reglab/statecodes huggingface dataset:
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 14 - WHOLESALE DISTRIBUTORS › Section 68-14-7 - Wholesale distributors; minimum requirements for the storage and handling of prescription-only drugs and devices and for the establishment and maintenance of prescription-only drug and device distribution records

Current through Register Vol. 43, No. 28, July 11, 2024
Each wholesale distributor registrant shall meet the following
				minimum requirements for the storage and handling of prescription-only drugs
				and devices and for the establishment and maintenance of prescription-only drug
				and device distribution records by the registrant and its officers, agents,
				representatives, and employees:
(a)
			 Facilities. Each facility at which prescription-only drugs and devices are
			 stored, warehoused, handled, held, offered, marketed, transported from, or
			 displayed shall meet the following requirements:
(1) Be of suitable size and construction to
			 facilitate cleaning, maintenance, and proper operations;
(2) have storage areas designed to provide
			 adequate lighting, ventilation, temperature, sanitation, humidity, space,
			 equipment, and security conditions;
(3) have a quarantine area for storage of
			 prescription-only drugs and devices that are outdated, damaged, deteriorated,
			 misbranded, adulterated, counterfeit, or suspected of being counterfeit, or
			 that are in immediate or sealed, secondary containers that have been opened or
			 deemed unfit for distribution;
(4)
			 be maintained in a clean and orderly condition;
(5) be free from infestation by insects,
			 rodents, birds, or vermin of any kind;
(6) be a commercial location and not a
			 personal dwelling or residence;
(7)
			 have sufficient storage space to maintain records of all transactions for at
			 least five years; and
(8) be in a
			 location separate from any other wholesale distributor or pharmacy registered
			 by the board or another state.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 14 - WHOLESALE DISTRIBUTORS › Section 68-14-7a - Third-party logistics providers; minimum requirements for operation and maintenance of records

Current through Register Vol. 43, No. 28, July 11, 2024
Each third-party logistics provider registrant shall meet the
				following minimum requirements for operation and the maintenance of
				records:
(a) Facilities. Each facility
			 at which a third-party logistics provider is located shall meet the following
			 requirements:
(1) Be of suitable size and
			 construction to facilitate cleaning, maintenance, and proper
			 operations;
(2) have storage areas
			 designed to provide adequate lighting, ventilation, temperature, sanitation,
			 humidity, space, equipment, and security conditions;
(3) have a quarantine area for storage of
			 prescription-only drugs and devices that are outdated, damaged, deteriorated,
			 misbranded, adulterated, counterfeit, or suspected of being counterfeit or that
			 are in immediate or sealed, secondary containers that have been opened or
			 deemed unfit for distribution;
(4)
			 be maintained in a clean and orderly condition;
(5) be free from infestation by insects,
			 rodents, birds, or vermin of any kind;
(6) be in a location separate from any
			 pharmacy registered by the board or another state;
(7) be a commercial location and not a
			 personal dwelling or residence; and
(8) have sufficient storage space to maintain
			 records of all shipments pertaining to third-party logistics for at least five
			 years.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 14 - WHOLESALE DISTRIBUTORS › Section 68-14-7b - Outsourcing facilities; minimum requirements for operation and maintenance of records

Current through Register Vol. 43, No. 28, July 11, 2024
Each registrant who is the owner of an outsourcing facility
				shall meet the following minimum requirements for operation and the maintenance
				of records:
(a) Facilities. Each
			 outsourcing facility shall meet the following requirements:
(1) Be of suitable size and construction to
			 facilitate cleaning, maintenance, and proper operations;
(2) have storage areas designed to provide
			 adequate lighting, ventilation, temperature, sanitation, humidity, space,
			 equipment, and security conditions;
(3) have a quarantine area for storage of
			 prescription-only drugs and devices that are outdated, damaged, deteriorated,
			 misbranded, adulterated, or deemed unit for distribution;
(4) have a quarantine area designated for
			 holding products waiting for testing data before being released for
			 distribution;
(5) be maintained in
			 a clean and orderly condition;
(6)
			 be free from infestation by insects, rodents, birds, or vermin of any
			 kind;
(7) be a commercial location
			 and not a personal dwelling or residence; and
(8) have sufficient storage space to maintain
			 records of all shipments pertaining to outsourcing for at least ive
			 years.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 14 - WHOLESALE DISTRIBUTORS › Section 68-14-8 - Wholesale distributors transaction

