CHAPTER 89 SENATE BILL No. 541 (Amended by Chapter 159) An Act concerning the pharmacy act of the state of Kansas; veterinary medical teaching
hospital pharmacy; institutional drug rooms; amending K.S.A. 1999 Supp. 65-1626, 65-
1643 and 65-1645 and repealing the existing sections.
Be it enacted by the Legislature of the State of Kansas:

      Section  1. K.S.A. 1999 Supp. 65-1626 is hereby amended to read as
follows: 65-1626. For the purposes of this act:

      (a) ``Administer'' means the direct application of a drug, whether by
injection, inhalation, ingestion or any other means, to the body of a patient
or research subject by:

      (1) A practitioner or pursuant to the lawful direction of a practitioner,
or

      (2) the patient or research subject at the direction and in the presence
of the practitioner.

      (b) ``Agent'' means an authorized person who acts on behalf of or at
the direction of a manufacturer, distributor or dispenser but shall not
include a common or contract carrier, public warehouseman or employee
of the carrier or warehouseman when acting in the usual and lawful course
of the carrier's or warehouseman's business.

      (c) ``Board'' means the state board of pharmacy created by K.S.A. 74-
1603 and amendments thereto.

      (d) ``Brand exchange'' means the dispensing of a different drug prod-
uct of the same dosage form and strength and of the same generic name
than the brand name drug product prescribed.

      (e) ``Brand name'' means the registered trademark name given to a
drug product by its manufacturer, labeler or distributor.

      (f) ``Deliver'' or ``delivery'' means the actual, constructive or at-
tempted transfer from one person to another of any drug whether or not
an agency relationship exists.

      (g) ``Direct supervision'' means the process by which the responsible
pharmacist shall observe and direct the activities of a pharmacy student
or pharmacy technician to a sufficient degree to assure that all such ac-
tivities are performed accurately, safely and without risk or harm to pa-
tients, and complete the final check before dispensing.

      (h) ``Dispense'' means to deliver prescription medication to the ulti-
mate user or research subject by or pursuant to the lawful order of a
practitioner or pursuant to the prescription of a mid-level practitioner.

      (i) ``Dispenser'' means a practitioner or pharmacist who dispenses
prescription medication.

      (j) ``Distribute'' means to deliver, other than by administering or dis-
pensing, any drug.

      (k) ``Distributor'' means a person who distributes a drug.

      (l) ``Drug'' means: (1) Articles recognized in the official United States
pharmacopoeia, or other such official compendiums of the United States,
or official national formulary, or any supplement of any of them; (2) ar-
ticles intended for use in the diagnosis, cure, mitigation, treatment or
prevention of disease in man or other animals; (3) articles, other than
food, intended to affect the structure or any function of the body of man
or other animals; and (4) articles intended for use as a component of any
articles specified in clause (1), (2) or (3) of this subsection; but does not
include devices or their components, parts or accessories, except that the
term ``drug'' shall not include amygdalin (laetrile) or any livestock remedy,
as defined in K.S.A. 47-501 and amendments thereto, if such livestock
remedy has been registered in accordance with the provisions of article
5 of chapter 47 of the Kansas Statutes Annotated.

      (m) ``Electronic transmission'' means transmission of information in
electronic form or the transmission of the exact visual image of a docu-
ment by way of electronic equipment.

      (n) ``Generic name'' means the established chemical name or official
name of a drug or drug product.

      (o)  (1) ``Institutional drug room'' means any location where prescrip-
tion-only drugs are stored and from which prescription-only drugs are
administered or dispensed and which is maintained or operated for the
purpose of providing the drug needs of:

      (A) Inmates of a jail or correctional institution or facility;

      (B) residents of a juvenile detention facility, as defined by the Kansas
code for care of children and the Kansas juvenile justice code;

      (C) students of a public or private university or college, a community
college or any other institution of higher learning which is located in
Kansas; or

      (D) employees of a business or other employer.; or

      (E) persons receiving inpatient hospice services.

      (2) ``Institutional drug room'' does not include:

      (A) Any registered pharmacy;

      (B) any office of a practitioner; or

      (C) a location where no prescription-only drugs are dispensed and no
prescription-only drugs other than individual prescriptions are stored or
administered.

      (p) ``Medical care facility'' shall have the meaning provided in K.S.A.
65-425 and amendments thereto, except that the term shall also include
facilities licensed under the provisions of K.S.A. 75-3307b and amend-
ments thereto except community mental health centers and facilities for
the mentally retarded.

