medical marijuana dispensary permit application · medical marijuana dispensary permit application...
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1UpdatedFebruary1,2017–SeeGuidance
Medical Marijuana Dispensary Permit Application
Youmayapplyforonedispensarypermitinthisapplicationforanyofthemedicalmarijuanaregionslistedbelow.Aseparateapplicationmustbesubmittedforeachprimarydispensarylocationsoughtbytheapplicant.PleaseseetheMedicalMarijuanaOrganizationPermitApplicationInstructionsforatableofthecountieswithineachmedicalmarijuanaregionandthecountiesinwhichyouareeligibletolocateyourprimarydispensary.
Pleasechecktoindicatethemedicalmarijuanaregion,andspecifythecounty,forwhichyouareapplyingforadispensarypermit:
☐ Northwest ☐ Northcentral ☐ Northeast☐ Southwest ☐ Southcentral ☐ Southeast
County1(PrimaryDispensaryLocation):MontgomeryCounty2(ifapplicable): County3(ifapplicable):
Department of Health Use Only
# Received
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FacilityName:BlackLabRx-ColmarAddress:252BethlehemPike,SuiteA1City:Colmar State:PA ZipCode:18915County:Montgomery Municipality:HatfieldTownshipPLEASEPROVIDEADESCRIPTIONOFTHEPUBLICACCESSTOTHEDISPENSARYLOCATION,INCLUDINGANYLOCALPUBLICTRANSPORTATIONTHATMAYBEAVAILABLE:
BlackLabBotanicals,LLCd/b/aBlackLabRxhasplannedadispensarylocatedat252BethlehemPikeinColmar,PA.Therearemultiplemethodsofapproachtothislocation,whicharedetailedbelow.Thisisaconvenientlocationforpatientstoaccessfromanyofthemajorsurroundinginterstates.BlackLab’smanagementteamcarefullychosealocation,takingintoconsiderationpatientsafetyandaccessibility.Thislocationalsoallowsforconvenientparkingforcustomerswhodriveoraredriventothedispensarybycaretakers.InterstateApproachesbyCarorPublicTransport:Ifyouareapproachingfromthesouth,ourfacilityislocatedabout25minutesdrivingtimeNorthofI-276onRT309.Ifyouareapproachingfromthewest,ourfacilityisabout20minutesdrivingtimebytakingPA-63EtowardsDerstineRdandBergeyRdtoPA-309SinHatfieldTownship.Ifyouareapproachingfromthenorth,wearedirectlysouthonPA-309S,approximately20minutesdrivingtimefromQuakertown,PA.ThisrunsparalleltoI476Saswellifyouarefurthernorth.TrainlinesandSEPTA:ColmarstationisaSEPTARegionalRailStationinColmar,Pennsylvania.LocatedatBethlehemPikeandWalnutStreet,itservestheLansdale/DoylestownLineTheColmarStationisashort12-minutewalktothesite.
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PARKINGThereisaparkinglostassociatedwiththebuildingandcanbeusedforpatientparking.
SecondDispensaryLocationFacilityName: Address: City: State:PA ZipCode: County: Municipality: PLEASEPROVIDEADESCRIPTIONOFTHEPUBLICACCESSTOTHEDISPENSARYLOCATION,INCLUDINGANYLOCALPUBLICTRANSPORTATIONTHATMAYBEAVAILABLE:
Pleaselimityourresponsetonomorethan5,000words.
ThirdDispensaryLocationFacilityName: Address: City: State:PA ZipCode: County: Municipality: PLEASEPROVIDEADESCRIPTIONOFTHEPUBLICACCESSTOTHEDISPENSARYLOCATION,INCLUDINGANYLOCALPUBLICTRANSPORTATIONTHATMAYBEAVAILABLE:
Pleaselimityourresponsetonomorethan5,000words.
Part B – Diversity Plan (Scoring Method: 100 Points) INACCORDANCEWITHSECTION615OFTHEACT(35P.S.§10231.615),ANAPPLICANTSHALLINCLUDEWITHITS
APPLICATIONADIVERSITYPLANTHATPROMOTESANDENSURESTHEINVOLVEMENTOFDIVERSEPARTICIPANTSANDDIVERSE
GROUPSINOWNERSHIP,MANAGEMENT,EMPLOYMENT,ANDCONTRACTINGOPPORTUNITIES.DIVERSEPARTICIPANTSINCLUDEAPERSON,INCLUDINGANATURALPERSON;INDIVIDUALSFROMDIVERSERACIAL,ETHNICANDCULTURALBACKGROUNDSANDCOMMUNITIES;WOMEN;VETERANS;INDIVIDUALSWITHDISABILITIES;CORPORATION;PARTNERSHIP;ASSOCIATION;TRUSTOROTHERENTITY;ORANYCOMBINATIONTHEREOF,WHOARESEEKINGAPERMITISSUEDBYTHE
DEPARTMENTOFHEALTHTOGROWANDPROCESSORDISPENSEMEDICALMARIJUANA.DIVERSEGROUPSINCLUDETHEFOLLOWINGBUSINESSESTHATHAVEBEENCERTIFIEDBYATHIRD-PARTYCERTIFYINGORGANIZATION:ADISADVANTAGEDBUSINESS,MINORITY-OWNEDBUSINESS,ANDWOMEN-OWNEDBUSINESSASTHOSETERMSAREDEFINEDIN74PA.C.S.§303(B);ANDASERVICE-DISABLEDVETERAN-OWNEDSMALLBUSINESSORVETERAN-OWNEDSMALLBUSINESSASTHOSE
TERMSAREDEFINEDIN51PA.C.S.§9601.