Current through Register Vol. 43, No. 28, July 11, 2024
(a)
			 Notwithstanding any other provision of these regulations under article 14, a
			 wholesale distributor, duly registered with the board, may sell or deliver to a
			 layperson responsible for the control of an animal, a prescription-only drug to
			 be administered to the animal only if a licensed veterinarian practitioner has
			 issued, before the sale or delivery, a lawful written prescription or order for
			 the prescription-only drug in the course of an existing, valid
			 veterinarian-client-patient relationship as defined in
			 K.S.A.
			 47-816 and amendments thereto. As used in
			 these regulations under article 14, "wholesale distribution" shall include this
			 transaction.
(1) Except as otherwise provided
			 in this regulation, at the time the prescription-only drug leaves the
			 registered location of the wholesale distributor, the wholesale distributor
			 shall possess, at the registered location, a copy of the written prescription
			 or order for the drug.
(2) Except
			 as otherwise provided in this regulation, at the time the prescription-only
			 drug is delivered to the layperson, the person making the delivery shall
			 possess a copy of the written prescription or order for the drug.
(3) The wholesale distributor shall retain,
			 for a period of five years, a copy of the written prescription or order in a
			 manner that makes it readily available for review by a board representative.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 15 - NONPRESCRIPTION WHOLESALE DISTRIBUTORS › Section 68-15-1 - Nonprescription wholesale distributors

Current through Register Vol. 43, No. 28, July 11, 2024
"Nonprescription wholesale distributor" shall mean any person,
				partnership, corporation, or business firm registered in this state and
				engaging in the distribution of drugs that are not prescription-only drugs to
				persons or entities other than a consumer or patient.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 15 - NONPRESCRIPTION WHOLESALE DISTRIBUTORS › Section 68-15-2 - Nonprescription wholesale distributor registration required

Current through Register Vol. 43, No. 28, July 11, 2024
A nonprescription wholesale distributor may engage in the
				distribution of nonprescription drugs to persons or entities, other than a
				consumer or patient in Kansas, if both of the following conditions are met:
(a) The drugs are prepackaged, fully
			 prepared by the manufacturer or distributor for use by a consumer, and
			 appropriately labeled.
(b) The
			 distributor has first obtained a registration to do so from the board.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 15 - NONPRESCRIPTION WHOLESALE DISTRIBUTORS › Section 68-15-4 - Minimum requirements for storage

Current through Register Vol. 43, No. 28, July 11, 2024
All drugs shall be stored at appropriate temperatures and under
				appropriate conditions in accordance with any requirements in the labeling or
				packaging of the drugs, or with any requirements in the United States
				pharmacopeia: the national formulary (USP/NF), as in effect on March 15, 1999
				and published January 1, 1995.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 18 - UTILIZATION OF UNUSED MEDICATIONS › Section 68-18-1 - Transferring unused medications

Current through Register Vol. 43, No. 28, July 11, 2024
(a) Each
			 administrator or operator of an adult care home, pharmacist-in-charge of a mail
			 service pharmacy, and administrator of a medical care facility who wants to
			 become a donating entity, as defined in
			 L.
			 2008, ch. 9,
			 sec.
			 2 and amendments thereto, shall submit to the
			 board written notification of intent to participate in the unused medications
			 program. The notification shall be submitted on a form approved by the board.
(b) Before the transfer of each
			 unused medication to a qualifying center or clinic, each mail service pharmacy
			 and medical care facility that has become a donating entity as specified in
			 subsection (a) shall perform the following:
(1) Determine the quality and suitability of
			 each unused medication by a pharmacist's verification that the unused
			 medication meets the following requirements:
(A) Can be identified;
(B) is in the manufacturer's sealed
			 container, a pharmacy unit-dose package, or a hermetically sealed tamperevident
			 package from the pharmacy;
(C) has
			 not passed its beyond-use date;
(D) is not a controlled substance;
(E) has not been adulterated; and
(F) is not a medication that can be dispensed
			 only to a patient or resident registered with the drug manufacturer;
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 18 - UTILIZATION OF UNUSED MEDICATIONS › Section 68-18-2 - Accepting unused medications

Current through Register Vol. 43, No. 28, July 11, 2024
(a) Each
			 qualifying center or clinic that elects to participate in the unused
			 medications program shall submit to the board written notification of intent to
			 participate on a form approved by the board.
(b) Each qualifying center or clinic shall
			 maintain all unused medications in a storage unit with controlled access.
(c) After the acceptance of each
			 unused medication from an adult care home that has become a donating entity as
			 specified in K.A.R. 68-18-1(a), each qualifying center or clinic shall perform
			 the following:
(1) Determine the quality and
			 suitability of each unused medication by verification of a pharmacist that the
			 unused medication meets the following requirements, in addition to the
			 requirements of
			 L.
			 2008, ch. 9,
			 sec.
			 4 and amendments thereto:
(A) Can be identified; and
(B) is not a medication that can be dispensed
			 only to a patient or resident registered with the drug manufacturer;
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 18 - UTILIZATION OF UNUSED MEDICATIONS › Section 68-18-3 - Recall of unused medications

Current through Register Vol. 43, No. 28, July 11, 2024
(a) If an unused
			 medication is recalled and the qualifying center or clinic does not have the
			 lot number on the label to differentiate between the recalled medications and
			 the nonrecalled medications, all of the unused medications shall be destroyed.
(b) If a donating entity has
			 transferred an unused medication to a qualifying center or clinic, the
			 medication is subsequently recalled, and the donating entity has been notified
			 of the recall, the donating entity shall be responsible for notifying the
			 qualifying center or clinic of the recall.
(c) Each qualifying center or clinic in
			 possession of any unused medication that is expired, adulterated, or recalled
			 shall make a manifest for and destroy that medication.
(d) Following the destruction of any unused
			 medications, the manifest shall be signed by the consulting pharmacist and a
			 witness to verify the destruction. Each drug destruction manifest shall be
			 maintained for at least five years.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 19 - CONTINUOUS QUALITY ASSURANCE PROGRAMS › Section 68-19-1 - Minimum program requirements

