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Section: 195.0040 Beginning January 1, 2017--Registration requirements--revocation and suspension--review by administrative hearing commission--reapplication may be denied up to five years. RSMO 195.040


Published: 2015

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Missouri Revised Statutes













Chapter 195

Drug Regulations

←195.030

Section 195.040.1

195.040→

August 28, 2015

Beginning January 1, 2017--Registration requirements--revocation and suspension--review by administrative hearing commission--reapplication may be denied up to five years.

195.040. 1. No registration shall be issued under section 195.030

unless and until the applicant therefor has furnished proof satisfactory to

the department of health and senior services:



(1) That the applicant is of good moral character or, if the

applicant be an association or corporation, that the managing officers are

of good moral character;



(2) That the applicant is equipped as to land, buildings, and

paraphernalia properly to carry on the business described in his or her

application.



2. No registration shall be granted to any person who has within two

years been finally adjudicated and found guilty, or entered a plea of

guilty or nolo contendere, in a criminal prosecution under the laws of any

state or of the United States, for any misdemeanor offense or within seven

years for any felony offense related to controlled substances. No

registration shall be granted to any person who is abusing controlled

substances.



3. The department of health and senior services shall register an

applicant to manufacture, distribute or dispense controlled substances

unless it determines that the issuance of that registration would be

inconsistent with the public interest. In determining the public interest,

the following factors shall be considered:



(1) Maintenance of effective controls against diversion of controlled

substances into other than legitimate medical, scientific, or industrial

channels;



(2) Compliance with applicable state and local law;



(3) Any convictions of an applicant under any federal or state laws

relating to any controlled substance;



(4) Past experience in the manufacture or distribution of controlled

substances and the existence in the applicant's establishment of effective

controls against diversion;



(5) Furnishing by the applicant of false or fraudulent material

information in any application filed under this chapter;



(6) Suspension or revocation of the applicant's federal registration

to manufacture, distribute or dispense narcotics or controlled dangerous

drugs as authorized by federal law; and



(7) Any other factors relevant to and consistent with the public

health and safety.



4. Registration does not entitle a registrant to manufacture and

distribute controlled substances in Schedule I or II other than those

specified in the registration.



5. Practitioners shall be registered to dispense any controlled

substance or to conduct research with controlled substances in Schedules II

through V if they are authorized to dispense or conduct research under the

laws of this state. The department of health and senior services need not

require separate registration under this chapter for practitioners engaging

in research with nonnarcotic substances in Schedules II through V where the

registrant is already registered under this chapter in another capacity.

Practitioners registered under federal law to conduct research with

Schedule I substances may conduct research with Schedule I substances

within this state upon furnishing the department of health and senior

services evidence of that federal registration.



6. Compliance by manufacturers and distributors with the provisions

of federal law respecting registration, excluding fees, shall entitle them

to be registered under this chapter.



7. A registration to manufacture, distribute, or dispense a

controlled substance may be suspended or revoked by the department of

health and senior services upon a finding that the registrant:



(1) Has furnished false or fraudulent material information in any

application filed under this chapter;



(2) Has been convicted of a felony under any state or federal law

relating to any controlled substance;



(3) Has had his or her federal registration to manufacture,

distribute or dispense suspended or revoked;



(4) Has violated any federal controlled substances statute or

regulation, or any provision of this chapter or chapter 579 or regulation

promulgated under this chapter; or



(5) Has had the registrant's professional license to practice

suspended or revoked.



8. The department of health and senior services may warn or censure a

registrant; limit a registration to particular controlled substances or

schedules of controlled substances; limit revocation or suspension of a

registration to a particular controlled substance with respect to which

grounds for revocation or suspension exist; restrict or limit a

registration under such terms and conditions as the department of health

and senior services considers appropriate for a period of five years;

suspend or revoke a registration for a period not to exceed five years; or

deny an application for registration. In any order of revocation, the

department of health and senior services may provide that the registrant

may not apply for a new registration for a period of time ranging from one

to five years following the date of the order of revocation. All stay

orders shall toll this time period. Any registration placed under a

limitation or restriction by the department of health and senior services

shall be termed "under probation".



9. If the department of health and senior services suspends or

revokes a registration, all controlled substances owned or possessed by the

registrant at the time of suspension or the effective date of the

revocation order may be placed under seal by such agency and held pending

final disposition of the case. No disposition may be made of substances

under seal until the time for taking an appeal has elapsed or until all

appeals have been concluded, unless a court, upon application therefor,

orders the sale of perishable substances and the deposit of the proceeds of

the sale with the court. Upon a revocation order becoming final, all

controlled substances may be forfeited to the state.