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Section 3 – Diversity Plan Bychecking“Yes,”theapplicantaffirmsthatithasadiversityplanthatestablishesagoalofopportunityandaccessinemploymentandcontractingbythemedicalmarijuanaorganization.Theapplicantalsoaffirmsthatitwillmakeagoodfaithefforttomeetthediversitygoalsoutlinedinthediversityplan.ChangestothediversityplanmustbeapprovedbytheDepartmentofHealthinwriting.
TheapplicantfurtheragreestoreportparticipationlevelandinvolvementofDiverseParticipantsandDiverseGroupsintheformandfrequencyrequiredbytheDepartment,andtoprovideanyotherinformationtheDepartmentdeemsappropriateregardingownership,management,employment,andcontractingopportunitiesbyDiverseParticipantsandDiverseGroups.
Yes No
DIVERSITYPLAN
INNARRATIVEFORMBELOW,DESCRIBEAPLANTHATESTABLISHESAGOALOFDIVERSITYINOWNERSHIP,MANAGEMENT,EMPLOYMENTANDCONTRACTINGTOENSURETHATDIVERSEPARTICIPANTSANDDIVERSEGROUPSAREACCORDEDEQUALITY
OFOPPORTUNITY.TOTHEEXTENTAVAILABLE,INCLUDETHEFOLLOWING:
1. ThediversitystatusofthePrincipals,Operators,FinancialBackers,andEmployeesoftheMedicalMarijuanaOrganization.
2. AnofficialaffirmativeactionplanfortheMedicalMarijuanaOrganization.3. InternaldiversitygoalsadoptedbytheMedicalMarijuanaOrganization.4. Aplanfordiversity-orientedoutreachoreventstheMedicalMarijuanaOrganizationwill
conductduringthetermofthepermit.5. Contractswithdiversegroupsandtheexpectedpercentageanddollaramountofrevenuesthat
willbepaidtothediversegroups.6. AnymaterialsfromtheMedicalMarijuanaOrganization’smentoring,training,orprofessional
developmentprogramsfordiversegroups.7. AnyotherinformationthatdemonstratestheMedicalMarijuanaOrganization’scommitmentto
diversitypractices.8. Aworkforceutilizationreportincludingthefollowinginformationforeachjobcategorywithin
theMedicalMarijuanaOrganization:a. Thetotalnumberofpersonsemployedineachjobcategory,b. Thetotalnumberofmenemployedineachjobcategory,c. Thetotalnumberofwomenemployedineachjobcategory,d. Thetotalnumberofveteransineachjobcategory,e. Thetotalnumberofservice-disabledveteransineachjobcategory,andf. Thetotalnumberofmembersofeachracialminorityemployedineachjobcategory.
9. Anarrativedescriptionofyourabilitytorecordandreportonthecomponentsofthediversityplan.
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BlackLabBotanicalsOfficialDiversity/AffirmativeActionPlanIntroduction
AlongwithPennsylvania’slegislativeandexecutiveleadership,BlackLabBotanicals(BLB)recognizesmedicalmarijuana’spotentialtoaddresshumandiseasestatesthroughthedevelopmentofpharmaceuticalproducts.BLBalsorecognizesthesocietalgoalsthatcanbeachievedbygoodcorporatecitizenscommittedtoengaging,developing,andsustainingaworkforceinclusiveoftheraciallyandethnicallydiversepopulationofsoutheasternPennsylvania.BLB’sfoundingmembersareconfidentintheirabilitytoworkwithexisting,federallyestablishedmethodologiestoestablishaneffectiveworkforcethatreflectsthepopulationcharacteristicsofitsoperatingarea.
InternalDiversityGoalinthePharmaceuticalContext
Inthecontextofcommitments(i)toproducingpharmaceuticalproductsinamannerconsistentwiththeproductionstandardsotherwiseapplicableinAmerica,and(ii)toprovidingapositiveworkingenvironmentwithindustry-leadingcompensation,medicalandotherbenefits,401(k),andinternaldevelopmentandexternaltrainingopportunities,BLBisalsocommittedtooperatingwithaworkforcethatmatchesthediversityofthepopulationofsoutheasternPennsylvania.Inthespiritofsimultaneouslyadvancingeachofthesegoals,BLBoffersitsDiversity/AffirmativeActionPlan.
Asamatterofbasicinformation,basedonU.S.Censusdata,BLBunderstandstheAfrican-Americanpopulationinitsareatoconstituteapproximately37percentofthetotalpopulation,theCaucasianpopulationapproximately56percent,andtheAsianpopulationapproximately7percent.TheHispanicpopulation,whichtheCensusdeclarescanbefoundamongtheotherraces,constitutesapproximately15percentofthetotalpopulation,andisincludedwithintheotherracialcategories.BLB’sofficialandinternaldiversitygoalistomatchitsworkforcetothesepopulationcharacteristics.