Current through Register Vol. 43, No. 28, July 11, 2024
Each pharmacy's continuous quality improvement program shall
				meet the following minimum requirements:
(a) Meet at least once each quarter of each
			 calendar year;
(b) have the
			 pharmacy's pharmacist-in-charge in attendance at each meeting; and
(c) perform the following during each
			 meeting:
(1) Review all incident reports
			 generated for each re-portable event associated with that pharmacy since the
			 last quarterly meeting;
(2) for
			 each incident report reviewed, establish the steps taken or to be taken to
			 prevent a recurrence of the incident;
(3) review each board newsletter published
			 since the last quarterly meeting; and
(4) create a report of the meeting, including
			 at least the following information:
(A) A list
			 of the persons in attendance;
(B) a
			 list of the incident reports and newsletters reviewed; and
(C) a description of the steps taken or to be
			 taken to prevent recurrence of each incident reviewed.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 20 - CONTROLLED SUBSTANCES › Section 68-20-1 - Definitions

Current through Register Vol. 43, No. 28, July 11, 2024
As used in this article of the board's regulations, each of the
				following terms shall have the meaning specified in this regulation:
(a) "Act" means the uniform controlled
			 substances act of Kansas,
			 K.S.A.
			 65-4101 et seq., and amendments
			 thereto.
(b) "Basic class," when
			 referring to controlled substances listed in
			 K.S.A.
			 65-4105 and
			 K.S.A.
			 65-4107 and amendments thereto, means any of
			 the following:
(1) Each of the opiates,
			 including its isomers, esters, ethers, and salts, and salts of isomers, esters,
			 and ethers, whenever the existence of the isomers, esters, ethers and salts is
			 possible within the specific chemical designation listed in
			 K.S.A.
			 65-4105(b) and amendments
			 thereto;
(2) each of the opium
			 derivatives, including its salts and isomers, and salts of isomers, whenever
			 the existence of the salts, isomers, and salts of isomers is possible within
			 the specific chemical designation listed in
			 K.S.A.
			 65-4105(c) and amendments
			 thereto;
(3) each of the
			 hallucinogenic substances, including its salts and isomers, and salts of
			 isomers, whenever the existence of the salts, isomers, and salts of isomers is
			 possible within the specific chemical designation listed in
			 K.S.A.
			 65-4105(d) and amendments
			 thereto;
(4) each of the following
			 substances, whether produced directly or indirectly by extraction from
			 substances of vegetable origin, independently by means of chemical synthesis,
			 or by a combination of extraction and chemical synthesis:
(A) Opium, including raw opium, opium
			 extracts, opium fluid extracts, powdered opium, granulated opium, deodorized
			 opium, and tincture of opium;
(B)
			 apomorphine;
(C) codeine;
(D) ethylmorphine;
(E) hydrocodone;
(F) hydromorphone;
(G) metopon;
(H) morphine;
(I) oxycodone;
(J) oxymorphone;
(K) thebaine;
(L) mixed alkaloid of opium listed in
			 K.S.A.
			 65-4107(b) (1) and
			 amendments thereto;
(M) cocaine;
			 and
(N)
			 ecgonine;
(5) each of the
			 opiates, including its isomers, esters, ethers, and salts, whenever the
			 existence of the isomers, esters, ethers, and salts is possible within the
			 specific chemical designation listed in
			 K.S.A.
			 65-4107(c) and amendments
			 thereto;
(6) methamphetamine,
			 including its salts, isomers, and salts of isomers, when contained in any
			 injectable liquid;
(7) amphetamine,
			 its salts, optical isomers and salts of its optical isomers;
(8) phenmetrazine and its salts; or
(9) methylphenidate.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 20 - CONTROLLED SUBSTANCES › Section 68-20-9 - Fees for registration and reregistration

Current through Register Vol. 43, No. 28, July 11, 2024
(a) Fee amounts.
(1) For each registration or reregistration
			 of a manufacturer for each additional location in this state where controlled
			 substances are manufactured, the registrant shall pay a fee of $50.00.
(2) For each registration or
			 reregistration of each additional location from which controlled substances are
			 distributed, the registrant shall pay a fee of $50.00.
(3) For each registration or reregistration
			 of each location within this state where research or instructional activities
			 are conducted with controlled substances listed in schedules I through V, the
			 registrant shall pay a fee of $50.00.
(4) For each registration or reregistration
			 to conduct chemical analysis with controlled substances listed in schedules I
			 through V, as set out in
			 K.S.A.
			 65-4105,
			 K.S.A.
			 65-4107,
			 K.S.A.
			 65-4109,
			 K.S.A.
			 65-4111,
			 K.S.A.
			 65-4113 and amendments thereto, within this
			 state, the registrant shall pay a fee of $50.00.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 20 - CONTROLLED SUBSTANCES › Section 68-20-10 - Requirements of registration

