The purpose of this rule is to set forth guidelines related to fines, license suspension, and license revocation imposed upon medical marijuana treatment centers (MMTCs) for violations of rule and statute. The effect is to establish comprehensive ...
RULE NO.:RULE TITLE:
64-4.210MMTC Fines, Suspension, and Revocation.
PURPOSE AND EFFECT:
SUMMARY:
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: Pursuant to section 381.986(17), FS, rules adopted pursuant to section 381.986, FS, before July 1, 2020 are not subject to ss. 120.54(3)(b) and 120.541, F.S.
RULEMAKING AUTHORITY:
LAW IMPLEMENTED:
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS:
THE FULL TEXT OF THE PROPOSED RULE IS:
64-4.210 MMTC Fines, Suspension, and Revocation.
(1) Pursuant to section 381.986, F.S., the department provides within this rule disciplinary guidelines that will be imposed upon licensed MMTCs. The purposes of discipline are to punish MMTCs for violations; to deter them from future violations; to offer opportunities for rehabilitation, when appropriate; and to deter other applicants or licensees from committing violations.
(2) The department may suspend or revoke an MMTC license, or refuse to renew an MMTC license, if the department finds that an MMTC committed a violation as provided in 381.986(10)(f), F.S. For any such violation, the department may revoke or suspend an MMTC’s license for a period of time based upon the seriousness of the violation. Factors to be considered in determining the seriousness and length of the revocation or suspension include:
(a) frequency or number of occurrences;
(b) potential for rehabilitation;
(c) any prior violations;
(d) impact on the department;
(e) potential and/or actual harm to a qualified patient or a member of the public;
(f) willfulness and deliberateness of the violation;
(g) severity of noncompliance;
(h) length of noncompliance;
(i) any good faith effort made to prevent a violation; and
(j) any corrective action taken by the MMTC related to the current violation or prior violations.
(3) The department may, in addition to suspension, revocation, and any other penalties imposed under this chapter, impose a fine of up to $10,000 per violation, as set forth in the schedule provided in subsection (9). The schedule of fines is meant to serve as a guideline. The department will use the factors set forth in subsection (2) to determine the amount of the fine to impose within the range outlined in the schedule. The maximum fines listed in the schedule reflect the maximum fines that the department may impose per violation, per day. Where there are multiple incidents resulting in more than one violation of the same provision, the department may impose a fine, up to the maximum, for each violation, per day.
(4) Unless otherwise ordered by the department, an MMTC, during any period of license suspension, shall not cultivate, process, transport, or dispense marijuana, or allow patients or customers to enter the MMTC’s premises. Unless otherwise ordered by the department, an MMTC, during any period of license suspension, may continue to possess, cultivate, or process marijuana. The MMTC must fully account for all marijuana and must safeguard any marijuana in its possession or control during suspension. During suspension, the MMTC must maintain its premises in compliance with all representations in the MMTC’s application on file with the department and all requirements set forth in section 381.986, F.S., and department rule. Following a suspension, the department may allow the MMTC to resume operations by written notice after the MMTC has complied with any corrective action directives from the department.
(5) During any period of license suspension, an MMTC must place on all of its dispensary facilities in the front window, or on the front door, a notice indicating the length of the suspension and the reasons therefor. The notice shall measure a minimum of 8.5 inches in height by 11 inches in width and the lettering shall be at least 14-point font. The department will create and furnish the notice to the MMTC. If the MMTC maintains a website, the MMTC shall prominently display on the MMTC’s homepage the identical notice. The notice shall be maintained in place at the dispensaries and on the MMTC’s website until the period of suspension ends.
(6) The issuance of a suspension under this part does not relieve the MMTC of the obligation to timely comply with all license renewal requirements. A license suspension does not toll the MMTC’s license renewal deadline.
(7) No MMTC whose license has been revoked may apply for licensure under s. 381.986, F.S., and this chapter for at least five years from the date of such revocation. However, if an MMTC’s violation of statute or rule is a contributing factor to the death of a patient, the MMTC will be permanently barred from applying for licensure.
(8) If an MMTC’s license is suspended or revoked, no part of the application fee, supplemental licensure fee, or renewal fee will be returned.