DiversityPlanMethodology
BLB’sworkforceengagement,development,andsustainabilityplanembracestheopportunitytocreateamedicalmarijuanaGrower/Processorcapableofdevelopingarawmaterialwhosepharmaceuticalactivityhasbeenunderdevelopedforatleast50years.OurplanbeginswithcommunityengagementthroughsoutheasternPennsylvania’snumerouscollegesanduniversities.BLBhasestablishedcontactwiththeplacementofficesandthesciencedepartmentsofseveraloftheseinstitutions,includingTemple,Drexel,andStJoseph’s,toidentifyemployeesandresearchpartners.
BLB’sDiversity/AffirmativeActionPlanreflectstheapproachofthefederalaffirmativeactionguidelinesdescribedin41CFR60,includingcommunityoutreachandrecordkeeping.BecauseBLBwillbeaverysmallorganizationduringitsstart-upphase,eachadditionalemployeewill,necessarily,haveasignificantimpactonitspercentageracialcomposition.
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5. KeepingBLB’sOperationsDirectorinformedofequalopportunityprogressandreportingpotentialproblemareaswithinthecompanythroughquarterlyreports;
6. ReviewingBLB’sEEO/AAPforqualifiedminoritiesandwomenwithallmanagersandsupervisorsatalllevelstoensurethatthepolicyisunderstoodandisfollowedinallpersonnelactivities;
7. Auditingthecontentsofthecompany’sbulletinboardtoensurecomplianceinformationispostedandup-to-date;and
8. ServingasliaisonbetweenBLBandregulatoryagencies.
ResponsibilitiesofManagersandSupervisors:
ItistheresponsibilityofallmanagerialandsupervisorystafftoimplementBLB’sAAP.Theseresponsibilitiesinclude,butarenotlimitedto:
1. Assistingintheidentificationofproblemareas,formulatingsolutions,andestablishingdepartmentalgoalsandobjectiveswhennecessary;
2. Reviewingthequalificationsofallapplicantsandemployeestoensurequalifiedindividualsaretreatedinanondiscriminatorymannerwhenhiring,promotion,transfer,andterminationactionsoccur;and
3. Reviewingthejobperformanceofeachemployeetoassesswhetherpersonnelactionsarejustifiedbasedontheemployee’sperformanceofhisorherduties
ExampleofCorrectiveandPreventiveActionReportIdentificationofProblemAreasAreasofConcern CorrectiveActions•Underutilizationofminoritiesandwomenin[jobclassification]whereexternal-hiringopportunitiesoccurred.Concernregardinglowminorityandfemaleapplicantflowrateresultingfrominadequaterecruitmentforbothjobgroups.
•Nolaterthan[datewithin90days],notifymanagementandprofessionalrecruitmentsources,inwriting,ofBLB’sinterestinattractingqualifiedminoritiesandwomentoapplyforjobopenings.•NolaterthanMarch1,2018,expandBLB’srecruitmentprogramtocollegesanduniversitieswithsignificantpercentagesofminorityandfemalestudents.
•Underutilizationofwomenin[jobclassification]entry-levelblue-collarjobs.Concernregardinglowfemaleapplicantflowrateresultingfrominadequaterecruitment.
•Nolaterthan[datewithin90days],contactthelocalYWCAandsimilarcommunityorganizations,localvocationalschool,andtrainingcenterstoinformthemofBLB’sinterestinattracting
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qualifiedfemaleapplicants.
•Highterminationrateforfemalesin[jobclassification].
•Immediatelyreviewexitinterviewsurveyofterminatedfemalestoconfirmvoluntaryreasonforleaving
BlackLabBotanicalsAction-OrientedPrograms
BLBhasinstitutedactionprogramstoeliminateidentifiedproblemareasandtohelpachievespecificaffirmativeactiongoals.Theseprogramsinclude:
1. Conductingannualanalysesofjobdescriptionstoensuretheyaccuratelyreflectjobfunctions;
2. Reviewingjobdescriptionsbydepartmentandjobtitleusingjobperformancecriteria;
3. Makingjobdescriptionsavailabletorecruitingsourcesandavailabletoallmembersofmanagementinvolvedintherecruiting,screening,selectionandpromotionprocesses;
4. Evaluatingthetotalselectionprocesstoensurefreedomfrombiasthrough:
a. Reviewingjobapplicationsandotherpre-employmentformstoensureinformationrequestedisjob-related;
b. Evaluatingselectionmethodsthatmayhaveadisparateimpacttoensurethattheyarejob-relatedandconsistentwithbusinessnecessity;
c. Trainingpersonnelandmanagementstaffonproperinterviewtechniques;and
d. TraininginEEOformanagementandsupervisorystaff;
5. Usingtechniquestoimproverecruitmentandincreasetheflowofminorityandfemaleapplicants.BLBcurrentlyundertakesthefollowingactions:
a. Includesthephrase"EqualOpportunity/AffirmativeActionEmployer"inallprintedemploymentadvertisements;
b. Placeshelpwantedadvertisement,whenappropriate,inlocalminoritynewsmediaandwomen'sinterestmedia;
c. Disseminatesinformationonjobopportunitiestoorganizationsrepresentingminorities,womenandemploymentdevelopmentagencieswhenjobopportunitiesoccur;
d. Encouragesallemployeestoreferqualifiedapplicants;
e. Activelyrecruitsatsecondaryschools,juniorcolleges,collegesanduniversitieswithsignificantminorityorfemaleenrollments;andrequestsemploymentagenciestoreferqualifiedminoritiesandwomen;
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6. Performingaself-auditofitscompensationpractices;and
7. Ensuringthatallemployeesaregivenequalopportunityforpromotion.Thisisachievedby:
a. Postingpromotionalopportunities;
b. Offeringcounselingtoassistemployeesinidentifyingpromotionalopportunities,trainingandeducationalprogramstoenhancepromotionsandopportunitiesforjobrotationortransfer;and
c. Evaluatingjobrequirementsforpromotion
InternalAuditandReportingSystem
TheFinanceandAdministrationManagerhastheresponsibilityfordevelopingandpreparingtheformaldocumentsoftheEEO/AAP.TheFinanceandAdministrationManagerisresponsiblefortheeffectiveimplementationoftheEEO/AAP;however,responsibilityislikewisevestedwitheachdepartmentmanagerandsupervisor.BLB’sauditandreportingsystemisdesignedto:
• MeasuretheeffectivenessoftheEEO/AAPprogram;
• Documentpersonnelactivities;
• Identifyproblemareaswhereremedialactionisneeded;and
• DeterminethedegreetowhichBLB’sEEO/AAPgoalsandobjectiveshavebeenobtained.
