65-1655.Information required of applicant forregistration to distributeat wholesale any drugs; factors in reviewing qualifications of applicants;denial of application if not in public interest; qualifications of personnel;inspection by the board; rules and regulations.(a) The board shall require an applicant for registration to distribute atwholesale any drugs under K.S.A. 65-1643 and amendments thereto, or anapplicant for renewal of such a registration, to provide the followinginformation:
(1) The name, full business address and telephone number of the applicant;
(2) all trade or business names used by the applicant;
(3) addresses, telephone numbers, and the names of contact persons for allfacilities used by the applicant for the storage, handling and distribution ofprescription drugs;
(4) the type of ownership or operation of the applicant;
(5) the name of the owner or operator, or both, of the applicant, including:
(A) If a person, the name of the person;
(B) if a partnership, the name of each partner, and the name of thepartnership;
(C) if a corporation, the name and title of each corporate officer anddirector, the corporate names and the name of the state of incorporation;
(D) if a sole proprietorship, the full name of the sole proprietor and thename of the business entity; and
(6) such other information as the board deems appropriate. Changes in anyinformation in this subsection (a) shall be submitted to the board as requiredby such board.
(b) In reviewing the qualifications for applicants for initial registrationor renewal of registration to distribute at wholesale any drugs, the boardshall consider the following factors:
(1) Any convictions of the applicant under any federal, state or local lawsrelating to drug samples, wholesale or retail drug distribution or distributionof controlled substances;
(2) any felony convictions of the applicant under federal or state laws;
(3) the applicant's past experience in the manufacture or distribution ofprescription drugs, including controlled substances;
(4) the furnishing by the applicant of false or fraudulent material in anyapplication made in connection with drug manufacturing or distribution;
(5) suspension or revocation by federal, state or local government of anylicense or registration currently or previously held by the applicant for themanufacture or distribution of any drugs, including controlled substances;
(6) compliance with registration requirements under previously grantedregistrations, if any;
(7) compliance with requirements to maintain or make available to the boardor to federal state or local law enforcement officials those records requiredby federal food, drug and cosmetic act, and rules and regulations adoptedpursuant thereto; and
(8) any other factors or qualifications the board considers relevant to andconsistent with the public health and safety.
(c) After consideration of the qualifications for applicants forregistration to distribute at wholesale any drugs, the board may deny aninitial application for registration or application for renewal of aregistration if the board determines that the granting of such registrationwould not be in the public interest. The authority of the board under thissubsection to deny a registration to distribute at wholesale any drugs shall bein addition to the authority of the board under subsection (e) ofK.S.A.65-1627 and amendments thereto or subsection (e) of K.S.A. 65-1645 andamendments thereto.
(d) The board by rules and regulations shall require that personnel employedby persons registered to distribute at wholesale any drugs have appropriateeducation or experience, or both, to assume responsibility for positionsrelated to compliance with state registration requirements.
(e) The board by rules and regulations may implement this section to conformto any requirements of the federal prescription drug marketing act of 1987 (21U.S.C. 321 et seq.) in effect on the effective date of this act.
(f) Each facility that engages in wholesale distribution must undergo aninspection by the board or a third party recognized by the board to inspect andaccredit wholesale distributors for the purpose of inspecting the wholesaledistribution operations prior to initial registration and periodicallythereafterin accordance with a schedule to be determined by the board but not less thanonce every three years. The board shall have the authority to waiveregistration requirements for wholesale distributors that are accredited by anaccreditingagency approved by the board.The board shall adoptrules and regulations to establish standards and requirements for the issuanceand maintenance of a wholesale distributor registration, including inspectionsofwholesale distributor facilities domiciled in the state.
(1) Individual or third party inspectors must demonstrate to the board thatthey have received training or demonstrate familiarity with the inspectionstandards. Evidence such as a letter of certification from a training program,notice from the inspector's employing third party organization or other meansrecognized by the board shall be accepted as meeting the requirement.
