H1024B1635A01720 LKK:CMD 06/15/21 #90 A01720
AMENDMENTS TO HOUSE BILL NO. 1024
Sponsor: SENATOR REGAN
Printer's No. 1635
Amend Bill, page 1, line 23, by inserting after
"requirements;"
in academic clinical research centers and clinical registrants,
further providing for academic clinical research centers and
for clinical registrants;
Amend Bill, page 1, line 28, by striking out ""caregiver"
and" and inserting
"caregiver,"
Amend Bill, page 5, line 24, by inserting after
"regulations)."
After submission of required documentation to the
department, medical marijuana organizations may allow
employees to work in a supervised capacity until the
department formally approves the employee's affiliation with
the medical marijuana organization. Any employee who the
department determines to be unable to meet the affiliation
requirements under section 614 shall be terminated by the
medical marijuana organization immediately.
Amend Bill, page 6, line 29, by inserting after
"COMMUNICATION"
, automation
Amend Bill, page 6, line 30, by inserting after
"ORGANIZATION'S"
enterprise resource planning,
Amend Bill, page 7, line 11, by striking out "801(E)" and
inserting
801(b) and (e)
2021/90LKK/HB1024A01720 - 1 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
Amend Bill, page 7, line 11, by inserting after "802(A)(1)"
, 2001.1(a), 2002(a) and (b)
Amend Bill, page 7, line 24, by inserting after "OBTAIN"
and transport bulk
Amend Bill, page 7, line 24, by inserting after "POSTHARVEST"
medical marijuana
Amend Bill, page 7, line 29, by inserting after "DERIVED"
or processed
Amend Bill, page 7, line 30, by inserting after "MARIJUANA"
or medical marijuana plants
Amend Bill, page 8, line 3, by inserting after "Remediate"
microbial
Amend Bill, page 8, lines 3 and 4, by striking out "seeds,
immature medical marijuana plants, medical marijuana plants, "
Amend Bill, page 8, line 5, by striking out "flower or" and
inserting
and
Amend Bill, page 8, lines 5 through 7, by striking out
"before final" in line 5, all of line 6 and "marijuana product
for independent laboratory testing" in line 7 and inserting
after a failed test by an independent laboratory
Amend Bill, page 8, line 9, by inserting after "the"
microbial
Amend Bill, page 10, line 6, by inserting after
"COMMUNICATION"
, automation
Amend Bill, page 10, line 7, by inserting after
"ORGANIZATION'S"
enterprise resource planning,
Amend Bill, page 10, line 29, by inserting after
2021/90LKK/HB1024A01720 - 2 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
"Commonwealth"
as determined by the seed-to-sale system
Amend Bill, page 11, line 2, by inserting after "product"
and once within six months of the expiration date
Amend Bill, page 11, by inserting between lines 4 and 5
(b) Requirements.--A dispensary shall have a physician or a
pharmacist [onsite] available, either in person or remotely, to
verify patient certifications and to consult with patients and
caregivers at all times during the hours the dispensary is open
to receive patients and caregivers. If a dispensary has more
than one separate location, a physician assistant or a certified
registered nurse practitioner may [be onsite at] verify patient
certifications and consult with patients and caregivers, either
in person or remotely, at each of the other locations in lieu of
the physician or pharmacist. A physician, a pharmacist, a
physician assistant or a certified registered nurse practitioner
shall, prior to assuming duties under this paragraph,
successfully complete the course established in section 301(a)
(6). A physician may not issue a certification to authorize
patients to receive medical marijuana or otherwise treat
patients at the dispensary.
* * *
Amend Bill, page 11, by inserting between lines 18 and 19
Section 2001.1. Academic clinical research centers.
(a) General rule.--An academic clinical research center must
be approved and certified by the department before the academic
clinical research center may contract with a clinical
registrant. An academic clinical research center shall only
contract with one clinical registrant. The accredited medical
school that is seeking approval and certification from the
department as an academic clinical research center must provide
all information required by the department, including
information for the individual who will be the primary contact
for the academic clinical research center during the
department's review of the application. The accredited medical
school must also provide all information required by the
department for any licensed acute care hospital that the
accredited medical school will operate or partner with during
the time that it may be approved and certified as an academic
clinical research center by the department.
* * *
Section 2002. Clinical registrants.
(a) Approval.--The department may approve up to [eight] ten
clinical registrants. Each clinical registrant may provide
medical marijuana at not more than six separate locations. The
total number of locations authorized to dispense medical
2021/90LKK/HB1024A01720 - 3 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
marijuana under this section shall not exceed [48] 60. The
grower/processor and dispensary permits issued to clinical
registrants approved under this section shall be in addition to
the 25 grower/processor and 50 dispensary permits issued by the
department in accordance with section 616(1) and (2). The
limitations relating to number and location in sections 616(1)
and (2) and 603(d) do not apply. A clinical registrant may not
hold more than one grower/processor and one dispensary permit.
Once the department approves [the] an entity as a clinical
registrant, the entity shall comply with this chapter. The
following shall apply:
(1) The department shall open applications for
additional academic clinical research clinics and issue
approvals to qualified academic clinical research clinics
within 90 days of passage and shall open applications for
additional clinical registrants within 120 days of passage
and issue approvals or permits to qualified clinical
registrants within 180 days of passage. If the statutory
maximum numbers of academic clinical research clinics and
clinical registrants are not approved within 180 days of the
passage, the department will reopen the application process
for academic clinical research clinics and clinical
registrants , if an academic clinical research center requests
it to do so.
(2) (Reserved).
(b) Requirements.--The following shall apply to clinical
registrants:
* * *
(4) When the department issues a permit as a
grower/processor or a dispensary to an entity seeking
approval as a clinical registrant, the issuance shall not be
construed to reduce the number of permits for
growers/processors and dispensaries authorized under section
616(1) and (2).
(i) The department shall not approve an applicant
for a grower/processor license if the applicant has
previously had a contractual relationship with an
academic clinical research center whereby the academic
clinical research center or its affiliate provided advice
to the applicant regarding, among other areas, patient
health and safety, medical applications and dispensing
and management of controlled substances and the applicant
subsequently sold or assigned for profit to another
entity their responsibility under the contractual
relationship.
(ii) (Reserved).
* * *
(7) The clinical registrant shall have all of the same
rights as a grower/processor permittee and must comply with
all other requirements, and provided all rights of other
grower/processor permittees, of this act regarding growing,
2021/90LKK/HB1024A01720 - 4 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
processing and dispensing medical marijuana.
(8) A grower/processor facility owned by a clinical
registrant may sell its medical marijuana products only to
[the clinical registrant's dispensary facilities and the] all
dispensary facilities [of other clinical registrants]. The
facility may sell seeds, medical marijuana plants and medical
marijuana products to, or exchange seeds, medical marijuana
plants and medical marijuana products with, any other
grower/processor facility holding a permit under Chapter 6 or
this chapter.
* * *
2021/90LKK/HB1024A01720 - 5 -
1
2
3
4
5
6
7
8
9
10
11