Thefollowingpersonnelactivitiesarereviewedtoensurenondiscriminationandequalemploymentopportunityforallindividualswithoutregardtotheirrace,color,sex,religion,ornationalorigin:
• Recruitment,advertising,andjobapplicationprocedures;
• Hiring,promotion,upgrading,awardoftenure,layoff,recallfromlayoff;
• Ratesofpayandanyotherformsofcompensationincludingfringebenefits;
• Jobassignments,jobclassifications,jobdescriptions,andsenioritylists;
• Sickleave,leavesorabsence,oranyotherleave;
• Training,apprenticeships,attendanceatprofessionalmeetingsandconferences;and
• Anyotherterm,condition,orprivilegeofemployment.
ThefollowingdocumentsaremaintainedasacomponentofBLB’sinternalauditprocess:
1. Anapplicantflowlogshowingthename,race,sex,dateofapplication,jobtitle,interviewstatusandtheactiontakenforallindividualsapplyingforjobopportunities;
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2. Summarydataofexternaljoboffersandhires,promotions,resignations,terminations,andlayoffsbyjobgroupandbysexandminoritygroupidentification;
3. Summarydataofapplicantflowbyidentifying,atleast,totalapplicants,totalminorityapplicants,andtotalfemaleapplicantsforeachposition;
4. Maintenanceofemploymentapplications(nottoexceedoneyear);and
5. RecordspertainingtoBLB’scompensationsystem.
BLB’sauditsystemincludesaquarterlyreportdocumentingBLB’seffortstoachieveitsEEO/AAPresponsibilities.ManagersandsupervisorsareaskedtoreportanycurrentorforeseeableEEO/AAPproblemareasandareaskedtooutlinetheirsuggestions/recommendationsforsolutions.Ifproblemareasarise,themanagerorsupervisoristoreportproblemareasimmediatelytotheFinanceandAdministrationManager.Duringquarterlyreporting,thefollowingoccurs:
1. TheFinanceandAdministrationManagerwilldiscussanyproblemsrelatingtosignificantrejectionratios,EEO/AAPcharges,etc.,withtheOperationsDirector;and
2. TheFinanceandAdministrationManagerwillreportthestatusoftheBLBsEEO/AAPgoalsandobjectivestotheOperationsDirector.TheFinanceandAdministrationManagerwillrecommendremedialactionsfortheeffectiveimplementationoftheEEO/AAP.
BlackLabBotanicalsEqualOpportunity/AffirmativeActionPlan
GuidelinesonDiscriminationBecauseofReligionorNationalOrigin
ItisthepolicyofBLBtotakeaffirmativeactiontoensurethatapplicantsareemployed,withoutregardtotheirrace,color,sex,religionornationalorigin.Suchactionincludes,butisnotlimitedtothefollowingemploymentpractices:hiring,promotion,demotion,transfer,recruitmentorrecruitmentadvertising,layoff,termination,ratesofpayorotherformsofcompensationandselectionfortraining.
Employmentpracticeshavebeenreviewedtodeterminewhetherfemalesandmales,andmembersofthevariousracial,religiousand/orethnicgroupsarereceivingfairconsiderationforjobopportunities.Attentionhasbeendirectedtowardexecutiveandmiddlemanagementlevels.
1. ThepolicyconcerningBLB’sobligationtoprovideequalemploymentopportunitywithoutregardtorace,color,sex,religionornationaloriginiscommunicatedtoallemployeesviaemployeehandbooks,policystatementandtheEqualOpportunity/AffirmativeActionProgram.
2. InternalprocedureshavebeendevelopedinthisprogramtoensurethatBLB’s
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7.
8.
B. PLEASEDESCRIBETHEEMPLOYEEQUALIFICATIONSOFEACHPRINCIPALANDEMPLOYEE.
1. Pleaserefertothedocucumenttitled:
2. BlackLabBotanicalsLLC_03202017_Dispensary_EMPLOYEEQUALIFICATIONS,DESCRIPTIONOFDUTIESANDTRAINING(CONTD.)
3.
