Current through Register Vol. 49, No. 18, September 16, 2024
PURPOSE: This amendment requires applicants to apply
for registrations through an electronic online system and eliminates the paper
application process.
(1)
Database and Survey Process.
(A) Applicants
may apply for and receive a registration that is effective for up to twelve
(12) months.
(B) Applicants shall
apply through the department's electronic online system.
(C) Simultaneously with completing an
application for a controlled substances registration, practitioners may also
complete an annual voluntary census to assist the department in determining
practitioner shortages and underserved regions of the state. Required questions
and fields for controlled substance registrations are marked with an asterisk
(*) in the electronic online system.
(2) Period of Registration.
(A) Any registration shall be current and
effective for twelve (12) months from the date issued or until the expiration
date assigned at the time the registration is issued. No person who is required
to be registered shall conduct any activity for which registration is required
without a current registration. No controlled substance activities shall take
place after a registration expires until a new registration has been
issued.
(B) At the time any
registration is issued, the registration shall be assigned to one of twelve
(12) groups which shall correspond to the months of the year. The expiration
date of all registrations within any group shall be the last day of the month
designated for that group.
(C)
Registrations for manufacturers and distributors may be assigned to a single
group, and the expiration date may be less than twelve (12) months from the
date the registration was issued.
(D) Training program registrations may be
assigned to a single group, and the expiration date may be less than twelve
(12) months from the date the registration was issued.
(E) A certificate of registration shall be
made available online and printable to the registrant which shall include the
name and address of the registrant, the expiration date of the registration,
and a registration number for the convenience of identifying a registration or
a registrant. The same registration number may be used for a new registration
for the same person.
(3)
Requirements for All Applicants.
(A) Any
person who is required to be registered and who is not so registered may apply
online for registration at any time. No person required to be registered shall
engage in any activity for which registration is required until the application
for registration is processed and the registration is issued. All applications
are for new registrations.
(B)
Applications for registration shall be made on online forms designated by the
Department of Health and Senior Services. Application for registration shall be
completed online and submitted electronically via the Missouri Department of
Health and Senior Services' website at
https://health.mo.gov/safety/bndd/
along with the required fee.
(C) An
application shall contain the electronic signature of the applicant and shall
be provided to the Department of Health and Senior Services with any required
fee. This is a nonrefundable processing fee.
(D) An application which does not contain or
is not accompanied by the required information or fee may be denied sixty (60)
days after notifying the applicant of the deficiency.
(E) An application may be withdrawn by making
a written request to the Department of Health and Senior Services.
(F) A person who is registered may conduct
activities with controlled substances in Schedules II, III, I V, and V, as
authorized by statute, unless a registration is restricted as to schedules or
activities because of a settlement agreement, probation, or other disciplinary
action taken by the Department of Health and Senior Services, the Drug
Enforcement Administration, or a professional licensing board. Authority to
conduct activities with controlled substances in Schedule I requires a separate
application and registration.
(4) All applicants shall make full, true, and
complete answers on the application. The Department of Health and Senior
Services may require an applicant to submit documents or written statements of
fact relevant to the application as considered necessary to determine whether
the application should be granted. The failure of the applicant to provide
these documents or statements within sixty (60) days after being requested to
do so shall be considered to be a waiver by the applicant of an opportunity to
present these documents or facts for consideration in granting or denying the
application.