      (q) ``Manufacture'' means the production, preparation, propagation,
compounding, conversion or processing of a drug either directly or in-
directly by extraction from substances of natural origin, independently by
means of chemical synthesis or by a combination of extraction and chem-
ical synthesis and includes any packaging or repackaging of the drug or
labeling or relabeling of its container, except that this term shall not in-
clude the preparation or compounding of a drug by an individual for the
individual's own use or the preparation, compounding, packaging or la-
beling of a drug by: (1) A practitioner or a practitioner's authorized agent
incident to such practitioner's administering or dispensing of a drug in
the course of the practitioner's professional practice; (2) a practitioner,
by a practitioner's authorized agent or under a practitioner's supervision
for the purpose of, or as an incident to, research, teaching or chemical
analysis and not for sale; or (3) a pharmacist or the pharmacist's author-
ized agent acting under the direct supervision of the pharmacist for the
purpose of, or incident to, the dispensing of a drug by the pharmacist.

      (r) ``Person'' means individual, corporation, government, govern-
mental subdivision or agency, partnership, association or any other legal
entity.

      (s) ``Pharmacist'' means any natural person licensed under this act to
practice pharmacy.

      (t) ``Pharmacist in charge'' means the pharmacist who is responsible
to the board for a registered establishment's compliance with the laws
and regulations of this state pertaining to the practice of pharmacy, man-
ufacturing of drugs and the distribution of drugs. The pharmacist in
charge shall supervise such establishment on a full-time or a part-time
basis and perform such other duties relating to supervision of a registered
establishment as may be prescribed by the board by rules and regulations.
Nothing in this definition shall relieve other pharmacists or persons from
their responsibility to comply with state and federal laws and regulations.

      (u) ``Pharmacy,'' ``drug store'' or ``apothecary'' means premises, lab-
oratory, area or other place: (1) Where drugs are offered for sale where
the profession of pharmacy is practiced and where prescriptions are com-
pounded and dispensed; or (2) which has displayed upon it or within it
the words ``pharmacist,'' ``pharmaceutical chemist,'' ``pharmacy,'' ``apoth-
ecary,'' ``drugstore,'' ``druggist,'' ``drugs,'' ``drug sundries'' or any of these
words or combinations of these words or words of similar import either
in English or any sign containing any of these words; or (3) where the
characteristic symbols of pharmacy or the characteristic prescription sign
``Rx'' may be exhibited. As used in this subsection, premises refers only
to the portion of any building or structure leased, used or controlled by
the licensee in the conduct of the business registered by the board at the
address for which the registration was issued.

      (v) ``Pharmacy student'' means an individual, registered with the
board of pharmacy, enrolled in an accredited school of pharmacy.

      (w) ``Pharmacy technician'' means an individual who, under the direct
supervision and control of a pharmacist, may perform packaging, manip-
ulative, repetitive or other nondiscretionary tasks related to the processing
of a prescription or medication order and who assists the pharmacist in
the performance of pharmacy related duties, but who does not perform
duties restricted to a pharmacist.

      (x) ``Practitioner'' means a person licensed to practice medicine and
surgery, dentist, podiatrist, veterinarian, optometrist licensed under the
optometry law as a therapeutic licensee or diagnostic and therapeutic
licensee, or scientific investigator or other person authorized by law to
use a prescription-only drug in teaching or chemical analysis or to conduct
research with respect to a prescription-only drug.

      (y) ``Preceptor'' means a licensed pharmacist who possesses at least
two years' experience as a pharmacist and who supervises students ob-
taining the pharmaceutical experience required by law as a condition to
taking the examination for licensure as a pharmacist.

      (z) ``Prescription'' means, according to the context, either a prescrip-
tion order or a prescription medication.

      (aa) ``Prescription medication'' means any drug, including label and
container according to context, which is dispensed pursuant to a prescrip-
tion order.

      (bb) ``Prescription-only drug'' means any drug whether intended for
use by man or animal, required by federal or state law (including 21
United States Code section 353, as amended) to be dispensed only pur-
suant to a written or oral prescription or order of a practitioner or is
restricted to use by practitioners only.

      (cc) ``Prescription order'' means: (1) An order to be filled by a phar-
macist for prescription medication issued and signed by a practitioner or
a mid-level practitioner in the authorized course of professional practice;
or (2) an order transmitted to a pharmacist through word of mouth, note,
telephone or other means of communication directed by such practitioner
or mid-level practitioner.