4.
5.
6.
7.
8.
C. PLEASEDESCRIBETHESTEPSTHEAPPLICANTWILLTAKETOASSURETHATEACHPRINCIPALANDEMPLOYEEWILLMEETTHETWO-HOURTRAININGREQUIREMENTUNDERTHEACTANDREGULATIONS.
1. Pleaserefertothedocucumenttitled:
2. BlackLabBotanicalsLLC_03202017_Dispensary_EMPLOYEEQUALIFICATIONS,DESCRIPTIONOFDUTIESANDTRAINING(CONTD.)
3.
4.
5.
6.
7.
8.
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PLEASEPROVIDEANEXPLANATIONOFANYRESPONSESABOVETHATWEREANSWEREDASA“NO”ANDHOWYOUWILLMEET
THESEREQUIREMENTSBYTHETIMETHEDEPARTMENTDETERMINESYOUTOBEOPERATIONALUNDERTHEACTANDREGULATIONS:
N/A
B. PLEASEDESCRIBEYOURPLANSREGARDINGTHESTORAGEOFMEDICALMARIJUANAANDMEDICALMARIJUANA
PRODUCTSWITHINYOURFACILITY:
DOH REDACTED
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PLEASEPROVIDEANEXPLANATIONOFANYRESPONSESABOVETHATWEREANSWEREDASA“NO”ANDHOWYOUWILLMEET
THESEREQUIREMENTSBYTHETIMETHEDEPARTMENTDETERMINESYOUTOBEOPERATIONALUNDERTHEACTANDREGULATIONS:
N/A
C. PLEASEDESCRIBEYOURAPPROACHREGARDINGTHEIMPLEMENTATIONOFANINVENTORYMANAGEMENTPROCESS.THISAPPROACHMUSTALSOINCLUDEAPROCESSTHATPROVIDESFORTHERECALLOFMEDICALMARIJUANAPRODUCTS
ANDTHEMANAGEMENTOFMEDICALMARIJUANAPRODUCTRETURNSFROMYOUTOTHEORIGINATING
GROWER/PROCESSOR:
DOH REDACTED
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Section 16 – Sanitation and Safety
A. PLEASEPROVIDEASUMMARYOFTHEINTENDEDSANITATIONANDSAFETYMEASURESTOBEIMPLEMENTEDATEACH
PROPOSEDFACILITYLISTEDINTHEPERMITAPPLICATION.THESEMEASURESSHOULDCOVER,BUTARENOTBELIMITED
TO,THEFOLLOWING:AWRITTENPROCESSFORCONTAMINATIONPREVENTION,PESTPROTECTIONPROCEDURES,MEDICALMARIJUANAPRODUCTHANDLERRESTRICTIONS,ANDHAND-WASHINGFACILITIES.
Section16–SanitationandSafety
RegulatoryReferences
• §1161.34SanitationandSafety
• §27.153Restrictionsonfoodhandlers.
StandardOperatingProcedures
• SanitationPractices
• SafetyPractices
• EmployeeHandbook
• RightsandResponsibilitiesHandbookforPatients
ResponsiblePersonnel
• SecurityManager
• DispensaryManager
3rdPartyCertificationforPost-LicenseEngagement
• PatientFocusedCertification(non-profitbasedtraining,education,andcertification)
Overview
TheSecurityandDispensaryManagerareresponsiblefortheimplementationofpoliciesandprocedurestoprotectallpersonnelinalloperations.TheMedicalDirectorandSeniorBLBManagers(“SeniorManagement”)willprovideallBLBemployeeswithadequatesafetytrainingtocomplywithstandardoperations.SeniorManagementwillconsistentlyensurealldepartmentspecificsafetyprotocolsaredevelopedandmaintainedtoensureasafeworkingenvironment.PatientFocusedCertification(PFC)willbeutilizedforregulatoryinspectionpreparedness,andassessmentofallSOPs,policies,andprocedures
TheBLBDispensaryfacilitywillmaintainsanitaryconditionstoreducethepotentialforcontaminationoradulterationofthemedicalmarijuanaproductsstoredwithinthefacility.Thefollowingpoliciesand
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procedureswillapply:
• Wastewillbepropertyremovedandplacedintoexteriorreceptaclesforarefuseservicetopickup.
• Theconditionofthefacilitywillbekeptingoodrepair.Walls,floors,andceilingswillbecleanandingoodfunctioningorder.
• Practicestopreventpestswillbeestablishedthroughanintegratedpestmanagementsystem.Techniquestodeterandmanagethepresenceofpestswillbemaintainedinsideaswellasexternalareasofthebuilding.
• Allcleaningchemicalsorsanitizingagentswillbeclearlymarked/labeledandstoredoutofreachofunauthorizedpersons.
• Employeesindirectcontactwithmedicalmarijuanaproductsshalladheretofoodhandlingguidelinesasseenin§27.153.
• Signswillbepostedinstructingallemployeestowashhandsbeforereturningtowork
• Sufficienthandwashingstationswillbeprovidedtobothemployeesandpatients.
• Adequateandeasilyaccessiblelavatorieswillbeprovidedtoemployeeswhichwillbekeptinsanitaryconditionandgoodworkingorder.