(9) The department will use the following schedule as a guideline for disciplinary fines. The complete statutory requirement may be found in the statutory provision cited directly in the violation column.
VIOLATION
MINIMUM FINE PER VIOLATION, PER DAY
MAXIMUM FINE PER VIOLATION, PER DAY
(a)
Section 381.986(8)(e)4.
$500
$1,000
(b)
Section 381.986(8)(e)6.c., F.S.
$500
$1,000
(c)
Section 381.986(8)(e)6.d., F.S.
$500
$1,000
(d)
Section 381.986(8)(e)7., F.S.
$500
$1,000
(e)
Failure to hold a permit to operate as a food establishment pursuant to chapter 500, the Florida Food Safety Act, and compliance with all the requirements for food establishments pursuant to chapter 500 and any rules adopted thereunder if the medical marijuana treatment center produces edibles.
Section 381.986(8)(e)8., F.S.
$500
$1,000
(f)
Production and distribution of an edible that contains more than 200 milligrams of tetrahydrocannabinol.
Section 381.986(8)(e)8., F.S.
$500
$1,000
(g)
Production and distribution of any shapes, forms, and ingredients prohibited for edibles by s. 381.986(8)(e)8., F.S., or department rule.
Section 381.986(8)(e)8., F.S.
$500
$1,000
(h)
Processing or dispensing edibles prior to the effective date of the department rule on edibles.
Section 381.986(8)(e)8., F.S.
$500
$1,000
(i)
Operating in violation of the standards and requirements for the storage, display, or dispensing of edibles set out in s. 381.986(8)(e)8., F.S., or department rule.
Section 381.986(8)(e)8., F.S.
$500
$1,000
(j)
Section 381.986(8)(e)10., F.S.
$500
$1,000
(k)
Failure to reserve two processed samples from each marijuana batch and to retain such samples for at least nine (9) months
Section 381.986(8)(e)11.d., F.S.
$500
$1,000
(l)
Section 381.986(8)(e)16.c., F.S.
$500
$1,000
(m)
Section 381.986(8)(f)1., F.S.
$500
$1,000
(n)
Section 381.986(8)(f)2., F.S.
$500
$1,000
(o)
Section 381.986(8)(f)4., F.S.
$500
$1,000
(p)
Section 381.986(8)(f)5., F.S.
$500
$1,000
(q)
Section 381.986(8)(f)6., F.S.
$500
$1,000
(r)
Section 381.986(8)(f)7., F.S.
$500
$1,000
(s)
Section 381.986(8)(f)8., F.S.
$500
$1,000
(t)
Section 381.986(8)(f)9., F.S.
$500
$1,000
(u)
Section 381.986(8)(f)10., F.S.
$500
$1,000
(v)
Section 381.986(8)(g)1., F.S.
$500
$1,000
(w)
Section 381.986(8)(g)1.g.(III), F.S.
$500
$1,000
(x)
Section 381.986(8)(g)2., F.S.
$500
$1,000
(y)
Section 381.986(8)(g)3., F.S.
$500
$1,000
(z)
Section 381.986(8)(g)4., F.S.
$500
$1,000
(aa)
Section 381.986(8)(g)5., F.S.
$500
$1,000
(bb)
Section 381.986(8)(g)6., F.S.
$500
$1,000
(cc)
Engaging in advertising that is visible to members of the public from any street, sidewalk, park, or other public place in violation of s. 381.986(8)(h), F.S.
Section 381.986(8)(h), F.S.
$500
$1,000
(dd)
Engaging in advertising online and marketing advertising in violation of s. 381.986(8)(h)2., F.S.
Section 381.986(8)(h), F.S.
$500
$1,000
(ee)
Section 381.986(8)(i), F.S.
$500
$1,000
(ff)
Section 381.986(10)(f)8., F.S.
$500
$1,000
(gg)
Section 381.986(10)(f)12., F.S.
$500
$1,000
(hh)
Section 381.986(8)(e)6.b., F.S. and section 381.986(8)(e)11.a., F.S.
$1,000
$2,000
(ii)
Production and distribution of single serving portion of an edible that exceeds 10 milligrams of tetrahydrocannabinol.