Current through Register Vol. 43, No. 28, July 11, 2024
(a) Persons
			 required to register. Every person who manufactures, distributes, or dispenses
			 any controlled substances within this state, or who proposes to engage in the
			 manufacture, distribution, or dispensing of any controlled substance in this
			 state shall obtain annually a registration unless exempted by law or pursuant
			 to subsections (d) through (g) of this regulation. Only persons actually
			 engaged in these activities in this state shall be required to obtain a
			 registration.
(b) Separate
			 registration for independent activ-ities.
(1)
			 The following six groups of activities shall be deemed to be independent of
			 each other:
(A) Manufacturing controlled
			 substances;
(B) distributing
			 controlled substances;
(C)
			 dispensing, conducting research, other than research described in paragraph
			 (b)(1)(D), with, and conducting instructional activities with, controlled
			 substances listed in schedules II through V;
(D) conducting research with narcotic drugs
			 listed in schedules II through V for the purpose of continuing the dependence
			 on these drugs of a narcotic drug-dependent person in the course of conducting
			 an authorized clinical investigation in the development of a narcotic addict
			 rehabilitation program pursuant to a notice of claimed investigational
			 exemption for a new drug approved by the food and drug administration;
(E) conducting research and
			 instructional activities with controlled substances listed in schedule I; and
(F) conducting chemical analysis
			 with controlled substances listed in any schedule.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 20 - CONTROLLED SUBSTANCES › Section 68-20-10a - Electronic transmission of a controlled substance prescription

Current through Register Vol. 43, No. 28, July 11, 2024
(a) Each
			 prescription drug order transmitted electronically shall be issued for a
			 legitimate medical purpose by a prescriber acting within the course of
			 legitimate professional practice.
(b) Each prescription drug order communicated
			 by way of electronic transmission shall fulfill all the requirements of K.A.R.
			 68-2-22 .
(c) A prescription drug
			 order, including that for any controlled substance listed in schedules II, III,
			 IV, and V, may be communicated by electronic transmission in accordance with 21
			 C.F.R. part 1311.
(d) Each
			 electronic prescription drug order created and transmitted in conformance with
			 21 C.F.R. part 1311 shall be considered an original, written, signed
			 prescription drug order.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 20 - CONTROLLED SUBSTANCES › Section 68-20-11 - Applications for registration

Current through Register Vol. 43, No. 28, July 11, 2024
(a) The
			 expiration date of all registrations shall be the last day of June in each
			 year.
(b) Each application for the
			 following types of registration shall include the controlled substances code
			 number for each basic class or substance to be covered by the registration:
(1) Registration to handle any basic class of
			 controlled substances listed in schedule I, except registration to conduct
			 chemical analysis with such classes;
(2) registration to manufacture a basic class
			 of controlled substances listed in schedules II through V; and
(3) registration to conduct research with any
			 narcotic controlled substance in schedules II through V.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 20 - CONTROLLED SUBSTANCES › Section 68-20-13 - Hearings generally

Current through Register Vol. 43, No. 28, July 11, 2024
In any case where the board shall hold a hearing on any
				registration or application therefor, the procedures for such hearing shall be
				conducted in accordance with the procedural provisions of the act and paragraph
				68-20-13 of these regulations. Any hearing under this part shall be independent
				of and not in lieu of, criminal proceedings or other proceedings under the act
				or any other law of this state.
(A)
			 Purpose of hearing The board shall hold a hearing for the purpose of receiving
			 factual evidence regarding the issues involved in the denial, revocation, or
			 suspension of any registration. Extensive argument should not be offered into
			 evidence but rather presented in opening or closing statements of counsel or in
			 memoranda or proposed findings of fact and conclusions of law.
(B) Waiver or modification of rules The board
			 or its presiding officer (with respect to matters pending before him), may
			 modify or waive any rule or regulation in paragraph 68-20-13 of these
			 regulations by notice in advance of the hearing, if the board determines that
			 no party in the hearing will be unduly prejudiced and the ends of justice will
			 thereby be served. Such notice of modification or waiver shall be made a part
			 of the records of the hearing.
(C)
			 Hearing; waiver.
(1) Any person entitled to a
			 hearing may file with the board a waiver of an opportunity for a hearing or to
			 participate in a hearing, together with a written statement regarding his
			 position on the matters of fact and law involved in such hearing. Such
			 statement, if admissible, shall be made a part of the record and shall be
			 considered in light of the lack of opportunity for cross-examination in
			 determining the weight to be attached to matters of fact asserted therein.
(2) If any person entitled to a
			 hearing or to participate in a hearing waives his opportunity to participate in
			 the hearing, the board may proceed without the presence of such person.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 20 - CONTROLLED SUBSTANCES › Section 68-20-14 - Modification, transfer and termination of registration

