394             1997 Session Laws of Kansas             Ch. 112

An Act concerning the regulation of pharmacists; persons engaged in the practice of phar-
macy; amending K.S.A. 65-1626, as amended by section 118 of chapter 229 of the 1996
Session Laws of Kansas, and 65-1643 and K.S.A. 1996 Supp. 65-1642 and repealing the
existing sections.

Be it enacted by the Legislature of the State of Kansas:

Section. 1. K.S.A. 65-1626, as amended by section 118 of chapter
229 of the 1996 Session Laws of Kansas, 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.

(g) (h) ``Dispense'' means to deliver prescription medication to the
ultimate user or research subject by or pursuant to the lawful order of a
practitioner.

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

(i) (j) ``Distribute'' means to deliver, other than by administering or
dispensing, any drug.

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

(k) (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) articles 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 document
by way of electronic equipment.

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

(m) (o) (1) ``Institutional drug room'' means any location where pre-
scription-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.

(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.

(n) (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
amendments thereto except community mental health centers and facil-
ities for the mentally retarded.

(o) (q) ``Manufacture'' means the production, preparation, propaga-
tion, compounding, conversion or processing of a drug either directly or
indirectly by extraction from substances of natural origin, independently
by means of chemical synthesis or by a combination of extraction and

396             1997 Session Laws of Kansas             Ch. 112

chemical synthesis and includes any packaging or repackaging of the drug
or labeling or relabeling of its container, except that this term shall not
include the preparation or compounding of a drug by an individual for
the individual's own use or the preparation, compounding, packaging or
labeling 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.

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

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

(r) (t) ``Pharmacist in charge'' means the pharmacist who is respon-
sible to the board for a registered establishment's compliance with the
laws and regulations of this state pertaining to the practice of pharmacy,
manufacturing 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.

(s) (u) ``Pharmacy,'' ``drug store'' or ``apothecary'' means premises,
laboratory, 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 di-
rect supervision and control of a pharmacist, may perform packaging,
manipulative, repetitive or other nondiscretionary tasks related to the
processing of a prescription or medication order and who assists the phar-

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macist in the performance of pharmacy related duties, but who does not
perform duties restricted to a pharmacist.

(t) (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.

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

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

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

(x) (bb) ``Prescription-only drug'' means any drug required by the
federal or state food, drug and cosmetic act to bear on its label the legend
``Caution: Federal law prohibits dispensing without prescription.''

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

(z) (dd) ``Probation'' means the practice or operation under a tem-
porary license, registration or permit or a conditional license, registration
or permit 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.

(aa) (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.

(bb) (ff) ``Retail dealer'' means a person selling at retail nonprescrip-
tion 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

398             1997 Session Laws of Kansas             Ch. 112

nonprescription drugs shall not include: (1) A controlled substance; (2) a
drug the label of which is required to bear substantially the statement
``Caution: Federal law prohibits dispensing without prescription''; or (3)
a drug intended for human use by hypodermic injection.

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

(dd) (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.

Sec. 2. K.S.A. 1996 Supp. 65-1642 is hereby amended to read as
follows: 65-1642. (a) Each pharmacy shall be equipped with proper phar-
maceutical utensils, in order that prescriptions can be properly filled and
United States pharmacopoeia and national formulary preparations prop-
erly compounded, and with proper sanitary appliances which shall be kept
in a clean and orderly manner. The board shall prescribe the minimum
of such professional and technical equipment which a pharmacy shall at
all times possess, and such list shall include the latest revisions of the
United States pharmacopoeia dispensing information and all supplements
thereto. The ratio of supportive personnel performing nonjudgmental
functions in the compounding area of the pharmacy under the direction
of a pharmacist, excluding pharmacist interns, to licensed pharmacists
shall not exceed a one-to-one ratio in other than medical care facility
pharmacies and a two-to-one ratio for medical care facility pharmacies
except that any pharmacy may be specifically authorized by the board to
exceed the ratio established under this subsection for that pharmacy upon
the approval of a specific plan describing the manner in which additional
supportive personnel shall be supervised.

(b) (1) Each pharmacy shall at all times maintain a list of the names
of pharmacy technicians employed by the pharmacy and shall post in a
conspicuous location in the prescription area of the pharmacy the name

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of the pharmacy technician currently on duty at the pharmacy, if any. A
pharmacy technician shall work under the direct supervision and control
of a pharmacist. It shall be the responsibility of the pharmacist to deter-
mine that the pharmacy technician is in compliance with the applicable
rules and regulations of the board, and the pharmacist who supervises a
pharmacy technician shall be responsible for the acts and omissions of the
pharmacy technician in the performance of the pharmacy technician's
duties. The ratio of pharmacy technicians to pharmacists in the prescrip-
tion area of a pharmacy shall not exceed a two-to-one ratio.