10. The department of health and senior services may, upon review,

terminate any restriction or limitation previously imposed upon a

registration by the department of health and senior services if the

registrant has remained in compliance with the imposed restrictions or

limitations and local, state and federal laws since the time the

restrictions or limitations were imposed.



11. The department of health and senior services shall promptly

notify the Drug Enforcement Administration, United States Department of

Justice, or its successor agency, of all orders suspending or revoking

registration and all forfeitures of controlled substances.



12. If after first providing the registrant an opportunity for an

informal conference, the department of health and senior services proposes

to deny, suspend, restrict, limit or revoke a registration or refuse a

renewal of registration, the department of health and senior services shall

serve upon the applicant or registrant written notice of the proposed

action to be taken on the application or registration. The notice shall

contain a statement of the type of discipline proposed, the basis therefor,

the date such action shall go into effect and a statement that the

registrant shall have thirty days to request in writing a hearing before

the administrative hearing commission. If no written request for a hearing

is received by the department of health and senior services within thirty

days of the applicant's or registrant's receipt of the notice, the proposed

discipline shall take effect thirty-one days from the date the original

notice was received by the applicant or registrant. If the registrant or

applicant makes a written request for a hearing, the department of health

and senior services shall file a complaint with the administrative hearing

commission within sixty days of receipt of the written request for a

hearing. The complaint shall comply with the laws and regulations for

actions brought before the administrative hearing commission. The

department of health and senior services may issue letters of censure or

warning and may enter into agreements with a registrant or applicant which

restrict or limit a registration without formal notice or hearing.



13. The department of health and senior services may suspend any

registration simultaneously with the institution of proceedings under

subsection 7 of this section if the department of health and senior

services finds that there is imminent danger to the public health or safety

which warrants this action. The suspension shall continue in effect until

the conclusion of the proceedings, including review thereof, unless sooner

withdrawn by the department of health and senior services, dissolved by a

court of competent jurisdiction or stayed by the administrative hearing

commission.



(RSMo 1939 § 9835, A.L. 1971 H.B. 69, A.L. 1978 S.B. 651, A.L. 1987

H.B. 51 & 49, A.L. 1989 S.B. 215 & 58, A.L. 1994 S.B. 594, A.L.

1997 H.B. 635, A.L. 1998 H.B. 1147, et al., A.L. 2014 S.B. 491)



Effective 1-01-17





1998



1998



195.040. 1. No registration shall be issued under section 195.030 unless

and until the applicant therefor has furnished proof satisfactory to the

department of health and senior services:



(1) That the applicant is of good moral character or, if the applicant be

an association or corporation, that the managing officers are of good moral

character;



(2) That the applicant is equipped as to land, buildings, and

paraphernalia properly to carry on the business described in his application.



2. No registration shall be granted to any person who has within two

years been finally adjudicated and found guilty, or entered a plea of guilty

or nolo contendere, in a criminal prosecution under the laws of any state or

of the United States, for any misdemeanor offense or within seven years for

any felony offense related to controlled substances. No registration shall be

granted to any person who is abusing controlled substances.



3. The department of health and senior services shall register an

applicant to manufacture, distribute or dispense controlled substances unless

it determines that the issuance of that registration would be inconsistent

with the public interest. In determining the public interest, the following

factors shall be considered:



(1) Maintenance of effective controls against diversion of controlled

substances into other than legitimate medical, scientific, or industrial

channels;



(2) Compliance with applicable state and local law;



(3) Any convictions of an applicant under any federal or state laws

relating to any controlled substance;



(4) Past experience in the manufacture or distribution of controlled

substances and the existence in the applicant's establishment of effective

controls against diversion;



(5) Furnishing by the applicant of false or fraudulent material

information in any application filed under sections 195.005 to 195.425;



(6) Suspension or revocation of the applicant's federal registration to

manufacture, distribute or dispense narcotics or controlled dangerous drugs

as authorized by federal law; and



(7) Any other factors relevant to and consistent with the public health

and safety.



4. Registration does not entitle a registrant to manufacture and

distribute controlled substances in Schedule I or II other than those

specified in the registration.