Current through Register Vol. 43, No. 28, July 11, 2024
(A) Modification
			 in registration Any registrant may apply to modify his registration to
			 authorize the handling of additional controlled substances by submitting a
			 letter of request to the state board of pharmacy. The letter shall contain the
			 registrant's name, address, registration number and the substance and/or
			 schedules to be added to his registration and shall be signed by the same
			 person who signed the most recent application for registration or
			 reregistration. If the registrant is seeking to handle additional controlled
			 substances listed in schedule I for the purpose of research or instructional
			 activities, he shall attach one copy of the federally approved research
			 protocol describing each research project involving the additional substances,
			 or two copies of a statement describing the nature, extent and duration of such
			 instructional activities, as appropriate. One-half of the original fees shall
			 be required to be paid for said modification. The request for modification
			 shall be handled in the same manner as an application for registration.
(B) Termination of registration
			 The registration of any person or location shall terminate if and when such
			 person or authorized representative of a location dies, ceases legal existence,
			 discontinues business or professional practice or changes the location as shown
			 on the certificate of registration. Any registrant who ceases legal existence,
			 discontinues business or professional practice, or changes location as shown on
			 the certificate of registration, shall notify the board promptly of such fact
			 and forthwith deliver the certificate of registration directly to the secretary
			 or executive secretary of the board. In the event of a change in name or
			 mailing address the person or authorized representative of the location shall
			 notify the board promptly in advance of the effective date of this change by
			 filing the change of name or mailing address with the board. This change shall
			 be noted on the original application on file with the board.
(C) Transfer of registration No registration
			 or any authority conferred thereby shall be assigned or otherwise transferred
			 except upon such conditions as the board may specifically designate and then
			 only pursuant to its written consent.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 20 - CONTROLLED SUBSTANCES › Section 68-20-15a - Security requirements

Current through Register Vol. 43, No. 28, July 11, 2024
(a) General
			 security requirements. Each applicant and registrant shall provide effective
			 controls and procedures to guard against theft and diversion of controlled
			 substances in conformance with the security requirements of federal law,
			 including the requirements of 21 CFR 1301.71 as in effect on April 1, 1999,
			 which are hereby adopted by reference.
(b) Physical security controls for
			 nonpractitioners shall comply with the requirements of 21 CFR 1301.72 and
			 1301.73 as in effect on April 1, 1999, which are hereby adopted by reference.
(c) Other security controls for
			 nonpractitioners.
(1) Good faith inquiry.
			 Before distributing a controlled substance to any person whom the registrant
			 does not know to be registered to possess a controlled substance, each
			 registrant shall make a good faith inquiry with the board to determine that the
			 person is registered to possess a controlled substance.
(2) Suspicious orders. Each registrant shall
			 design an operative system to disclose to the registrant any suspicious orders
			 of controlled substances. Each registrant shall inform the board of suspicious
			 orders when discovered. Suspicious orders shall include orders of unusual size,
			 orders deviating from a normal pattern, and orders of unusual frequency.
(3) A controlled substance listed
			 in schedules II through V shall not be distributed on a gratuitous basis by a
			 manufacturer or distributor to a practitioner, mid-level practitioner,
			 pharmacist, or any other person.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 20 - CONTROLLED SUBSTANCES › Section 68-20-15b - Notification to board; suspected diversion, theft, or loss of controlled substances

Current through Register Vol. 43, No. 28, July 11, 2024
Either the pharmacist-in-charge or the pharmacy owner shall
				notify the board in writing within one day of any suspected diversion, theft,
				or loss of any controlled substance and, upon completion, shall provide the
				board with a copy of the completed DEA 106 form issued by the U.S. department
				of justice.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 20 - CONTROLLED SUBSTANCES › Section 68-20-16 - Records and inventories of registrants

Current through Register Vol. 43, No. 28, July 11, 2024
(a) Except as
			 provided in this regulation, each registrant shall keep records and maintain
			 inventories in conformance with the recordkeeping and inventory requirements of
			 21 C.F.R.
			 1304.04(a)(2), (a)(3), (f), (g), (h)(1), (h) (2), (h)(3), and
			 (h)(4), as in effect on February 1, 2022,
			 which are hereby adopted by reference. Except as otherwise provided in this
			 regulation, the registrant shall maintain executed order forms and controlled
			 substance inventories at the registered facility and keep the records on file
			 for at least five years.
(b) After
			 the initial inventory is taken, the registrant shall take a subsequent
			 inventory of all controlled substances and drugs of concern on hand at least
			 every year but no later than 375 days after the date of the previous inventory.
			 All controlled substances and drugs of concern shall be inventoried on the same
			 calendar date.
(c) Each required
			 inventory of schedule II controlled substances and nonliquid dosage forms of
			 other controlled substances and drugs of concern shall be taken by exact
			 count.
(d) Each registrant handling
			 schedule V controlled substances and drugs of concern shall be subjected to the
			 same inventory and recordkeeping requirements specified in subsections (a) and
			 (b).
(e) Each inventory of
			 controlled substances shall be maintained in legible, hard-copy format and
			 shall include the following:
(1) The date the
			 inventory was conducted;
(2) the
			 name, license or registration number, and signature of each individual
			 participating in the inventory; and
(3) documentation of whether the inventory
			 was taken before the opening of business or after the close of business. If the
			 pharmacy is open 24 hours per day and does not close, the time that the count
			 was taken shall be documented.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 20 - CONTROLLED SUBSTANCES › Section 68-20-17 - Order forms