(2) The board shall adopt such rules and regulations as are necessary
to ensure that pharmacy technicians are adequately trained as to the
nature and scope of their lawful duties.

(b) (c) Each pharmacy shall keep a suitable book or file which records
every prescription order filled at the pharmacy and a medication profile
record system as provided under subsection (c) (d). The book or file of
prescription orders shall be kept for a period of not less than five years.
The book or file of prescription orders shall at all times be open to in-
spection by members of the board, the secretary of health and environ-
ment, the duly authorized agents or employees of such board or secretary
and other proper authorities.

(c) (d) (1) A medication profile record system shall be maintained in
all pharmacies for persons for whom prescriptions are dispensed. The
following information shall be recorded: (A) The name and address of the
patient for whom the medication is intended; (B) the prescriber's name,
the original date the prescription is dispensed and the number or desig-
nation identifying the prescription; and (C) the name, strength and quan-
tity of the drug dispensed and the name of the dispensing pharmacist;
and (D) drug allergies and sensitivities.

(2) Upon receipt of a prescription order, the pharmacist shall examine
the patient's medication profile record before dispensing the medication
to determine the possibility of a harmful drug interaction or reaction to
the medication. Upon recognizing a potential harmful drug interaction or
reaction to the medication, the pharmacist shall take appropriate action
to avoid or minimize the problem which shall, if necessary, include con-
sultation with the prescriber with documentation of actions taken on the
prescription record.

(3) A medication profile record shall be maintained for a period of
not less than five years from the date of the last entry in the record.

(4) All prescription drug orders communicated by way of electronic
transmission shall conform to federal and state laws and the provisions
of the board's rules and regulations.

(d) (e) No registration shall be issued or continued for the conduct
of a pharmacy until or unless the provisions of this section have been
complied with.

400             1997 Session Laws of Kansas             Ch. 112

Sec. 3. K.S.A. 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
pharmacists or to medical care facilities.

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(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 drug product the label of which is required to
bear substantially the statement: ``Caution: Federal law prohibits dis-
pensing without prescription''; or (3) a drug product intended for human
use by hypodermic injection; but such a retail dealer shall not be author-
ized to display any of the words listed in subsection (s) 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 intern student without first ob-
taining a registration to do so from the board, in accordance with rules
and regulations adopted by the board, and paying a pharmacy intern stu-
dent registration fee of $25 to the board.

New Sec. 4. (a) For the purpose of the pharmacy act of the state of
Kansas, the following persons shall be deemed to be engaged in the prac-
tice of pharmacy:

(1) Persons who publicly profess to be a pharmacist, or publicly pro-
fess to assume the duties incident to being a pharmacist and their knowl-
edge of drugs or drug actions, or both;

(2) persons who attach to their name any words or abbreviation in-
dicating that they are a pharmacist licensed to practice pharmacy in Kan-
sas.

(b) ``Practice of pharmacy'' means the interpretation and evaluation
of prescription orders; the compounding, dispensing and labeling of drugs
and devices pursuant to prescription orders; the participation in drug
selection according to state law and participation in drug utilization re-

402             1997 Session Laws of Kansas             Ch. 112

views; the proper and safe storage of prescription drugs and prescription
devices and the maintenance of proper records thereof in accordance with
law; consultation with patients and other health care practitioners about
the safe and effective use of prescription drugs and prescription devices;
and participation in the offering or performing of those acts, services,
operations or transactions necessary in the conduct, operation, manage-
ment and control of a pharmacy. Nothing in this subsection shall be con-
strued to add any additional requirements for registration or for a permit
under the pharmacy act of the state of Kansas or for approval under
subsection (g) of K.S.A. 65-1643 and amendments thereto, or to prevent
persons other than pharmacists from engaging in drug utilization review,
or to require persons lawfully in possession of prescription drugs or pre-
scription devices to meet any storage or record keeping requirements
except such storage and record keeping requirements as may be otherwise
provided by law or to affect any person consulting with a health care
practitioner about the safe and effective use of prescription drugs or pre-
scription devices.

Sec. 5. K.S.A. 65-1626, as amended by section 118 of chapter 229 of
the 1996 Session Laws of Kansas, and 65-1643 and K.S.A. 1996 Supp.
65-1642 are hereby repealed.

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

Approved April 22, 1997.