      (dd) ``Probation'' means the practice or operation under a temporary
license, registration or permit or a conditional license, registration or per-
mit of a business or profession for which a license, registration or permit
is granted by the board under the provisions of the pharmacy act of the
state of Kansas requiring certain actions to be accomplished or certain
actions not to occur before a regular license, registration or permit is
issued.

      (ee) ``Professional incompetency'' means:

      (1) One or more instances involving failure to adhere to the appli-
cable standard of pharmaceutical care to a degree which constitutes gross
negligence, as determined by the board;

      (2) repeated instances involving failure to adhere to the applicable
standard of pharmaceutical care to a degree which constitutes ordinary
negligence, as determined by the board; or

      (3) a pattern of pharmacy practice or other behavior which demon-
strates a manifest incapacity or incompetence to practice pharmacy.

      (ff) ``Retail dealer'' means a person selling at retail nonprescription
drugs which are prepackaged, fully prepared by the manufacturer or dis-
tributor for use by the consumer and labeled in accordance with the
requirements of the state and federal food, drug and cosmetic acts. Such
nonprescription drugs shall not include: (1) A controlled substance; (2) a
prescription-only drug; or (3) a drug intended for human use by hypo-
dermic injection.

      (gg) ``Secretary'' means the executive secretary of the board.

      (hh) ``Unprofessional conduct'' means:

      (1) Fraud in securing a registration or permit;

      (2) intentional adulteration or mislabeling of any drug, medicine,
chemical or poison;

      (3) causing any drug, medicine, chemical or poison to be adulterated
or mislabeled, knowing the same to be adulterated or mislabeled;

      (4) intentionally falsifying or altering records or prescriptions;

      (5) unlawful possession of drugs and unlawful diversion of drugs to
others;

      (6) willful betrayal of confidential information under K.S.A. 65-1654
and amendments thereto;

      (7) conduct likely to deceive, defraud or harm the public;

      (8) making a false or misleading statement regarding the licensee's
professional practice or the efficacy or value of a drug;

      (9) commission of any act of sexual abuse, misconduct or exploitation
related to the licensee's professional practice; or

      (10)  performing unnecessary tests, examinations or services which
have no legitimate pharmaceutical purpose.

      (ii) ``Mid-level practitioner'' means an advanced registered nurse
practitioner issued a certificate of qualification pursuant to K.S.A. 65-1131
and amendments thereto who has authority to prescribe drugs pursuant
to a written protocol with a responsible physician under K.S.A. 65-1130
and amendments thereto or a physician's assistant registered pursuant to
K.S.A. 65-2896a and amendments thereto who has authority to prescribe
drugs pursuant to a written protocol with a responsible physician under
K.S.A. 65-2896e and amendments thereto.

      (jj) ``Veterinary medical teaching hospital pharmacy'' means any lo-
cation where prescription-only drugs are stored as part of an accredited
college of veterinary medicine and from which prescription-only drugs
are distributed for use in treatment of or administration to a non-human.

      Sec.  2. K.S.A. 1999 Supp. 65-1643 is hereby amended to read as
follows: 65-1643. On and after the effective date of this act, It shall be
unlawful:

      (a) For any person to operate, maintain, open or establish any phar-
macy within this state without first having obtained a registration from
the board. Each application for registration of a pharmacy shall indicate
the person or persons desiring the registration, including the pharmacist
in charge, as well as the location, including the street name and number,
and such other information as may be required by the board to establish
the identity and exact location of the pharmacy. The issuance of a regis-
tration for any pharmacy shall also have the effect of permitting such
pharmacy to operate as a retail dealer without requiring such pharmacy
to obtain a retail dealer's permit. On evidence satisfactory to the board:
(1) That the pharmacy for which the registration is sought will be con-
ducted in full compliance with the law and the rules and regulations of
the board; (2) that the location and appointments of the pharmacy are
such that it can be operated and maintained without endangering the
public health or safety; (3) that the pharmacy will be under the supervision
of a pharmacist, a registration shall be issued to such persons as the board
shall deem qualified to conduct such a pharmacy.

      (b) For any person to manufacture within this state any drugs except
under the personal and immediate supervision of a pharmacist or such
other person or persons as may be approved by the board after an inves-
tigation and a determination by the board that such person or persons is
qualified by scientific or technical training or experience to perform such
duties of supervision as may be necessary to protect the public health and
safety; and no person shall manufacture any such drugs without first ob-
taining a registration so to do from the board. Such registration shall be
subject to such rules and regulations with respect to requirements, sani-
tation and equipment, as the board may from time to time adopt for the
protection of public health and safety.