Current through Register Vol. 43, No. 28, July 11, 2024
Each transfer of any schedule I or II controlled substance
				shall require the use of a drug enforcement agency (DEA) 222 form issued by the
				United States attorney general in accordance with 21 CFR part 1305 or an
				electronic order placed in accordance with 21 CFR part 1311.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 20 - CONTROLLED SUBSTANCES › Section 68-20-18 - Information concerning prescriptions

Current through Register Vol. 43, No. 28, July 11, 2024
(a) Any
			 prescription for a controlled substance may be filled by a pharmacist if the
			 prescription has been issued by a prescriber who meets the following
			 requirements:
(1) Is legally authorized to
			 prescribe controlled substances in Kansas or is authorized by the laws of
			 another state; and
(2) is either
			 registered or exempted from registration under
			 K.S.A.
			 65-4116 or
			 K.S.A.
			 65-4117 and amendments
			 thereto.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 20 - CONTROLLED SUBSTANCES › Section 68-20-18a - Information concerning prescriptions; recordkeeping; pharmacy prescription application

Current through Register Vol. 43, No. 28, July 11, 2024
(a) Each controlled
			 substance shall be supplied or dispensed directly to a patient only pursuant to
			 a prescription issued in accordance with
			 K.A.R.
			 68-20-18. Each controlled substance shall be
			 supplied at a registered facility for immediate facility administration to the
			 ultimate user only pursuant to a medication order.
(b) Each dispensing, partial filling, or
			 refilling of a prescription for a controlled substance shall be entered on the
			 back of the prescription with the date, quantity, and name or initials of the
			 pharmacist providing the final verification.
(c) As an alternative to the procedures
			 provided by subsection (b), a pharmacy prescription application may be used for
			 the storage and retrieval of dispensing, refill, and partial filling
			 information for prescription orders for controlled substances if all of the
			 following requirements are met:
(1) Each
			 computerized system shall provide on-line retrieval, by computer monitor
			 display or hard-copy printout, of original prescription order, refill, and
			 partial fill information for those prescription orders that are authorized for
			 filling. Each display or printout of information shall include the following:
(A) The original prescription
			 number;
(B) the date of issuance of
			 the original prescription order by the prescriber;
(C) the dates of dispensing or partial
			 filling;
(D) the full name and
			 address of the patient;
(E) the
			 name, address, and DEA registration number of the prescriber;
(F) the name, strength, dosage form, quantity
			 of the controlled substance prescribed, and the quantity dispensed, if
			 different from the quantity prescribed;
(G) the identification code, or name or
			 initials of the dispensing pharmacist;
(H) the total number of refills authorized by
			 the prescriber, if applicable and allowable; and
(I) the total number of doses dispensed to
			 date for that prescription order.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 20 - CONTROLLED SUBSTANCES › Section 68-20-20 - Controlled substances listed in schedules III, IV, and V

Current through Register Vol. 43, No. 28, July 11, 2024
(a) A pharmacist
			 may dispense any controlled substance listed in schedule III, IV, or V that is
			 a prescription-only drug pursuant only to a prescription issued in accordance
			 with K.A.R. 68-20-18.
(b) Additional quantities of controlled
			 substances listed in schedule III, IV, or V may be authorized by a prescriber
			 through an oral refill authorization transmitted to the pharmacist if all of
			 the following conditions are met:
(1) The
			 total quantity authorized, including the amount of the original prescription,
			 does not exceed five refills or extend beyond six months from the date of issue
			 of the original prescription.
(2)
			 The pharmacist obtaining the oral authorization records on the reverse of the
			 original prescription the following:
(A) The
			 date;
(B) the quantity of
			 refill;
(C) the number of
			 additional refills authorized; and
(D) the initials of the pharmacist who
			 received the authorization from the prescriber.
(3) The quantity of each additional refill
			 authorized is equal to or less than the quantity authorized for the initial
			 filling of the original prescription.
(4) The prescriber executes a new
			 prescription as provided in
			 K.A.R.
			 68-20-18 for any additional quantities beyond
			 the five-refill, six-month limitation.
(5) The authorization of additional
			 quantities is documented by either of the methods specified in
			 K.A.R.
			 68-20-18a.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 20 - CONTROLLED SUBSTANCES › Section 68-20-22 - Selling without a prescription

