Florida Administrative Code (Last Updated: July 17, 2024) |
64. Department of Health |
D64. Departmental |
64-4. Compassionate Use |
1(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 penalize MMTCs for violations; to deter them from future violations; to offer opportunities for correction, when appropriate; and to deter other applicants or licensees from committing violations.
55(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 Section 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 of the violation include:
125(a) Frequency or number of occurrences;
131(b) Potential for rehabilitation;
135(c) Any prior violations;
139(d) Impact on the department;
144(e) Potential and/or actual harm to a qualified patient or a member of the public;
159(f) Willfulness and deliberateness of the violation;
166(g) Severity of noncompliance;
170(h) Length of noncompliance;
174(i) Any good faith effort made to prevent a violation; and
185(j) Any corrective action taken by the MMTC related to the current violation or prior violations.
201(3) 202The department may, in addition to or in lieu of 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. 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. For violations that are ongoing and continuous in nature, each day a violation continues constitutes a distinct violation.
344(4) An MMTC must fully account for all marijuana and must safeguard marijuana in its possession or control during any period of license suspension. During the suspension, the MMTC must maintain its premises in compliance with 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 after the MMTC has complied with any corrective action directives from the department. An MMTC may resume operations upon its receipt of written notice from the department authorizing the MMTC to resume operations.
436(5) During any period of license suspension, the department may require an MMTC to place on all of its dispensing 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. The department may require the MMTC to prominently display the notice on the homepage of the MMTC’s website. Such notice shall be maintained in place until the period of suspension ends.
545(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.
581(7) No MMTC whose license has been revoked may apply for licensure under Section 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.
640(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.
664(9) The department will use the following schedule as a guideline for disciplinary fines. T679he complete statutory requirement may be found by referring to the statutory provision cited.
693VIOLATION
694MINIMUM FINE PER VIOLATION
698MAXIMUM FINE PER VIOLATION
702(a)
703Section 381.986(8)(e)4., F.S.
706$500
707$1,000
709(b)
710Section 381.986(8)(e)6.c., F.S.
713$500
714$1,000
716(c)
717Section 381.986(8)(e)6.d., F.S.
720$500
721$1,000
723(d)
724Section 381.986(8)(e)7., F.S.
727$500
728$1,000
730(e)
731Failure 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.
777Section 381.986(8)(e)8., F.S.
780$500
781$1,000
783(f)
784Production and distribution of an edible that contains more than 200 milligrams of tetrahydrocannabinol.
798Section 381.986(8)(e)8., F.S.
801$500
802$1,000
804(g)
805Production and distribution of any shapes, forms, and ingredients prohibited for edibles by Section 381.986(8)(e)8., F.S., or department rule.
824Section 381.986(8)(e)8., F.S.
827$500
828$1,000
830(h)
831Processing or dispensing edibles prior to the effective date of the department rule on edibles.
846Section 381.986(8)(e)8., F.S.
849$500
850$1,000
852(i)
853Operating in violation of the standards and requirements for the storage, display, or dispensing of edibles set out in Section 381.986(8)(e)8., F.S., or department rule.
878Section 381.986(8)(e)8., F.S.
881$500
882$1,000
884(j)
885Section 381.986(8)(e)10., F.S.
888$500
889$1,000
891(k)
892Failure to reserve two processed samples from each marijuana batch and to retain such samples for at least nine (9) months
913Section 381.986(8)(e)11.d., F.S.
916$500
917$1,000
919(l)
920Section 381.986(8)(e)16.c., F.S.
923$500
924$1,000
926(m)
927Section 381.986(8)(f)1., F.S.
930$500
931$1,000
933(n)
934Section 381.986(8)(f)2., F.S.
937$500
938$1,000
940(o)
941Section 381.986(8)(f)4., F.S.
944$500
945$1,000
947(p)
948Section 381.986(8)(f)5., F.S.
951$500
952$1,000
954(q)
955Section 381.986(8)(f)6., F.S.
958$500
959$1,000
961(r)
962Section 381.986(8)(f)7., F.S.