Section 381.986(8)(e)8., F.S.
$1,000
$2,000
(jj)
Production and distribution of an edible with a potency variance greater than 15 percent.
Section 381.986(8)(e)8., F.S.
$1,000
$2,000
(kk)
Section 381.986(8)(e)9., F.S.
$1,000
$2,000
(ll)
Section 381.986(8)(e)11.c., F.S.
$1,000
$2,000
(mm)
Failure to test processed marijuana using a medical marijuana testing laboratory before it is dispensed.
s. 381.986(8)(e)11.d., F.S.
$1,000
$2,000
(nn)
Dispensing marijuana when the test results indicate one or more of the following: low-THC cannabis does not meet the definition of low-THC cannabis; the concentration of tetrahydrocannabinol fails to meet the potency requirements of s. 381.986, F.S.; the labeling of the concentration of tetrahydrocannabinol and cannabidiol is not accurate; the marijuana is not free from contaminants that are unsafe for human consumption.
Section 381.986(8)(e)11.d., F.S.
$1,000
$2,000
(oo)
Failure to take corrective action within 30-days of receiving a Notice of Deficiency from the department that the medical marijuana treatment center test results show non-compliance with Section 381.986(8)(e)11.d., F.S.
$1,000
$2,000
(pp)
Failure to retain records of all testing and samples of each homogenous batch of marijuana for at least 9 months; or contract with a marijuana testing laboratory to perform audits on the medical marijuana treatment center’s standard operating procedures, testing records, and samples.
Section 381.986(8)(e)11.d., F.S.
$1,000
$2,000
(qq)
Use of a laboratory that has not been certified by the department under s. 381.988, F.S., when at least one laboratory holds the required certification.
Section 381.986(8)(e)11.d., F.S.
$1,000
$2,000
(rr)
Section 381.986(8)(e)11.e., F.S.
$1,000
$2,000
(ss)
Section 381.986(8)(e)11.f., F.S.
$1,000
$2,000
(tt)
Section 381.986(8)(e)12., F.S.
$1,000
$2,000
(uu)
Section 381.986(8)(e)13., F.S.
$1,000
$2,000
(vv)
Failure to seal each edible in plain, opaque wrapping marked only with the marijuana universal symbol.
Section 381.986(8)(e)15., F.S.
$1,000
$2,000
(ww)
Failure to dispense an edible in a receptacle that is plain, opaque, white and without depictions of the product or images other than the medical marijuana treatment center’s department-approved logo and the marijuana universal symbol.
Section 381.986(8)(e)15., F.S.
$1,000
$2,000
(xx)
Failure to label the receptacle with a list all the following: edible’s ingredients, storage instructions, an expiration date, a legible and prominent warning to keep away from children and pets, a warning that the edible has not been produced or inspected pursuant to federal food safety laws.
$1,000
$2,000
(yy)
Section 381.986(8)(e)16.b., F.S.
$1,000
$2,000
(zz)
Section 381.986(8)(e)16.d., F.S.
$1,000
$2,000
(aaa)
Section 381.986(8)(e)16.e, F.S.
$1,000
$2,000
(bbb)
Failure to provide the following where the dispensing of marijuana occurs: a separate waiting area with sufficient space and seating, and at least one private consultation area that is isolated from the waiting area and area where dispensing occurs.
Section 381.986(8)(f)3., F.S.
$1,000
$3,000
(ccc)
Section 381.986(8)(b)8., F.S.
$1,000
$3,000
(ddd)
Section 381.986(8)(e)5., F.S.
$1,000
$3,000
(eee)
Display of products in the waiting area of the premises where dispensing of marijuana occurs.
Section 381.986(8)(f)3., F.S.
$1,000
$3,000
(fff)
Dispensing marijuana or marijuana delivery devices in the waiting area of the premises where dispensing of marijuana occurs.
Section 381.986(8)(f)3., F.S.
$1,000
$3,000
(ggg)
Section 381.986(8)(e), F.S.
$2,500
$5,000
(hhh)
Section 381.986(8)(e)16.f., F.S.
$2,500
$5,000
(iii)
Section 381.986(8)(e)16.g., F.S.