• BLBDispensarywillcomplywithallstateandlocalbuildingcoderequirements.
EmployeeSanitation:
Employeesthatworkindirectcontactwithmedicalmarijuanaaresubjecttotherestrictionsoffoodhandlers(section27.153,relatingtorestrictionsoffoodhandlers).Employeesshallconformtosanitarypracticesasfollows:
• Maintainadequatepersonalhygiene.
• Washhandsthoroughlybeforestartingworkandanyothertimehandshavebecomesoiledorcontaminated,andalltimespriortodispensingmedicalmarijuanatoapatientorcaregiver.
• Anyworkerdiagnosedwith,orsuspectedofhavinganyofthefollowingdiseasesisprohibitedforhandlingmarijuanaproducts;Amebiasis,EnterohemorrhagicE.coli,Shigellosis,Typhoidfeverorparatyphoidfever, HepatitisA,viralhepatitis,orjaundiceofunspecifiedetiology,orPersistentdiarrhea
SAFETY
Incompliancewithfederallaw,allemployeesareentitledtoasafeworkplace.BLBwillprovideaworkplacefreeofknownhealthandsafetyhazards.Employeeswillbeinformedandhavetherighttospeakupaboutthemwithoutfearofretaliation.Employeeswillhave:
• AnnualOSHA-relatedtrainingfor;
A. PersonalProtectiveEquipment-TheOccupationalSafety&HealthAdministration(OSHA)requiresemployerstoevaluateallworkareastodeterminewhetherhazardsarepresent,orarelikelytobepresent,whichnecessitatetheuseofpersonalprotectiveequipment(PPE).TheJobSafetyAssessmentFormhasbeendesignedto
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aidintheselectionofappropriatePPEinworkareaswhereknownorpotentialhazardsexist.
§ BLBwillutilizeaJobSafetyAssessmenttoaidintheselectionofappropriatePPEinworkareaswhereknownorpotentialhazardsexist.
• Lockout/Tagout-AsrequiredbytheOSHAStandard29CFR1910.147,TheControlofHazardousEnergySources(Lockout/Tagout),thispolicycontainsthenecessaryelementsofanenergycontrolprogram,whichincludesdocumentedLockout/Tagoutprocedures,employeetraining,periodicinspectionsandthemeanstoenforcecompliance.
• Chemicalhazardsintheworkplace,asrequiredbytheOSHAHazardCommunicationStandard(29CFR1910.1200).
§ ItistheresponsibilityofthereceivingagenttoassurethatnochemicalsarereceivedintothebuildingwithoutaMaterialSafetyDataSheet/SafetyDataSheet(MSDS/SDS)onfile.
• FireEvacuation/EmergencyEvacuationPolicy
• BLBwillpostForm300logsincompliancewithOSHA’sFormsforRecordingWork-RelatedInjuriesandIllnesses
• Safetyprotocolsforjobhazardanalysismustincludeataminimum:
1. Employeeaccidentreportingandinvestigationpolicies,
2. Firepreventionandresponseplans,
3. Materialshandlingandhazardcommunicationspolicies,and
4. Personalprotectiveequipmentpolicies.
FirstAid
Theoperationwillbeequippedwitheasilyaccessiblefirstaidkits.Eachkitiseasilyaccessiblewithintheworkareas.EachkitischeckedmonthlybytheDirectorordesigneetoensurethatitisfullyequippedandthatallitemsintheboxarewithinthedateofexpiration.
WorkplaceIncidentReportingandInvestigation:BLBmaintainsrecordsofallaccidents,whetherminorormajor.AnIncidentReportFormisfilledoutforanincidenceoraccident,andsubmitedittotheappropriatedepartment.FormsarereviewedbytheDirectorandaction(ifany)willbetaken.IncidentReportingFormscanalsobeusedtoreportanyunsafepracticesobservedbyemployees.
MaterialStorage
Theoperationmayutilizesomechemicals(i.e.,cleaningagents)on-sitethatareconsideredhazardous.Toxiccleaningcompounds,sanitizingagentsandsolventsmustbelabeledandstoredinsuchawaythatpreventscontaminationofmedicalmarijuanaandinamannerthatcomplieswithapplicablelawsandregulations.Flammableliquids(i.e.,rubbingalcohol)arestoredinaflammablesolventcabinet.TheSafetyDataSheet(SDS)foreachchemicalisavailableelectronicallyinthedocumentmanagementsystemandshouldbereadandunderstoodbeforeusinganychemical.
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FireSafety
Employeesandvisitorswillrequiredtobefamiliarwiththelocationofallemergencyexits.Employeetrainingwillincludefamiliarizingthemwiththeoperationoffireextinguishers.
Employeesshouldlearnthepotentialfirehazardsintheirarea.FireextinguishersareratedasA,B,C,orD(orcombinationsthereof)foruseagainstthedifferentclassesoffires.Employeeswillbetrainedontheirrolesandresponsibilitiesduringafireandwillfamiliarizethemselveswiththeratingsoftheextinguisherslocatedinthevariousareassothattheymayknowwhattypesoffirescanbeextinguishedwiththem.Additionalfiresafetypoliciesinclude:
• Attempttofightsmallfiresonly,andonlyifthereisanescaperoutebehindyou.