(2) The board may register a wholesale distributor that is licensed orregistered under thelaws of another state if:
(A) The requirements of that state are deemed by the board to besubstantially equivalent; or
(B) the applicant is inspected and accredited by a third party recognized andapproved by the board.
(g) A person licensed or approved by the federal food and drug administrationto engage in the manufacture of drugs or devices engaged in wholesaledistribution need only satisfy the minimum federal requirements for licensureprovided in federal food and drug administration regulations 21 C.F.R. Part 205to provide wholesale distribution services.
(h) The board by rule and regulation shall establish standards andrequirements for the issuance and maintenance of a wholesale distributorregistration, including, but not limited to, requirements regarding thefollowing:(1) An application and renewal fee; (2) a surety bond; (3) registration andperiodic inspections; (4) certification of a designated representative; (5)designation of a registered agent; (6) storage of drugs and devices; (7)handling, transportation and shipment of drugs and devices; (8) security; (9)examination of drugs and devices and treatment of those found to beunacceptable as defined by the board; (10) due diligence regarding otherwholesale distributors; (11) creation and maintenance of records, includingtransaction records; and (12) procedures for operation.
(i) This section shall be part of and supplemental to thepharmacy act ofthe state of Kansas.
History: L. 1991, ch. 189, § 1;L. 1995, ch. 106, § 4;L. 2007, ch. 177, § 35; May 17.
65-1655.Information required of applicant forregistration to distributeat wholesale any drugs; factors in reviewing qualifications of applicants;denial of application if not in public interest; qualifications of personnel;inspection by the board; rules and regulations.(a) The board shall require an applicant for registration to distribute atwholesale any drugs under K.S.A. 65-1643 and amendments thereto, or anapplicant for renewal of such a registration, to provide the followinginformation:
(1) The name, full business address and telephone number of the applicant;
(2) all trade or business names used by the applicant;
(3) addresses, telephone numbers, and the names of contact persons for allfacilities used by the applicant for the storage, handling and distribution ofprescription drugs;
(4) the type of ownership or operation of the applicant;
(5) the name of the owner or operator, or both, of the applicant, including:
(A) If a person, the name of the person;
(B) if a partnership, the name of each partner, and the name of thepartnership;
(C) if a corporation, the name and title of each corporate officer anddirector, the corporate names and the name of the state of incorporation;
(D) if a sole proprietorship, the full name of the sole proprietor and thename of the business entity; and
(6) such other information as the board deems appropriate. Changes in anyinformation in this subsection (a) shall be submitted to the board as requiredby such board.
(b) In reviewing the qualifications for applicants for initial registrationor renewal of registration to distribute at wholesale any drugs, the boardshall consider the following factors:
(1) Any convictions of the applicant under any federal, state or local lawsrelating to drug samples, wholesale or retail drug distribution or distributionof controlled substances;
(2) any felony convictions of the applicant under federal or state laws;
(3) the applicant's past experience in the manufacture or distribution ofprescription drugs, including controlled substances;
(4) the furnishing by the applicant of false or fraudulent material in anyapplication made in connection with drug manufacturing or distribution;
(5) suspension or revocation by federal, state or local government of anylicense or registration currently or previously held by the applicant for themanufacture or distribution of any drugs, including controlled substances;
(6) compliance with registration requirements under previously grantedregistrations, if any;
(7) compliance with requirements to maintain or make available to the boardor to federal state or local law enforcement officials those records requiredby federal food, drug and cosmetic act, and rules and regulations adoptedpursuant thereto; and
(8) any other factors or qualifications the board considers relevant to andconsistent with the public health and safety.
(c) After consideration of the qualifications for applicants forregistration to distribute at wholesale any drugs, the board may deny aninitial application for registration or application for renewal of aregistration if the board determines that the granting of such registrationwould not be in the public interest. The authority of the board under thissubsection to deny a registration to distribute at wholesale any drugs shall bein addition to the authority of the board under subsection (e) ofK.S.A.65-1627 and amendments thereto or subsection (e) of K.S.A. 65-1645 andamendments thereto.