(5) Applications for
Individual Practitioner Registrations. Applications by physicians,
veterinarians, optometrists, podiatrists, and researchers for Missouri
Controlled Substance Registrations shall include:
(A) The applicant's full legal name (first
name, middle name, and last name), including any suffixes such as junior,
senior, or III, gender, race, and ethnicity;
(B) A listing of all addresses and practice
locations where controlled substance activities will be taking place. The
applicant's street addresses, cities, zip codes, counties, and state. The
number of hours worked per week for each location shall be provided for
performing direct patient care (non-hospital), administration, research,
teaching, in-patient hospital care, and other. The applicant shall also
identify his or her primary, principle practice location, where he or she
spends the most time. This will be the principle practice address that appears
on the controlled substances registration. A physical street address is
required and post office box addresses shall not be accepted;
(C) Whether the application is for a
physician, veterinarian, optometrist, podiatrist, or researcher;
(D) His or her anticipated drug activities
such as administering, prescribing, or dispensing;
(E) The required fee and fee information. If
claiming an exemption from a fee, the applicant shall identify the name of the
government agency that employs him or her;
(F) His or her business telephone number, fax
number, email address, federal controlled substances registration number, if
applicable; professional degree, if applicable; and professional license
number, if applicable. If the applicant has an application pending for a
federal controlled substances registration number, the applicant shall indicate
the application is pending;
(G)
Whether the applicant, or any officer of a corporate applicant, or individual
employed by any applicant having access to controlled substances, has ever
entered a plea of guilty, no contest, nolo contendere, or
otherwise been convicted of any violation of any state or federal law related
to the possession, manufacture, distribution, dispensing, or prescribing of
controlled substances. If the answer is yes, the applicant shall provide an
explanation;
(H) If the applicant
is an individual or a registrant that holds a professional license, whether he
or she is currently licensed and registered to practice his or her profession
under the laws of this state;
(I)
If the applicant is not an individual or registrant that holds a professional
license, the applicant shall answer yes or no to whether the applicant is
currently authorized to conduct business under the laws of this
state;
(J) Previous Discipline. If
the applicant currently holds or has previously held a state or federal
controlled substance registration or state professional license or
registration, the applicant shall answer yes or no to whether the applicant's
license, registration, or application or renewal thereof has ever been
surrendered, revoked, suspended, denied, restricted, or placed on probation and
if any such action is pending. If the answer is yes, the applicant shall
provide an explanation;
(K) Whether
the applicant is abusing or has abused or been treated for or diagnosed with
addiction regarding controlled substances during the past year. For purposes of
this subsection, "abusing" or "abused" means using or having used a controlled
substance in a manner not authorized under Chapter 195, RSMo;
(L) Copies and attachments of any guilty
pleas, convictions, or disciplinary actions identified in subsections (G) and
(J) of this section, if the department does not already have them on
file;
(M) The electronic signature
of the individual applicant;
(N)
His or her Social Security number and date of birth (MM/DD/YYYY);
(O) The date the application is
signed;
(P) What drug schedules the
applicant is requesting authority in; and
(Q) A listing of mid-level practitioners by
name and license number with whom applicant has agreements pursuant to Chapter
334, RSMo.
(6)
Applications for Pharmacies and Businesses. Applications for retail pharmacies
and ambulance services, ambulatory surgery centers, analytical laboratories,
correctional centers, distributors, exporters, hospices, hospitals, importers,
manufacturers, narcotic treatment programs, long-term care facility E-kits,
teaching institutions, researchers, or other applicants not listed in sections
(5)-(8), shall include:
(A) The applicant's
full legal name, and if applicable, d/b/a name;
(B) The applicant's tax ID number, if
applicable;
(C) The applicant's
facility license number, if applicable, and federal controlled substances
registration number. If the applicant has an application pending for a federal
controlled substances registration number, the applicant shall indicate an
application is pending;
(D) The
applicant's email address;
(E) The
applicant's principle Missouri business street address, city, state, county,
and zip code as it will appear on the controlled substances registration
certificate. Post office box numbers shall not be accepted. A separate mailing
address may also be provided;
(F)
The applicant's business telephone number and fax number;
(G) The applicant's type of business
activity, licensure type, licensure agency, and license number;
(H) What controlled substance schedules the
applicant is requesting authority in;
(I) The applicant's criminal history
information as it pertains to controlled substance laws. The applicant shall
answer yes or no as to whether the owner, CEO or administrator, corporate
officer, medical director, pharmacist in charge, or any employee with access to
controlled drugs has ever pled guilty, no contest, nolo
contendere, or ever been convicted of any violation of state or
federal law relating to controlled substances;
(J) Whether there are any previous or pending
disciplinary actions regarding the applicant's professional license or any
controlled substance registration, whether the applicant's privileges or
authority have been revoked, surrendered, suspended, restricted, or placed on
probation, or if any application for a state license or any drug registration
has ever been denied;
(K) The
application shall be submitted online with the required fee and fee
information. If claiming an exemption from a fee, the applicant must identify
the name of the government agency;
(L) Copies and attachments of any guilty
pleas, convictions, or disciplinary actions identified in subsections (I) and
(J) of this section, if the department does not already have them on
file;
(M) If the applicant is a
retail business, the applicant shall provide a letter from the Missouri
Department of Revenue that documents that no Missouri taxes are due and the
applicant is in good standing; and
(N) The applicant shall electronically sign
and date an application. An application may be signed by the owner, chief
executive officer or administrator, corporate officer, medical director, or
pharmacist in charge.