• Extinguishersshouldbeinspectedmonthly.Itshouldbeensuredthat:
o Theextinguisherisnotblockedbyequipment,coats,orotherobjectsthatcouldinterferewithaccessinanemergency.
o Thepressureisattherecommendedlevel.
o Thenozzleorotherpartsarenotobstructed.
o Thepinandtamperseal(ifpresent)isintact.
o Therearenodents,leaks,rust,chemicaldepositsandothersignsofabuse/wear.Wipeoffanycorrosivechemicals,oil,gunk,etc.thatmayhavelandedontheextinguisher.
Fireextinguishersshouldbepressuretestedafter5yearstoensurethatthecylinderissafetouse.Iftheextinguisherisdamagedorneedsrecharginggetitreplacedimmediately.Iftheextinguisherisuseditshouldberechargedimmediately,regardlessofhowmuchwasused.
Evacuations:Intheeventthatthealarmissounded,followpostedevacuationroutesestablishedforeacharea.Donotuseelevators.Onceoutsidethebuildingmoveawayfromthedoortoallowotherstoexit,andheadthedesignatedarea.
Labeling&Packaging:Inadherenceto1161.28,Medicalmarijuanaproductsmustonlybeidentifiedbythenameofthegrower/processor,thenameofthedispensary,theformandspeciesofmedicalmarijuana,thepercentageofTHCandCBDcontainedinthemedicalmarijuanaproduct,andanyotherlabelingrequiredbytheDepartment.Theproductswillonlybedispensedtoapatientorcaregiverinasealedandproperlylabeledpackage.
BLBDirectorswillensurethatthelabelofthefinishedproduct:
• Containsawarningthatunauthorizeduseisunlawfulandwillsubjectthepurchaserorusertocriminalpenalties.
• Containsthefollowingwarningstating:Thisproductisformedicinaluseonly.Womenshouldnotconsumeduringpregnancyorwhilebreastfeedingexceptontheadviceofthepractitionerwhoissuedthecertificationand,inthecaseofbreastfeeding,theinfant'spediatrician.Thisproductmightimpairtheabilitytodriveoroperateheavymachinery.Keepoutofreachofchildren.
• Containsawarningthatthemedicalmarijuanamustbekeptintheoriginalcontainerinwhichitwasdispensed.
PennsylvaniaDepartmentofHealthMedicalMarijuanaDispensaryPermitApplication
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• Iseasilyreadable.
• Isconspicuouslyplacedonthepackage.
• Includesthename,addressandpermitnumberofthegrower/processor.
• Liststhetype,quantityoftheproductandtheamountofindividualdosescontainedwithinthepackageandthespeciesandpercentageofTHCandCBD,andotherapplicableingreidents.
• Includesthenameandaddressofthedispensary,anexpirationandpackingdate,properstorageinstructions,andanyotherinformationrequiredbytheDepartment.
InaccordanceistheCommonwealthofPennsylvania’sguidelines,thelabelshallnotbearanyresemblanceto:
• Atrademarked,characteristicorproduct-specializedpackagingofanycommerciallyavailablefoodorbeverageproduct.
• Anystatement,artworkordesignthatcouldreasonablyleadanindividualtobelievethatthepackagecontainsanythingotherthanmedicalmarijuana.
• Anyseal,flag,crest,coatofarmsorotherinsigniathatcouldreasonablymisleadanindividualtobelievethattheproducthasbeenendorsed,manufacturedorapprovedforusebyanystate,countyormunicipalityoranyagencythereof.
• Anycartoon,colorscheme,image,graphicorfeaturethatmightmakethepackageattractivetochildren.
EmergencyActionPlan
1) AfullydetailedEmergencyActionPlanwillbemaintainedbytheSecurityManagerinalocationvisibletoallemployees.
i) AllemployeeswillhaveyearlytrainingontheEmergencyActionPlan.ii) Theplanwillincludephonenumbersandcontactnamesforutilitycontacts(electricity,
water,gas,oil),securitycompanycontacts,localfireandpolice,aswellasacalllistofSeniorManagerstobenotifiedintheeventofanemergency.