(d) The board by rules and regulations shall require that personnel employedby persons registered to distribute at wholesale any drugs have appropriateeducation or experience, or both, to assume responsibility for positionsrelated to compliance with state registration requirements.
(e) The board by rules and regulations may implement this section to conformto any requirements of the federal prescription drug marketing act of 1987 (21U.S.C. 321 et seq.) in effect on the effective date of this act.
(f) Each facility that engages in wholesale distribution must undergo aninspection by the board or a third party recognized by the board to inspect andaccredit wholesale distributors for the purpose of inspecting the wholesaledistribution operations prior to initial registration and periodicallythereafterin accordance with a schedule to be determined by the board but not less thanonce every three years. The board shall have the authority to waiveregistration requirements for wholesale distributors that are accredited by anaccreditingagency approved by the board.The board shall adoptrules and regulations to establish standards and requirements for the issuanceand maintenance of a wholesale distributor registration, including inspectionsofwholesale distributor facilities domiciled in the state.
(1) Individual or third party inspectors must demonstrate to the board thatthey have received training or demonstrate familiarity with the inspectionstandards. Evidence such as a letter of certification from a training program,notice from the inspector's employing third party organization or other meansrecognized by the board shall be accepted as meeting the requirement.
(2) The board may register a wholesale distributor that is licensed orregistered under thelaws of another state if:
(A) The requirements of that state are deemed by the board to besubstantially equivalent; or
(B) the applicant is inspected and accredited by a third party recognized andapproved by the board.
(g) A person licensed or approved by the federal food and drug administrationto engage in the manufacture of drugs or devices engaged in wholesaledistribution need only satisfy the minimum federal requirements for licensureprovided in federal food and drug administration regulations 21 C.F.R. Part 205to provide wholesale distribution services.
(h) The board by rule and regulation shall establish standards andrequirements for the issuance and maintenance of a wholesale distributorregistration, including, but not limited to, requirements regarding thefollowing:(1) An application and renewal fee; (2) a surety bond; (3) registration andperiodic inspections; (4) certification of a designated representative; (5)designation of a registered agent; (6) storage of drugs and devices; (7)handling, transportation and shipment of drugs and devices; (8) security; (9)examination of drugs and devices and treatment of those found to beunacceptable as defined by the board; (10) due diligence regarding otherwholesale distributors; (11) creation and maintenance of records, includingtransaction records; and (12) procedures for operation.
(i) This section shall be part of and supplemental to thepharmacy act ofthe state of Kansas.
History: L. 1991, ch. 189, § 1;L. 1995, ch. 106, § 4;L. 2007, ch. 177, § 35; May 17.
65-1655.Information required of applicant forregistration to distributeat wholesale any drugs; factors in reviewing qualifications of applicants;denial of application if not in public interest; qualifications of personnel;inspection by the board; rules and regulations.(a) The board shall require an applicant for registration to distribute atwholesale any drugs under K.S.A. 65-1643 and amendments thereto, or anapplicant for renewal of such a registration, to provide the followinginformation:
(1) The name, full business address and telephone number of the applicant;
(2) all trade or business names used by the applicant;
(3) addresses, telephone numbers, and the names of contact persons for allfacilities used by the applicant for the storage, handling and distribution ofprescription drugs;
(4) the type of ownership or operation of the applicant;
(5) the name of the owner or operator, or both, of the applicant, including:
(A) If a person, the name of the person;
(B) if a partnership, the name of each partner, and the name of thepartnership;
(C) if a corporation, the name and title of each corporate officer anddirector, the corporate names and the name of the state of incorporation;
(D) if a sole proprietorship, the full name of the sole proprietor and thename of the business entity; and
(6) such other information as the board deems appropriate. Changes in anyinformation in this subsection (a) shall be submitted to the board as requiredby such board.