(7) Applications for Dentists. Applications
for dentists with the degrees of D.D.S. or D.M.D. shall include:
(A) The applicant's full legal name (first
name, middle name, and last name), including any suffixes such as junior,
senior, or III;
(B) His or her
Social Security number and date of birth (MM/DD/YYYY);
(C) The applicant's federal controlled
substances registration number. If the applicant has an application pending for
a federal controlled substances registration number, the applicant shall
indicate the application is pending;
(D) The applicant's gender, race, and
ethnicity;
(E) The applicant's
email address;
(F) The applicant's
primary specialty and any board certification;
(G) Whether the applicant is licensed to
practice and conduct activities and the applicant's licensure type, license
number, and name of licensing agency;
(H) What drug schedules the applicant is
requesting to conduct activities in;
(I) The applicant's anticipated drug
activities such as administering, prescribing, or dispensing;
(J) The applicant's street addresses, city,
zip code, county, and state of their primary, principle practice location,
where they spend the most time. This will be the address that appears on the
controlled substances registration. Post office box numbers shall not be
accepted. Applicants shall also provide any secondary practice locations and
the number of chair-side work hours per week at each location. The number of
hours worked per week for each location shall be provided for performing direct
patient care (non-hospital), administration, research, teaching, in-patient
hospital care, and other;
(K) The
applicant's business phone number and fax number;
(L) The applicant's criminal history
information as it pertains to controlled substance laws. The applicant shall
answer yes or no as to whether the applicant or any employees with access to
controlled drugs have ever pled guilty, no contest, nolo
contendere, or ever been convicted of any violation of state or
federal law relating to controlled substances;
(M) Information regarding any previous or
pending disciplinary actions regarding the applicant's professional license or
any controlled substance registration, as to whether the applicant's privileges
or authority have been revoked, surrendered, suspended, restricted, or placed
on probation, or if any application for a state license or any drug
registration has ever been denied;
(N) Whether the applicant is abusing or has
abused or been treated for or diagnosed with addiction regarding controlled
substances during the past year. For purposes of this subsection, "abusing" or
"abused" means using or having used a controlled substance in a manner not
authorized under Chapter 195, RSMo;
(O) The application shall be submitted with
the required fee and fee information. If claiming an exemption from a fee, the
applicant shall identify the name of the government agency that employs him or
her;
(P) The applicant shall
provide copies and attachments of any guilty pleas, convictions, or
disciplinary actions identified in subsections (L) and (M) of this section, if
the department does not already have them on file; and
(Q) The applicant shall sign and date an
application submitted electronically.
(8) Applications for Mid-Level Practitioners.
Applications for midlevel practitioners as defined by
21 CFR
1300.01(b)(28) such as
advanced practice nurses and physician assistants shall include:
(A) The applicant's full legal name (first
name, middle name, and last name), including any suffixes such as junior,
senior, or III;
(B) The applicant's
social security number and date of birth (MM/DD/YYYY);
(C) The applicant's federal controlled
substances registration number. If the applicant has an application pending for
a federal controlled substances registration number, the applicant shall
indicate the application is pending;
(D) The applicant's gender, race, and
ethnicity;
(E) The applicant's
email address;
(F) Whether the
applicant is licensed to practice and conduct activities and the applicant's
licensure type, license number, and name of licensing agency;
(G) What controlled substance schedules (III,
I V, or V) the applicant is requesting to conduct activities in;
(H) Which physicians the applicant has
collaborative or supervision agreements with;
(I) A copy of the applicant's collaborative
or supervision agreements with physicians, and a list of controlled substances
from each physician that the mid-level practitioner is authorized to conduct
activities with, in that agreement;
(J) The applicant's street address, city, zip
code, county, and state of the applicant's primary, principle practice
location. This will be the principle address that appears on the controlled
substances registration. Post office boxes shall not be accepted. Applicants
shall also provide any secondary practice location addresses and the number of
hours worked per week for each location for performing direct patient care
(non-hospital), administration, research, teaching, in-patient hospital care,
and other;
(K) The applicant's
business phone number and fax number;
(L) The applicant's criminal history
information as it pertains to controlled substance laws. The applicant shall
answer yes or no as to whether the applicant or any employee with access to
controlled drugs has ever pled guilty, no contest, nolo
contendere, or ever been convicted of any violation of state or
federal law relating to controlled substances;
(M) Information regarding any previous or
pending disciplinary actions regarding the applicant's professional license or
any controlled substance registration, as to whether the applicant's privileges
or authority have been revoked, surrendered, suspended, restricted, or placed
on probation, or if any application for a state license or any drug
registration has ever been denied;
(N) Whether the applicant has abused or been
treated for or diagnosed with addiction regarding controlled substances during
the past year. For purposes of this subsection, "abusing" or "abused" means
using or having used a controlled substance in a manner not authorized under
Chapter 195, RSMo;
(O) The
application shall be submitted with the required fee and fee information. If
claiming an exemption from a fee, the applicant shall identify the name of the
government agency that employs the applicant;
(P) The applicant shall provide copies and
attachments of any guilty pleas, convictions, or disciplinary actions
identified in subsections (L) and (M) of this section, if the department does
not already have them on file; and
(Q) The applicant shall sign and date an
application submitted electronically.
*Original authority: 195.195, RSMo 1957, amended 1971,
1989, 1993.