Section 17 – Recordkeeping
A. PLEASEPROVIDEASUMMARYOFYOURRECORDKEEPINGPLANATEACHPROPOSEDFACILITYLISTEDINTHEPERMITAPPLICATION.THISPLANSHOULDCOVER,BUTISNOTLIMITEDTO,RECORDSOFINVENTORYANDALLDISPENSINGTRANSACTIONS:
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Section17–RecordKeepingRegulatoryReferences
• 21CFR111SubpartP§111.605and§111.610• §1161.39ElectronicTrackingSystem• 21CFR11ElectronicRecords:ElectronicSignatures
StandardOperatingProcedures• RecordRetention• GoodDocumentationPractices(ISO9000)
ResponsiblePersonnel• DispensaryManager• Pharmacists• PharmacyTechnicians• Receptionist• FinanceandAccountingPersonnel
RecordkeepingOverviewofPoliciesandproceduresTheoperationwill:
• Maintainrecordsofeachreceiptandtestingofmarijuanaproducts• Recordsincludethenameofthecultivation,processing,ormanufacturingoperationor
vendor• Recordsincludequantityandadescriptionofthemarijuanaproductofsufficientspecificity• Minimizedeliveriesattimesandinlocationswherecompliantindividualsarepresent• Theoperationwillinformallcultivation,processing,andmanufacturingoperationsandall
vendorsoftheestablishedpolicies• Allrecordsareavailableonrequesttotheregulatoryagencyandauthorizedindividualsin
compliancewithHIPPAandPersonalHealthInformationstandards.• Leadpharmacistmustauthorizereleaseofrecordstoany3rdparties
TheDispensaryManagerwillberesponsibleforsecurelymaintainingallrecords,logs,reports,inventories,andotherdocumentsinanauditableformatfornolessthanthreeyears.Electronicrecords:BlackLabBotanicalsshallmaintainallcompanyrecordsinanelectronicformat.Acloudbasedback-upsystemwillprovideasecondlocationforaduplicatecopyofallrecords.TheISO9000accrediteddocumentmanagementsystemistheprimarydatabaseforallinternalrecords.Recordsshallbemaintainedinthecompany’sinventorycontrolsystemandattachedtothebatchforwhichthereportwasissued.Recordswillbekeptasoriginalsandastruecopiesoraselectronicrecords.Allelectronicrecordswillcomplywithpart21CFR11ElectronicRecordsforelectronicsignaturesPaperrecords:Theoperationwillmaintainnotebooksandworksheets.Additionally,qualityassuranceemployeerecordsmaycontainpaperdocumentsincludingtrainingdocumentationforms.Allhumanresourcesrecordswillbemaintainedbyadministrativemanagementandsecurelystoredinaccordancewithallemploymentlaws.Allpaperrecordsrelatedtolaboratoryoperationsorpersonnelwillbescannedandmaintainedinthelaboratorymanagementsystem.Notebooksandlogswillbemaintainedinsecurefilingcabinetsaccessiblebyamanagerandanydesignees.Recordmaintenance:Inaccordancewithregulations,allelectroniccompanyrecordswillbe
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Section 19 Dispensary
BusinessHistoryandCapacitytoOperate
ThemembersofBlackLabBotanicalaresuccessfulprofessionalbusinessmenandwomenwithcombinedexperienceof100yearsinthemedical,construction,realestate,retail,andlegalindustries.AllarelifelongPennsylvaniaresidents.MembershaveseveralsuccessfulbusinessesalreadyinSoutheasternPAthatwillbearesourceofadministrative,accounting,andcompliancepersonnelforthisnewventure. ThecorecompetenciesofBlackLabBotanical’sprincipals,operators,andmanagementwillallowforsuccessful,compliant,andmutuallybeneficialoperationofafullyintegratedmedicalmarijuanaentity.Theexpertise,experience,andinvaluableinsightprovidedbyBLB’sorganizationwillallowforeasytransitionintotheindustry.Theoperators’skillsetswillbedetailedinaccordancewiththebusinessplan’sstartup,intermediate,andfulloperatingphases. Ateachstageofprogression,theBLBteamwillgrowinproportiontoitsbusinessneedsandeachteammemberbringsauniquesetofskills,guidance,andknowledge.BlackLabBotanicalsissubmittingapplicationstoreceiveapermittooperatetwomedicalcannabisdispensariesininRegion1.OurdispensarieswillretailhighqualitymedicinalcannabisproductsinfullcompliancewithallStateofPennsylvanialawsandregulationsassociatedwiththeCompassionateuseofthePAMedicalMarijuanaProgram.. Duringthestartupphaseofoperations,thefocusoftheorganizationwillbetobuildoutitsfacilities,installcertifiedequipment,andtrainacompetentstaffaboutthemarijuanaindustry.BLBisexcitedtoacceptandmastertheregulatorycompliancemandatedtorunapharmaceuticalcalibercompany.Theindirectexperienceandmanagementofheavilyregulatedindustrywillallowforeasytransitionintodirectingasuccessfuldispensary.Additionally,thesubstantiallevelofbusinessexpertiseandoutsiderelevantexperiencewillpositionBLBtodiligentlyfollowanddemonstratemasteryoftheexpectationsofregulatorystandardsestablishedbyboththestateandfederalregulations. ItisinternallyunderstoodbyourorganizationthatpatientsafetyandproductqualityisoftheutmostimportancetorunasuccessfuloperationinthePennsylvaniaMedicalMarijuanaProgram.Tomaintainthediligentstandardsandexpectationssetforthbythestate,BLBhasavarietyofindustries’expertisecontainedwithinuppermanagementtoshowadaptabilitytotheevolvingindustry.Wehavesurroundedourselveswiththebestintheindustry.
BlackLabBotanicalsWebsite:www.blacklabpa.com
BlackLabBotanicalsLLC_03202017_Dispensary_AttachmentH
FileContentSummary Page 1
BlackLabBotanicals,LLC–PA-100 Page 2-8
AnnmariePerlman,Principal Page 9
DavidH.Perlman,Principal Page 10
GeraldHamburg,Principal Page 11
MaryA.Magid,Principal Page 12
DavidS.Niggeman,Principal Page 13
BarryD.Gutin,Principal Page 14
LawrenceI.Cohen,Principal Page 15
GiacominaMassaro-Giordano,M.D.,Principal Page 16
PhilipA.Mandato,Jr.,M.D.,Principal Page 17
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