Current through Register Vol. 43, No. 28, July 11, 2024
Any controlled substance listed in schedule II, III, IV, or V
				that is not a prescription-only drug may be sold by a pharmacist without a
				prescription to a purchaser at retail if all of the following conditions are
				met:
(a) The sale of any substance
			 that is a methamphet-amine precursor is made in accordance with
			 K.S.A.
			 65-16,102, and amendments thereto, and with
			 21 C.F.R.
			 1314.20,
			 21 C.F.R. 1314.25,
			 21 C.F.R.
			 1314.30,
			 21 C.F.R.1314.100, and
			 21 C.F.R.
			 1314.105 as in effect on August 31,
			 2022.
(b) The sale of any substance
			 that is not a methamphet-amine precursor meets all of the following conditions:
(1) Approval of the sale is made only by a
			 pharmacist and not by a nonpharmacist employee, even if under the supervision
			 of a pharmacist.
(2) The pharmacist
			 does not sell at retail more than 240 cc (8 ounces) of any controlled substance
			 containing opium or more than 120 cc (4 ounces) of any other controlled
			 substance to the same purchaser in any 48-hour period.
(3) The pharmacist does not sell at retail
			 more than 48 dosage units of any controlled substance containing opium or more
			 than 24 dosage units of any other controlled substance to the same purchaser in
			 any 48-hour period.
(4) The
			 purchaser is at least 18 years of age.
(5) The pharmacist requires every purchaser
			 of a controlled substance to furnish suitable identification that includes
			 proof of age.
(6) The pharmacist
			 maintains a bound record book for the dispensing of controlled substances. The
			 record book shall contain the name and address of the purchaser, the name and
			 quantity of controlled substance purchased, the date of each purchase, and the
			 name or initials of the pharmacist who approved the sale of the substance to
			 the purchaser. The record book shall be kept readily retrievable at the
			 registered location for five years.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 20 - CONTROLLED SUBSTANCES › Section 68-20-32 - 8-bromo-6-(2-fuorophenyl)-1-methyl-4H-benzo[f] [1,2,4]triazolo[4,3-a][1,4]diazepine included in schedule I

Current through Register Vol. 43, No. 28, July 11, 2024
(a)
			 8-bromo-6-(2-fuorophenyl)-1-methyl-4H-benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine
			 (other name: fubromazolam), including its salts, isomers, and salts of isomers,
			 shall be classified as a schedule I controlled substance.
(b) This regulation shall expire on July 1,
			 2024.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 20 - CONTROLLED SUBSTANCES › Section 68-20-33 - 6-(2-chlorophenyl)-1-methyl-8-nitro-4 H -benzo[ f] [1,2,4]triazolo[4,3- a ][1,4]diazepine included in schedule I

Current through Register Vol. 43, No. 28, July 11, 2024
(a)
			 6-(2-chlorophenyl)-1-methyl-8-nitro-4H-benzo[f] [1,2,4]triazolo[4,3-a][1,4]diazepine
			 (othername: clonazolam), including its salts, isomers, and salts of isomers, shall
			 be classified as a schedule I controlled substance.
(b) This regulation shall expire on July 1,
			 2024.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 21 - PRESCRIPTION MONITORING PROGRAM › Section 68-21-1 - Definitions

Current through Register Vol. 43, No. 28, July 11, 2024
As used in this article of the board's regulations, each of the
				following terms shall have the meaning specified in this regulation:
(a) "Authentication" means the provision of
			 information, an electronic device, or a certificate by the board or its
			 designee to a requester that allows the requester to electronically access
			 prescription monitoring information. The authentication may include the
			 provision of a user name, a password, or an electronic identification device or
			 certificate.
(b) "DEA" means the
			 drug enforcement administration of the United States department of
			 justice.
(c) "Dispenser
			 identification number" means the DEA number. If a DEA number is not issued to
			 the dispenser, the dispenser identification number means the NPI number or the
			 Kansas license number.
(d) "Drug
			 enforcement administration number" means a unique registration number issued to
			 a practitioner authorized by the DEA to prescribe controlled
			 substances.
(e) "National provider
			 identifier" and "NPI" mean a unique 10-digit number issued by the national
			 provider identifier registry and used to identify each practitioner whose
			 services are authorized by medicaid or medicare.
(f) "Patient identification number" means
			 that patient's unexpired temporary or permanent driver's license number,
			 state-issued identification card number, or pharmacy system-generated
			 identification number. If the patient does not have one of those numbers, the
			 dispenser shall use the patient's first, middle, and last initials, followed by
			 the patient's eight-digit birth date. The patient identification number shall
			 not include a social security number.
(g) "Report" means a compilation of data
			 concerning a dispenser, patient, drug of concern, or scheduled substance as
			 defined in
			 K.S.A.
			 65-1682, and amendments thereto.
(h) "Valid photographic identification" means
			 any of the following:
(1) An unexpired
			 driver's license, state identification card, or instruction permit;
(2) an unexpired official passport issued by
			 any nation;
(3) a United States
			 military identification card; or
(4) an unexpired identification card issued
			 by a United States Indian tribe.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 21 - PRESCRIPTION MONITORING PROGRAM › Section 68-21-2 - Electronic reports