$2,500
$5,000
(jjj)
Section 381.986(10)(f)3., F.S.
$5,000
$10,000
(kkk)
Section 381.986(10)(f)5., F.S.
$5,000
$10,000
(lll)
Section 381.986(10)(f)6., F.S.
$5,000
$10,000
(mmm)
Section 381.986(8)(c)
$5,000
$10,000
(nnn)
Section 381.986(8)(e)2.
$5,000
$10,000
(ooo)
Section 381.986(8)(e)6.a., F.S.
$5,000
$10,000
(ppp)
Failure to recall edibles, including all edibles made from the same batch of marijuana, which: fail to meet the potency requirements of s. 381.986(8)(e)11.d., F.S.; are unsafe for human consumption; or for which the labeling of the tetrahydrocannabinol and cannabidiol concentration is inaccurate.
Section 381.986(8)(e)11.d., F.S.
$5,000
$10,000
(qqq)
Section 381.986(10)(f)7., F.S.
$5,000
$10,000
(rrr)
Section 381.986(10)(f)9., F.S.
$5,000
$10,000
(sss)
Section 381.986(10)(f)10., F.S.
$5,000
$10,000
(ttt)
Section 381.986(10)(f)11., F.S.
$5,000
$10,000
(uuu)
Section 381.986(10)(f)13., F.S.
$5,000
$10,000
(vvv)
Section 381.986(8)(b)9., F.S.
$5,000
$10,000
(www)
Deviation, without approval of the department, from the criteria demonstrated and representations made in the MMTC’s application on file with the department, which includes any amendments or variances that have been approved by the department.
Section 381.986(8)(e), F.S.
$5,000
$10,000
(xxx)
Section 381.986(8)(b)3., F.S.
$5,000
$10,000
(yyy)
Section 381.986(8)(b)4., F.S.
$5,000
$10,000
(zzz)
Section 381.986(8)(b)5., F.S.
$5,000
$10,000
(aaaa)
Failing to maintain the performance bond required under Section 381.986(8)(b)6., F.S.
$5,000
$10,000
(bbbb)
Failing to maintain, in lieu of a performance bond, an irrevocable letter of credit required under Section 381.986(8)(b)7.a., F.S.
$5,000
$10,000
(cccc)
Section 381.986(8)(b)7.b., F.S.
$5,000
$10,000
(dddd)
Section 381.986(8)(b)10., F.S.
$5,000
$10,000
(eeee)
Section 381.986(8)(e)11.b., F.S.
$5,000
$10,000
(ffff)
Section 381.986(8)(e)16.h., F.S.
$5,000
$10,000
(gggg)
Section 381.986(10)(f)4., F.S.
$5,000
$10,000
(hhhh)
Section 381.986(10)(f)6., F.S.
$5,000
$10,000
(iiii)
Section 381.986(8)(b)2., F.S.
$5,000
$10,000
(jjjj)
A violation of any other provision of section 381.986, Florida Statutes, or department rule, not listed in this chart is subject to the full range of penalties listed in this rule.
Section 381.986(10)(f)1., F.S.
Rulemaking Authority 381.986(10)(h); Law Implemented 381.986(10), FC. History—New.
NAME OF PERSON ORIGINATING PROPOSED RULE: Courtney Coppola, Chief of Staff and Marijuana Coordinator
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Scott A. Rivkees, MD, Surgeon General and Secretary
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: December 11, 2019
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: December 10, 2019
Document Information
- Comments Open:
- 12/16/2019
- Summary:
- This rule establishes disciplinary guidelines that will be imposed upon licensed MMTCs for violations of rule and statute.
- Purpose:
- The purpose of this rule is to set forth guidelines related to fines, license suspension, and license revocation imposed upon medical marijuana treatment centers (MMTCs) for violations of rule and statute. The effect is to establish comprehensive and consistent disciplinary penalties related to MMTCs.
- Rulemaking Authority:
- 381.986(10)(h), FS
- Law:
- 381.986(10), FS
- Contact:
- Courtney Coppola (850) 245-4274 or Courtney.Coppola@flhealth.gov.
- Related Rules: (1)
- 64-4.210. MMTC Fines, Suspension, and Revocation