965$500
966$1,000
968(s)
969Section 381.986(8)(f)8., F.S.
972$500
973$1,000
975(t)
976Section 381.986(8)(f)9., F.S.
979$500
980$1,000
982(u)
983Section 381.986(8)(f)10., F.S.
986$500
987$1,000
989(v)
990Section 381.986(8)(g)1., F.S.
993$500
994$1,000
996(w)
997Section 381.986(8)(g)1.g.(III), F.S.
1000$500
1001$1,000
1003(x)
1004Section 381.986(8)(g)2., F.S.
1007$500
1008$1,000
1010(y)
1011Section 381.986(8)(g)3., F.S.
1014$500
1015$1,000
1017(z)
1018Section 381.986(8)(g)4., F.S.
1021$500
1022$1,000
1024(aa)
1025Section 381.986(8)(g)5., F.S.
1028$500
1029$1,000
1031(bb)
1032Section 381.986(8)(g)6., F.S.
1035$500
1036$1,000
1038(cc)
1039Engaging in advertising that is visible to members of the public from any street, sidewalk, park, or other public place in violation of Section 381.986(8)(h), F.S.
1065Section 381.986(8)(h), F.S.
1068$500
1069$1,000
1071(dd)
1072Engaging in advertising online and marketing advertising in violation of Section 381.986(8)(h)2., F.S.
1085Section 381.986(8)(h), F.S.
1088$500
1089$1,000
1091(ee)
1092Section 381.986(8)(i), F.S.
1095$500
1096$1,000
1098(ff)
1099Section 381.986(10)(f)8., F.S.
1102$500
1103$1,000
1105(gg)
1106Section 381.986(10)(f)12., F.S.
1109$500
1110$1,000
1112(hh)
1113Section 381.986(8)(e)6.b., F.S. and Section 381.986(8)(e)11.a., F.S.
1120$1,000
1122$2,000
1124(ii)
1125Production and distribution of single serving portion of an edible that exceeds 10 milligrams of tetrahydrocannabinol.
1141Section 381.986(8)(e)8., F.S.
1144$1,000
1146$2,000
1148(jj)
1149Production and distribution of an edible with a potency variance greater than 15 percent.
1163Section 381.986(8)(e)8., F.S.
1166$1,000
1168$2,000
1170(kk)
1171Section 381.986(8)(e)9., F.S.
1174$1,000
1176$2,000
1178(ll)
1179Section 381.986(8)(e)11.c., F.S.
1182$1,000
1184$2,000
1186(mm)
1187Failure to test processed marijuana using a medical marijuana testing laboratory before it is dispensed.
1202Section 381.986(8)(e)11.d., F.S.
1205$1,000
1207$2,000
1209(nn)
1210Dispensing 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 Section 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.
1272Section 381.986(8)(e)11.d., F.S.
1275$1,000
1277$2,000
1279(oo)
1280Failure 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.
1323Section 381.986(8)(e)11.d., F.S.
1326$1,000
1328$2,000
1330(pp)
1331Use of a laboratory that has not been certified by the department under Section 381.988, F.S., when at least one laboratory holds the required certification.
1356Section 381.986(8)(e)11.d., F.S.
1359$1,000
1361$2,000
1363(qq)
1364Section 381.986(8)(e)11.e., F.S.
1367$1,000
1369$2,000
1371(rr)
1372Section 381.986(8)(e)11.f., F.S.
1375$1,000
1377$2,000
1379(ss)
1380Section 381.986(8)(e)12., F.S.
1383$1,000
1385$2,000
1387(tt)
1388Section 381.986(8)(e)13., F.S.
1391$1,000
1393$2,000
1395(uu)
1396Failure to seal each edible in plain, opaque wrapping marked only with the marijuana universal symbol.
1412Section 381.986(8)(e)15., F.S.
1415$1,000
1417$2,000
1419(vv)
1420Failure 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.
1455Section 381.986(8)(e)15., F.S.
1458$1,000
1460$2,000
1462(ww)
1463Failure 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.
1510Section 381.986(8)(e)15., F.S.