Current through Register Vol. 43, No. 28, July 11, 2024
(a) Except as
			 specified in subsections (d) and (e), each dispenser shall file a report with
			 the board for each scheduled substance and drug of concern sold in Kansas or to
			 an address in Kansas. This report shall be submitted by the end of the next
			 business day from the day that the drug is sold.
(b) Except as specified in subsections (c),
			 (d), and (e), each dispenser that does not dispense scheduled substances or
			 drugs of concern in Kansas or to an address in Kansas during the reporting
			 period specified in subsection (a) shall file a zero report with the board.
			 Each zero report shall be fled by the end of the next business day.
(c) Any dispenser that meets the following
			 conditions may submit a written request to the board for an exemption from
			 subsection (b):
(1) The dispenser does not
			 monthly dispense more than 10 prescriptions for scheduled substances and drugs
			 of concern in Kansas or to an address in Kansas.
(2) The dispenser is unable to automate
			 submission of a zero report.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 21 - PRESCRIPTION MONITORING PROGRAM › Section 68-21-4 - Notice of requests for information

Current through Register Vol. 43, No. 28, July 11, 2024
Each dispenser who may access information maintained by the
				board on each drug of concern and scheduled substance dispensed to one of the
				dispenser's patients for the purpose of providing medical or pharmaceutical
				care shall notify the patient of this access to program information by
				performing either of the following:
(a) Posting an easily viewable sign at the
			 place where prescription orders are issued or accepted for dispensing;
			 or
(b) providing written material
			 about the dispenser's access to program information.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 21 - PRESCRIPTION MONITORING PROGRAM › Section 68-21-5 - Access to program information

Current through Register Vol. 43, No. 28, July 11, 2024
(a) Any patient or
			 patient's designee may obtain a report listing all program information that
			 pertains to the patient by submitting a written request to the board on a form
			 provided by the board, which shall include the following:
(1) The patient's name and, if applicable,
			 the name of the patient's designee;
(2) the patient's residential address and, if
			 applicable, the residential address of the patient's designee;
(3) the patient's telephone number and, if
			 applicable, the telephone number of the patient's designee;
(4) the time period for which information is
			 being requested;
(5) a copy of a
			 valid photographic identification of the patient or the patient's designee;
			 and
(6) if the requester is not the
			 patient, a copy of official documents establishing either legal guardianship or
			 power of attorney.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 21 - PRESCRIPTION MONITORING PROGRAM › Section 68-21-6 - Reciprocal agreements with other states or government entities to share information

Current through Register Vol. 43, No. 28, July 11, 2024
(a)
			 Reciprocal agreements with one or more of the following entities within the
			 United States may be entered into by the board to share program data if the
			 entity's prescription monitoring program is compatible with the program:
(1) A state, commonwealth, district, or
			 territory;
(2) a military or
			 veteran health system;
(3) an
			 Indian health system or service; or
(4) a city, county, municipality, or
			 township.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 21 - PRESCRIPTION MONITORING PROGRAM › Section 68-21-7 - Drugs of concern

Current through Register Vol. 43, No. 28, July 11, 2024
(a) Each
			 of the following shall be classified as a drug of concern:
(1) Any product containing all three of these
			 drugs: butalbital, acetaminophen, and caffeine;
(2) any compound, mixture, or preparation
			 that contains any detectable quantity of ephedrine, its salts or optical
			 isomers, or salts of optical isomers and is exempt from being reported to the
			 statewide electronic logging system for the sale of methamphetamine
			 precursors;
(3) any compound,
			 mixture, or preparation that contains any detectable quantity of
			 pseudoephedrine, its salts or optical isomers, or salts of optical isomers and
			 is exempt from being reported to the statewide electronic logging system for
			 the sale of methamphetamine precursors;
(4) promethazine with codeine; and
(5) any product, compound, mixture, or
			 preparation that contains gabapentin.
Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 22 - ELECTRONIC SUPERVISION OF MEDICAL CARE FACILITY'S PHARMACY PERSONNEL › Section 68-22-1 - Definitions

Current through Register Vol. 43, No. 28, July 11, 2024
(a) "Medical care
			 facility" shall have the meaning provided in
			 K.S.A.
			 65-1626(w), and amendments
			 thereto.
(b) "Pharmacy student"
			 shall have the meaning provided in
			 K.S.A.
			 65-1626(ee), and amendments
			 thereto, and shall include a pharmacy intern registered with the
			 board.
(c) "Pharmacy technician"
			 shall have the meaning provided in
			 K.S.A.
			 65-1626(ff), and amendments
			 thereto.
(d) "Real-time," when used
			 to describe the transmission of information through data, video, and audio
			 links, shall mean that the transmission is sufficiently rapid that the
			 information is available simultaneously to the electronically supervising
			 pharmacist and the pharmacy student or pharmacy technician being electronically
			 supervised in the medical care facility's pharmacy.
(e) "Electronic supervision" shall mean the
			 oversight provided by a pharmacist licensed in Kansas and supervising, by means
			 of real-time communication equipment that meets the operating requirements
			 listed in K.A.R. 68-22-5, a registered pharmacy student or pharmacy technician
			 who is working in a Kansas medical care facility's pharmacy.