5. Practitioners shall be registered to dispense any controlled

substance or to conduct research with controlled substances in Schedules II

through V if they are authorized to dispense or conduct research under the

laws of this state. The department of health and senior services need not

require separate registration under sections 195.005 to 195.425 for

practitioners engaging in research with nonnarcotic substances in Schedules II

through V where the registrant is already registered under sections 195.005

to 195.425 in another capacity. Practitioners registered under federal law

to conduct research with Schedule I substances may conduct research with

Schedule I substances within this state upon furnishing the department of

health and senior services evidence of that federal registration.



6. Compliance by manufacturers and distributors with the provisions of

federal law respecting registration (excluding fees) shall entitle them to be

registered under sections 195.005 to 195.425.



7. A registration to manufacture, distribute, or dispense a controlled

substance may be suspended or revoked by the department of health and senior

services upon a finding that the registrant:



(1) Has furnished false or fraudulent material information in any

application filed under sections 195.005 to 195.425;



(2) Has been convicted of a felony under any state or federal law

relating to any controlled substance;



(3) Has had his federal registration to manufacture, distribute or

dispense suspended or revoked;



(4) Has violated any federal controlled substances statute or regulation,

or any provision of sections 195.005 to 195.425 or regulation promulgated

pursuant to sections 195.005 to 195.425; or



(5) Has had the registrant's professional license to practice suspended

or revoked.



8. The department of health and senior services may warn or censure a

registrant; limit a registration to particular controlled substances or

schedules of controlled substances; limit revocation or suspension of a

registration to a particular controlled substance with respect to which

grounds for revocation or suspension exist; restrict or limit a registration

under such terms and conditions as the department of health and senior

services considers appropriate for a period of five years; suspend or revoke a

registration for a period not to exceed five years; or deny an application

for registration. In any order of revocation, the department of health and

senior services may provide that the registrant may not apply for a new

registration for a period of time ranging from one to five years following

the date of the order of revocation. All stay orders shall toll this time

period. Any registration placed under a limitation or restriction by the

department of health and senior services shall be termed "under probation".



9. If the department of health and senior services suspends or revokes a

registration, all controlled substances owned or possessed by the registrant

at the time of suspension or the effective date of the revocation order may

be placed under seal by such agency and held pending final disposition of the

case. No disposition may be made of substances under seal until the time for

taking an appeal has elapsed or until all appeals have been concluded, unless

a court, upon application therefor, orders the sale of perishable substances

and the deposit of the proceeds of the sale with the court. Upon a

revocation order becoming final, all controlled substances may be forfeited

to the state.



10. The department of health and senior services may, upon review,

terminate any restriction or limitation previously imposed upon a

registration by the department of health and senior services if the

registrant has remained in compliance with the imposed restrictions or

limitations and local, state and federal laws since the time the

restrictions* or limitations were imposed.



11. The department of health and senior services shall promptly notify

the Drug Enforcement Administration, United States Department of Justice, or

its successor agency, of all orders suspending or revoking registration and

all forfeitures of controlled substances.



12. If after first providing the registrant an opportunity for an

informal conference, the department of health and senior services proposes to

deny, suspend, restrict, limit or revoke a registration or refuse a renewal

of registration, the department of health and senior services shall serve

upon the applicant or registrant written notice of the proposed action to be

taken on the application or registration. The notice shall contain a

statement of the type of discipline proposed, the basis therefor, the date

such action shall go into effect and a statement that the registrant shall

have thirty days to request in writing a hearing before the administrative

hearing commission. If no written request for a hearing is received by the

department of health and senior services within thirty days of the

applicant's or registrant's receipt of the notice, the proposed discipline

shall take effect thirty-one days from the date the original notice was

received by the applicant or registrant. If the registrant or applicant makes

a written request for a hearing, the department of health and senior services

shall file a complaint with the administrative hearing commission within

sixty days of receipt of the written request for a hearing. The complaint

shall comply with the laws and regulations for actions brought before the

administrative hearing commission. The department of health and senior

services may issue letters of censure or warning and may enter into

agreements with a registrant or applicant which restrict or limit a

registration without formal notice or hearing.



13. The department of health and senior services may suspend any

registration simultaneously with the institution of proceedings under

subsection 7 of this section if the department of health and senior services

finds that there is imminent danger to the public health or safety which

warrants this action. The suspension shall continue in effect until the

conclusion of the proceedings, including review thereof, unless sooner

withdrawn by the department of health and senior services, dissolved by a

court of competent jurisdiction or stayed by the administrative hearing

commission.



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