      (c) For any person to distribute at wholesale any drugs without first
obtaining a registration so to do from the board.

      (d) For any person to sell or offer for sale at public auction or private
sale in a place where public auctions are conducted, any drugs without
first having obtained a registration from the board so to do, and it shall
be necessary to obtain the permission of the board in every instance where
any of the products covered by this section are to be sold or offered for
sale.

      (e) For any person to in any manner distribute or dispense samples
of any drugs without first having obtained a permit from the board so to
do, and it shall be necessary to obtain permission from the board in every
instance where the samples are to be distributed or dispensed. Nothing
in this subsection shall be held to regulate or in any manner interfere
with the furnishing of samples of drugs to duly licensed practitioners, to
mid-level practitioners, to pharmacists or to medical care facilities.

      (f) Except as otherwise provided in this subsection (f), for any person
operating a store or place of business to sell, offer for sale or distribute
any drugs to the public without first having obtained a registration or
permit from the board authorizing such person so to do. No retail dealer
who sells 12 or fewer different nonprescription drug products shall be
required to obtain a retail dealer's permit under the pharmacy act of the
state of Kansas or to pay a retail dealer new permit or permit renewal fee
under such act. It shall be lawful for a retail dealer who is the holder of
a valid retail dealer's permit issued by the board or for a retail dealer who
sells 12 or fewer different nonprescription drug products to sell and dis-
tribute nonprescription drugs which are prepackaged, fully prepared by
the manufacturer or distributor for use by the consumer and labeled in
accordance with the requirements of the state and federal food, drug and
cosmetic acts. Such nonprescription drugs shall not include: (1) A con-
trolled substance; (2) a prescription-only drug; or (3) a drug product in-
tended for human use by hypodermic injection; but such a retail dealer
shall not be authorized to display any of the words listed in subsection
(u) of K.S.A. 65-1626 and amendments thereto, for the designation of a
pharmacy or drugstore.

      (g) For any person to sell any drugs manufactured and sold only in
the state of Kansas, unless the label and directions on such drugs shall
first have been approved by the board.

      (h) For any person to operate an institutional drug room without first
having obtained a registration to do so from the board. Such registration
shall be subject to the provisions of K.S.A. 65-1637a and amendments
thereto and any rules and regulations adopted pursuant thereto.

      (i) For any person to be a pharmacy student without first obtaining
a registration to do so from the board, in accordance with rules and reg-
ulations adopted by the board, and paying a pharmacy student registration
fee of $25 to the board.

      (j) For any person to operate a veterinary medical teaching hospital
pharmacy without first having obtained a registration to do so from the
board. Such registration shall be subject to the provisions of section 4 and
amendments thereto and any rules and regulations adopted pursuant
thereto.

      Sec.  3. K.S.A. 1999 Supp. 65-1645 is hereby amended to read as
follows: 65-1645. (a) Application for registrations or permits under K.S.A.
65-1643 and amendments thereto shall be made on a form prescribed
and furnished by the board. Applications for registration to distribute at
wholesale any drugs shall contain such information as may be required
by the board in accordance with the provisions of K.S.A. 65-1655 and
amendments thereto. The application shall be accompanied by the fee
prescribed by the board under the provisions of this section. When such
application and fees are received by the executive secretary of the board
on or before the due date, such application shall have the effect of tem-
porarily renewing the applicant's registration or permit until actual issu-
ance or denial of the renewal. However, if at the time of filing a pro-
ceeding is pending before the board which may result in the suspension,
probation, revocation or denial of the applicant's registration or permit,
the board may declare, by emergency order, that such application for
renewal shall not have the effect of temporarily renewing such applicant's
registration or permit. Separate applications shall be made and separate
registrations or permits issued for each separate place at which is carried
on any of the operations for which a registration or permit is required by
K.S.A. 65-1643 and amendments thereto except that the board may pro-
vide for a single registration for a business entity registered to manufac-
ture any drugs or registered to distribute at wholesale any drugs and
operating more than one facility within the state, or for a parent entity
with divisions, subsidiaries or affiliate companies, or any combination
thereof, within the state when operations are conducted at more than one
location and there exists joint ownership and control among all the enti-
ties.