1513$1,000
1515$2,000
1517(xx)
1518Section 381.986(8)(e)16.b., F.S.
1521$1,000
1523$2,000
1525(yy)
1526Section 381.986(8)(e)16.d., F.S.
1529$1,000
1531$2,000
1533(zz)
1534Section 381.986(8)(e)16.e, F.S.
1537$1,000
1539$2,000
1541(aaa)
1542Failure 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.
1581Section 381.986(8)(f)3., F.S.
1584$1,000
1586$3,000
1588(bbb)
1589Section 381.986(8)(e)5., F.S.
1592$1,000
1594$3,000
1596(ccc)
1597Display of products in the waiting area of the premises where dispensing of marijuana occurs.
1612Section 381.986(8)(f)3., F.S.
1615$1,000
1617$3,000
1619(ddd)
1620Dispensing marijuana or marijuana delivery devices in the waiting area of the premises where dispensing of marijuana occurs.
1638Section 381.986(8)(f)3., F.S.
1641$1,000
1643$3,000
1645(eee)
1646Section 381.986(8)(e), F.S.
1649$2,500
1651$5,000
1653(fff)
1654Section 381.986(8)(e)16.f., F.S.
1657$2,500
1659$5,000
1661(ggg)
1662Section 381.986(8)(e)16.g., F.S.
1665$2,500
1667$5,000
1669(hhh)
1670Section 381.986(10)(f)3., F.S.
1673$5,000
1675$10,000
1677(iii)
1678Section 381.986(10)(f)5., F.S.
1681$5,000
1683$10,000
1685(jjj)
1686Section 381.986(10)(f)6., F.S.
1689$5,000
1691$10,000
1693(kkk)
1694Section 381.986(8)(c), F.S.
1697$5,000
1699$10,000
1701(lll)
1702Section 381.986(8)(e)2., F.S.
1705$5,000
1707$10,000
1709(mmm)
1710Section 381.986(8)(e)6.a., F.S.
1713$5,000
1715$10,000
1717(nnn)
1718Failure to recall edibles, including all edibles made from the same batch of marijuana, which: fail to meet the potency requirements of Section 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.
1761Section 381.986(8)(e)11.d., F.S.
1764$5,000
1766$10,000
1768(ooo)
1769Section 381.986(10)(f)7., F.S.
1772$5,000
1774$10,000
1776(ppp)
1777Section 381.986(10)(f)9., F.S.
1780$5,000
1782$10,000
1784(qqq)
1785Section 381.986(10)(f)10., F.S.
1788$5,000
1790$10,000
1792(rrr)
1793Section 381.986(10)(f)11., F.S.
1796$5,000
1798$10,000
1800(sss)
1801Section 381.986(10)(f)13., F.S.
1804$5,000
1806$10,000
1808(ttt)
1809Deviation, 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.
1844Section 381.986(8)(e), F.S.
1847$5,000
1849$10,000
1851(uuu)
1852Failing to maintain the performance bond required under Section 381.986(8)(b)7.a., F.S.
1863$5,000
1865$10,000
1867(vvv)
1868Failing to maintain, in lieu of a performance bond, an irrevocable letter of credit required under Section 381.986(8)(b)7.b., F.S.
1887$5,000
1889$10,000
1891(www)
1892Section 381.986(8)(e)11.b., F.S.
1895$5,000
1897$10,000
1899(xxx)
1900Section 381.986(8)(e)16.h., F.S.
1903$5,000
1905$10,000
1907(yyy)
1908Section 381.986(10)(f)4., F.S.
1911$5,000
1913$10,000
1915(zzz)
1916Section 381.986(10)(f)2., F.S.
1919$5000
1920$10,000
1922(aaaa)
1923A violation of any other provision of section 381.986, F.S., or department rule, not listed in this chart.
1941Section 381.986(10)(f)1., F.S.
1944$100
1945$10,000
1947Rulemakin1948g Authority 381.986(10)(h) FS. Law Implemented 381.986(10) 1955FS1956. History‒New 19586-10-20.