(b) In reviewing the qualifications for applicants for initial registrationor renewal of registration to distribute at wholesale any drugs, the boardshall consider the following factors:
(1) Any convictions of the applicant under any federal, state or local lawsrelating to drug samples, wholesale or retail drug distribution or distributionof controlled substances;
(2) any felony convictions of the applicant under federal or state laws;
(3) the applicant's past experience in the manufacture or distribution ofprescription drugs, including controlled substances;
(4) the furnishing by the applicant of false or fraudulent material in anyapplication made in connection with drug manufacturing or distribution;
(5) suspension or revocation by federal, state or local government of anylicense or registration currently or previously held by the applicant for themanufacture or distribution of any drugs, including controlled substances;
(6) compliance with registration requirements under previously grantedregistrations, if any;
(7) compliance with requirements to maintain or make available to the boardor to federal state or local law enforcement officials those records requiredby federal food, drug and cosmetic act, and rules and regulations adoptedpursuant thereto; and
(8) any other factors or qualifications the board considers relevant to andconsistent with the public health and safety.
(c) After consideration of the qualifications for applicants forregistration to distribute at wholesale any drugs, the board may deny aninitial application for registration or application for renewal of aregistration if the board determines that the granting of such registrationwould not be in the public interest. The authority of the board under thissubsection to deny a registration to distribute at wholesale any drugs shall bein addition to the authority of the board under subsection (e) ofK.S.A.65-1627 and amendments thereto or subsection (e) of K.S.A. 65-1645 andamendments thereto.
(d) The board by rules and regulations shall require that personnel employedby persons registered to distribute at wholesale any drugs have appropriateeducation or experience, or both, to assume responsibility for positionsrelated to compliance with state registration requirements.
(e) The board by rules and regulations may implement this section to conformto any requirements of the federal prescription drug marketing act of 1987 (21U.S.C. 321 et seq.) in effect on the effective date of this act.
(f) Each facility that engages in wholesale distribution must undergo aninspection by the board or a third party recognized by the board to inspect andaccredit wholesale distributors for the purpose of inspecting the wholesaledistribution operations prior to initial registration and periodicallythereafterin accordance with a schedule to be determined by the board but not less thanonce every three years. The board shall have the authority to waiveregistration requirements for wholesale distributors that are accredited by anaccreditingagency approved by the board.The board shall adoptrules and regulations to establish standards and requirements for the issuanceand maintenance of a wholesale distributor registration, including inspectionsofwholesale distributor facilities domiciled in the state.
(1) Individual or third party inspectors must demonstrate to the board thatthey have received training or demonstrate familiarity with the inspectionstandards. Evidence such as a letter of certification from a training program,notice from the inspector's employing third party organization or other meansrecognized by the board shall be accepted as meeting the requirement.
(2) The board may register a wholesale distributor that is licensed orregistered under thelaws of another state if:
(A) The requirements of that state are deemed by the board to besubstantially equivalent; or
(B) the applicant is inspected and accredited by a third party recognized andapproved by the board.
(g) A person licensed or approved by the federal food and drug administrationto engage in the manufacture of drugs or devices engaged in wholesaledistribution need only satisfy the minimum federal requirements for licensureprovided in federal food and drug administration regulations 21 C.F.R. Part 205to provide wholesale distribution services.
(h) The board by rule and regulation shall establish standards andrequirements for the issuance and maintenance of a wholesale distributorregistration, including, but not limited to, requirements regarding thefollowing:(1) An application and renewal fee; (2) a surety bond; (3) registration andperiodic inspections; (4) certification of a designated representative; (5)designation of a registered agent; (6) storage of drugs and devices; (7)handling, transportation and shipment of drugs and devices; (8) security; (9)examination of drugs and devices and treatment of those found to beunacceptable as defined by the board; (10) due diligence regarding otherwholesale distributors; (11) creation and maintenance of records, includingtransaction records; and (12) procedures for operation.
(i) This section shall be part of and supplemental to thepharmacy act ofthe state of Kansas.
History: L. 1991, ch. 189, § 1;L. 1995, ch. 106, § 4;L. 2007, ch. 177, § 35; May 17.
