic data transfer
where feasible, and where not feasible, on reporting forms
promulgated by the Board of Pharmacy. The information required to
be submitted by the provisions of this article shall be required to
be filed no more frequently than once a week.
(c) (d) (1) The State Board of Pharmacy shall provide for the
electronic transmission of the information required to be provided
by this article by and through the use of a toll-free telephone line.
(2) A dispenser, who does not have an automated record keeping
system capable of producing an electronic report in the established
format may request a waiver from electronic reporting. The request
for a waiver shall be made to the State Board of Pharmacy in
writing and shall be granted if the dispenser agrees in writing to report the data by submitting a completed "Pharmacy Universal Claim
Form" as defined by legislative rule.
§
60A-9-4. Required information.
(a)
(1) Except for the substances referenced in subsection
(e), section two-hundred twelve, article two of this chapter,
whenever a medical services provider dispenses a controlled
substance listed in the provisions of section two hundred six,
article two of this chapter, or whenever a prescription for the
controlled substance is filled by: (i) A pharmacist or pharmacy in
this state; (ii) a hospital, or other health care facility, for
out-patient use; or (iii) a pharmacy or pharmacist, licensed by the
Board of Pharmacy, but situated outside this state for delivery to
a person residing in this state, the medical services provider,
health care facility, pharmacist or pharmacy shall, in a manner
prescribed by rules promulgated by the Board of Pharmacy under this
article, report the following information, as applicable:
(1) (A) The name, address, pharmacy prescription number and
DEA controlled substance registration number of the dispensing
pharmacy;
(2) (B) The name, address and birth date of the person for
whom the prescription is written;
(3) (C) The name, address and drug enforcement administration
controlled substances registration number of the practitioner
writing the prescription;
(4) (D) The name and national drug code number of the Schedule
II, III and IV controlled substance dispensed;
(5) (E) The quantity and dosage of the Schedule II, III and IV
controlled substance dispensed;
(6) (F) The date the prescription was filled; and
(7)
(G) The number of refills, if any, authorized by the
prescription.
(b) (2) The Board of Pharmacy may prescribe by rule
promulgated under this article the form to be used in prescribing
a Schedule II, III and IV substance if, in the determination of the
Board, the administration of the requirements of this section would
be facilitated.
(c) (3) Reporting required by this section is not required for
a drug administered directly to a patient or a drug dispensed by a
practitioner at a facility licensed by the state:
Provided, That
the quantity dispensed is limited to an amount adequate to treat
the patient for a maximum of seventy-two hours with no greater than
two seventy-two hour cycles in any fifteen day period of time.
(b) Whenever a pharmacist or licensed pharmacist technician
dispenses, sells or distributes the substance referred to in
subsection (e), section two-hundred twelve, article two of this
chapter, the pharmacist or licensed pharmacist technician shall, in
a manner prescribed by rules promulgated by the Board of Pharmacy
under this article, collect and report the following information:
(1) The date of the transaction;
(2) The name of the person; and
(3) The name and the amount of the substance purchased,
received, or otherwise acquired.
§60A-9-5. Confidentiality; limited access to records; period of
retention; no civil liability for required reporting.
The information required by this article to be kept by the
State Board of Pharmacy is confidential and is open to inspection
only by inspectors and agents of the State Board of Pharmacy,
members of the West Virginia State Police expressly authorized by
the Superintendent of the West Virginia State Police to have access
to the information, authorized agents of local law-enforcement
agencies as a member of a drug task force, authorized agents of the
Federal Drug Enforcement Agency, duly authorized agents of
licensing boards of practitioners in this state and other states
authorized to prescribe Schedules II, III and IV controlled
substances, prescribing practitioners and pharmacists and persons
with an enforceable court order or regulatory agency administrative
subpoena:
Provided, That all information released by the State
Board of Pharmacy,
except for information relating to substances
referred to in subsection (e), section two hundred twelve, article
two of this chapter, must be related to a specific patient or a
specific individual or entity under investigation by any of the
above parties except that practitioners who prescribe controlled
substances may request specific data related to their drug
enforcement administration controlled substance registration number
or for the purpose of providing treatment to a patient. The Board
shall maintain the information required by this article for a
period of not less than five years. Notwithstanding any other
provisions of this code to the contrary, data obtained under the provisions of this article may be used for compilation of
educational, scholarly or statistical purposes as long as the
identities of persons or entities remain confidential. No
individual or entity required to report under section four of this
article may be subject to a claim for civil damages or other civil
relief for the reporting of information to the Board of Pharmacy as
required under and in accordance with the provisions of this
article.
NOTE: The purpose of this bill is to limit access to certain
chemicals used in the production of methamphetamines.
Strike-throughs indicate language that would be stricken from
the present law, and underscoring indicates new language that would
be added.
§60A-4-411a is new; therefore, strike-throughs and
underscoring have been omitted.