      (b) The fees required for the issuing of the licenses, registrations or
permits under the pharmacy act of the state of Kansas shall be fixed by
the board as herein provided, subject to the following:

      (1) Pharmacy, new registration not more than $150, renewal not
more than $125;

      (2) pharmacist, examination fee not more than $350;

      (3) pharmacist, examination fee for previously licensed pharmacist
not more than $250;

      (4) pharmacist, biennial renewal fee not more than $200;

      (5) pharmacist, evaluation fee not more than $250;

      (6) pharmacist, reciprocal licensure fee not more than $250;

      (7) pharmacist, penalty fee, not more than $500;

      (8) manufacturer, new registration not more than $500, renewal not
more than $400;

      (9) wholesaler, new registration not more than $500, renewal not
more than $400, except that a wholesaler dealing exclusively in nonpres-
cription drugs, the manufacturing, distributing or dispensing of which
does not require registration under the uniform controlled substances act,
shall be assessed a fee for registration and reregistration not to exceed
$50;

      (10) special auction not more than $50;

      (11) samples distribution not more than $50;

      (12) institutional drug room, new registration not more than $40, re-
newal not more than $35;

      (13) retail dealer selling more than 12 different nonprescription drug
products, new permit not more than $12, renewal not more than $12; or

      (14) certification of grades for each applicant for examination and
registration not more than $25.; or

      (15) veterinary medical teaching hospital pharmacy, new registration
not more than $40, renewal not more than $35.

      (c) For the purpose of fixing fees, the board may establish classes of
retail dealers' permits for retail dealers selling more than 12 different
nonprescription drug products, and the board may fix a different fee for
each such class of permit.

      (d) The board shall determine annually the amount necessary to carry
out and enforce the provisions of this act for the next ensuing fiscal year
and shall fix by rules and regulations the fees authorized for such year at
the sum deemed necessary for such purposes. The fees fixed by the board
under this section immediately prior to the effective date of this act shall
continue in effect until different fees are fixed by the board by rules and
regulations as provided under this section.

      (e) The board may deny renewal of any registration or permit re-
quired by K.S.A. 65-1643 and amendments thereto on any ground which
would authorize the board to suspend, revoke or place on probation a
registration or permit previously granted pursuant to the provisions of
K.S.A. 65-1643 and amendments thereto. Registrations and permits is-
sued under the provisions of K.S.A. 65-1643 and 65-1644 and amend-
ments thereto shall be conspicuously displayed in the place for which the
registration or permit was granted. Such registrations or permits shall not
be transferable. All such registrations and permits except retail dealer
permits shall expire on June 30 following date of issuance. Retail dealers'
permits shall expire on the last day of February. All registrations and
permits shall be renewed annually. Application blanks for renewal of reg-
istrations and permits shall be mailed by the board to each registrant or
permittee at least 30 days prior to expiration of the registration or permit.
If application for renewal is not made before 30 days after such expiration,
the existing registration or permit shall lapse and become null and void
on the date of its expiration, and no new registration or permit shall be
granted except upon payment of the required renewal fee plus a penalty
equal to the renewal fee. Failure of any registrant or permittee to receive
such application blank shall not relieve the registrant or permittee from
the penalty hereby imposed if the renewal is not made as prescribed.

      (f) In each case in which a license of a pharmacist is issued or renewed
for a period of time less than two years, the board shall prorate to the
nearest whole month the license or renewal fee established pursuant to
K.S.A. 65-1645 and amendments thereto.

      (g) The board may require that fees paid for any examination under
the pharmacy act of the state of Kansas be paid directly to the examination
service by the person taking the examination.

      New Sec.  4. (a) Distribution and control of prescription-only drugs
in a veterinary medical teaching hospital pharmacy shall be under the
supervision of a pharmacist in charge. The pharmacist in charge shall also
be responsible for establishing and maintaining adequate policies and
procedures for training of personnel; storage and maintenance of pre-
scription-only drugs and equipment; quality assurance, labeling, packag-
ing and distribution of prescription-only drugs; recordkeeping and secu-
rity.

      (b) The board shall adopt such rules and regulations relating to the
policies and procedures for veterinary medical teaching hospital phar-
macies as necessary for proper control of prescription-only drugs by such
veterinary medical teaching hospital pharmacies and adequate safety.

      (c) This section shall be part of and supplemental to the pharmacy
act of the state of Kansas.

 Sec.  5. K.S.A. 1999 Supp. 65-1626, 65-1643 and 65-1645 are hereby
repealed.

 Sec.  6. This act shall take effect and be in force from and after its
publication in the Kansas register.

Approved April 16, 2000.
 Published in the Kansas Register April 27, 2000.
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